QA-40M QA1290 User & Service Manual Rev 0

Copyright © 1997 by METRON. All rights reserved. METRON: USA 1345 Monroe NW, Suite 255A Grand Rapids, MI 49505 Phone: (+1) 888 863-8766 Fax: (+1) 616 454-3350 E-mail: [email protected]

FRANCE 30, rue Paul Claudel 91000 Evry, France Phone: (+33) 1 6078 8899 Fax: (+33) 1 6078 6839 E-mail: [email protected]

NORWAY Travbaneveien 1 N-7044 Trondheim, Norway Phone: (+47) 7382 8500 Fax: (+47) 7391 7009 E-mail: [email protected]

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-40M Defibrillator 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 analyzer, 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-40M Defibrillator 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-40M Defibrillator Analyzer. Neither METRON nor its local representatives will accept, nor be bound by any other form of guarantee concerning the QA-40M Defibrillator 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.

Trademarks Duracell is a registered trademark of Duracell, Inc. Centronix is a registered trademark of Centronix Corporation. 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.

1-2

Table of Contents MANUAL REVISION RECORD... 1-5 1.

INTRODUCTION... 1-7 1.1 QA-40M Features ... 1-7 1.2 Specifications ... 1-7 1.3 General Information... 1-10

2.

INSTALLATION ... 2-11 2.1 2.2 2.3 2.4 2.5 2.6

3.

OPERATING QA-40M ... 3-15 3.1 3.2 3.3 3.4

4.

Introduction ... 4-19 Test Preparation... 4-19 Energy Test ... 4-20 Cardioversion Test... 4-21 Maximum Energy Charging Time Test ... 4-23

CONTROL AND CALIBRATION... 5-25 5.1 5.2 5.3 5.4

6.

Control Switches and Connections ... 3-15 QA-40M Menu and Function Keys ... 3-16 Menu and Messages... 3-16 Test Result Printouts ... 3-18

TESTING ... 4-19 4.1 4.2 4.3 4.4 4.5

5.

Receipt, Inspection and Return... 2-11 Setup ... 2-12 Power ... 2-12 Internal Paddles ... 2-13 Special Contacts ... 2-13 PRO-Soft QA-40M/45 ... 2-13

Required Test Equipment... 5-25 Preparation ... 5-25 References... 5-25 Test ... 5-25

COMPONENT FUNCTIONS AND PARTS ... ERROR! BOOKMARK NOT DEFINED. 6.1 6.2 6.3 6.4 6.5

Theory of Operation ...Error! Bookmark not defined. Processor Board...Error! Bookmark not defined. Sensor Board ...Error! Bookmark not defined. ECG Signal Distribution Board ...Error! Bookmark not defined. Component Parts ...Error! Bookmark not defined.

APPENDIX A: DIAGRAMS ... ERROR! BOOKMARK NOT DEFINED. Processor Board Component Location ...Error! Bookmark not defined. Processor Board Schematic Diagram Part 1 ...Error! Bookmark not defined. Processor Board Schematic Diagram Part 2 ...Error! Bookmark not defined.

1-3

Processor Board Schematic Diagram Part 3 ...Error! Bookmark not defined. Sensor Board Component Location...Error! Bookmark not defined. Sensor Board Schematic Diagram Part 4 ...Error! Bookmark not defined. Sensor Board Schematic Diagram Part 5 ...Error! Bookmark not defined. Sensor Board Schematic Diagram Part 6 ...Error! Bookmark not defined. ECG Signal Distribution Board Component Location ...Error! Bookmark not defined. ECG Signal Distribution Board Schematic Diagram Part 7...Error! Bookmark not defined. APPENDIX B: ERROR REPORT FORM, QA-40M ... 5-29 APPENDIX C: SUGGESTION FORM, QA-40M... 5-31

1-4

Manual Revision Record This record page is for recording revisions to your QA-40M User and Service 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

0

-

Initial Release

Signature of Person Entering Change

1-5

This page intentionally left blank.

1-6

1. Introduction This chapter describes the Metron’s QA-40M Defibrillator Analyzer features and specifications. 1.1 QA-40M Features The QA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and is designed to be used by trained service technicians. It measures the energy output, and ensures that the defibrillator complies with specified requirements. QA-40M 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 QA40M contact plates. Thus, the defibrillator is connected through the load resistance. When the defibrillator is discharged, QA-40M calculates and displays the energy delivered. 1.2 Specifications 1. Energy Output Measurement High Range Voltage

<5000 volts

Maximum current

120 amperes

Maximum energy

1000 Joules

Accuracy

 2 % of reading for >100 Joules

Trigger level

 2 Joule of reading for <100 Joules 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

Accuracy

 2% of reading for >20 Joules

Trigger level

 2 Joule of reading for <20 Joules 20 volts

Playback amplitude

1 mV/200 V Lead I

Test pulse

Approx. 4 Joules

Load Resistance

50 ohms  1%, non-inductive (<1 H) 0.1 Joules

Display Resolution Measurement Time Window Absolute Max. Peak Voltage Pulse Width

100 ms

Cardioversion

Measured time delay  2 ms

6000 volts 100 ms

1-7

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

 1 ms

Charge Time Measurement From 0.1 seconds to 99.9 seconds. 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

1-8

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

50 Hz sine 2 Hz triangle wave

Normal Sinus Rates

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

Accuracy Amplitudes

 1% of selection 0.5, 1.0, 1.5 and 2.0 mV (Lead II)

Accuracy

 5 % (Lead II 1.0 mV)

Automatic ECG Rate Test Arrhythmia Selections 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

Schock 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

1-9

1.3 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 -232C (1) for Computer control

Power

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

Mechanical Specifications Housing

High impact plastic case

Height

9.8 cm

Width

24.8 cm

9.8 in.

Depth

28.0 cm

11.0 in.

Weight

1.85 kg (with battery)

4.1 lbs.

Printer Port

Centronics Interface

3.9 in.

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-40M

(P/N 13050)

Additional Accessories Defib. paddle adapter (specify defibrillator type) Carrying case

(P/N 13410) (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. Periodic Inspection The unit should be calibrated every 12 months.

1-10

2. Installation This chapter explains unpacking, receipt inspection and claims, and the general procedures for QA-40M setup. 2.1 Receipt, Inspection and Return 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-40M Defibrillator 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)

•

User and Service manual QA-40M (P/N 13050)

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.

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.

2-11

2.2 Setup 1.

Equipment connection is as shown in the typical setup below.

2.

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

1.

Main On/Off Switch. QA-40M 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 sys-

NOTE 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. Refer to the PRO-Soft QA40M/45 Users Manual for more information.

2.3 Power

2-12

tem'. 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.

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

NOTE Remove the batteries and disconnect the AC Adapter if you do not intend to use the QA-40M for an extended period ofPaddles time. 2.4 Internal

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).

4.

Battery Eliminator. METRON’s AC Adapter plug-in power supply transformer allows you to use the QA-40M 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. 2.5 Special Contacts 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)

2.6 PRO-Soft QA-40M/45 PRO-Soft QA-40M/45 is a front-end test automation and presentation tool for METRON's QA-40M Defibrillator Analyzer. It allows you to conduct the same tests, but by remote control via an IBMcompatible 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 tests can be run independently from PRO-Soft 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.

2-13

NOTE PRO-Soft QA-40M 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.

2-14

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 the QA-MAP program or other equipment files. Protocols can be created easily for each defibrillator 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.

3. Operating QA-40M This chapter explains the operating controls, switches and menus of the QA-40M, details how to use them in testing , and provides general information on printouts and operator maintenance. 3.1 Control Switches and Connections Top Panel

1.

Power Switch

Turns the power on and off.

2.

Range Switch

Switches between Low and High ranges of defibrillator energy.

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

5.

Contact Surfaces

The defibrillator’s paddles are placed on these so that the discharged energy passes through the instrument in defib. mode and that the pacer signal passes through the instru-

3-15

ment with a fixed 50 ohm load in the PACE mode. 6.

Low Level ECG Connectors

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

7.

High Level ECG Jack

1/4” standard phone-jack for amplitude of 1 V/mV of low level Lead 1 signal.

8.

Oscilloscope Output

BNC-contact for attenuated signal in real time.

9.

RS-232 Serial Port

9-pin D-sub

10.

Printer Outlet Port

14-25 pin D-sub

11.

Location of Batteries

2 compartments in the base of the instrument can be opened to replace the batteries.

12.

Battery Eliminator Socket

Battery contact for connecting 9V 30 mA battery eliminator.

Rear Panel

3.2 QA-40M Menu and Function Keys The QA-40M 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 has two pages. The next pages of the menu is selected by pressing more-2, or more-1. 3.3 Menu and Messages 1.

3-16

Startup Screen. The following screen will be displayed for 2 seconds after the QA-40M 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)

3.

ECG WAVES (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.

PERF. WAVE (Performance ECG) (F2).

Choose desired selection by pressing UP (F2) or DOWN (F3). Save this under ‘Wave” in the STATUS field by pressing SELECT (F-4). Press CANCEL (F5) to cancel selection.

3-17

5.

CHARGE TIME (F3). Used to test the battery and charging capacitor in the defibrillator. It changes the text ‘Delay’ to ‘Chrg T : xx.x S’ 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 (F-4). Press CANCEL (F5) to cancel selection.

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.

8.

PLAY PULSE (F2) enables playback of the last discharge. See the discussion on playback of energy wave on page 4-3.

9.

SYSTEM TEST (F1)

Choose a test variant by pressing UP (F2) or DOWN (F3) or TEST PULSE (F1). Press CANCEL (F5) to cancel selection. Also, Chapter 5, Control and Calibration, for additional information on ‘ECG0’, ‘ECG+’ and ‘ECG-’ (paragraphs 5.4.10-12) and ‘A/D-read’ (paragraph 5.4.20). ‘Memory’ is for factory testing. 10. REMOTE CONTR. (Remote Control) (F4) enables communication with a PC with test automation software. Required software: PRO-Soft QA-40/45.

3.4 Test Result Printouts QA-40M 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.

3-18

4. Testing This chapter describes QA-40M testing preparation and procedures. 4.1 Introduction QA-40M measures the energy output, and ensures that the defibrillator complies with specified requirements. It has a built-in load resistance of 50 ohms, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the QA-40M contact plates. Thus, the defibrillator is connected through the load resistance. When the defibrillator is discharged, QA-40M 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-40M measures and records the voltage pulse every 100 s, 1000 times, for a total time of 100 ms. The squares of the voltages are then summed, multiplied by 100 s, and divided by the load resistance, 50 ohms. 1000

1000

E =  (V ) • dt / R =  (V2) • 100 s / 50 ohms 2

0

0

The unit for energy is 'joule', which is equal to Ws (Watt second). 4.2 Test Preparation 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-40M 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.

4-19

4.3 Energy Test 1.

•

Use the HIGH range for normal adult testing.

•

Use the LOW range for low energy testing, where the energy does not exceed 50 Joule and the peak voltage does not exceed 1200 volts.

2.

Securely place the defibrillator paddles on the QA-40M 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-40M, 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 QA40M's load resistance.

3.

QA-40M calculates the energy delivered over the load resistance and displays the result in joules under RESULT.

Note 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

Select a suitable energy range using the mode switch.

QA-40M also shows the energy measured, the maximum voltage and the maximum current in the energy wave. Following the discharge from the defibrillator, QA-40M shows a playback of the wave from the ECG output. A new pulse can be generated when the LCD display shows 'LOCAL'.

4-20

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-40M 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.