Metron QA-45 Service manual

QA-45

User & Service Manual

QA-45 Defibrillator and

Transutaneous Pacemaker Analyzer

P/N 13060

Copyright  2001 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]

Disclaimer

METRON provides this publication as is without warranty of any kind, either express or implied, in­cluding but not limited to the implied warranties of merchantability or fitness for any particular purpose.
Further, METRON reserves the right to revise this publication and to make changes from time to time to
the content hereof, without obligation to METRON or its local representatives to notify any person of
such revision or changes. Some jurisdictions do not allow disclaimers of expressed or implied warranties
in certain transactions; therefore, this statement may not apply to you.

Limited Warranty

METRON warrants that the QA-45 Defibrillator/Transcutaneous Pacemaker Analyzer will substan­tially conform to published specifications and to the documentation, provided that it is used for the pur­pose for which it was designed. METRON will, for a period of twelve (12) months from date of purchase,
replace or repair any defective system, if the fault is due to a manufacturing defect. In no event will
METRON or its local representatives be liable for direct, indirect, special, incidental, or consequential
damages arising out of the use of or inability to use the QA-45 Defibrillator/Transcutaneous Pacemaker
Analyzer, even if advised of the possibility of such damages. METRON or its local representatives are
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 QA-45 Defibrillator/Transcutaneous Pacemaker Analyzer. Neither METRON nor its lo­cal representatives will accept, nor be bound by any other form of guarantee concerning the QA-45 De­fibrillator/Transcutaneous Pacemaker Analyzer other than this guarantee. Some jurisdictions do not allow
disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not
apply to you.

ii

Table of Contents

1. Introduction........................................................................................................................................1

1.1 QA-45 Features ...........................................................................................................................1

1.2 Defibrillator Analyzer Specifications..........................................................................................2

1.3 Transcutaneous PPacemaker Analyzer Specifications.............................................................5

1.4 General Information......................................................................................................................6

2. Installation..........................................................................................................................................1

2.1 Receipt, Inspection and Return...................................................................................................1

2.2 Setup..............................................................................................................................................1

2.3 Power ............................................................................................................................................2

2.4 Internal Paddles.............................................................................................................................4

2.5 Special Contacts............................................................................................................................4

2.6 PRO-Soft QA-40M/45..................................................................................................................4

3. Operating QA-45................................................................................................................................1

3.1 Control Switches and Connections.............................................................................................1

3.2 QA-45 Menu and Function Keys.................................................................................................3

3.3 Menu and Messages: Defibrillator Mode....................................................................................4

3.4 Menu and Messages: Transcutaneous Pacemaker Mode.........................................................6

3.5 Test Result Printouts.....................................................................................................................8

4. Defibrillator Mode Testing...............................................................................................................1

4.1 Introduction..................................................................................................................................1

4.2 Test Preparation............................................................................................................................1

4.3 Energy Test ..................................................................................................................................3

4.4 Cardioversion Test........................................................................................................................4

4.5 Maximum Energy Charging Time Test.......................................................................................6

4.6 Shock Advisory Algorithm Test.................................................................................................7

5. Transcutaneous Pacemaker Mode Testing.....................................................................................1

5.1 Introduction..................................................................................................................................1

5.2 Testing Preparation ......................................................................................................................1

5.3 Demand Sensitivity Test..............................................................................................................3

5.4 Refractory Period Test..................................................................................................................5

6. Control and Calibration....................................................................................................................1

6.1 Required Test Equipment............................................................................................................1

6.2 Preparation....................................................................................................................................1

6.3 References.....................................................................................................................................1

6.4 Test................................................................................................................................................1

7. Component Functions and Parts......................................................................................................1

7.1 Theory of Operation .....................................................................................................................1

7.2 Processor Board.............................................................................................................................1

7.3 Sensor Board.................................................................................................................................3

7.4 ECG Signal Distribu- tion Board..................................................................................................4

7.5 Pacer Unit......................................................................................................................................5

7.6 Component Parts ..........................................................................................................................6

Appendix A – Diagrams ........................................................................................................................A-1

Appendix B – Error Report Form........................................................................................................B-1

Appendix C – Improvement Suggestion Form....................................................................................C-1

iii

Manual Revision Record

This record page is for recording revisions to your QA-45 User & Service Manual that have been
published by METRON AS 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 su-

perseded 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

2.60-1 4-30-01 General update

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1.1 QA-45 Features

1. Introduction

This chapter describes the Metron’s QA-45 Defibrillator /
Transcutaneous Pacemaker Analyzer features and specifications.

The QA-45 Analyzer is a precision instrument for testing defibrilla­tors and transcutaneous pacemakers, and is designed to be used by
trained service technicians.

The defibrillator function of the QA-45 measures the energy output,
and ensures that the defibrillator complies with specified require­ments. QA-45 has a built-in load resistance of 50 ohm, which
roughly corresponds to the impedance of the human body. The de­fibrillator pads are placed on the QA-45 contact plates. Thus, the de­fibrillator is connected through the load resistance. When the defib­rillator is discharged, QA-45 calculates and displays 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.

1

1.2 Defibrillator Analyzer Specifications

1. Energy Output Measurement

High Range

Voltage <5000 volts

Maximum current 120 amperes

Maximum energy 1000 Joules

Accuracy

Trigger level 100 volts

Playback amplitude 1 mV/1000 V Lead I

Test pulse 100 + 4 Joules

Low Range

Voltage <1000 volts

Maximum current 24 amperes

Maximum energy 50 Joules

± 2 % of reading for >100 Joules
± 2 Joule of reading for <100 Joules

Accuracy

Trigger level 20 volts

Playback amplitude 1 mV/200 V Lead I

Test pulse Approx. 4 Joules

Load Resistance

Display Resolution 0.1 Joules

Measurement Time
Window
Absolute Max. Peak
Voltage
Pulse Width 100 ms

Cardioversion

Oscilloscope Output

High measure range 1000:1 amplitude-attenuated

Low measure range 200:1 amplitude-attenuated

Waveform Storage And Playback

Discharge can be viewed via ECG outputs and paddles.

Output: 200:1 Time Base expansion.

Sync Time Measurements

Timing window Starts - 40 ms at each R-wave peak.

Test waveforms All waveform simulations available.

Delay time accuracy

Charge Time Measurement

From 0.1 seconds to 99.9 seconds.

± 2% of reading for >20 Joules
± 2 Joule of reading for <20 Joules

50 ohms ± 1%, non-inductive (<1 µH)

100 ms

6000 volts

Measured time delay ± 2 ms

± 1 ms

2

2. ECG Wave

ECG General

Lead configuration 12-lead simulation. RL, RA, LA, LL, V1-6

Output impedance Limb leads 1000 ohms to RL

V Leads 1000 ohms to RL

All other signals are in relative proportion to Lead amplitude as follows:
The amplitudes are shown for a Lead I amplitude by 1 mV:

Lead I 1.0 mV (LA - RA)

Lead II 1.5 mV (LL - RA)

Lead III 0.5 mV (LL - LA)

V Lead 1.5 mV (V - 1/3 (LL+LA+RA))

High Level Output (ECG Jack)

1/4" standard phone-jack with an amplitude of 1V/mV of low level Lead
II signal

Defibrillator Contact Plates

Same amplitude as Lead I low level ECG.

1 mV between contact surfaces.

Playback

200 to 1 time-base expansion of defibrillator pulse by playback to
ECG Leads

Manual ECG Performance Test

DC Pulse 4 seconds 1.0 mV

Square wave 2 Hz 1.0 mV p-p biphasic

Triangular wave 2 Hz 1.0 mV

Sine 0.1, 0.2, 0.5, 10, 40, 50, 60, and 100 Hz

Amplitude 0.5, 1.0, 1.5, 2.0 mV (Lead II)

Accuracy

± 5 % (Lead II 1.0 mV)

ECG Performance Test

Gain/Damping 2 Hz square wave

Frequency Response

Low Frequency 4 second DC pulse

Band Pass 10 Hz sine

Monitor -3dB point: 40 Hz sine

Power Line Notch
Filter
Linearity 2 Hz triangle wave

Normal Sinus

Rates 30, 60, 80, 120, 180, 240 and 300 BPM.

Accuracy

Amplitudes 0.5, 1.0, 1.5 and 2.0 mV (Lead II)

Accuracy

Automatic ECG Rate Test

Arrhythmia Selections

vfib Ventricular Fibrillation

afib Atrial Fibrillation

50 Hz sine

±1% of selection

±5 % (Lead II 1.0 mV)

3

blk II Second degree A-V block

RBBB Right Bundle Branch Block

PAC Premature Atrial Contraction

PVC_E Early PVC

PVC_STD PVC

PVCRonT R on T PVC

mfPVC Multifocal PVC

bigeminy Bigeminy

run5PVC Bigeminy Run of 5 PVCs

vtach Ventricular Tachycardia

Shock Advisory Test Algorithms

ASYS Asystole

SVTa_90 Supraventricular Tachycardia

PVT_140

PVT_ 160

MVT_140

MVT_160

CVF Course Ventricular Fibrillation

FVF Fine Ventricular Fibrillation

4

1.3 Transcutaneous PPace-

maker Analyzer Specifications

1. TEST LOAD RANGE

2. PULSE MEASUREMENTS

3. DEMAND SENSITIVITY TEST

50 to 2300 ohms in step of:

50 ohm up to 200 ohms

100 ohm from 200 up to 2300 ohms

Accuracy

Oscilloscope Output

50 - 150 ohm 10.24:1 amplitude attenuation

200 - 500 ohm 41:1 amplitude attenuation

600 - 2300 ohm 164:1 amplitude attenuation

Amplitude 4 to 300 mA (100 ohm load)

Accuracy

Max. Amplitude 300 mA all loads

Rate 30 to 800 ppm

Accuracy

Pulse width 0.6 to 80 ms

Accuracy

Waveforms Square(SQR), Triangle(TRI), and Havemine

ECG output Amplitude 0 - 4 mV

Pacer input (Load depended)

Amplitude (50 ohm) 0 10 mV

Resolution (50 ohm)

Amplitude: (≥500 ohm) 0 - 100 mV
Resolution: (≥500 ohm) 1 mV

Defib. Pads Amplitude 0 10 mV

Resolution 0.1 mV

Waveform width 10, 25, 40, 100 and 200 ms

Pacer rate 30 to 120 ppm

50 - 1300 ohm ±1%
1400 - 2300 ohm ±1.5 %

±5 % or ±0.5 mA

±1% or 2 ppm

±1% or ±0.3 ms

(SSQ)

Resolution 40 µV

40 µV

Immunity Test

50/60 Hz Interference Signal

ECG output 0 - 4 mV peak in steps of 0.4 mV

Pacer input (Load dependent)

0 - 10 mV peak in steps of 1 mV (50 ohm)

0 - 100 mV peak in steps of 10 mV (≥500

ohm)

Defibrillator pads 0 - 10 mV peak in steps of 1 mV

5

4. Refractory Period Measurement

20 to 500 ms (both Pacing and Sensing) Accuracy: ±2 ms

1.4 General Information

Temperature Requirements

+15°C to +35°C when operating
0°C to +50°C in storage

Display

Type LCD graphic display

Alphanumeric format 6 lines, 40 characters

Data Input/ Output (2) Parallel printer port (1); Bi-directional RS

Power

Mechanical Specifications

Housing High impact plastic case

Height 9.8 cm 3.9 in.

Width 24.8 cm 9.8 in.

Depth 28.0 cm 11.0 in.

Weight 2.06 kg (with battery) 4.5 lbs

Recommended Printer HP DeskJet 500C / 550C and Canon BJ

-232C (1) for Computer control

2 x 9 volt alkaline Battery Duracell
MN1604 (or equivalent) for 20 -25 opera­tional hours, or 240 VAC (Battery Elimina­tor), 115 VAC for US.

-10SX.



Standard Accessories

110 V or 220 V AC Adapter (P/N 17021)

Internal paddle-contact adapter (P/N 13403)

Ground contact adapter (P/N 13404)

Snap-to-banana adapters (10 pk) (P/N 17023)

User and Service Manual QA-45 (P/N 13060)

Additional Accessories

Defib. paddle adapter

(specify defibrillator type) (P/N 13410)

Pacemaker external load cable

(specify type pacemaker type} (P/N 13415)

Carrying case (P/N 13422)

Carrying case, ext. printer (P/N 10500)

PRO-Soft QA-40M/45 software (P/N 13600)

PRO-Soft QA-40M/45 DEMO (P/N 13601)

User Manual PRO-Soft QA-40M/45 (P/N 13605)

Storage

Store in the carrying case in dry surroundings within the temperature range
specified, without battery. There are no other storage requirements.

6

Periodic Inspection

The unit should be calibrated every 12 months.

7

2.1 Receipt, Inspec-

tion and Return

2. Installation

This chapter explains unpacking, receipt inspection and claims, and
the general procedures for QA-45 setup.

1. Inspect the outer box for damage.

2. Carefully unpack all items from the box and check to see that
you have the following items:

• QA-45 Defibrillator/Transcutaneous Pacemaker Analyzer

(PN 17020)

• 110 V or 220 V AC Adapter (P/N 17021)

• Internal paddle-contact adapter (P/N 13403)

• Ground contact adapter (P/N 13404)

• 10 pack, Snap-to-banana adapter (P/N 17023)

• QA-45 User and Service manual (P/N 13060)

3. If you note physical damage, or if the unit fails to function ac­cording to specification, inform the supplier immediately.
When METRON AS or the company’s representative, is in­formed, measures will be taken to either repair the unit or dis­patch a replacement. The customer will not have to wait for a
claim to be investigated by the supplier. The customer should
place a new purchase order to ensure delivery.

2.2 Setup

4. When returning an instrument to METRON AS, or the company
representative, fill out the address label, describe what is wrong
with the instrument, and provide the model and serial numbers.
If possible, use the original packaging material for return ship­ping. Otherwise, repack the unit using:

• a reinforced cardboard box, strong enough to carry the

weight of the unit.

• at least 5 cm of shock-absorbing material around the unit.

• nonabrasive dust-free material for the other parts.

Repack the unit in a manner to ensure that it cannot shift in the

box during shipment.

METRON’s product warranty is on page ii of this manual. The

warranty does not cover freight charges. C.O.D. will not be ac­cepted without authorization from METRON A.S or its repre­sentative.

1. Equipment connection is as shown in the typical setup below.

1

2. If PRO-Soft QA-40M/45 is being used, 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. However, if you are not using
PRO-Soft QA-40M/45, and are sending directly to a printer for
printouts, attach the printer cable to the 25-pin outlet port.

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-45. Refer to
the PRO-Soft QA-40M/45
Users Manual for more informa­tion.

NOTE

2.3 Power

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

2

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

NOTE

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).

3

4. Battery Eliminator

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

NOTE

2.4 Internal Paddles

2.5 Special Contacts

2.6 PRO-Soft QA-40M/45

METRON’s AC Adapter plug-in power supply transformer al-

lows you to use the QA-45 anywhere a standard electrical outlet
is available. To attach the AC Adapter insert the adapter’s small
connector into the micro jack labeled “Batt. Elim. 9V DC” on
the right rear of the unit. Plug the large connector into the near­est 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 adapters to suit the ma­jority of these defibrillators. These are available as accessories.
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)

PRO-Soft QA-40M/45 is a front-end test automation and presenta­tion tool for METRON's QA-40M/45 Defibrillator/Transcutaneous
Pacemaker Analyzer. It allows you to conduct the same tests, but
by remote control via an IBM-compatible PC/XT with MS Windows
(Version 3.1 or later). Additionally, the program has additional fea­tures to enhance your defibrillator and pacemaker maintenance.

Each of the QA-40M/45 tests can be run independently from PRO­Soft in the “Manual” test mode. Results are shown on the PC screen
during testing, and the user is prompted to set the tested equipment
accordingly. At the conclusion of tests, the user may print a report,
store the test and results on disk, or both. Combinations of tests can
be created and stored as “Test Sequences.” The program maintains a
library of these sequences. In this way you can store and retrieve se­quences that are appropriate for each kind of equipment being tested
at your facility.

PRO-Soft QA-40M/45 has its
own user manual, which con­tains all the information con­cerning the program. If you or­der a demonstration version of
the program you also receive
the manual.

NO TE

4

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 data can be entered manually into
the protocol, or it may be retrieved by PRO-Soft from database soft­ware or other equipment files. Protocols can be created easily for
each defibrillator or transcutaneous pacemaker in your inventory,
and stored for use. Test protocols with results can be printed, or

stored on disk, and the results of testing can be sent back to the
equipment database to close a work order and update the service his­tory.

5

3.1 Control Switches and Connections

Top Panel

3. Operating QA-45

This chapter explains the operating controls, switches and menus of
the QA-45, details how to use them in testing , and provides general
information on printouts and operator maintenance.

1. Power Switch Turns the power on and off.

2. Mode Switch Switches between PACE and Low / High ranges of defibrilla-

3 LCD Display Shows messages, test results and function menus.

4 Function Keys Fl - F5 are used to select the functions shown on the bottom

5. Contact Surfaces The defibrillator’s paddles are placed on these so that the

tor energy.

line of the LCD display, i.e., for selecting the function that is
directly above the key.

discharged energy passes through the instrument in defib.
mode and that the pacer signal passes through the instru­ment with a fixed 50 ohm load in the PACE mode.

1

6. Low Level ECG
Connectors

7. Pacer Input
Connectors

10 color-coded 4 mm safety terminals with snap-to-banana
adapters.

The pacer output cables are connected to these so that the
pacer signal passes through the instrument with a variable
load selectable from 50 to 2300 ohms.

2

Rear Panel

3.2 QA-45 Menu and Function Keys

8. High Level ECG Jack 1/4” standard phone-jack for amplitude of 1 V/mV of low

9. Oscilloscope Output BNC-contact for attenuated signal in real time.

10. RS-232 Serial Port 9-pin D-sub

11. Printer Outlet Port 14-25 pin D-sub

12. Location of Batteries 2 compartments in the base of the instrument can be

13. Battery Eliminator
Socket

level Lead 1 signal.

opened to replace the batteries.

Battery contact for connecting 9V 100 mA battery elimina­tor.

The QA-45 uses display and programmable function keys to provide
flexibility and control over the operations. The upper part of the
screen displays messages, status and results. The menu bar is at the
bottom of the display. The function keys are numbered from Fl to
F5.

A function is selected by pressing the key located directly under the
Menu Item displayed in the menu bar. A menu unit is written in cap­ital letters.

The menu comprises three pages. The next pages of the menu are
selected by pressing more-2, more-3 or more-1.

3

3.3 Menu and Messages: Defibrillator Mode

1. Startup Screen. The following screen will be displayed for 2
seconds after the QA-45 has been switched on.

2. Main Menu

a. Main Menu Bar (Page 1) - Mode switch in Low or High

position.

b. Second Menu Bar (Page 2)

c. Third Menu Bar (Page 3)

3. ECG WAVE (F1)

Choose desired wave by pressing UP (F2) or DOWN (F3). Save

this under ‘Wave” in the STATUS field by pressing SELECT
(F4). Press CANCEL (F5) to cancel selection.

4

4. ADV. ALG. (Advisory Algorithms) (F2).

These ECG algorithms are meant to test the analysis and prompt-

ing feature of automatic and semi-automatic defibrillators.
Choose desired selection by pressing UP (F2) or DOWN (F3).
Save this under ‘Wave” in the STATUS field by pressing
SELECT (F4). Press CANCEL (F5) to cancel selection.

5. CHARGE TIME (F3). Used to test the battery and charging
capacitor in the defibrillator. It changes the text ‘Delay’ to
‘Chrg T’ in the RESULT field in the main menu.

6. PRINT HEADER (F4). Automatically writes a heading for the
new test protocol.

7. WAVE AMPL. (Wave Amplitude) (F1).

Choose desired amplitude by pressing UP (F2) or DOWN (F3).

Save this under ‘Ampl” in the STATUS field by pressing
SELECT (F4). Press CANCEL (F5) to cancel selection.

8. PLAY PULSE (F2) enables playback of the last discharge.

9. PERF. WAVE (Performance ECG) (F3).

Choose desired wave by pressing UP (F2) or DOWN (F3). Save

this under ‘Wave” in the STATUS field by pressing SELECT
(F4). Press CANCEL (F5) to cancel selection.

10. SYSTEM TEST (F1) .

5

Note

QA-40M has an internally gener­ated test pulse. The control pulse
is set at 1.2 Joules in the Low
range and 28.5 Joules in the High
range. The test pulse is not a cali­bration pulse, and should not be
used as an indication of the gen­eral accuracy of the instrument.
The test pulse is a good control for
testing functions.

3.4 Menu and Messages:
Transcutaneous

Pacemaker Mode

Choose a test variant by pressing UP (F2) or DOWN (F3) or

TEST PULSE (F1). Press CANCEL (F5) to cancel selection.

For ‘ECG0’, ‘ECG+’ and ‘ECG-’ see Chapter 6, Control and
Calibration. For ‘A/D-read’, see paragraph 7.3.7, page 7-5.
Memory’ is for factory testing. Also, see paragraph 4.3.5, page
4-3.

11. REMOTE CONTR. (Remote Control) (F4) enables communi­cation with a PC with test automation software. Required soft­ware: PRO-Soft QA-40/45.

1. Startup Screen. The following screen will be displayed for 2
seconds after the QA-45 has been switched on.

2. Main Menu

a. Main Menu Bar (Page 1) - Mode switch in PACE position.

6

b. Second Menu Bar (Page 2)

3. SELECT LOAD (F1)

Choose desired PACER load by pressing UP (F2) or DOWN

(F3) and then SELECT (F4). Press CANCEL (F5) to cancel
selection.

4. SELECT NOISE (F2)

Choose desired noise for the immunity test by UP (F2) or

DOWN (F3) and then SELECT (F4). Press CANCEL (F5) to
cancel selection.

5. PRINT HEADER (F3). Automatically writes a heading for the
new test protocol.

6. PRINT RESULT (F3). Prints the results of measurements.

7. SELECT WAVE (F2)

7

3.5 Test Result Printouts

Choose desired waveform for the sensitivity test by pressing UP

(F2) or DOWN (F3) and then SELECT (F4). Press CANCEL
(F5) to cancel selection.

8. SENS. TEST (Sensitivity Test) (F2). Sensitivity is the QRS
minimum amplitude (mV) required to cause the pacemaker to
operate in the demand mode. This waveform is delayed from
the pacer pulse so that it is outside the pacing refractory period.
See ‘Sensitivity Measurements’ in Chapter 5.

9. REF. PER TEST (F3). Used to test time interval (ms) if the
pacemaker is insensitive to any external inputs, the maximum
time interval after the generation of a pacer pulse and maximum
time interval after a QRS wave. See ‘Pacing Refractory Period’
and ‘Sensing Refractory Period’ in Chapter 5.

10. REMOTE (Remote Control) (F4) enables communication with
a PC with test automation software. Required software: PRO­Soft QA-40/45.

1. Defibrillator Mode. QA-45 automatically prints out the test re­sults, via the printer output, after each discharge generated. Se­lect PRINT HEADER (F4) if you want to print out a page with
a new header.

2. Pace Mode. QA-45 prints out the test results, after the measure­ments, when you press PRINT RESULT (F4) in the Main
menu.

8

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9

4.1 Introduction

4. Defibrillator Mode Testing

This chapter describes QA-45 defibrillator mode testing.

The defibrillator function of the QA-45 measures the energy output,
and ensures that the defibrillator complies with specified require­ments. QA-45 has a built-in load resistance of 50 ohm, which
roughly corresponds to the impedance of the human body. The de­fibrillator pads are placed on the QA-45 contact plates. Thus, the de­fibrillator is connected through the load resistance. When the defib­rillator is discharged, QA-45 will calculate and display the energy
delivered.

Defibrillator energy is defined as an integral of the moment of the
discharged energy from the defibrillator. The energy is equal to the
square of the voltage, divided by the load resistance.

E =  p dt =  V2 / R dt =  V2 dt / R

QA-45 measures and records the voltage pulse every 100 µs, 1000

times, for a total time of 100 ms. The squares of the voltages are

then summed, multiplied by 100 µs, and divided by the load resis-

tance, 50 ohms.

1000 1000

4.2 Test Preparation

E =  (V2) • dt / R =  (V2) • 100 µs / 50 ohms

0 0

The unit for energy is 'joule', which is equal to Ws (Watt second).

1. If checking ECG monitoring, prompting, or triggering from the
ECG, connect the low level or high level ECG connectors to the
ten 4 mm AHA color-coded safety terminals or standard phone
jack, as appropriate.

2. Switch the QA-45 on. The following will be displayed in the
LCD display for about two seconds:

3. The following main menu will then appear. It will show LO­CAL, indicating that the testing is not remotely controlled by
PRO-Soft QA-40M/45 test automation software.

1

2

4.3 Energy Test

If the maximum voltage for a se­lected range is exceeded, the LCD
display will show ‘WARNING!
Overload’

APEX (+) pad → right plate
STERNUM pad → left plate

Note

1. Select a suitable energy range using the mode switch.

• Use the HIGH range for normal adult testing.

• Use the LOW range for low energy testing, where the en-

ergy does not exceed 50 Joule and the peak voltage does
not exceed 1200 volts.

2. Securely place the defibrillator paddles on the QA-45 contact
plates, and discharge the defibrillator. The APEX (+) pad
should be connected to the right-hand plate, and the STERNUM
pad to the left plate. This ensures correct signal polarity for the
oscilloscope output. A reversal of this configuration will not
damage the QA-45, nor will it give incorrect energy readings.
However, the polarity of the oscilloscope output will simply be
reversed. The discharge from the defibrillator is transferred to
the QA-45's load resistance.

3. QA-45 calculates the energy delivered over the load resistance
and displays the result in joules under RESULT. See below:

QA-45 also shows the energy measured, the maximum voltage

and the maximum current in the energy wave. Following the
discharge from the defibrillator, QA-45 shows a playback of the
wave from the ECG output. A new pulse can be generated when
the LCD display shows 'LOCAL'.

4. Following a discharge from the defibrillator, the instrument
shows a playback of the wave from the ECG output. The dis­play will thus be in playback mode. When this is shown in one
line, QA-45 automatically prints out the result.

5. The discharged pulse can be repeated. To do this press more-2
(F5) to advance to page 2 of the main menu.

Press PLAY PULSE (F2). The display will show 'Oper: Play-

back,' and displays the result in joules under RESULT.

3

4.4 Cardioversion Test

Following playback, the apparatus is ready to receive a new dis-

charge from the defibrillator. The display will show 'LOCAL'.

6. When testing automatic defibrillators, it is quite common to have
to select 'vfib' from the ECG menu 'ECG WAVE' for the 'ven­tricular fibrillation' wave. Automatic defibrillators typically do
not fire without seeing 'v-fib'.

1. Select ECG WAVE (F1) from the main menu.

2. The ECG Wave menu opens. QA-45 includes the following ECG
wave selection for cardioversion tests, or for the testing of elec­trocardiograph monitors.

Normal Sine Rates: 30, 60, 80, 120, 180, 240 and 300 BPM.
ECG Arrhythmia types as follows:

vfib Ventricular Fibrillation
afib Atrial Fibrillation
blk II Second degree A-V block
RBBB Right Bundle Branch Block
PAC Premature Atrial Contraction
PVC_E Early PVC
PVC_STD PVC
PVCRonT R on T PVC
mfPVC Multifocal PVC
bigeminy Bigeminy
run5PVC Bigeminy Run of 5 PVCs
vtach Ventricular Tachycardia

4

Select a desired wave by pressing UP (F2) or DOWN (F3).

Save this under ‘Wave” in the STATUS field by pressing SE-
LECT (F4). Press CANCEL (F5) to cancel selection.

3. QA-45 includes the following ECG wave amplitude options:

0.5 mV, 1.0 mV, 1.5 mV and 2.0 mV. To change wave ampli­tude select more-2 on the main menu. Select WAVE AMPL.
(F1).

5

The Wave Amplitude Menu appears:

APEX (+) pad → right plate
STERNUM pad → left plate

4.5 Maximum Energy Charging Time Test

Select the desired amplitude by pressing UP (F2) or DOWN

(F3). Save this under ‘Ampl” in the STATUS field by pressing
SELECT (F4). Press CANCEL (F5) to cancel selection.

4. Set the defibrillator to synchronized cardioversion mode. Dis­charge the defibrillator over the instrument's load resistance.

5. QA-45 measures the time delay in milliseconds (ms) between the
top of the 'R' wave and the discharging of the defibrillator
pulse. This delay will be shown in the LCD display as: 'Delay:
xxx ms'.

QA-45 also shows the energy measured, the maximum voltage

and the maximum current in the energy wave. Following the
discharge from the defibrillator, QA-45 shows a playback of the
wave from the ECG output. A new pulse can be generated when
the LCD display shows 'LOCAL'.

1. The charge time function is used to test the battery and the
charging capacitor in the defibrillator.

2. Set the defibrillator to maximum energy.

3. Securely place the defibrillator paddles on the QA-45 contact
plates, and discharge the defibrillator. The APEX (+) pad
should be connected to the right-hand plate, and the STERNUM
pad to the left plate. This ensures correct signal polarity for the
oscilloscope output. A reversal of this configuration will not
damage the QA-45, nor will it give incorrect energy readings.
However, the polarity of the oscilloscope output will simply be
reversed. The discharge from the defibrillator is transferred to
the QA-45's load resistance.

4. Select CHARGE TIME (F3) from the main menu and the
charge button on the defibrillator simultaneously.

6

4.6 Shock Advisory Algorithm Test

When the defibrillator is charged, discharge it through the instru-

ment.

5. Charging time will be shown in the display as ‘Chrg T: xx.x MS’
under RESULT.

1. This tests the analysis and prompting of automatic and semi-au­tomatic defibrillators. A series of arrhythmia is available for
analysis by the defibrillator that should then prompt the user to
‘shock’ of ‘no shock,’ in accordance with national and interna­tional guidelines, as shown below:

ASYS No shock
SVTa_90 No shock
PVT_140 No shock
MVT_140 No shock
CVF Shock
FVF Shock
PVT_160 Shock
MVT_160 Shock

2. Select ADV. ALG. (F2) from the main menu.

3. The Advisory Algorithms Menu opens.

7

Select the desired rhythm by pressing UP (F2) or DOWN (F3).

Save this under ‘Wave” in the STATUS field by pressing Se-
lect. Press CANCEL (F5) to cancel selection. The ECG signal
is output through the low-level ECG connectors, high-level
ECG connector, and paddle contact plates on the QA-45.

4. Set the defibrillator to analyze the ECG rhythm and operate in
the automatic and semi-automatic mode.

5. Records the defibrillator’s response.

8

5. Transcutaneous Pacemaker Mode Testing

5.1 Introduction

5.2 Testing Preparation

This chapter explains QA-45 transcutaneous, or pacer mode testing,

QA-45 tests all types of transthoracic pacemakers. The testing is
menu driven, and simple to operate. QA-45 measures and displays a
pacer 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.

1. Connect the pacer output cables to the pacer input connectors.

2. Switch the mode switch to ‘PACE’ mode.

3. Turn the QA-45 on. The following will be displayed in the LCD
display for about two seconds:

4. The following main menu will then appear:

5. Press SELECT LOAD (F1). The following load options will
appear:

The load range is 50 to 2300 ohms in steps of 50 ohms up to 200

ohms, and 100 ohms from 200 up to 2300 ohms

1

Select the desired noise form by pressing UP (F2) or DOWN

(F3) and then Select (F4). Press CANCEL (F5) to cancel the
selection. After selection the main menu will reappear.

2

6. Select the desired waveform by pressing UP (F2) or DOWN
(F3) and then SELECT (F4). Press CANCEL (F5) to cancel
the selection. After selection the main menu will reappear.

7. For Immunity Testing Only. The immunity test determines the
pacemaker’s susceptibility to 50/60 Hz interference signals. If
you desire to test immunity simultaneously with other testing,
press SELECT NOISE (F2). The following load options will
appear:

5.3 Demand Sensitivity Test

Select the desired noise form by pressing UP (F2) or DOWN

(F3) and then SELECT (F4). Press CANCEL (F5) to cancel

the selection. After selection the main menu will reappear.

1. General. Sensitivity is the minimum QRS amplitude (mV) re­quired to cause the pacemaker to operate in the demand mode.
During sensitivity measurement three different waveforms are
selectable with widths varying in steps from 10 to 200 ms. This
waveform is delayed from the pacer pulse so that it is outside
the pacing refractory period. QA-45 then checks whether this
wave is sensed or not by the pacemaker.

If it is not sensed, a message 'exceeded' is displayed which

means that the pacemaker needs an amplitude more than 100
mV for sensing at that setting. If the wave is sensed, QA-45
then reduces the amplitude in steps until it reaches the lowest
value required for the pacemaker to sense it. (The internal algo­rithm used converges to the lowest value in the least number of
cycles.) This lowest value is the sensitivity.

2. Procedure

a. From the main menu press more-2, then SELECT WAVE

(F1).

3

4

b. The following menu will be displayed:

c. Select the desired waveform by pressing UP (F2) or

DOWN (F3) and then Select (F4). Press CANCEL (F5) to
cancel the selection. After selection the main menu will
reappear.

d. Select SENS. TEST (F2). The following display will ap-

pear:

5.4 Refractory Period Test

e. Upon completion of testing the results will be displayed un-

der RESULT. Press SENS. TEST. CANCEL (F5) to can­cel the test.

1. General. This test is used to test the time interval in millisec­onds (ms) during which the pacemaker is insensitive to any ex­ternal inputs. QA-45 does this by measuring the maximum time
interval after the generation of a pacer pulse, and maximum
time interval after a QRS wave.

a. Refractory Period. A time interval in milliseconds, during

which a pacemaker is insensitive to any external inputs. If a
QRS is detected during this period, the pacemaker ignores
it. On the other hand, if a QRS is detected outside the re­fractory interval, then the pacemaker resets its internal

5

timer and the next pacer pulse is generated after a delay of
one time period from this QRS wave.

b. Paced Refractory Period. The maximum time interval af-

ter the generation of a pacer pulse during which time the
presence of a QRS wave is ignored.

The measurement of paced refractory period takes a few
cycles of the pacemaker output. First, QA-45 measures the
pacer-to-pacer interval T. Then, it puts out a square wave
40 milliseconds wide, delayed by delay time D, which is
more than the pacing refractory period, from the last pacer
pulse. The pacemaker senses this square wave. The delay
time D is gradually decremented in subsequent cycles until
the square waveform is not sensed by the pacemaker. The
maximum value of the delay time D, for which the pace
maker does not sense the square wave, is the paced refrac­tory period.

c. Sensed Refractory Period. The maximum time interval

after a QRS wave is sensed by the pacemaker during which
time the presence of a second QRS wave is ignored.

The sensed refractory period is measured in a similar man­ner, except that QA-45 now generates two square waves in­stead of one. The first square wave is generated at a fixed
time delay from a pacer pulse, which is greater than the
paced refractory period. The pacemaker always senses this
square wave.

The second square wave is generated at a delay D from the
first square wave. The initial value of D is selected to be
greater than the sensed refractory period. Therefore the first
time the pacemaker is on it also senses the second square
wave. In subsequent cycles, the delay 'D' is gradually re­duced until the pacemaker is unable to sense the second
square wave. The maximum value of D, for which the
pacemaker does not sense the second square wave, is the
sensed refractory period.

2. Procedure

a. From the main menu press more-2. Press REF. PER.

TEST (F3).

b. The following display will appear while testing:

6

c. Upon completion of testing the results will be displayed un-

der RESULT. Press REF. PER. CANCEL (F5) to cancel
the test.

7

This page intentionally left blank.

8

6.1 Required Test Equipment

6.2 Preparation

6. Control and Calibration

This chapter explains the QA-45 maintenance procedures, including
testing and calibration.

• Digital multimeter, 10 uV resolution, 0.1% accuracy.

• Frequency counter

• Oscilloscope

• Variable VIA power supply

• 10 V (+0.01 v) power source

• Pulse generator: square pulse, 10 ms width, 10V amplitude, 80

pulses per. minutes (for pacer module).

Set the switches on QA-45 to the following positions:

Mode: Low
Power: Off

Connect a power supply to the battery eliminator input on QA-45.

Adjust the power supply to 9V (±0.2v) with a power limitation of
200 mA (±50 mA).

6.3 References

6.4 Test

The function keys are numbered 1 to 5, with switch 1 farthest to left.

1. Set power to ON. Wait 3 seconds, and measure the current from

the power supply. Requirement: 68 mA (±5 mA).

2. Adjust P2 on the processor board to obtain the best possible con­trast on the display. The display should show the main menu
and the result with 0-data. Press function switch 5 and check
that QA-45 changes between various menus. Adjust P103 out of
limit.

3. Set power to OFF, and then back to ON after about 1 second.
The display should show the software version number for a
brief period, before showing the main active display. (By test
under production a additional item shall be used.)

4. Measure the operating voltages in QA-45 with the multimeter.
The following values are acceptable:

Test point

- +

Level Maximum

Deviation

1

TP8 - TP6 +8.8V
TP8 - TP4 -8.0V
TP8 - TP2 +2.5V
TP8 - TP5 -8V +2 -1V

TP8 - TP3 +5V

±0.2V
±0.3V
±0.075V

±0.1V

5. Connect the frequency counter to TP7 and read the frequency.

Requirement: 2 MHz (±0.002 MHz).

6. Slowly reduce the voltage from the power supply until the in­stant the display gives the message: 'Change battery, and reset
system'. Measure the operating voltage with the multimeter.

Requirement: 6.9V (±0.3v). Return the operating voltage to

9.0V. and reset QA-45 by switching off the power for a short
period.

7. Select 80 BPM in the ECG Wave Menu. Connect the oscillo­scope to TP1 for signal, and TP8 to ground. Check that QA-45
generates a 80 BPM signal with an amplitude of approximately
250 mV on the R pulse. Connect the oscilloscope to the High
Level ECG contact and check that the same signal is present,
only with an amplitude of approximately 1V on the R pulse.

8. Set power to OFF. Measure the resistance from the RL output to
the RA, LA and LL outputs.

Requirement: 1000 ohm (±30 ohm).

9. Measure the resistance from the RL output to the V2, V3, V4,
V5 and V6 outputs.

Requirement: 1000 ohm (±30 ohm).

10. Set power to ON and go into the SYSTEM TEST (F1) of the
page 3 menu and choose ECG + by moving the cursor and
pressing SELECT (F4). Measure and adjust the voltage be-

tween TP1 and TP8 to 0.490V ±1 mV. Choose ECG 0 from

menu. Measure the voltage between TP1 and TP8 and check
that it is between +20 mV and -10 mV.

11. Choose ECG + from the System Test Menu, measure the volt­ages between the ECG outputs, and check that they fall within
the limits shown in the following table:

Contact Power limit Nom. Value Upper limit

RL - RA 1.20 mV 1.35 mV 1.50 mV
RL - LA 2.40 mV 2.65 mV 2.90 mV
RL - LL 3.00 mV 3.35 mV 3.70 mV
RL - V1 2.70 mV 3.02 mV 3.30 mV
RL - V2 3.30 mV 3.72 mV 4.10 mV
RL -V3 4.00 mV 4.49 mV 5.00 mV
RL - V4 4.50 mV 5.06 mV 5.60 mV
RL- V5 4.00 mV 4.49 mV 5.00 mV
RL - V6 3.30 mV 3.72 mV 4.10 mV

12. Measure the voltage at the High ECG output.

Requirement: 2.0V (±0.05v).

2

13. Measure and check that the voltage between the defibrillator

pads is 2 mV ±50 µV. Choose ECG - by moving the cursor and

pressing SELECT (F4). Measure and check that the voltage be-

tween the defibrillator pads is -2 mV ±50 µV.

14. Set the power to Off, and wait 10 seconds. Measure and note
the exact value of the resistance between the defibrillator pads.

Requirement: 50 ohm (±0.5 ohm).

Set the power switch to ON while simultaneously holding down

function key 1, until the main menu appears. The main menu
will now be quickly replaced by the menu for calibrating resis­tance. Adjust two measurement values by pressing + and -. The
values will be stored in QA-45's EEPROM when SAVE &
QUIT is pressed.

15. Set the power switch to Off. Remove the covers at J106 and
J107. Measure the resistance between TP101 and TP102.

Requirement: 2 MOhm (±2 kOhm).

Repeat the measurement for TP103 and TP104.

16. Replace the covers at J106 and J107. Check that the Mode
switch is set to Low. Measure the resistance between TP102 and
TP105.

Requirement: 2 kOhm (±2 ohm).

Measure the resistance between TP108 and TP100.

Requirement: 2 kOhm (±2 ohm).

17. Set the Mode switch to High. Measure the resistance between
TP102 and TP106.

Requirement 10 kOhm (±10 ohm).

Measure the resistance between TP109 and TP100.

Requirement 10 kOhm (±10 ohm).

18. Measure the resistance between TP102 and TP113.

Requirement: 200 kOhm (±200 ohm).

Measure the resistance between TPl14 and TP100.

Requirement: 200 kOhm (±200 ohm).

3

19. Measure the resistance between TP102 and TP107.

Requirement 10 kOhm (±10 ohm).

Measure the resistance between TP104 and TP110.

Requirement 10 kOhm (±10 ohm).

20. Set power switch to ON. Connect a frequency counter to pin 3
on IC106 and measure the frequency.

Requirement: 1.9 MHz (±200 kHz).

21. Measure the voltage between TPl12 and TP100. Adjust P104

until the voltage is 5V (±0.0005v).

22. Go to the System Test Menu and choose A/D-read by moving
the cursor and pressing SELECT (F4). The input voltage at the
A/D converter should be displayed on the screen. The value is
updated once every second. Adjust P103 until the value is as
close to 0 as possible.

23. Connect a 10V (±0.01v) power source between TP107 and

TP110. Check that the Mode switch is set to High. Adjust P102
until the displayed value is 1997.5 mV and 2000 mV. Change
the polarity on the power source and re-measure the voltage.
Adjust P102 and P103 until the value displayed is between

1997.5 and 2000 mV regardless of the polarity status. Check

that the scope output is +2000 mV (±20 mV) or -2000 mV (±20

mV). Remove the power source and secure P102, P103 and
P104. Switch Off the power.

24. Connect a printer to the printer port. Switch on the power. heck
that the Mode switch is set to High. Go to the System Test
Menu and activate TEST PULSE (F1). Check that QA-45
gives a correct printout, that the energy measurement on the

display and printer is 125 Joules (±20 %), and that the measured

voltage is approx. 2500 V. Set the Mode switch to Low and ac­tivate TEST PULSE (F1). Check that the measured energy

value is approx. 5 Joules (±20 %), and that the measured volt-

age is approx. 500V.

25. Connect a PC to the serial port and try to control QA-45 re­motely. Check that communication functions in both directions.

26. Go to the System Test Menu and choose ECG +. (Last setting
for pacer should be default setting: 500 ohm). Measure the volt­ages In pacer module with the multimeter. The following values
are acceptable:

Test point

- +

TP1 - TP5 -2.378V
TP1 - TP6 +2.378V

Level Maximum

Deviation

±23 mV
±23 mV

4

27. Connect a 10V (±0.01v) power source to the pacer input. (Last

setting for pacer should be default setting: 500 ohm). Measure
the voltages on pacer module with the multimeter. The follow­ing values are acceptable:

Test point

- +

TP1 - TP2 +61.04 mV
TP1 - TP3 +244.1 mV
TP1 - TP4 +0.9766 V

Level Maximum

Deviation

±625 µV
±2.5 mV
±10 mV

28. Go out of the System Test Menu and choose pacer program
with the slide switch. Go to the SELECT LOAD (F1) and
choose 50 ohm. Connect a ohm meter to the pacer input and
measure the resistance for all load settings. The following val­ues are acceptable:

Nominal Min. value Max. value

50 ohm 49.5 ohm 50.5 ohm
100 ohm 99 ohm 101 ohm
150 ohm 148.5 ohm 151.5 ohm
200 ohm 198 ohm 202 ohm
300 ohm 297 ohm 303 ohm
400 ohm 396 ohm 404 ohm
500 ohm 495 ohm 505 ohm
600 ohm 594 ohm 606 ohm
700 ohm 693 ohm 707 ohm
800 ohm 792 ohm 808 ohm
900 ohm 892 ohm 909 ohm

1000 ohm 990 ohm 1010 ohm
1100 ohm 1089 ohm 1111 ohm
1200 ohm 1188 ohm 1212 ohm
1300 ohm 1287 ohm 1313 ohm
1400 ohm 1379 ohm 1421 ohm
1500 ohm 1478 ohm 1522 ohm
1600 ohm 1576 ohm 1624 ohm
1700 ohm 1675 ohm 1725 ohm
1800 ohm .1773 ohm 1827 ohm
1900 ohm 1872 ohm 1928 ohm
2000 ohm 1970 ohm 2030 ohm
2100 ohm 2069 ohm 2131 ohm
2200 ohm 2167 ohm 2233 ohm
2300 ohm 2266 ohm 2335 ohm

Open

(43.78 ohm)

43.649 ohm 43.911 ohm

29. Set the pacer load to 50 ohm. Connect a pulse generator to the
pacer input. Check that the measured values: (If the pulse gen­erator not handle 10V amplitude in 50 ohm, you must scale the
values).

Parameter Value Max. Deviation

Rate: 80 ppm
Width: 10 ms
Amplitude: 200 mA
Energy: 20.0 mJ

±0.5 ppm
±0.3 ms
±1.5 mA
±2.0 mJ

5

30. Set the pacer load to 500 ohm. Connect a pulse generator to the

pacer input. The following values are acceptable:

Parameter Value Max. Deviation

Rate: 80 ppm
Width: 10 ms
Amplitude: 20 mA
Energy: 2.0 mJ

±0.5 ppm
±0.3 ms
±1 mA
±0.5 mJ

31. Set the pacer load to 1000 ohm. Connect a pulse generator to
the pacer input. The following values are acceptable:

Parameter Value Max. Deviation

Rate: 80 ppm
Width: 10 ms
Amplitude: 10 mA
Energy: 1.0 mJ

±0.5 ppm
±0.3 ms
±1 mA
±0.5 mJ

The test is complete!

6

7.1 Theory of Operation

7. Component Functions and Parts

This chapter provides a detailed description of the functions of the
main components of the QA-45, as well as a parts list for cross-ref­erence.

The QA-45 is based on 4 circuit boards: a processor board, sensor
board, ECG signal distribution board and pacer module. The boards
are described in 12 circuit diagrams which are located in Appendix
A. Diagrams 1 through 4 describe the processor board; Diagrams 5
through 8 describe the sensor board; Diagrams 9 and 10 describe the
ECG distribution board, and Diagrams 11 and 12 describe the pacer
module.

The QA-45 Defibrillator/Transcutaneous Pacer Analyzer is a battery
powered unit, based on a microprocessor and analogue electronics
with precision data acquisition circuits. Using controls on the front
panel of the unit, one can analyze defibrillator and pacer pulses,
when these are discharged through built-in load resistors. The unit
can also generate a number of different ECG, test and stimulus sig­nals. The measurement results appear on an LCD display, and can
be output to a printer. A serial port (RS-232C) makes remote control
from a PC possible. All measurement and control signals are con­nected via contacts on the top and rear of the unit. To operate the
unit, there are 5 soft keys linked with menus on the LCD display.

7.2 Processor Board

(Refer to QA-45 Processor Board Component Location Diagram
and Schematic Diagrams 1-3)

1. Printer Output (Schematic Diagram 1). QA-45 has a printer
output with a standard 25-pin D-sub contact for Centronics in­terface. The output is based on 3 HCMOS circuits: IC9, IC10

and IC11. All the circuits are connected to I/O-ports on the mi­croprocessor. ICll is a latch for the 8 parallel data lines. IC9 is
the driver for outgoing control signals, while IC10 is a buffer
for incoming control signals. RP1 contains pull-up resistors for
the input lines. All connections to the printer contact are filtered
to reduce high frequency radiation.

2. Serial Port (Schematic Diagram 1). The serial port is suitable
for 9-pin RS-232C format. The QA-45 is configured as DTE
(data terminal equipment) and should be connected to, for ex­ample, a PC with a null-modem cable. IC6 is the driver for the
data signals. All handshakes take place via software. The con­trol signals are routed back to the contact.

3. Curve Generator (Schematic Diagram 1).

1

ECG curves are generated by the microprocessor based on data

tables. The processor updates the 8-bit D/A-converter in IC1
(channel A), usually 500 times per second. IC-3 converts cur­rent to voltage, and IC-2 makes the signal bipolar. The ampli­tude is adjusted using P1, and the zero point is adjusted using
P4. From pin 1 on IC2 (TP-1) the stimulus signal is led via ca­bles to resistive voltage dividers on the ECG signal distribution
card.

IC1 D/A-converter part B sets the reference level for the curve

generator D/A-converter part A. Part B thus determines the am­plitude of the stimulus signal. The DC value for maximum am­plitude is read back by the microprocessor's 10-bit A/D-input
El, and can therefore be adjusted precisely.

The other half of IC2 is used for operating the high-level output

for the ECG signal. The circuit has an amplification of 4 times.
The signal is filtered for high frequency noise with F18 before it
is conducted to contact J8. C3 ensures bandwidth limitation in
IC2. D9 is over voltage protection.

4. Power Supply (Schematic Diagram 2).

The unit is powered either from 2 internal 9V batteries or from

an external 9V DC power supply. The batteries are connected in
parallel via J6 and J10, while the external power supply can be
connected to J7. D1 protects against incorrect polarization. R16
is a PTC fuse that provides high impedance if too much power
is drawn. F19 provides high-frequency filtering and protects
against voltage transients from the power supply. The supply
voltage is conducted to the sensor board through the power
switch and back. F23 and F24 ensure reduction of high-fre­quency radiation from the power supply cables.

After the power switch SW108, the supply voltage is conducted

to the power supply circuits. The supply voltage is also used di­rectly as internal +9V. IC5 is a capacitive switch regulator that
regulates -9V from the +9V. These voltages will alternate, and
may vary from 7V to 12V.

IC4 is a series regulator that supplies the circuits with +5V. The

circuit has an output that resets the micro controller when the
+5V voltage falls below 4.75V. D6 and C13 provide the printer
output with its own +5V. D6 will block power inflow through
the printer cable when the QA-45 is switched off.

D7 and D8 rectify an AC signal from pin 2 IC-5, and build up a

voltage of -18V via C29. From this voltage, IC17 generates bias
voltage to the LCD display. The bias voltage is about -7V, and
is adjusted using P2 to set the contrast of the display.

5. Microprocessor (Schematic Diagram 3).

The microprocessor IC13 contains the CPU, RAM, A/D-con-

verter, parallel I/O and serial I/O. Y1 functions as a clock and

2

7.3 Sensor Board

time reference for the processor. The frequency on TP7 is the
crystal frequency/4 (2 MHz).

U9 is an EPROM that stores the processor's program. The circuit

can store 128 Kbytes of program data. IC16 is a RAM circuit
used for storage of measurement data. Together with the LCD
display, these circuits are connected directly to the micropro­cessor's bus. IC15 is a PAL that sends chip-select signals to the
EPROM, RAM and LCD display. The PAL circuit is in the
base, and can be replaced if the program is updated. IC7 is a se­rial EEPROM that stores calibration data. Data is transferred
via the processor's I/O ports.

The A/D converter in the processor is used to monitor the battery

voltage. The voltage is divided by R12 and R13, and fed into
the A/D converter via port E0. The Vref. voltage from IC12

(Diagram 1) is used as the reference for the A/D (VRH).

(Refer to QA-45 Sensor Board Component Location Diagram and
Schematic Diagrams 4-6)

1. Serial Interface (Schematic Diagram 4). Signal transfer be­tween the processor board and the sensor board is in digital se­ries form. IC108 is a serial-to-parallel converter that sends data
to the signal M UX ICl14. IC112 reads parallel data from the
switches used for operation. The data format is adapted to the
microprocessor's SPI interface, and clocked by the SCK clock
from the processor. The A/D converter IC104 (Diagram 3) has
its own serial interface connected to the SPI lines.

2. Switches For Operation (Schematic Diagram 4).

The front panel on the QA-45 has 5 push buttons and 2 sliding

controls for operation. The push buttons SW101 - SW105 are
soft keys to which different functions are assigned by the soft­ware. The switches are read from the processor via ICl12.

SW108 is an On/Off switch that breaks the battery voltage (see

Diagram 2). SW106 (Diagram 6) sets the input attenuation by
selecting different resistor values. The switch also has a digital
connection (HI_LO and PACED signal) so that the micropro­cessor can read the switch position.

3. Stimulus Output (Schematic Diagram 4). IClll amplifies the
stimulus signal from the processor board, and sends this differ­entially to the pads. R141 is connected to the range selector
SW106, which provides different amplification for pacer stimuli
and defibrillation stimuli.

4. Scope Output (Schematic Diagram 5). Scope output is fed with
a signal from IC114, which is an analogue MUX. The signal
can be selected digitally from 4 sources; the scope signal from
the input amplifier for the defibrillator pads, or 3 versions (lev-

3

els) of the input signal from the pacer module. IC110 buffers
the signal, which is fed to J109 via R129.

5. Internal Power Supply Sensor Board (Schematic Diagram 5).
IC107 regulates the -9 volt potential down to stable -5V for use
in the A/D converter system. Dl14 prevents incorrect polariza­tion and latch-up when the QA-45 is switched on and off. D108,
D109 and Dl10 provide over-voltage protection.

6. Measurement Input (Schematic Diagram 6).

R185 and R186 together make up a 50-ohm load resistance for

the discharges from the defibrillator being tested. The voltage
over the resistors is conducted via IC101 and IC102 into the A/

D converter IC104. This samples the voltage every 100 µs, and

the measurement values are transferred digitally to the micro­processor.

The measurement input is based on an attenuator that consists

primarily of a differentially connected operational amplifier
(IC101). Using SW109, the attenuation can be set as 10, 200 or
1000 times. The output signal from IC101 may fluctuate from
+5 to -5 Volt. With an input attenuation of 1000, the measure­ment range becomes +5000 to -5000 Volt (High Range). With
an input attenuation of 200, the measurement range becomes
+1000 to -1000 Volt (Low Range). With an input attenuation of
10, the measurement range becomes +50 to -50V (pacer mode).

IC102 is used as an addition amplifier. Here, the measurement

signal is added to an offset signal generated by the other half of
IC102, set using P103. A test signal can also be added in to test
the A/D converter function. P102 adjusts the input attenuation.

7.4 ECG Signal Distribu­tion Board

7. A/D Converter (Schematic Diagram 6). The A/D converter sys­tem consists of IC104, IC105 and, IC106. IC104 is the A/D con­verter itself, while IC105 is the voltage reference, and IC106 is
the clock generator.

The analogue signal is fed into the A/D converter on pin 7, and

the measurement result is read serially on pins 15 to 18. The A/
D has a differential input, and can function with 12- or 13-bit
resolution. IC106 is a square wave oscillator that generates the
clock signal to the analogue part of the A/D converter. The fre­quency of the signal is nominally 1.9 MHz, but may vary be­tween 1.7 and 2.1 MHz.

IC105 is the voltage reference for the A/D converter. P104 can

be used for precise adjustment of the voltage to exactly 5 Volt
(TPl12).

(Refer to QA-45 ECG Distribution Board Component Location Dia­gram and Schematic Diagram 7)

4

7.5 Pacer Unit

Here, the stimulus signal (ECG-signal) is fed through 10 attenuators
that set up the correct level for the outputs. The output impedance to
earth is 500 ohm for all outputs. Filters on the outputs ensure damp­ing of high-frequency components in the signal.

(Refer to QA-45 ECG Pacer Unit Component Location Diagram
and Schematic Diagram 8)

The pacer module consists of 3 blocks. These are the resistor group,
stimulus output and input amplifier.

1. Resistor Group. The value of the load resistance for the pacer
input is set using 6 relays, which are connected over a range of
resistors. The relays are controlled by U4, which in turn is con­trolled from the microprocessor via a serial interface. The relay
configuration is determined in the software, and the relays are
operated in such a way that the load resistance can be varied
from 50 to 2300 ohm, with 50/100 ohm resolution. The relays
are of the side stable (latching) type, and will therefore use no
power from the batteries except when they are operated. Before
the relays are set, they are all reset via pin 18 on U4.

2. Stimulus Output. The stimulus signal that is generated on the
processor board is fed to U1, which, together with U2, makes
up a programmable gain block. The signal is amplified with U3,
and fed differentially over the load resistance via R17 and R18.
As the load resistance may be varied, and R17 and R18 are con­stant, the amplitude out from U3 must be adapted to the load
setting. This is done using the gain block (U1 and u2), which is
controlled from the microprocessor via the same serial interface
as U4.

3. Input Amplifier. The input signal is measured over the load re­sistor with the differential amplifier U5. The measurement sig­nal is fed to the A/D converter's MUX from the output on U5.
U6 contains 2 amplifiers that each have a gain of 4 times (12
dB). The outputs from these amplifiers are also added to the A/
D converter MUX, so that one can choose between 3 different
dynamic measurement ranges. The measurement ranges are se­lected according to the load setting.

5

7.6 Component Parts

COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE

PROCESSOR BOARD

Processor board AR-095 1
Microprocessor MC68HC11G5FN 1 IC13
RAM LH5160HD-10L 1 IC16
EPROM 27C010-120 1 IC14
EEPROM X24C16P 1 IC7
PAL PAL. 22V10Z-25PC 1 IC15
D/A converter MX7528KN 1 IC1
Op.amp LM358P 1 IC17
Op.amp LT1013DN8 2 IC2, IC3
V-ref. LM-385Z-2V5 2 IC12, IC18
Timer LMC555CN 1 IC106
Port 74HC05N 1 IC9
Bus driver 74HC541N 1 IC10
Latch 74HC573N 1 ICll
Volt. Regulator LP2951CN 1 IC4
Volt. Converter LT1054CN8 1 IC5
IC base 20 pin DIL 1 IC1
IC base 20 pin SIL 1 IC14
IC base 24 pin 300mil 1 IC15
IC base 84 pin PLCC 1 IC13
LCD display DMF5005N 1
Diode 1N4148 2 D2,D5
Schottky diode 1N5819 2 D4, D6
Schottky diode BAT54 2 D7, D8
Zener diode 13V 1 D1
Transzorbdiode BZW06-6V4B 1 D3
Transzorbdiode BZW06-17B 3 D9 - Dll
Crystal 8 MHz 1 Y1
Resistor 1K0 1% 0.5W 1 R8
Resistor 2K2 1% 0.5W 1 R9
Resistor 3K3 1% 0.5W 1 R13
Resistor 10K 1% 0.5W 3 R6, R10, Rll
Resistor 18K 1% 0.5W 1 R19
Resistor 22K 1% 0.5W 1 R12
Resistor 30K 1% 0.5W 1 R7
Resistor 40K 1% 0.5W 1 R1
Resistor 47K 1% 0.5W 3 R5, R14, R18
Resistor 80K 1% 0.5W 2 R3, R4
Resistor 10M 1% 0.5W 1 R2
Resistor OR 1 L4
PTC resistor MF-R030 Boums 1 R16
Potentiometer 50K 1-turn 1 P2
Potentiometer 10K 20 turn 1 P1
Resistor pack 5 x 2K2 1 RP3
Resistor pack 8 x 4K7 1 RP4
Resistor pack 8 x 10K 2 RP1, RP2
Cer. capacitor 22pF 50V 2 C1, C2
Multilay. X7R lnF 50V 1 C3
Multilay. X7R 4n7 50V 1 C4
Multilay. X7R 100nF 50V 9 C6 - Cll, C15, C16, C19
Electrolyte Capacitor

Electrolyte Capacitor
Electrolyte Capacitor
RF coil 1.2mH 2 L2, L3

10µF 16V
100µF 16V
10µF 30V

1 C13
6 C18, C23 - C27
1 C28 - C30

6

COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE

EMI Filter DSS306-91Y 28 F1-F18, F21, F22, F25 - F31
EMI Filter DSS710-D22 1 F19
EMI Filter DSS306-91F 9 F20, F23, F24, F32 - F34, F37 - F38
Battery contact FemaleS-G9312#0 1 J7
Header 2 pole 2 J6, J10
Phono-base CLIFF PHS2A 1 J8
D-sub 9p Male 90 degrees 1 J2
D-sub 28p Female 90 de-

grees
Flat cable terminal 26P 2 J35, Jll
Flat cable plug 16P 1
Flat cable plug 20P 1
Box header 20P 1 J9
Connector 36-pol 1 TP101 -TP9
Flat cable 16 leads 280 mm
Flat cable 25 leads 200 mm

SENSOR BOARD

Sensor board AR-082 1
Volt. regulator MAX664CPA 1 IC107
A/D converter LTC1290CCN 1 IC104
Op.amp TL1413CN8 3 IC102, ICl10, IClll
Op.amp LT1012ACN8 1 IC101
V-ref. LT1027CCN8-5 1 IC105
Timer LMC555CN 1 IC106
Shift register 74HC589AN 1 ICl12
Shift register 74HC595AN 1 IC108
NAND port 74HC00AN 1 ICl13
Multiplexer 74HC4052P 1 ICl14
Diode 1N4148 3 Dlll - Dl13
Zener diode 5V1 4 D104 - D107
Schottky diode 1N5819 1 Dl14
Transzorb diode BZW06-10B 2 D101, D102
Transzorb diode BZW06-17B 3 D108 - Dl10
Resistor 47R 1% 0.5W 1 R184
Resistor 100R 1% 0.5W 1 R192
Resistor 499R 1% 0.5W 3 R131, R138, R139
Resistor 1K0 1% 0.5W 1 R129
Resistor 2K0 0.1% 0.5W 2 R121, R124
Resistor 3K16 0.1% 0.5W 1 R140
Resistor 3K3 1% 0.5W 1 R132
Resistor 3K74 1% 0.5W 1 R130
Resistor 3K9 0.1% 0.5W 16 R1245-R151, R153 - R159, R180,

Resistor 4K7 0.1% 0.5W 1 R141
Resistor 5K36 1% 0.5W 2 R188, R193
Resistor 8K06 1% 0.5W 1 R109, Rl18
Resistor 10K 0.1% 0.5W 4 R122, R123, R125, R126
Resistor 10K 1% 0.5W 5 R128,R136,R137,R143,R190
Resistor 20K 0.1% 0.5W 3 R127, R142, R144
Resistor 20K 1% 0.5W 1 R135
Resistor 40K2 1% 0.5W 1 R134
Resistor 90K9 1% 0.5W 1 R191
Resistor 180K 1% 0.5W 2 R133, R189
Resistor 200K 0.1% 0.5W 2 R120, R187
Resistor 249K 0.1% 0.5W 16 R101 - R108, Rl10 - Rl17
Resistor 10M 1% 0.5W 3 R194 - R196
Resistor 0R 2 L102, L103
Resistor N.C. 1 Rl19
Power resistor 25R 1% 2 R185, R186
Potentiometer 1K 20-turn 1 P102

1 J1

R181

7

COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE

Potentiometer 10K 20 turn 2 P103, P104
Resistor pack 8 x 10K 1 RP101
Cer. capacitor 220pF 50V 1 C102
Cer. capacitor 470pF 50V 1 C101
Multilay. X7R 10nF 50V 1 Cl13
Multilay. X7R 100nF 50V 11 C104-Cl12, Cl16, C120
Multilay. X7R 470nF 50V 1 C114
Electrolyte Capacitor

Tantal
RF coil 1.2mH 1 L101

EMI Filter DSS306-91Y 1 F101
Sliding switch 4P3T 1 SW106
Sliding switch 4PDT 1 SW108
Pressure switch 15.501 5 SW101 - SW105
Switch top 16.300.09 5
KK contact 2 pole pin 2 J102, J109
KK contact 2 pole house 3
Pin for KK 6
BNC base 1
Solder washer for BNC base 1
Cable 120 mm
Cable 230 mm
Base 16 pin 1 J101
Spacer M3x5 nylon 4
Screw M3x12 nylon 4
Nut M3 nylon 4

ECG SIGNAL DISTR. BOARD

ECG signal distr. circuit board AR-094 1
Resistor 499R 1% 0.5W 10 R2, R3, R5, R7, R9, Rll, R13, R15,

Resistor 47K5 1% 0.5W 1 R14
Resistor 53K6 1% 0.5W 2 R12, R16
Resistor 64K9 1% 0.5W 2 R10, R18
Resistor 72K3 1% 0.5W 1 R6
Resistor 80K6 1% 0.5W 1 R8
Resistor 90K9 1% 0.5W 1 R4
Resistor 180K 1% 0.5W 1 R1
N.C. D1
EMI Filter 2n2 DSS306 10 F1 - F10
KK contact 1 J1
KK contact house 2 J1
Pin for KK 4 J1
Connector 36-pol 2 TP1, TP2
Cable 1L+Sk 120 mm

100µF 25V

10µF 25V

1 C103
4 C115, Cl17-C119

R17, R19

PACER UNIT

Pacer circuit board PCB1 AR-081 1
D/A converter DAC8043FP 1 U1
Op.amp LT1413CN8 2 U2, U3
Op.amp LT1012ACN8 1 U5
Op.amp LT1112CN8 1 U6
Relay driver UCN5842A 1 U4
Resistor 7R5 1% 0.5W 1 R32
Resistor 49R9 0.1% 0.5W 2 Rll, R7
Resistor 100R 0.1% 0.5W 1 R2
Resistor 420R 0.1% 0.5W 2 R3, R30
Resistor 820R 0.1% 0.5W 3 R4, R5, R31
Resistor 820R 1% 0.5W 3 R22, R33, R34
Resistor 1690R 0.1% 0.5W 1 R6

8

COMPONENT PART TYPE/VALUE QTY. DIAGRAM REFERENCE

Resistor 1K52 0.1% 0.5W 2 R21, R22
Resistor 1K8 1% 0.5W 1 R12
Resistor 2K 0.1% 0.5W 1 Rll
Resistor 10K 0.1% 0.5W 4 R9, R13, R,?.5, R28
Resistor 10K 1% 0.5W 3 R15, R24, R27
Resistor 20K 0.1% 0.5W 4 R8, R10, R14, R16
Resistor 24K 0.1% 0.5W 2 R17, R18
Resistor 30K 0.1% 0.5W 2 R26, R29
Resistor 249K 0.1% 0.5W 2 R19, R20
Multilay. X7R 100nF 50V 8 C1 - C5, C7, C8, C10
Electrolyte Capacitor

N.C. C6
RF coil 1.2mH 1 L1
Relay -B201 4 K1 - K4
Relay -B101 2 K5, K6
Connector 2x36-pol 1 J1
KK contact 4-pol 1 J4
Connector 36-pol 1 TP1 -TP6

100µF 25V

1 C9

9

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10

Appendix A - Diagrams

Processor Board Component Location Diagram............................................................................A-2

Schematic Diagram Part 1 (Processor Board)................................................................................A-3

Schematic Diagram Part 2 (Processor Board)...............................................................................A-4

Schematic Diagram Part 3 (Processor Board)................................................................................A-5

Sensor Board Component Location Diagram................................................................................A-6

Schematic Diagram Part 4 (Sensor Board).....................................................................................A-7

Schematic Diagram Part 5 (Sensor Board)....................................................................................A-8

Schematic Diagram Part 6 (Sensor Board)....................................................................................A-9

ECG Signal Distribution Board Component Location Diagram.................................................A-10

Schematic Diagram Part 7 (ECG Signal Distribution Board).....................................................A-11

Pacer Unit Component Location Diagram..................................................................................A-12

Schematic Diagram Part 8 (Pacer Unit)......................................................................................A-13

A-1

A-2

A-3

A-4

A-5

A-6

A-7

A-8

A-9

A-10

A-11

A-12

A-13

USA

1345 Monroe NW, Suite 255A
Grand Rapids, MI 49505
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

From: (name)       Phone:      
Address:       Fax:

E-mail:      
      Date:

FRANCE

30, rue Paul Claudel
91000 Evry, France
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

NORWAY

Travbaneveien 1
N-7044 Trondheim, Norway
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

Error Report

Product:       Version:       Serial no.:

Description of the situation prior to the error:      

Description of the error:        

(METRON AS internally)
Comments:

Received date:       Correction date:       Ref No.       Critical Normal Minor

USA

1345 Monroe NW, Suite 255A
Grand Rapids, MI 49505
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

FRANCE

30, rue Paul Claudel
91000 Evry, France
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

NORWAY

Travbaneveien 1
N-7044 Trondheim, Norway
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

B-1

From:
(name)
Address:       Fax:

      Phone:      

E-mail:      
      Date:

Improvement Suggestion

Product:       Version:      

Description of the suggested improvement:      

(METRON AS internally)
Comments:

Received date:       Correction date:       Ref No.       Critical Normal Minor

C-2

.

USA

1345 Monroe NW, Suite 255A
Grand Rapids, MI 49505
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

.

FRANCE

30, rue Paul Claudel
91000 Evry, France
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

NORWAY

Travbaneveien 1
N-7044 Trondheim, Norway
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]