Metron QA-45, QA-40M User Manual

P R O - S o f t Q A - 4 0 M / 4 5

U s e r M a n u a l

D e f i b r i l l a t o r - / T r a n s c u t a n e o u s

P a c e m a k e r A n a l y z e r

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Copyright  1997 by METRON. All rights reserved.

METRON:

USA _ FRANCE NORWAY

1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1
Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, Norway
Phone: [phone] Phone: [phone] Phone: [phone]
Fax: [phone] Fax: [phone] Fax: [phone]
E-mail: [e-mail] E-mail: [e-mail] E-mail: [e-mail]

License

By using the enclosed program and/or installing the files from the original disks to your hard drive, you are
agreeing to become bound by the terms of this agreement. If you do not agree to the terms of this agreement, return
all materials in this package to METRON U.S. within 30 days for a refund.

You have purchased a software license granting you the right to use the software contained herein. METRON
U.S. retains ownership of this software on the original disks, as well as any subsequent copies on any media or in
any form. METRON U.S. does not sell any rights to the software. METRON U.S. grants you the right to use the
software on the amount of computers for which you have purchased a License. If you wish to use this software for
more computers than you have Licenses, you must purchase additional Licenses from METRON U.S.
Your License to the program contained in the software grants you, the purchaser, permission to use the pro­gram for the purpose to which it was designed. The program files, in whole or in part, and all copyright or other
intellectual and proprietary rights therein are and remain the property of METRON U.S..

THIS SOFTWARE IS LICENSED ONLY TO YOU, THE LICENSEE, AND MAY NOT BE TRANS­FERRED TO ANYONE WITHOUT THE WRITTEN CONSENT OF METRON U.S. Any authorized transferee
of the software shall be bound by the terms and conditions of this License. In no event may you transfer, assign,
rent, lease, sell, or otherwise dispose of the software on a temporary or permanent basis except as expressly pro­vided herein.

This License is governed by the State of Michigan and shall benefit METRON U.S., its successors, and as­signs. Licensee consents to jurisdiction in the state and federal courts located in the State of Michigan.

Limited Warranty/Disclaimer of Liability

METRON U.S. warrants that the software will substantially conform to published specifications and to the
documentation, provided that it is used on the computer hardware and with the operating system for which it was
designed. METRON U.S. will replace defective media or documentation, or correct substantial software errors at
no charge within 90 days of purchase. Contact METRON U.S. for information. If METRON U.S. is unable to cor­rect the problem, the License fee will be refunded to you. These are your sole remedies for any breach of war­ranty.

BECAUSE SOFTWARE IS INHERENTLY COMPLEX AND MAY NOT BE COMPLETELY
FREE OF ERRORS, YOU ARE ADVISED TO VERIFY YOUR WORK. In no event will METRON
U.S. be liable for direct, indirect, special, incidental, or consequential damages arising out of the use
of or inability to use the software or documentation, even if advised of the possibility of such dam­ages. METRON U.S. is not responsible for any costs, loss of profits, loss of data, or claims by third
parties due to use of, or inability to use the software.

Trademarks

IBM is a registered trademark, and PC/XT is a trademark of IBM Corporation. Microsoft is a registered trade­mark and Windows is a trademark of Microsoft Corporation.

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Table of Contents

MANUAL REVISION RECORD..........................................................................................................5

1. ABOUT PRO-SOFT QA-40M/45.......................................................................................................7

1.1 Introduction ..................................................................................................................................7

1.2 PRO-Soft QA-40M/45..................................................................................................................7

1.3 About your Manual.......................................................................................................................8

1.4 Updating PRO-Soft Program Files...............................................................................................8

2. GETTING STARTED..........................................................................................................................9

2.1 System Requirements....................................................................................................................9

2.2 Installing PRO-Soft .....................................................................................................................9

2.3 Initial Startup...............................................................................................................................10

2.4 Option Settings............................................................................................................................11

2.5 Printing Test Results...................................................................................................................14

3. TESTING SETUP...............................................................................................................................15

3.1 Equipment Setup.........................................................................................................................15

3.2 Power ..........................................................................................................................................15

3.3 Internal Paddles...........................................................................................................................16

3.4 Special Contacts..........................................................................................................................16

3.5 Initializing Remoting -Defibrillator Mode.................................................................................16

3.6 Initializing Remoting -Pacemaker Mode (QA-45 only)..........................................................17

4. MANUAL TESTING.........................................................................................................................18

4.1 Defibrillator Discharge (Energy) Test........................................................................................18

4.2 ECG Performance Test...............................................................................................................20

4.3 Shock Advisory Algorithm Test.................................................................................................22

4.4 Pacemaker Accuracy Test (QA-45 Only)...................................................................................23

4.5 Pacemaker Sensitivity Test (QA-45 Only).................................................................................24

4.6 Pacemaker Refractory Period Test (QA-45 Only) ....................................................................25

5. SEQUENCE TESTING.....................................................................................................................28

5.1 Sequence Form Window.............................................................................................................28

5.2 Defibrillator Test Sequence Setup..............................................................................................29

5.3 Pacemaker Test Sequence Setup................................................................................................30

5.4 Running a Sequence....................................................................................................................32

5.5 Sequence File Management........................................................................................................33

6. EMERGENCY SEQUENCE TRAINING.......................................................................................34

6.1 Sequence Setup...........................................................................................................................34

6.2 Running Emergency Sequences 1 - 7.........................................................................................35

6.3 Running Cardio Sequence...........................................................................................................36

7. SELECT CLOSE TO TERMINATE THE TEST AND RETURN TO THE MAIN SCREEN.

...................................................................................................................................................................36

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8. CHECKLISTS....................................................................................................................................37

8.1 Checklist Form Window.............................................................................................................37

8.2 Checklist Files Management ......................................................................................................37

9. PROTOCOLS.....................................................................................................................................39

9.1 Protocol Form Window...............................................................................................................39

9.2 Protocol Database........................................................................................................................41

9.3 Protocol File Management..........................................................................................................42

9.4 Importing Data ..........................................................................................................................43

10. TROUBLESHOOTING...................................................................................................................45

APPENDIX A: ERROR REPORT FORM, PRO-SOFT QA-40M/45...........................................47

APPENDIX B: SUGGESTION FORM, PRO-SOFT QA-40M/45.................................................49

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Manual Revision Record

This record page is for recording revisions to your PRO-Soft QA-40M/45 User Manual that have
been published by METRON or its authorized representatives. We recommend that only the man­agement or facility representative authorized to process changes and revisions to publications:

• make the pen changes or insert the revised pages;

• ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as

superseded and placed in a superseded document file, and;

• enter the information below reflecting that the revisions have been entered.

Rev No Date Entered Reason Signature of Person Entering Change

0 - Initial Release

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This page intentionally left blank.

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1.1 Introduction

1. About PRO-Soft QA-40M/45

The QA-40M and QA-45 Analyzers are precision instruments for
testing defibrillators and, additionally with the QA-45, transcuta­neous pacemakers. They are designed to be used by trained techni­cians.

The defibrillator function of the QA-40M and QA-45 measures the
energy output, and ensures that the defibrillator complies with speci­fied requirements. QA-40M and QA-45 have built-in load resis­tances of 50 ohms, which roughly correspond to the impedance of
the human body. The defibrillator pads are placed on the analyzers’
contact plates. Thus, the defibrillator is connected through the load
resistance. When the defibrillator is discharged, the analyzers calcu­late and display the energy delivered.

In the pacer function the QA-45 tests all types of transthoracic pace­makers. The testing is menu driven, and simple to operate. QA-45
measures and displays a pulse’s amplitude, rate, energy and width. It
also conducts demand sensitivity tests, measuring and displaying re­fractory periods, and immunity tests, which determine the pacemak­er’s susceptibility to 50/60 Hz interference.

Testing with the QA-40M/45 is usually a matter of setting up the
preferred simulation parameters. Using PRO-Soft QA-40M/45 sim­plifies the process by providing an all Windows-based environment
through which simulation parameters are created by the user and
sent to the QA-40M/45 unit.

1.2 PRO-Soft QA-40M/45

PRO-Soft QA-40M/45 has two testing methods: manual or se­quence. The manual method allows you to set up test parameters
quickly, and run one of the following stand alone tests. There are no
restrictions on the parameters used.

Defibrillator Discharge Test ECG Performance Test

Shock Advisory Algorithm Test Pacemaker Accuracy Test

Pacemaker Sensitivity Test Pacemaker Refractory Period Test

Test results are entered on the screen during testing. At the conclu­sion of testing the user may print a report, store the tests and results
on disk, or both.

Combinations of tests can be created and stored as “sequences.”
PRO-Soft QA-40M/45 maintains a library of these sequences. In this
way the user can store and retrieve sequences that are appropriate
for the kind of equipment being tested. Sequences can then be used
independently, or can be attached to a checklist, written procedure,
and equipment data in the form of a test “protocol.” The equipment

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1.3 About your Manual

data can be entered manually into the protocol, or it may be re­trieved by PRO-Soft from the QA-MAP program, or other equip­ment files. Protocols with test results can be printed, or stored on
disk. Also, the results of testing can be sent to QA-MAP, or other
equipment maintenance management program, to close a work order
and update the defibrillator/transcutaneous pacemaker’s service his­tory.

An additional feature of PRO-Soft QA-40M/45 is its ability to make
QA-40/45 serve as a training aid device for medical staff personnel
who operate defibrillators in the course of their duties. Several ECG
waveform emergency sequences are incorporated into the program.
These sequences interact with incoming defibrillator pulses, simu­lating various patient cardiovascular conditions.

This manual is designed to assist you in the basic procedures for cre­ating test protocols with PRO-Soft QA-40M/45. It also covers all
features resident in the full PRO-Soft program. Familiarity with Mi­crosoft Windows and its features is assumed. If you are unfamiliar
with it, we recommend that you use your Microsoft Windows User’s
Guide along with this manual.

This manual contains the following standardized text formatting
conventions:

This Represents

Bold title case Menu items and control buttons that can be selected

to perform operations. The underline ( _ ) represents
the shortcut key. For example, “Select File, Save” in-
structs you to press ”Alt+F,” then press “Alt+S.“ The
comma (,) between selections indicates that both se­lections are to be made in sequence.

< braces > Text information specified and entered by the user.

CAPITALS File names and paths. For example, “QAMDAT.50”

The menu under discussion

1.4 Updating PRO-Soft

Program Files

When installing upgrades,
backup or copy the original
program files to ensure that
data you desire to retain is
not overwritten.

NOTE

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Occasionally, updated versions of PRO-Soft QA-40M/45 program
files are posted on METRON’s Web Site (http://www.metron­biomed. com). These can be downloaded through file transfer proce­dures. Registered users should contact their local METRON repre­sentative for more information regarding updating.

2.1 System Requirements

2. Getting Started

The following are the minimum requirements for installation:

• IBM PC/XT-compatible machine, 80486 SX 25 MHZ or

higher.

• A 3.5" floppy drive.

• An EGA, VGA, 8514, Hercules or compatible display (rec-

ommended: VGA).

• 8 MB of RAM.

• 1 MB of unoccupied hard disk space, plus 3 MB of free

space on the drive contained the WINDOWS:\SYSTEM di­rectory.

• Microsoft Windows version 3.11 or later version.

• Metron QA-40M/45.

• RS-232 cable (null modem/data transfer configured).

• Printer for reports. (MS-Windows compatible)

2.2 Installing PRO­Soft

1. Start Windows.

2. Insert PRO-Soft QA-40M/45 install disk # 1 into drive A
(or B).

3. Select Run from the File Menu in the Windows Program
Manager. (In Win 95, click the Start button and then se­lect Run.)

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If you are installing PRO­Soft QA-40M/45 for the
first time, we recommend
using the default drive,
directory, and program
group (C:\QA-40M/45)

4. Type <drive:\setup>. Then, click the OK button. If you
are installing PRO-Soft QA-40M/45 from a server or
shared directory, type the full path plus setup.

5. When setup starts, the following dialog box will appear.
Type in the desired drive and directory for PRO-Soft QA­40M/45, then click the Continue button.

6. After setup is completed, a program group will be cre­ated in the Windows Program Manager called "PRO-Soft
QA-40M/45," or another name you provided during in­stallation.

2.3 Initial Startup

7. Remove the last disk and store the install disks in a safe
place.

The first time that PRO-Soft QA-40M/45 is run, information has to
be entered, and the program configured for further use.

1. To start the program, double-click on the QA-40M/45
icon.

2. The following dialog box will appear. Enter the Estab-
lishment <license holder name>, and the Code <alphanu­meric license number> exactly as written on the license
agreement supplied:

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Be careful to enter the name
and code exactly as written
on the license agreement.

3. When you click the OK button the PRO-Soft QA-40M/45
main application window is displayed:

Protocol Checklist

2.4 Option Settings

Options

General Ctl+G
Reports Ctl+R

The Main Application Window contains menus as well as
an icon bar. This bar enables the user to advance quickly
to the following program operations through pressing the
appropriate icon:

Defibrillator
Discharge
Test

Pacemaker
Sensitivity
Test

ECG
Performance
Test

Emergency
Sequence
Test

I I I I I I

I I I I I I

Sequence Equipment

Information

Pacemaker
Accuracy
Test

Pacemaker
Refractory
Period Test

Shock
Advisory
Algorithm Test

To configure program parameters click the Option Menu. Two fur­ther selections appear: General, which sets program pathing param­eters, and Reports, which sets standardized report headers .

Help

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1. G eneral. When selected, the following dialog box appears:

In the topmost section of this box there are three tabs: PRO-
Soft, QA-40M/45, and QA-MAP. By clicking one of these
tabs, its corresponding card will be displayed, containing the
settings available for the item described on the tab.

After editing the option settings press OK to save changes, or
Cancel to discard them. When a <Path> text box is highlighted
the Browse button will also be available and, by pressing this
button, a file window will be displayed where you can select the
appropriate path.

a. P RO-Soft Tab. This tab provides basic identification of the

operator of the test equipment, as well as pathing directions
for the PRO-Soft program in order for it to function. The
configuration parameters and their descriptions are:

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Operator: The person executing the tests.

Load protocol
at startup:

Path in the
PRO-Soft files: Path to the QA-40M/45 database files.

Path to procedure
files:

This option, when checked, automati­cally advances the program and opens
to a blank protocol window at startup.

Default path to the files where the test
procedures are stored.

The operator, automatic loading, and pathing settings, once
made, become the default settings. To change the defaults,
enter new operator and pathing settings or, in the case of
automatic protocol loading, uncheck the box. Then, save by
pressing OK.

b. Q A-40M/45 Tab. This tab is used to enter the serial num-

ber of the QA-40M/45 utilized for testing, and to set the
communications port (COM1-4) to be utilized for initiating
the QA-40M/45 remote setting at start-up. Once entered,
these become the default settings. To change the defaults,

enter a new serial number or enter a new COM Port, and
save by pressing OK.

c. Q A-MAP Tab. Most QA-MAP interaction control settings

included in the PRO-Soft options may be changed during
the execution of the PRO-Soft QA-MAP Program1. How­ever, the following default settings are only available
through the PRO-Soft QA-40M/45 options menu:

Path: Path to the QA-MAP file QAMDAT.MDB.

List equipment codes
when retrieving data:

Retrieve from QA-MAP:

- Equipment data

- Sequence

- Procedure

Controls whether the equipment list window
or the equipment code text box window
opens in the retrieval operation.

Sets the defaults as to the types of informa­tion extracted from QA-MAP.

Once entered, these become the default settings. To change
them, enter new setting and save by pressing OK.

2. R eport. When selected, the following dialog box appears:

Report header title: The path and filename of the header to be

Report language: This text box is blank, as default is auto-

Margins in millimeters: Path to the QA-40M/45 database files.

Font name: Report default font.

Font size: Report default font size.

used on all reports.

matically English. If other languages are
desired, contact your METRON represen­tative for the appropriate files.

The heading layout of test reports can be customized by
editing the file ‘STANDARD.HDR’ in the PRO-Soft di­rectory with any text editor (e.g., MS Windows Notpad).
See Appendix A for further guidance.

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Available separately from your Metron Representative.

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2.5 Printing Test Results

1. Test results are printed by selecting the Print button on the test
result window.

If this is the first test result for a manual test session you will be
prompted to fill in a Equipment Information Form (see below).

Each time a test is run thereafter, the printed result is buffered.
A complete report will be sent to the printer when the test win­dow is closed.

2. After selecting Print (or after entering the Equipment Informa­tion Form and selecting OK) the following window appears.
This is for prepublication review, and is in a WYSIWYG for­mat.

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Window controls enable you to enlarge the results, and navigate
from one page to the next. When review is complete, press the
Print button.

3.1 Equipment Setup

3. Testing Setup

Communication between the PRO-Soft QA-40M/45 and the
QA-40M/45 is based upon an RS-232C interface, that is standard on
most modern personal computers. The operation is essentially a
“master-slave” configuration, whereby the computer operates the
QA-40M/45.

Attach an RS-232 (null modem/data transfer configured) cable to
the 9-pin D-sub outlet port located at the rear of the QA-45. Do not
attach the printer cable to the QA-45. See below.

Some RS-232C cables are
missing the connection be­tween the seventh and the
eighth wires in the cable.
The cable may still be
called NULL-modem, but it
will not work with the
QA-40M/45.

3.2 Power

Do not use mercury, air or
carbon-zinc batteries.

NOTE

NOTE

1. Main On/Off Switch. QA-45 should remain off for at
least 5 seconds before switching on again, in order to al­low the test circuits to discharge fully.

2. Low Battery Power. If battery power falls below 6.9

volts (± 0.3 volts), the display will show 'Change battery,

and reset system'. This means that the battery should ei­ther be replaced or the instrument should be connected to
a battery eliminator. The main switch has to be switched
off and then on again in order to use the instrument.

3. Changing Batteries. Open the compartments in the base
of the instrument, replace the old batteries with new ones,
and close the compartment covers. Use 9 volt alkaline
batteries (Duracell MN1604 or similar).

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NOTE

Remove the batteries and
disconnect the AC Adapter
if you do not intend to use
the QA-40M/45 for an ex­tended period of time.

3.3 Internal Paddles

3.4 Special Contacts

4. Battery Eliminator

METRON’s AC Adapter plug-in power supply trans­former allows you to use the QA-40M/45 anywhere a
standard electrical outlet is available. To attach the
adapter insert its small connector into the micro jack la­beled “Batt. Elim. 9V DC” on the right rear of the unit.
Plug the large connector into a standard electrical outlet.

To be able to test defibrillators with internal paddles, an internal
paddle adapter has to be used. These contacts have a banana plug
that is attached to the standard paddle contact, and which is pro­tected by a plastic insulation washer.

Certain defibrillators (automatic models and those with pacer op­tions) have special contacts that are fastened to the electrodes at­tached to the patient. Metron AS has special accessory adapters to
suit the majority of these defibrillators. They are more or less the
same as the internal pad adapter except that they have a special
adapter on the top, which matches the contact on the defibrillator.

Defibrillator paddle adapter (specify defibrillator type): (P/N 13410)

Pacemaker external load cable (specify type pacemaker type): (P/N 13415)

3.5 Initializing Remoting ­Defibrillator Mode

1. Before initiating remote control, ensure that the:

• RS-232C cable is securely connected to the communication

ports on the QA-40M/45 and your computer.

• Proper communications port has been assigned.

• ‘Mode’ Switch is in the ‘HIGH’ or ‘LOW’ position.

High For Normal adult testing

Low For low energy testing, where energy does not exceed 50

joules, and peak voltage does not exceed 1200 volts.

• Low or high level ECG connectors are connected to the ten

4 mm AHA color-coded safety terminals, or standard phone
jack, as appropriate.

2. With the QA-40M/45 switched ON, advance to the Second
Main Menu Bar by pressing more-2 (F5):

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