Alaris MedSystem III 286X User manual

Software User Manual

Field Maintenance Software Version 5.0

MedSystem III® Infusion Pump

Model 286X

Alaris® Products

June 2006

GENERAL CONTACT INFORMATION

Cardinal Health
Alaris® Products

10221 Wateridge Circle

San Diego, California 92121
http://www.cardinalhealth.com/alaris

Customer Advocacy

Clinical and technical feedback.

North America:
Phone: [phone], Ext. 7812
E-Mail: [e-mail]

Technical Support - North America

Maintenance, service information support, and troubleshooting.

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: [phone] Canada - Phone: [phone]

Table of Contents

INTRODUCTION

ABOUT FMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

WARNINGS AND CAUTIONS

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Warnings
Cautions

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SOFTWARE REVISION HIGHLIGHTS
ABBREVIATIONS/ACRONYMS
COMMANDS/DEFINITIONS
INSTRUMENT PROGRAMMING AND FMS FUNCTIONS

Instrument Programming

Calibration Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Event, Alarm, and Status Log Functions

Other FMS Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

INSTALLATION AND SETUP

SYSTEM REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Software

SOFTWARE INSTALLATION

Unpacking FMS Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Installing Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Cable Hookup
Uninstalling Software

Checking Installed Software Version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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STARTING FMS

GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Running FMS
Main Menu Options
Serial Port Setup
General Page Layout
On-line Help
Automatic Maintenance Mode Recognition

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FIELD MAINTENANCE SOFTWARE

CUSTOMIZING PARAMETERS: INSTRUMENT CONFIGURATION MODE . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Custom Instrument Configurations
Reset Faults (Selection 00)
Clear Instrument Logs (Selection 01)
Reset Rate, VR, and Time to Default Values (Selection 02)
Set Instrument Serial Number (Selection 03)
Set User Information Line (Selection 04)
Special Note Message / Enable / Set Date (Selection 05, 06, 07)
Clear Battery Installation Dates and Clear Battery Log (Selection 08, 09)

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Field Maintenance Software

Model 286X, v5.0

Software User Manual

Table of Contents i

FIELD MAINTENANCE SOFTWARE (CONTINUED)

CUSTOMIZING PARAMETERS: INSTRUMENT CONFIGURATION MODE (CONTINUED)

Reset Device Specific Parameters (Selection 10)
Enable/Disable ClrAir Softkey (Selection 11)
Change Rate Breakpoint for ClrAir Softkey (Selection 12)
Lock/Unlock Dose Rate Calculator (Selection 13)
Set Keep Vein Open Rate (Selection 14)

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Set Maximum Primary Rate (Selection 15). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Set Maximum Primary Volume Remaining (Selection 16)
Set Maximum Secondary Rate (Selection 17)
Set Maximum Secondary Volume Remaining (Selection 18)
Enable/Disable Audio Volume Ramping (Selection 19)
Set OFF Delay (Selection 20)

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Set Main Battery Installation Date (Selection 21)
Set Memory-Backup Battery Installation Date (Selection 22)

Set Fractional Scrolling Breakpoint (General Purpose II and Operating Room II only) 3
(Selection 23)

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Lock/Unlock Device Type Change (Selection 24)
Lock/Unlock IVPB (Selection 25)

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Enable/Disable ALL Settings for VR (Selection 26)

Set Air-in-Line Alarm Sensitivity (Selection 27) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Set Incremental Pressure (Selection 28)
Set Maximum Pressure (Selection 29)

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Lock/Unlock Dose Parameters (Selection 30)
Reset Configuration Data (Selection 31)

INSTRUMENT PROGRAMMING

Dose Calculator
Batch Programming

CALIBRATION

Calibration Options
Calibration Prerequisites
Starting Calibration
Full Calibration

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Cassette/Latch Sensor/OPSI Calibration
Patient-side Occlusion Calibration
Fluid-side Occlusion Calibration
Calibration Data Menu

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Full Calibration Information Menu
Exiting Calibration Menu

LOGS MENU

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Storing a Log to File
Displaying a Log
Printing a Log
Exiting Logs Menu

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EXITING FMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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ii Table of Contents

Field Maintenance Software

Model 286X, v5.0

Software User Manual

APPENDIX

PARAMETER VERIFICATION PROCEDURES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Verification Procedure A
Verification Procedure B
Verification Procedure C
Verification Procedure D

SERVICE INFORMATION

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Software Return

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TRADEMARKS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

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Field Maintenance Software

Model 286X, v5.0

Software User Manual

Table of Contents iii

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iv Table of Contents

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Introduction

Product Notification:

• Documentation provided with this product may reference product(s) not present in
your facility or not yet available for sale in your area.

• Field Maintenance Software (FMS) User Manual is designed to assist Biomedical
personnel in customizing the MedSystem III

®

infusion pump (instrument) to meet

special needs of their institutions.

• Main text discusses different features of FMS and how to initiate them. Appendices
provide additional information for instrument Configuration, Calibration, and Log
Menu pages.

• All KEY NAMES are written in regular type as they appear on instrument or computer
keyboard. All SCREEN MESSAGES are as they appear on screen, except they are
in italic type, and Menu Titles are in regular type with only first letters capitalized.

• For more information on other MedSystem III

®

infusion pump features, refer to

instrument Directions for Use (DFU).

About FMS

This software is provided under and subject to a license from Cardinal Health.

Presented herein is a detailed description of FMS, a program that runs on a personal
computer (PC) running Windows 2000 or Windows XP. This program assists
organizations in servicing and customizing configuration of instrument. This manual is to
be used only with instrument software versions 4.0 or higher.

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Introduction 1

Warnings and Cautions

WARNING

A

is an alert to a potential hazard which could result in serious personal

injury and/or product damage if proper procedures are not followed.

CAUTION

A

is an alert to a potential hazard which could result in minor personal

injury and/or product damage if proper procedures are not followed.

WARNINGS

• At no time should FMS be used to configure instrument while it is connected to a
patient.

• Ensure instrument is in operational status before returning it to patient use.

• FMS version 5.0 is not compatible with instrument software versions 3.0 and 3.5

CAUTIONS

Hospital policies and procedures should be consulted when determining appropriate
air-in-line thresholds. As a general guideline, set lowest thresholds appropriate when
patient susceptibility to infused air is an important consideration.

2 Introduction

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Software Revision Highlights

Below are examples of differences between FMS Dos version 2.24 and FMS Windows
version 5.0. User interface changes have also occurred due to differences in systems.

DOS Windows

If more than one configuration function is
executed, FMS prompts user to save a
configuration file. If only one function is
executed FMS will NOT prompt user to
save a configuration file.

User can not change directory when
saving a file.

An option is selected either by using up or
down arrow keys on computer keyboard to
highlight desired option, or by typing fi rst
character of desired option (such as L to
select Logs Menu).

A selected option is executed by pressing
enter key.

No delay in establishing and ending
communications between instrument and
computer.

If one or more configuration function is
exectued, FMS prompts user to save
configuration file.

User can choose which directory to save
fi le in.

An option is selected by clicking it with
mouse.

A selected option is executed by clicking
ok button on screen with mouse.

A slight delay in establishing and ending
communications between instrument
and computer due to a more robust
communication method.

Navigating menu items can only be
accomplished when establishing
communication with instrument.

2 COM port options available, COM1 and
COM2.

Reports are navigated using only up or
down arrows.

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Navigating menu items can be
accomplished with or without establishing
communication with instrument.

8 COM port options available, COM1
through COM8.

Reports are navigated using horizontal
and vertical scroll bars.

Introduction 3

Abbreviations / Acronyms

CIDLIP Cassette Indentifi cation/Latch in Place
ClrAir Clear Air
COM Communications
CP Controller Pressure
DRC Dose Rate Calculator
FMS Field Maintenance Software
GP General Purpose
GP2 General Purpose II
GPII General Purpose II
IBM International Business Machines
ID Identifi cation
KVO Keep Vein Open
LCD Liquid Crystal Display
NN Neonatal
NiCd Nickel Cadmium
OR Operating Room
OR2 Operating Room II
ORII Operating Room II
PC Personal Computer
PSOD Patient Side Occlusion Detection
vol Volume
VR Volume Remaining

4 Introduction

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Commands / Definitions

With FMS, user can customize configuration of instrument from a menu of parameters.
User highlights a selected Configuration Command on Instrument Configuration
Command Menu, and then places instrument in Maintenance Mode by following
directions on screen.

This list of commands will be displayed as follows:
00 Reset Faults - Allows pump channel to be reset from Service to an operational

status.
01 Clear Log - Allows user to clear all entries in internal Event, Status, or Alarm Log.
02 Reset Rate, Volume Remaining, Time Remaining - Resets rate, VR, and time

remaining to factory default settings. This should be used in event of a Watchdog
(30,x) Range Error.

03 Set Instrument Serial Number - Allows user to enter instrument serial number
for display on User Information and Instrument Settings pages.

04 Set User Information Line - Allows an institution to enter their ID number, code,
or name for display on User Information page. Limited to 25 characters including
spaces.

05 Enable/Disable Special Notes - Allows user to enable/disable Special Note
page feature.

06 Set Date To Display Special Note - Allows user to set date for Special Notes page.
Page displays every time instrument is turned on.

07 Set Special Note Messages - Allows user to enter up to five lines of text, 27
characters per line including spaces on Special Notes page.

08 Clear Main Battery Date - Allows main battery installation date and Battery
Log to be cleared.

09 Clear Backup Battery Date - Allows only backup battery installation date to be
cleared.

10 Reset Device Specific Parameters - Automatically resets all device type specific
parameters in instrument to factory default values.

11 Enable/Disable ClrAir Softkey - Allows user to enable/disable ClrAir
softkey for a specific device type.

12 Change Rate Breakpoint for ClrAir - Allows user to set a specific device type and
specific Clear Air rate breakpoint, below which ClrAir softkey is not available.

13 Lock/Unlock Dose Rate Calculator - Allows user to lock out Dose Rate
Calculator feature.

14 Set KVO Rate for Device Type - Set Keep Vein Open (KVO) Rate for a specific
device type, which occurs following an Infusion Complete Advisory.

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Introduction 5

Commands / Definitions (Continued)

15 Set Maximum Rate for Device Type - Set maximum limit for Primary infusion rates
for a specific device type.

16 Set Maximum VR for Device Type - Set maximum limit for Primary VR for a
specific device type.

17 Set Max Secondary Rate for Device - Set maximum limit for Secondary infusion
rates for a specific device type.

18 Set Max Secondary VR for Device - Set maximum limit for Secondary VR for a
specific device type.

19 Enable/Disable Audio Ramping - Allows automatic ramping of alarm audio
volume to be enabled or disabled when alarms are ignored.

20 Set Instrument Off Delay (1, 3, 5, 10 seconds) - Allows user to set period of
time that OFF key must be pressed and held to turn off instrument.

21 Set Main Battery Install Date - Allows instrument’s memory to maintain date NiCd
battery pack was last changed.

22 Set Backup Battery Install Date - Allows instrument’s memory to maintain date
memory-backup battery was last changed.

23 Set Fractional Scrolling Breakpt - Allows user to set breakpoint at which
VR and Rate change from increments of tenths of a milliliter (0.1) to increments of 1
milliliter (1.0) (for General Purpose II and Operating Room II device types only).

24 Lock/Unlock Device Type Change - Allows instrument to be locked in current
device type.

25 Lock/Unlock IVPB - Allows all three channels to be locked in current channel
mode (such as, Basic, Dual Rate).

26 Enable/Disable ALL Setting for VR - Allows a channel to infuse until container is
empty, rather than infusing a set volume remaining (VR) (applicable for Operating
Room and Operating Room II device types only).

27 Set Air-in-Line Alarm Sensitivity - Set threshold at which an Air-in-Line alarm occurs
for a specific device type.

28 Set Pressure Increment - Set incremental pressure over baseline at which a
Patient-side Occlusion alarm occurs for a specific device type.

29 Set Maximum Pressure - Sets maximum pressure at which a Patient-side
Occlusion alarm occurs.

30 Lock/Unlock Dose Parameters - Allows user to access and change drug
concentration and dose rate units for all drugs.

31 Reset Instrument Configuration Data - Automatically resets non-device type specific
instrument configuration parameters to factory default settings, including rate, VR
and time.

6 Introduction

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Instrument Programming and FMS Functions

Instrument Programming

Programming Menu is available from Main Menu by highlighting Instrument
Programming. The following selections are displayed:

• Dose Rate Calculator - Allows user to select and program a Dose Rate Calculator

Drug Table confi guration to an instrument.

• Batch Programming - Allows user to execute a set of confi guration commands by

selecting a Batch Programming fi le, then reviewing and executing sequential
commands in fi le.

• Quit Programming - Returns user to Main Menu.

Calibration Functions

Calibration data can be stored, displayed, or printed by using appropriate FMS
commands.

Calibration operations provided by FMS:

• Full Calibration (all channels)

• Cassette/Latch Sensor Calibration (all channels)

• Patient-Side Occlusion Calibration (all channels)

• Fluid-Side Occlusion Calibration (all channels)

• Single Calibration Menu (single channel)

• Calibration Data Menu

• Full Calibration Information

• Quit Calibration

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Introduction 7

Instrument Programming and FMS Functions (Continued)

Event, Alarm, and Status Log Function

Logs Menu functions provided by FMS:

• Retrieves Event, Status, Alarm, or All Logs from instrument and stores it to a fi le

• Displays Event, Status, Alarm, or All Logs from either instrument or a fi le

• Prints Event, Status, Alarm, or All Logs from a fi le

Other FMS Functions

• Obtains on-line help information at any time by pressing F1 key

• Displays available commands when F3 key is pressed (under Instrument

Confi guration)

• Displays parameter ranges and units when F4 key is pressed (under Instrument

Confi guration)

• Selects desired communication port (COM1 through COM8)

• Recognizes critical errors and issues prompts to process them

• Recognizes disk full errors and prompts user accordingly. An empty disk can be

inserted and operation repeated

• Recognizes old instrument communications protocol (version 3.5 and earlier)

NOTE: During FMS operation, Control C input from keyboard is ignored.

8 Introduction

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Installation and Setup

System Requirements

FMS uses a PC serial communications (COM) port to communicate with an instrument.

Hardware

• IBM-PC or compatible with a minimum of 512K memory

• CD ROM Drive

• Serial port (COM1 through COM8)

• EGA, CGA, or VGA display

• 9- to 25-pin (female to male) adapter (as needed)

• Serial to USB adapter (as needed) (See note below)

• Printer (optional)

NOTE: If using a serial to USB adapter, because no serial port is available, Windows

will assign a COM port number. If assigned number is higher than 8, consult the adapter
documentation to reassign the port number.

Software

• Microsoft Windows 2000 or Windows XP Operating System. Use of one of these
operating systems is required to provide necessary support.

• Field Maintenance Software (FMS) version 5.0

Software Installation

Unpacking FMS Kit

FMS kit should contain following items:

• RS-232 cable with 7-pin connector (optional)

• Field Maintenance Software CD ROM

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Installation and Setup 9

Software Installation (Continued)

Installing Software

This CD contains the following:
Adobe Acrobat Reader 6.0.1
FMS Application Software
FMS Directions for Use

Accessing the Directions for Use*

The DFU can be opened directly from the CD or from within Adobe Acrobat Reader.

Access from the CD

1. On the CD locate the DFU PDF file in the FMS folder.

2. Double click on the file to open it.

3. If desired, save file to directory of choice.

Access from Adobe Acrobat Reader

1. Select [File] from the menu, then select [Open].

2. Navigate to the FMS folder on the CD using the [Open] dialog [Look in] option.

3. Select the DFU file, then [Open].

4. If desired, save file to directory of choice.

Accessing the FMS Application

The FMS application can be run from the CD. It is, however, recommended that the
application be run from the Hard Drive.

1. On the CD locate the FMS folder. The following files are in the folder:

• DRUGDEFT.SET

• FMS.EXE

• X40DA.RL

• X40DE.RL

• X40DS.RL

2. Copy the FMS folder to directory of choice on Hard Drive.

*If Adobe Acrobat 6.0.1 is needed, see text file in “Adobe Acrobat 6.0.1” folder.

NOTE: Icon associated with FMS.EXE will be displayed in directory where FMS is located,

in task bar when FMS is in use, and as the shortcut icon.

10 Installation and Setup

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Software Installation (Continued)

Cable Hookup

Connect special 7-pin connector on serial cable to COM port on side of instrument.
Connect 25-pin connector end to selected COM port of PC. If PC uses a 9-pin
connector, use a 9- to 25-pin (female to male) adapter.

Turn instrument on in Maintenance Mode by simultaneously pressing ON/OFF and
MORE OPTIONS keys. LCD should now read Maintenance and indicate current device
type. Instrument is now ready for FMS.

Uninstalling Software

CAUTION

Software uninstall program automatically and permanently deletes unsaved data.
To avoid this, save any unsaved data before uninstall procedure is performed.

1. Select Start  Settings  Control Panel.

• Control Panel window opens.

2. Double-click Add or Remove Programs.

3. Select FMS.

4. Click Remove.

5. Follow prompts to complete uninstall procedure.

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Installation and Setup 11

Software Installation (Continued)

Checking Installed Software Version

Select About Button from main menu.

• About box opens.

• To close about box press enter or click OK.

NOTE: 5.0 in illustrated display represents
current software version.

About FMS Software Version

12 Installation and Setup

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Starting FMS

General Information

Running FMS

To open FMS, select FMS shortcut on desktop.
OR
Select Start ► Programs ► Alaris Products ► FMS v5.0 ► Title Page opens.

Title page

Verify software, version appearing on Title Page is correct, press enter or click OK to
bring up FMS Main Menu functions. Serial port information will also be displayed on title
page.

NOTE: Date and time set on the computer are used by FMS when storing instrument Logs

and Calibration Data, so it is important that these values are correct.

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Starting FMS 13

Main Menu

Software Installation (Continued)

Main Menu Options

Verify date, time on Main Menu are correct. If date or time are incorrect, exit by
executing Quit Program option on FMS Main Menu. Then set correct date/time on
computer.

An option is selected either by using up and down arrow keys on computer keyboard to
highlight desired option, by typing fi rst character of desired option (such as, L to select
Logs Menu), double clicking on menu item or highlighting item and clicking OK.

To execute selected option, press Enter key. If there are two options having same fi rst
character, they will be alternately selected when key is pressed (such as, fi rst C will
select Confi guration command; second C will select Calibration menu).

For an overall program fl ow of FMS, refer to “Overall Program Flow of FMS” fi gure.

14 Starting FMS

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Software Installation (Continued)

Overall Program Flow of FMS

F1

Help

Context Sensitive

<ESC>

Execute FMS program

<ESC>

Q

<ESC>

F

L

Program

Quit FMS

FMS Setup

Configuration

<ESC>

Logs Menu

Exit to Windows

Menu

Event Log

E

1st A

Menu

Alarm Log

Menu

Status Log

S

All Logs

2nd A

Menu

Menu

Quit Log

Q

FMS Icon

Title Page

NOTE: and indicates commands

Main Menu

2nd C

<ESC>

I

<ESC>

1st C

<ESC>

<ESC>

Calibration Menu

<ESC>

Instrument

Programming

<ESC>

Instrument

Configuration

Full Calibration

1st F

DRC

D

Menu

Help

Commands

F3, F4

All Channels

P,

C,

Menu

Batch

Configuration

Pages

All Channels

Single Calibration

F

B

Menu

Programming

Quit Instrument

Single Calibration

S

Q

All Channels

Menu

Programming

Information

Full Calibration

3rd F

Data Menu

Calibration

2nd C

Menu

Quit Calibration

Q

Field Maintenance Software

Model 286X, v5.0

Software User Manual

Starting FMS 15