METRON QA-45 Troubleshooting guide

QA-45
User & Service Manual
QA-45 Defibrillator and
Transutaneous Pacemaker Analyzer
P/N 13060

Copyright  2001 by METRON. All rights reserved.
METRON:
USA __ F ANCE ________________ NO WAY________________
1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1
Grand apids, 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 publicatio as is without warra ty of a y ki d, either express or implied, i -
cludi g but ot limited to the implied warra ties of mercha tability or fit ess for a y particular purpose.
Further, METRON reserves the right to revise this publicatio a d to make cha ges from time to time to
the co te t hereof, without obligatio to METRON or its local represe tatives to otify a y perso of
such revisio or cha ges. Some jurisdictio s do ot allow disclaimers of expressed or implied warra ties
i certai tra sactio s; therefore, this stateme t may ot apply to you.
Limited Warranty
METRON warra ts that the QA-45 Defibrillator/Tra scuta eous Pacemaker A alyzer will substa -
tially co form to published specificatio s a d to the docume tatio , provided that it is used for the pur-
pose for which it was desig ed. METRON will, for a period of twelve (12) mo ths from date of purchase,
replace or repair a y defective system, if the fault is due to a ma ufacturi g defect. I o eve t will
METRON or its local represe tatives be liable for direct, i direct, special, i cide tal, or co seque tial
damages arisi g out of the use of or i ability to use the QA-45 Defibrillator/Tra scuta eous Pacemaker
A alyzer, eve if advised of the possibility of such damages. METRON or its local represe tatives are
ot respo sible for a y costs, loss of profits, loss of data, or claims by third parties due to use of, or i -
ability to use the QA-45 Defibrillator/Tra scuta eous Pacemaker A alyzer. Neither METRON or its lo-
cal represe tatives will accept, or be bou d by a y other form of guara tee co cer i g the QA-45 De-
fibrillator/Tra scuta eous Pacemaker A alyzer other tha this guara tee. Some jurisdictio s do ot allow
disclaimers of expressed or implied warra ties i certai tra sactio s; therefore, this stateme t may ot
apply to you.
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Table of Contents
1. Introduction........................................................................................................................................1
1.1 QA-45 Features ...........................................................................................................................1
1.2 Defibrillator A alyzer Specificatio s..........................................................................................2
1.3 Tra scuta eous PPacemaker A alyzer Specificatio s.............................................................5
1.4 Ge eral I formatio ......................................................................................................................6
2. Installation..........................................................................................................................................1
2.1 Receipt, I spectio a d Retur ...................................................................................................1
2.2 Setup..............................................................................................................................................1
2.3 Power ............................................................................................................................................2
2.4 I ter al Paddles.............................................................................................................................4
2.5 Special Co tacts............................................................................................................................4
2.6 PRO-Soft QA-40M/45..................................................................................................................4
3. Operating QA-45................................................................................................................................1
3.1 Co trol Switches a d Co ectio s.............................................................................................1
3.2 QA-45 Me u a d Fu ctio Keys.................................................................................................3
3.3 Me u a d Messages: Defibrillator Mode....................................................................................4
3.4 Me u a d Messages: Tra scuta eous Pacemaker Mode.........................................................6
3.5 Test Result Pri touts.....................................................................................................................8
4. Defibrillator Mode Testing...............................................................................................................1
4.1 I troductio ..................................................................................................................................1
4.2 Test Preparatio ............................................................................................................................1
4.3 E ergy Test ..................................................................................................................................3
4.4 Cardioversio Test........................................................................................................................4
4.5 Maximum E ergy Chargi g Time Test.......................................................................................6
4.6 Shock Advisory Algorithm Test.................................................................................................7
5. Transcutaneous acemaker Mode Testing.....................................................................................1
5.1 I troductio ..................................................................................................................................1
5.2 Testi g Preparatio ......................................................................................................................1
5.3 Dema d Se sitivity Test..............................................................................................................3
5.4 Refractory Period Test..................................................................................................................5
6. Control and Calibration....................................................................................................................1
6.1 Required Test Equipme t............................................................................................................1
6.2 Preparatio ....................................................................................................................................1
6.3 Refere ces.....................................................................................................................................1
6.4 Test................................................................................................................................................1
7. Component Functions and arts......................................................................................................1
7.1 Theory of Operatio .....................................................................................................................1
7.2 Processor Board.............................................................................................................................1
7.3 Se sor Board.................................................................................................................................3
7.4 ECG Sig al Distribu- tio Board..................................................................................................4
7.5 Pacer U it......................................................................................................................................5
7.6 Compo e t Parts ..........................................................................................................................6
Appendix A – Diagrams ........................................................................................................................A-1
Appendix B – Error Report Form........................................................................................................B-1
Appendix C – Improvement Suggestion Form....................................................................................C-1
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Manual Revision Record
This record page is for recordi g revisio s to your QA-45 User & Service Manual that have bee
published by METRON AS or its authorized represe tatives. We recomme d that o ly the ma age-
me t or facility represe tative authorized to process cha ges a d revisio s to publicatio s:
•make the pe cha ges or i sert the revised pages;
•e sure that obsolete pages are withdraw a d either disposed of immediately, or marked as su-
perseded a d placed i a superseded docume t file, a d;
•e ter the i formatio below reflecti g that the revisio s have bee e tered.
ev No Date Entered eason Signature of Person Entering Change
2.60-1 4-30-01 Ge eral update
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This page intentionally left blank.
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1. Introduction
This chapter describes the Metro ’s QA-45 Defibrillator /
Tra scuta eous Pacemaker A alyzer features a d specificatio s.
1.1 QA-45 Features
The QA-45 A alyzer is a precisio i strume t for testi g defibrilla-
tors a d tra scuta eous pacemakers, a d is desig ed to be used by
trai ed service tech icia s.
The defibrillator fu ctio of the QA-45 measures the e ergy output,
a d e sures that the defibrillator complies with specified require-
me ts. QA-45 has a built-i load resista ce of 50 ohm, which
roughly correspo ds to the impeda ce of the huma body. The de-
fibrillator pads are placed o the QA-45 co tact plates. Thus, the de-
fibrillator is co ected through the load resista ce. Whe the defib-
rillator is discharged, QA-45 calculates a d displays the e ergy de-
livered.
I the pacer fu ctio the QA-45 tests all types of tra sthoracic pace-
makers. The testi g is me u drive , a d simple to operate. QA-45
measures a d displays a pulse’s amplitude, rate, e ergy a d width. It
also co ducts dema d se sitivity tests, measuri g a d displayi g re-
fractory periods, a d immu ity tests, which determi e the pacemak-
er’s susceptibility to 50/60 Hz i terfere ce.
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1.2 Defibrillator Analyzer
Specifications
1. Energy Output Measurement
High ange
Voltage <5000 volts
Maximum current 120 amperes
Maximum energy 1000 Joules
Accuracy ± 2 % of reading for >100 Joules
± 2 Joule of reading for <100 Joules
Trigger level 100 volts
Playback amplitude 1 mV/1000 V Lead I
Test pulse 100 + 4 Joules
Low ange
Voltage <1000 volts
Maximum current 24 amperes
Maximum energy 50 Joules
Accuracy ± 2% of reading for >20 Joules
± 2 Joule of reading for <20 Joules
Trigger level 20 volts
Playback amplitude 1 mV/200 V Lead I
Test pulse Approx. 4 Joules
Load esistance 50 ohms ± 1%, non-inductive (<1 µH)
Display esolution 0.1 Joules
Measurement Time
Window
100 ms
Absolute Max. Peak
Voltage
6000 volts
Pulse Width 100 ms
Cardioversion Measured time delay ± 2 ms
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 -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

2. ECG Wave
ECG General
Lead configuration 12-lead simulation. L, A, LA, LL, V1-6
Output impedance Limb leads 1000 ohms to L
V Leads 1000 ohms to L
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 - A)
Lead II 1.5 mV (LL - A)
Lead III 0.5 mV (LL - LA)
V Lead 1.5 mV (V - 1/3 (LL+LA+ A))
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 esponse
Low Frequency 4 second DC pulse
Band Pass 10 Hz sine
Monitor -3dB point: 40 Hz sine
Power Line Notch
Filter
50 Hz sine
Linearity 2 Hz triangle wave
Normal Sinus
ates 30, 60, 80, 120, 180, 240 and 300 BPM.
Accuracy ±1% of selection
Amplitudes 0.5, 1.0, 1.5 and 2.0 mV (Lead II)
Accuracy ±5 % (Lead II 1.0 mV)
Automatic ECG ate Test
Arrhythmia Selections
vfib Ventricular Fibrillation
afib Atrial Fibrillation
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blk II Second degree A-V block
BBB ight Bundle Branch Block
PAC Premature Atrial Contraction
PVC_E Early PVC
PVC_STD PVC
PVC onT on T PVC
mfPVC Multifocal PVC
bigeminy Bigeminy
run5PVC Bigeminy un 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 ANGE
50 to 2300 ohms in step of:
50 ohm up to 200 ohms
100 ohm from 200 up to 2300 ohms
Accuracy 50 - 1300 ohm ±1%
1400 - 2300 ohm ±1.5 %
Oscilloscope Output
50 - 150 ohm 10.24:1 amplitude attenuation
200 - 500 ohm 41:1 amplitude attenuation
600 - 2300 ohm 164:1 amplitude attenuation
2. PULSE MEASU EMENTS
Amplitude 4 to 300 mA (100 ohm load)
Accuracy ±5 % or ±0.5 mA
Max. Amplitude 300 mA all loads
ate 30 to 800 ppm
Accuracy ±1% or 2 ppm
Pulse width 0.6 to 80 ms
Accuracy ±1% or ±0.3 ms
3. DEMAND SENSITIVITY TEST
Waveforms Square(SQ ), Triangle(T I), and Havemine
(SSQ)
ECG output Amplitude 0 - 4 mV
esolution 40 µV
Pacer input (Load depended)
Amplitude (50 ohm) 0 10 mV
esolution (50 ohm) 40 µV
Amplitude: (≥500 ohm) 0 - 100 mV
esolution: (≥500 ohm) 1 mV
Defib. Pads Amplitude 0 10 mV
esolution 0.1 mV
Waveform width 10, 25, 40, 100 and 200 ms
Pacer rate 30 to 120 ppm
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. efractory Period Measurement
20 to 500 ms (both Pacing and Sensing) Accuracy: ±2 ms
1.4 General Information
Temperature equirements
+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 S
-232C (1) for Computer control
Power 2 x 9 volt alkaline Battery Duracell
MN1604 (or equivalent) for 20 -25 opera-
tional hours, or 240 VAC (Battery Elimina-
tor), 115 VAC for US.
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
ecommended Printer HP DeskJet 500C / 550C and Canon BJ
-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)
P O-Soft QA-40M/45 software (P/N 13600)
P O-Soft QA-40M/45 DEMO (P/N 13601)
User Manual P O-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. Installation
This chapter explai s u packi g, receipt i spectio a d claims, a d
the ge eral procedures for QA-45 setup.
2.1 eceipt, Inspec-
tion and eturn
1. I spect the outer box for damage.
2. Carefully u pack all items from the box a d check to see that
you have the followi g items:
•QA-45 Defibrillator/Tra scuta eous Pacemaker A alyzer
(PN 17020)
•110 V or 220 V AC Adapter (P/N 17021)
•I ter al paddle-co tact adapter (P/N 13403)
•Grou d co tact adapter (P/N 13404)
•10 pack, S ap-to-ba a a adapter (P/N 17023)
•QA-45 User and Service manual (P/N 13060)
3. If you ote physical damage, or if the u it fails to fu ctio ac-
cordi g to specificatio , i form the supplier immediately.
Whe METRON AS or the compa y’s represe tative, is i -
formed, measures will be take to either repair the u it or dis-
patch a replaceme t. The customer will ot have to wait for a
claim to be i vestigated by the supplier. The customer should
place a ew purchase order to e sure delivery.
4. Whe retur i g a i strume t to METRON AS, or the compa y
represe tative, fill out the address label, describe what is wro g
with the i strume t, a d provide the model a d serial umbers.
If possible, use the origi al packagi g material for retur ship-
pi g. Otherwise, repack the u it usi g:
•a rei forced cardboard box, stro g e ough to carry the
weight of the u it.
•at least 5 cm of shock-absorbi g material arou d the u it.
•o abrasive dust-free material for the other parts.
Repack the u it i a ma er to e sure that it ca ot shift i the
box duri g shipme t.
METRON’s product warra ty is o page ii of this ma ual. The
warra ty does ot cover freight charges. C.O.D. will ot be ac-
cepted without authorizatio from METRON A.S or its repre-
se tative.
2.2 Setup
1. Equipme t co ectio is as show i the typical setup below.
1

2. If PRO-Soft QA-40M/45 is bei g used, attach a RS-232 ( ull
modem/data tra sfer co figured) cable to the 9-pi D-sub outlet
port located at the rear of the QA-45. Do ot attach the pri ter
cable to the QA-45. See below. However, if you are ot usi g
PRO-Soft QA-40M/45, a d are se di g directly to a pri ter for
pri touts, attach the pri ter cable to the 25-pi outlet port.
2.3 Power
1. Main On/Off Switch. QA-45 should remai off for at least 5
seco ds before switchi g o agai , i order to allow the test cir-
cuits to discharge fully.
2. Low Battery ower. If battery power falls below 6.9 volts
(± 0.3 volts), the display will show 'Cha ge battery, a d reset
system'. This mea s that the battery should either be replaced or
the i strume t should be co ected to a battery elimi ator. The
NOTE
Some S-232C cables are
missing the connection be-
tween 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. efer to
the P O-Soft QA-40M/45
Users Manual for more informa-
tion.
2

mai switch has to be switched off a d the o agai i order to
use the i strume t.
3. Changing Batteries. Ope the compartme ts i the base of the
i strume t, replace the old batteries with ew o es, a d close
the compartme t covers. Use 9 volt alkali e batteries (Duracell
MN1604 or similar).
NOTE
Do not use mercury, air or car-
bon-zinc batteries.
3

4. Battery Eliminator
METRON’s AC Adapter plug-i power supply tra sformer al-
lows you to use the QA-45 a ywhere a sta dard electrical outlet
is available. To attach the AC Adapter i sert the adapter’s small
co ector i to the micro jack labeled “Batt. Elim. 9V DC” o
the right rear of the u it. Plug the large co ector i to the ear-
est sta dard electrical outlet.
2.4 Internal Paddles
To be able to test defibrillators with i ter al paddles, a i ter al
paddle adapter has to be used. These co tacts have a ba a a plug
that is attached to the sta dard paddle co tact, a d which is pro-
tected by a plastic i sulatio washer.
2.5 Special Contacts
Certai defibrillators (automatic models a d those with pacer op-
tio s) have special co tacts that are faste ed to the electrodes at-
tached to the patie t. Metro AS has special adapters to suit the ma-
jority of these defibrillators. These are available as accessories.
They are more or less the same as the i ter al pad adapter except
that they have a special adapter o the top, which matches the co -
tact o the defibrillator.
Defibrillator paddle adapter (specify defibrillator type): (P/N 13410)
Pacemaker external load cable (specify type pacemaker type): (P/N 13415)
2.6 P O-Soft QA-40M/45
PRO-Soft QA-40M/45 is a fro t-e d test automatio a d prese ta-
tio tool for METRON's QA-40M/45 Defibrillator/Tra scuta eous
Pacemaker A alyzer. It allows you to co duct the same tests, but
by remote co trol via a IBM-compatible PC/XT with MS Wi dows
(Versio 3.1 or later). Additio ally, the program has additio al fea-
tures to e ha ce your defibrillator a d pacemaker mai te a ce.
Each of the QA-40M/45 tests ca be ru i depe de tly from PRO-
Soft i the “Ma ual” test mode. Results are show o the PC scree
duri g testi g, a d the user is prompted to set the tested equipme t
accordi gly. At the co clusio of tests, the user may pri t a report,
store the test a d results o disk, or both. Combi atio s of tests ca
be created a d stored as “Test Seque ces.” The program mai tai s a
library of these seque ces. I this way you ca store a d retrieve se-
que ces that are appropriate for each ki d of equipme t bei g tested
at your facility.
Seque ces ca the be used i depe de tly, or ca be attached to a
checklist, writte procedure, a d equipme t data i the form of a
test “Protocol.” The equipme t data ca be e tered ma ually i to
the protocol, or it may be retrieved by PRO-Soft from database soft-
ware or other equipme t files. Protocols ca be created easily for
each defibrillator or tra scuta eous pacemaker i your i ve tory,
a d stored for use. Test protocols with results ca be pri ted, or
NOTE
emove the batteries and dis-
connect the AC Adapter if you
do not intend to use the QA-45
for an extended period of time.
OTE
P O-Soft QA-40M/45 has its
own user manual, which con-
tains all the information con-
cerning the program. If you or-
der a demonstration version of
the program you also receive
the manual.
4

stored o disk, a d the results of testi g ca be se t back to the
equipme t database to close a work order a d update the service his-
tory.
5

3. Operating QA- 5
This chapter explai s the operati g co trols, switches a d me us of
the QA-45, details how to use them i testi g , a d provides ge eral
i formatio o pri touts a d operator mai te a ce.
3.1 Control Switches
and Connections
Top Panel
1. Power Switch Turns the power on and off.
2. Mode Switch Switches between PACE and Low / High ranges of defibrilla-
tor 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-
ment with a fixed 50 ohm load in the PACE mode.
1

6. Low Level ECG
Connectors
10 color-coded 4 mm safety terminals with snap-to-banana
adapters.
7. Pacer Input
Connectors
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
8. High Level ECG Jack 1/4” standard phone-jack for amplitude of 1 V/mV of low
level Lead 1 signal.
9. Oscilloscope Output BNC-contact for attenuated signal in real time.
10. S-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
opened to replace the batteries.
13. Battery Eliminator
Socket
Battery contact for connecting 9V 100 mA battery elimina-
tor.
3.2 QA-45 Menu and
Function Keys
The QA-45 uses display a d programmable fu ctio keys to provide
flexibility a d co trol over the operatio s. The upper part of the
scree displays messages, status a d results. The me u bar is at the
bottom of the display. The fu ctio keys are umbered from Fl to
F5.
A fu ctio is selected by pressi g the key located directly u der the
Me u Item displayed i the me u bar. A me u u it is writte i cap-
ital letters.
The me u comprises three pages. The ext pages of the me u are
selected by pressi g more-2, more-3 or more-1.
3