Metron Safety Analyzer QA - 90 - Service User Manual
Metron Safety Analyzer QA - 90 - Service User Manual
Metron Safety Analyzer QA - 90 - Service User Manual
P/N 11025
V.3.13
FRANCE________
30, rue Paul Claudel
91000 Evry, France
Phone: (+33) 1 6078 8899
Fax: (+33) 1 6078 6839
E-mail: info@metron.fr
NORWAY ____
Travbaneveien 1
N-7044 Trondheim, Norway
Phone: (+47) 7382 8500
Fax: (+47) 7391 7009
E-mail: support@metron.no
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-90 Electrical Safety 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-90 Electrical Safety 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-90 Electrical Safety Analyzer. Neither METRON nor its local representatives will accept, nor be bound by any
other form of guarantee concerning the QA-90 Electrical Safety 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
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.
ii
Table of Contents
MANUAL REVISION RECORD ......................................................................................................... V
1.
2.
3.
5.
4.
iii
6.
Theory of Operation............................................................................................................6-1
Measuring System ...............................................................................................................6-2
Microprocessor System.......................................................................................................6-3
Component Parts .................................................................................................................6-4
iv
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
0
3.13-1
Date Entered
-
4-26-01
Reason
Initial Release
General update
vi
1. Introduction
This chapter describes the QA-90 Electrical Safety Testers features
and specifications.
1.1 QA-90 Features
The QA-90 represents a new generation of safety testing equipment. It
is the only automatic safety analyzer that can test units with different
classes of protection in one test run (e.g., cardiac float and body float
defibrillators). It is simple to use. All you need do is select the type
and class of equipment to test. When you press START, QA-90 executes the tests prescribed to the selected standard.
Test results may be printed out immediately, or stored internally in the
unit for later use. QA-90 has full remote control, and may be operated
from PRO-Soft QA-90 software. PRO-Soft QA-90 enables you to
make your own test protocols, store the information on disk, and export formatted data to any other database or equipment management
program. Individual test sequences may be compiled to satisfy national and international standards.
The following standards may be compiled either fully or in part:
IEC 60601.1, UL 2601.1, IEC 60601.1.1, UL 2601.1.1, IEC
60601.2.4, IEC 61010-1, EN 60601-1, VDE 0750 Tl/12-91, BS 5724,
CAN/CSA-C22.2 No 601.1-M90, AS 3200.1, NZS 6150:1990, VDE
0751 T1/12-90, VE 0751, UL 544, HEI 95, HEI 158 among others.
1.2 Specifications
1. Voltage Measurement
Measurements may be obtained in the following ways:
Range
Resolution
Accuracy
No. of Tests
2. Current Consumption
1-1
Range 2
Resolution
Accuracy
No. of Tests
3. Protective Earth
The test current is selectable from 25A or 1A, delivered from a transformer
with a maximum idle voltage of 6V. The measurement can be performed
on ground leads or between E+ and E- (floating inputs/outputs).
Range
Resolution
Accuracy
No. of Tests
0 - 2000 mOhm
1 mOhm
2% of full scale 1 LSD
1, 2, or multiple
4. Insulating Resistance
The measurement of the insulating resistance may be executed between
casing and power unit, or between patient module and power unit.
Test voltage:
No. of Tests:
Range
Resolution
Accuracy
1 - 50 mOhm
1 mOhm
2% of full scale 1 LSD
Range
Resolution
Accuracy
51 - 200 mOhm
1 mOhm
2% of full scale 1 LSD
5. Leakage Currents
All measurements can be performed with a IEC 601.1 filter (patient equivalent), or without (flat frequency response). The filter can be exchanged with
filters covering other standards. All measurements can be performed as
true RMS measurements, or AC/DC measurements.
The following leakage currents can be measured:
Ground leakage current
Enclosure leakage current
1-2
No. of Tests: 4
No. of Tests: 6 or multiple
No. of Tests: 6
No. of Tests: 2
No. of Tests: 6
No. of Tests: Multiple
0- 100 A
1 A
2% of full scale 1 LSD
Range 2
Resolution
Accuracy
100- 1000 A
1 A
2% of full scale 1 LSD
Range 3
Resolution
Accuracy
1,0 - 10,0 mA
1 A
1% of full scale 1 LSD
7. Frequency Response
DC - 1 MHz (-3dB) with a crest factor of >2
The applied test voltage for patient leakage current is 110% of the line voltage, delivered through a limiting resistor of 47 kOhm.
Power
Fuses
1-3
Mechanical Specifications
Housing
Height
Width
Depth
Weight
Metal case
13.2 cm
34.2 cm
30.5 cm
5.8 kg
3.9 in.
9.8 in.
11.0 in.
4.1 lbs.
Standard Accessories
User and Service Manual QA-90
(P/N 11025)
Additional Accessories
Carrying Case
Carrying case, ext. printer
Bar Code Reader
Isolating transformer 400VA
Isolating transformer 800VA
Test unit (ESA)
E input measuring cable (2m)
E input measuring cable (5m)
Clamp - crocodile type
PRO-Soft QA-90 software
PRO-Soft QA-90 DEMO
User/Service Manual PRO-Soft QA-90
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
(P/N
11100)
10500)
11400)
11401)
11410)
11402)
11411)
11415)
11412)
11200)
11201)
11225)
Storage
Store in the carrying case in dry surroundings within the temperature range specified. There are no other storage requirements.
Periodic Inspection
The unit should be calibrated every 12 months.
1-4
2. Installation
This chapter explains unpacking, receipt inspection and claims, and
the general procedures for initial QA-90 setup. Example test setup
procedures are contained in Chapter 4, Example Test Measurements.
2.1 Receipt, Inspection
and Return
1.
2.
Carefully unpack all items from the box and check to see that you
have the following items:
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 companys 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.
2-1
2.2 Setup
1.
Equipment connection is as shown in the typical setup below. Attach the printer cable to the 25-pin outlet port.
2.
If PRO-Soft QA-90 is being used, attach an RS-232C (null modem/data transfer configured) cable to the 9-pin D-sub outlet port
located at the rear of the QA-90. Do not attach the printer cable
to the QA-90. See below.
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-90. Refer to the PROSoft QA-90 Users Manual for more
information.
2.3 Power
Main On/Off Switch. QA-90 should remain off for at least 5
seconds before switching on again, in order to allow the test circuits
to discharge fully.
2.4 PRO-Soft QA-90
PRO-Soft QA-90 is a front-end test automation and presentation tool
for METRON's QA-90 Electrical Safety 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
2-2
program has additional features to automate and enhance your electrical safety testing.
Each of the QA-90 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.
NOTE
PRO-Soft QA-90 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.
2-3
2-4
3. Operating QA-90
This chapter explains the operating controls, switches and menus of
the QA-90, details how to use them in testing, and provides general
information on printouts and operator maintenance.
3.1 Control Switches and
Connections
Front Panel
1.
Key Pad
Clear:
Return:
Enter:
2.
Function Keys
F1-F4 are used to select the functions shown in the menu bar
at the bottom of the display, i.e., for selecting the function that
is directly above the key. F5-F7 are used to select the function, or enter information in the message field in the same
line.
LCD Display
3-1
Patient Leads
5.
Dual
6.
Encl.
7.
Earth
8.
Contact
Rear Panel
Power Switch
10.
9-pin D-sub
11.
12.
9.
3-2
13.
Mains QA-90
14.
Auxiliary Power
15.
Fuse
16.
Earthing Contact
VALUE ACCEPTED
MAX. CHARACTERS
Instrument code
alphanumeric
20
Separator
1 (must be included)
Instrument class
3 (must be included)
VALUE ACCEPTED
MAX. CHARACTERS
Module code
alphanumeric
20
Separator
1 (must be included)
No. of leads
numeric (0-99)
Separator
1 (must be included)
Type
BF, CF, B
2 (must be included)
Example: mnopqrst + 2 + B
3-3
Startup Screen. The following screens will be displayed in sequence for the first 10 seconds after the QA-90 has been switched
on.
METRON QA-90
F7
F6
Boot software
F1
F2
version: X.XX
F3
F5
F4
METRON QA-90
F7
F6
Version: X.XX
F1
F2
Date: DD/MM/YYYY
F3
F4
F1
2.
3-4
Main Menu
F2
F3
F5
F4
F7
F6
F5
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
F7
F6
F5
F4
3. MORE (F1). When MORE (F1) is pressed, the following display will appear:
Test according to
Test Type
Test Mode
GO BACK
F1
F2
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F7
F6
F5
F4
4.
MEMORY (F2)
QA-90s memory is divided into two parts: tests and sequences. If
you have several equivalent instruments to test, you can define one
test sequence for all the instruments and store it as a sequence.
You use this sequence to test all the instruments and store each of
the test results with the instruments respective equipment code.
The functions in the MEMORY menus enable you to store, retrieve, transfer, print and delete test results and sequences from the
memory. The four main memory displays are as follows.
3-5
Equipment Code :
...>
Store test in memory ..................>
Display test results ..................>
MORE
SEQ.MEM
TEST
MAIN MENU
F1
F2
F3
F2
F3
F2
F3
F2
F3
F6
F5
F7
F6
F5
F4
Equipment Code :
...>
Delete test in memory .................>
Delete all tests in memory ............>
MORE
GO BACK
MAIN MENU
F1
F7
F4
F1
F6
F5
F4
Equipment Code :
...>
Recall and transfer test from memory ..>
Recall and print test from memory .....>
MORE
GO BACK
MAIN MENU
F1
F7
F7
F6
F5
F4
The F5 and F6 function keys generate new displays as confirmation of an executed function or error message.
3-6
F7
F6
F5
F1
F2
F3
F4
F7
F6
F5
MORE
GO BACK
F1
F2
MAIN MENU
F3
F4
Sequence name :
...>
Delete sequence in memory .............>
Delete all sequences in memory ........>
GO BACK
MAIN MENU
F1
F2
F3
F7
F6
F5
F4
5. SETUP (F3)
This function is used for entering general information in connection with the test. Seven main displays are shown below.
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F2
QA-90 Serial no
IT-Net
Power-up delay time
MORE
GO BACK
F1
F2
QA-90 Serial no
IT-Net
Power-up delay time
MORE
GO BACK
F3
F7
...>
...>
MAIN MENU
F4
: XXXXX
.>
: N ..........>
: 2
Seconds.>
CAL.
MAIN MENU
F3
F6
F5
F7
F6
F5
F4
: XXXXX
.>
: N ..........>
: 2
Seconds.>
CAL.
MAIN MENU
F7
F6
F5
3-7
F1
F2
F3
F4
F1
F2
F3
F2
F3
3-8
F2
F3
N ...>
N ...>
25 A.>
MENU
F7
F6
F5
F6
F5
F4
F1
F7
F4
F1
N ...>
N ...>
N ...>
MENU
F4
N ...>
Y ...>
N ...>
MENU
F7
F6
F5
F1
F2
F3
F7
F6
F5
F4
F7
F5
F6
F1
F2
CAL.
MAIN MENU
F3
F4
Module Code :
.....>
No of leads :
.......................>
Type
: CF.......................>
ADD
GO BACK
PREV.
NEXT
F1
F2
F3
F7
F6
F5
F4
3-9
Press ADD (F1) to save in the memory. The number of modules stored will be shown in parenthesis in the Module Code
line.
7. START (F4).
This function starts the test sequence. Manual or automatic test
sequences are selected under MORE (F1) in MAIN MENU.
3.6 Measurements with
Several Modules in
Manual Mode
When you perform measurements on several modules in Manual
Mode and want to select which module to measure, use the following
procedure:
1.
F1
2.
F2
F1
F4
F2
: IEC60601.1 ......>
: Rapid ...........>
: Manual ..........>
START
F3
F7
F6
F5
F4
Press MORE (F1) in repeatedly until you find the desired measurement, e.g., Mains on applied part (F5).
MANUAL TEST SETUP
Mains Voltage .........................>
3-10
F6
F5
Press Test Mode (F5) and select Manual. Press START (F4).
Test according to
Test Type
Test Mode
GO BACK
3.
F3
F7
F7
F6
F1
4.
F2
F3
F5
F4
F1
F2
F3
F7
F6
F5
F4
5.
6.
7.
8.
9.
Operator
Establishment
Serial Number
Language
Calibration parameters
F7
F6
F5
3-11
F1
F2
F3
F4
Press STORE (F2) in SYSTEM SETUP and the display will show
you the setup parameters stored in flash.
3-12
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F2
F3
F7
...>
...>
MAIN MENU
F6
F5
F4
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
F6
F5
F4
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F7
F2
F3
F7
...>
...>
MAIN MENU
F6
F5
F4
Then go to the hidden menu under (F1), in the menu for Self
Calibration.
SELF CALIBRATION
Calibrate test lead, enclosure/earth ..>
Calibrate test lead, dual float .......>
GO BACK
MAIN MENU
F1
F2
F3
F7
F6
F5
F4
3-13
Note the values on the three constants that appear on the display.
Press and hold PL and CLR at the same time while turning
the QA-90 on.
Press ENTER ()
3-14
Choose menu 1 SET PARAMETERS and choose new parameters or default values.
If the communication is successful, >>>>>>> will appear continuously at the display on the QA-90. When the program is transmitted, a normal startup menu will appear on the QA-90. The
computer will either show a picture for program transmission, or a
clear screen.
4. Check the Calibration Constants
Check the calibration constants in the QA-90 through the hidden
menu. If necessary, press F5, F6 or F7 to type your noted calibration constants, then press ENTER ().
To store in Flash memory, go back to SYSTEM SETUP.
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F2
F3
F7
...>
...>
MAIN MENU
F6
F5
F4
Press STORE (F2) and the display will show you setup parameters stored in flash.
3-15
3-16
2.
3.
4.
In the SELF CALIBRATION window select an option by pressing either Calibrate test lead, enclosure/ground (F6) or Calibrate test lead, dual float (F5).
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
F7
F6
F5
F4
4-1
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F2
F7
...>
...>
MAIN MENU
F3
F4
SELF CALIBRATION
Calibrate test lead, enclosure/earth ..>
Calibrate test lead, dual float .......>
GO BACK
MAIN MENU
F1
5.
F2
F6
F5
F3
F7
F6
F5
F4
The test result for the calibration appears in the display when the
test is complete.
Test lead enclosure/grnd
Test lead, dual float
:
:
XXX mOhm
XXX mOhm
F7
F6
F5
F1
GO BACK
MAIN MENU
F2
F3
F4
NOTES
Ensure that the mains switch
on the instrument to be
tested is switched ON.
If the message REVERSED
POLARITY is shown in the
MAIN MENU, reverse the
mains plug.
4-2
1.
2.
3.
4.
5.
6.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
Test according to
Test Type
Test Mode
GO BACK
F1
F2
F3
F6
F5
F4
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F7
F7
F6
F5
F4
NOTE
Ensure that the mains
switch on the instrument to
be tested is switched ON.
4-3
1.
2.
3.
4.
5.
6.
7.
8.
9.
F1
4-4
F2
F3
F4
F7
F6
F5
Test according to
Test Type
Test Mode
GO BACK
F1
F2
: IEC60601.1 ......>
: Rapid ...........>
: Manual ..........>
START
F3
F7
F6
F5
F4
4-5
Module Code :
.....>
No of leads :
.......................>
Type
: CF.......................>
ADD
GO BACK
PREV.
NEXT
F1
F2
F3
F7
F6
F5
F4
NOTE
Ensure that the test leads
are calibrated BEFORE
the test.
1.
2.
3.
4.
5.
6.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
Test according to
Test Type
Test Mode
GO BACK
4-6
F3
F7
F6
F5
F4
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F7
F6
F5
F1
F2
F3
F4
F1
F2
F3
F2
F3
F1
F7
F6
F5
F4
Time :
Result :
Limit
:
START
F6
F5
F4
F1
F7
Seconds
mOhm
mOhm
GO BACK
MAIN MENU
F2
F3
F4
F7
F6
F5
1.
4-7
2.
3.
4.
5.
6.
7.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
Test according to
Test Type
Test Mode
GO BACK
F1
F2
F3
F2
F3
F2
F3
F7
F6
F5
F7
F6
F5
F4
4-8
F6
F5
F4
F1
F7
F4
F1
F6
F5
F4
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F7
F7
F6
F5
F1
F2
F3
F4
1.
2.
3.
4.
5.
6.
7.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
Test according to
Test Type
Test Mode
GO BACK
F1
F2
F3
F6
F5
F4
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F7
F7
F6
F5
F4
4-9
F1
4-10
F2
F3
F4
F7
F6
F5
F1
F2
Voltage :
F3
F7
F6
F5
F4
F7
F6
F1
F2
F3
F5
F4
1.
2.
3.
4.
5.
6.
7.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F7
F6
F5
4-11
F1
F2
Test according to
Test Type
Test Mode
GO BACK
F1
F2
F3
F4
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F2
F3
F2
F3
F2
F3
F6
F5
F7
F6
F5
F4
F1
F7
F4
F1
F6
F5
F4
F1
F7
F7
F6
F5
F4
4-12
NOTE
The QA-90 power cable
must also be connected.
If the equipment under test is to be tested for voltages and/or frequencies that differs from the nominal mains supply, the test voltage must
be connected to the auxiliary inlet. To route the auxiliary power to the
contact on the front panel, the procedure below must be executed.
1.
2.
3.
4.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
SYSTEM SETUP
Operator
:
Establishment :
MORE
STORE
CAL.
F1
F2
F3
F2
F3
F6
F5
F4
F7
...>
...>
MAIN MENU
F6
F5
F4
F1
F7
Y ...>
Y ...>
Y ...>
MENU
F7
F6
F5
F4
4-13
4-14
Test leads.
Insulated transformer.
1.
Startup Preparation
a.
b.
c.
d.
e.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
F7
F6
F5
F4
5-1
Test according to
Test Type
Test Mode
GO BACK
F1
F2
: IEC60601.1 ......>
: Rapid ...........>
: Automatic .......>
START
F3
F2
F3
F2
F3
2.
F2
F3
F7
F6
F5
F7
F6
F5
F4
Patient Lead Definition. To facilitate some calibration measurements patient leads need to be defined. To do so:
a.
Module Code :
.....>
No of leads :
.......................>
Type
: CF.......................>
ADD
GO BACK
PREV.
NEXT
F1
5-2
F6
F5
F4
F1
F7
F4
F1
F6
F5
F4
F1
F7
F2
F3
F4
F7
F6
F5
NOTE
The module numbers do not
need to be entered, as they
are defaulted as (1, 2, etc.)
b.
For Patient Leads 1-10 (white leads) press No. of leads (F6)
and key in 10. Press the Enter key.
c.
d.
For Patient Lead 11 (blue lead) press No. of leads (F6) and
key in 1. Press the Enter key.
e.
b.
4. Offset Adjustments. 1 Before conducting measurements offset adjustments must be made to the measuring devices. (Refer to schematic diagram E160.20.2600.U3, Prog. Amplifier/Lowpass QA90)
a.
b.
5-3
5-4
WARNING!
HIGH VOLTAGES ARE CAPABLE
OF CAUSING DEATH!
USE EXTREME CAUTION WHEN PERFORMING TESTS AND CALIBRATION. USE ONLY INSULATED TOOLS WHEN THE UNIT IS
PLUGGED IN, AND THE CASE HOUSING IS OFF.
5.3 Calibration
1. Enclosure Leakage Current
a.
b.
c.
d.
Check that both the level of this current, and the readout on
the QA-90 display, are equal.
e.
b.
c.
d.
Check that both the level of this current, and the readout on
the QA-90 display, are equal.
e.
Press GO BACK (F2), then MORE (F1) to advance to Manual Test Setup Window 3.
F1
F2
F3
F7
F6
F5
F4
b.
c.
d.
5-5
e.
Use a current source to generate an AC current between Patient Leads 1-10 and EARTH. Check that both the level of
this current, and the current readout on the QA-90 display,
are equal. Press STOP (F1).
f.
g.
h.
b.
c.
d.
e.
Use a current source to generate an DC current between Patient Leads 1-10 and EARTH. Check that both the level of
this current, and the current readout on the QA-90 display,
are equal. Press STOP (F1).
f.
g.
h.
5-6
F7
F6
F5
MORE
GO BACK
F1
F2
MAIN MENU
F3
F4
5-7
b.
c.
d.
e.
Use a current source to generate an DC current (20 A) between Patient Leads 1-9 and Lead 10, and between Patient
Leads 1-8 and Lead 9. Check that both the level of this current, and the current readout on the QA-90 display, are
equal. Press STOP (F1).
f.
F1
F2
F3
F7
F6
F5
F4
b.
c.
d.
e.
f.
Check that both the level of this current, and the current readout on the QA-90 display, are equal.
g.
5-8
a.
b.
c.
8.
9.
d.
e.
f.
Check that the level of this current, and the current readout
on the QA-90s display are equal. If necessary, adjust the
voltage to be equal on UUT and reference. The constant
used is the SP/VDML U-constant.
g.
h.
Supply Voltage. An insulated transformer is used for this measurement, except for step 7.f. below.
a.
b.
c.
d.
e.
f.
g.
h.
Current Consumption. This measurement is done with a resistive load connected to the mains outlet on the front panel of the
QA-90. The reference digital multimeter (HP34401 or similar), in
current (AC) mode, is in series with the load. Use the digital multimeter in the 0 - 3 A range, and the same instrument with a current probe (HP34330A or similar) in the range > 3 A. The probe
and digital multimeter are calibrated together.
a.
b.
c.
Press STOP (F1). Check that the UUT and the reference
digital multimeter values are equal. If they are not equal, adjust the CC I-constant.
5-9
d.
a.
b.
c.
d.
5-10
a.
b.
c.
d.
e.
f.
Trim the test voltage to within 500 1 V. Then, use a calibrated resistor to measure values in the range 1-200 M.
NOTE
Never set any of the constants higher than 99.999.
g.
Using a reference resistor of 90-110 M, calculate the IR Uconstant 2 such that the QA-90 measures as closely as possible to that reference.
h.
NOTE
Remember that the patient
leads must be defined (1-10).
i.
j.
k.
l.
o.
Check that the current displayed on the UUT is in accordance with Ohms Law (253 or 132 VAC /test-box impedance). The measured alternating voltage, divided by the
voltmeters internal resistance.
p.
Bar Code Reader (Optional). This checks the QA-90 Bar Code
Reader function and its ability to properly accept scan and con-
5-11
5-12
a.
b.
Equipment Code :
...>
Sequence Name :
...>
Class: CL1 ,0 leads in 0 modules.......>
MORE
MEMORY
SETUP
START
F1
F2
F3
F6
F5
F4
c.
Scan an improperly formatted instrument bar code. The QA90 should beep to indicate this error.
d.
e.
Follow the procedure in paragraph 3.6 to advance to the display window containing the Module Code, No. of Leads
and Type.
Module Code :
.....>
No of leads :
.......................>
Type
: CF.......................>
ADD
GO BACK
PREV.
NEXT
F1
2.
F7
F2
F3
F7
F6
F5
F4
f.
g.
Automatic Test Sequence with Printout. This checks the QA90s sequence testing function. For the printout function a printer
must be connected to the QA-90, and be ON. See chapter 2 for
additional information.
a.
Test according to
Test Type
Test Mode
GO BACK
F1
F2
: IEC60601.1 ......>
: Rapid ...........>
: Manual ..........>
START
F3
F7
F6
F5
F4
5-13
b.
c.
When the test is completed the following Test Results Window appears.
F1
d.
F2
F3
F7
F6
F5
F4
Press Print test results (F6). Check the printout for legibility. Then, press Print failed results (F5). Check the printout
for legibility.
IMPORTANT
5-14
1.
2.
3.
4.
6.
CC I-constant. Adjust the current measurement for Current Consumption. When the parameter value increases, the measurement
value decreases.
7.
5-15
6-1
All terminals for connecting the machine under test to are located on
the front panel. The mains contact is located on the rear panel adjacent to the mains switch marked Power QA-90.
6.2 Measuring System
Refer to drawing no. E160.20.2000. U1.
The measuring board covers the entire base of the cabinet housing.
Test currents are generated from the rear-left edge of the metering
board. The forward section to the left is the measurement amplification unit with power to frequency conversion against the processor
component. Approximately two-thirds of the right-hand side of the
board comprises relay (sequence) drives and related relays for setting
up the various measurement modes and measurement inputs. All
communications with the CPU board occur via optical isolators,
which isolate the measurement and CPU components from one another.
Refer to Schematic Diagram E160.20.2000. U1 (High Voltage Interface QA-90) (Measuring Preparation QA-90). The metering system is
divided into six function blocks. The diagram contains the function
blocks, as well as the sequence functions for power and auxiliary terminals on the rear panel of the QA-90. The T2070 Measurement
Transformer is used for "current consumption" measurements.
Refer to Schematic Diagram E160.20.2100.U3 (High Voltage Interface QA-90). The high voltage (mains) interface component has several functions. T2110 gives the power frequency and synchronization
signal to the High-Voltage Logic (U2210). U2210 generates a 50-60
Hz rectangular signal respectively to U2220A (to give 253 VAC to
VDE measurements and to Mains on applied part measurements) and
to U2220C (which gives 500 VDC to insulation resistance measurements). 2220D emits a rectangular signal with a DC offset. The amplitude is adjusted by respectively R2224 for AC and R2228 for DC.
U2240 is a screening circuit with a center frequency set by D2240 depending on the mains frequency. The screen converts the DC signal to
almost a sinus signal. This then goes to an amplifier/buffer, referred to
as the "High Voltage Drives" (refer to Schematic Diagram
E160.20.2300.U3 (High Voltage Drives QA-90)), which in turn feeds
T2150 (page 2).
For measuring mains on applied part (253 VAC) the signal goes from
T2150, through the S2151 relay and 47 kOhm series resistor (R2150,
R2151), to the measuring object. For measuring insulation resistance
(500 VDC), the signal passes through the S2151 relay to the rectifier
6-2
module comprising D1, D2 and C2150, C2151 and out to the measuring object via a 102 kOhm series resistance. The series resistances
protect the voltage generators, the equipment under test, and users
against the high test voltages.
Schematic Diagrams E 160.20.2400.U3 (Applied Part Matrix) and
E 160.20.2500.U3 (Measurement Matrix) comprise relays that are set
up in accordance with the different measurements to be performed.
Diagram 5 includes relays that belong to measurements on the patient
leads. Diagram 6 includes relays for other measurement items, relays
for connecting an attenuator and for a filter (patient equivalent).
Schematic Diagram E160.20.2600.U3 (Prog. Amplifier and Lowpass)
is the measuring unit itself with a balanced measurement amplifier
B&B PGA202 CU2600) with variable gain controlled by P via optical isolators. The measurement amplifier module is supplied by a
separate power supply, based on a DC-DC converter that provides +
15 Volt. The SGND earth system for this power is isolated from GND
and the mains. OPA602 and R2616 are used to offset adjustment of
the measurement amplifier. Normally this is unnecessary, thus there is
a jumper between pins 1 and 2 on S2600 to avoid using the DC offset
function. U2610 is a filter that is operated by the S2420 relay during
"insulating resistance" measurements. Signals from the measurement
amplifier continue to an RMS to DC converter AD536AK, which in
turn generates a DC signal on a circuit for voltage to frequency conversion (U2641) LM231WM. The output signal (A/D frequency) goes
to P via optical isolators.
6.3 Microprocessor System
Refer to Drawing No. E160.20.1000. U1, containing six schematic
diagrams.
Refer to Schematic Diagrams 1 through 3 (QA-90; Integrated Keyboard QA-90; and CPU QA-90). The processor system is divided into
5 function blocks comprising a CPU, memory, display, printer interface, serial and keypad interface, and keypad board.
The QA-90's CPU and keypad board are located behind the front panel. The unit comprises a processor system, display, control components, connection to the metering board, an RS-232 port, printer port,
and a port for the bar code pen.
The processor controls the measurement process in the QA-90. Measured analogue values are converted to an A/D frequency that is
6-3
DESCRIPTION
QTY.
6-4
74LS05 SO IC
74HC32T SMD
DS2404S SMD
PA28F400BX-T60ES
MAX238CWG SMD
PD431000AGW-70LL
UPD71055GB SMD
74HCT573T SMD
74HCT574T SMD
74HC7266 SMD IC
1K 4609X101 SILMOTST
1K 82R POTMETER
2
2
1
1
1
1
1
1
1
1
1
1
COMPONENT PART
DESCRIPTION
30-4400547
30-4400690
30-4402612
30-4402692
30-4406811
30-4436864
30-4480000
30-4490327
30-5514065
30-5514327
30-5515025
30-5600000
30-5600017
30-5600020
30-5601201
30-5605222
30-5629801
30-5670010
30-5670016
30-5670026
30-6600100
30-6600105
30-7404004
30-8100000
98+1140010
98+1140133
98+1140210
98+1140227
98+ 1140233
98+ 1140247
98+1140310
98+1140312
98+1140322
98+1140327
98+1140347
98+1140368
98+1140510
98+1140610
98+2500522
98+2500568
98+2713347
98+2714010
98+2714022
98+2714222
98+2714310
98+2714321
98+2714410
98+3010016
98+3500847
98+3610846
98+3610857
QTY.
1
1
1
1
1
1
1
1
1
1
1
1
1
1
23
2
1
2
2
1
1
1
1
1
5
1
2
1
1
11
15
1
3
1
8
1
1
8
1
1
1
1
1
1
21
31
3
1
2
6-5
COMPONENT PART
DESCRIPTION
QTY.
MEASURING BOARD
30+3000033
30+4274404
30+4400071
30+4400353
30+4405517
30+4405841
30+4440280
30+4474132
30+1410320
30+1410327
30+1440510
30+1840256
30+1840257
30+1800350
30+1800390
30+1860168
30+1860222
30+1860247
30+2042250
30+2410647
30+2410721
30+2600510
30+2713415
30+2800411
30+2800512
30+2810233
30+2810246
30+2810405
30+3410006
30+3500031
30+3500032
30+3801680
30+4400110
30+4400172
30+4400231
30+4402630
30+4420825
30+4430203
30+4430537
30+5514035
30+5514060
30+5514315
30+5514324
30+5515816
6-6
1 F 630V MKT1813-510635
3,3nF 400V B32520-B6332K
4,7nF 400V B32520-B8472K
0,1 F -47R RC-LEDD
DF06M 600V 1A LIKERETTER
TIP31C EFF. TRANS. NPN
TIP32C EFF. TRANS. PNP
T1612MJ 600V ISOL. TRIAC
LCA110E MOS-S-KOBLER
CNY17 OPTOKOBLER
LM231N IC
HCPi_2630 OPTOKOBLER
GAL20V8A-25QP EL. LP
PGA202BG
AD536AKQ
5238-3 3 POL MOLEX
5238-6 6 POL MOLEX
14P IC SOCCET M/DR.BEIN
24P IC SOCCET SMAL
5281-6 6PIN
1
1
2
2
1
9
1
1
1
1
1
1
1
2
1
1
1
1
1
2
1
1
1
2
1
1
1
2
1
1
1
1
2
2
1
1
7
1
1
1
1
1
5
2
1
1
1
COMPONENT PART
DESCRIPTION
30+5600000
30+5630016
30+5800000
30+5900244
30+5902101
30+5902201
30+5902401
30+6600110
30+7403099
30+7404200
30+7446540
30+8100633
30+8310200
30+8310601
30+8315138
30+8315139
30+8320016
30+8431215
98+1140047
98+1140118
98+1140133
99+1140127
99+1140147
99+1140151
99+1140210
99+1140222
99+1140251
99+1140310
99-1140351
99-1140510
99-3104003
99-3104007
QTY.
1
4
1
17
2
1
4
48
11
1
2
1
1
4
2
2
2
2
1
1
1
4
2
1
2
1
1
1
1
1
2
3
2
4
2
6-7
6-8
Class 0. The mains part is completely separated from any of the accessible parts. The separation is
achieved by basic insulation. This is not used in medical applications.
2.
Class 1. In addition to the basic insulation, there is protection via the protective earth conductor in
the mains lead. This is intended to connect all the equipments accessible parts to earth. The majority of electromedical equipment is Class 1 equipment.
3.
Class 2. Equipment of this class is constructed with double insulation, i.e., two distinct insulating
layers around the mains part. The purpose is that, should the basic insulation of the mains part fail,
and then a second insulating barrier exists to prevent the mains from coming into contact with the
user or patient. (See illustration below.)
A-1
4.
5.
Class 3. Equipment of this classification is no longer manufactured, and the classification was removed
from IEC 601.1 in 1988. The equipment was powered via an isolating, or safety transformer, which
generated at its secondary winding a Medical Safety Extra Low Voltage (MSELV).
Symbols. A particular degree of protection afforded a patient against an electric shock, arriving from
the applied part, defines the type of applied part. The symbols for each type of protection are shown below:
Symbols
B=
Description
Symbols
Description
Type B
Type B
Defib Protection
Type BF
Type BF
Defib Protection
Type CF
Type CF
Defib Protection
A-2
6.
Enclosure Tests
Systems Tests
A-3
A.2 Tests on Mains Powered Class 1 & 2 Equipment According To IEC 601.1/UL 2601.1
1.
2.
3.
Measures impedance of Protective Earth Terminal to all exposed parts of the instrument under
test, which are connected to the Protective Earth.
Normally includes the wiring in the mains cable (maximum 0.2 Ohms). Without the mains cable, the maximum is 0.1 Ohms.
Measures insulation resistance of power leads (live and neutral wires together) to the Protective Earth terminal of the instrument under test.
A-4
4.
5.
Measures insulation resistance between the Applied Part, to the Protective Earth terminal of
the instrument under test.
Measures earth leakage current of the instrument under test connected to the mains power
supply; normal and reversed polarity using S2.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Measures earth leakage current of the instrument under test, with one open supply lead interrupted (S1 = open); normal and reversed polarity using S2.
A-5
6.
7.
A-6
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Measures leakage current of the exposed metal parts of the instrument under test; normal and
reversed polarity using S2.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Measures leakage current of the exposed metal parts of the instrument under test, with one
open supply lead interrupted (S1 = open); normal and reversed polarity using S2.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
8.
9.
Measures leakage current of the exposed metal parts of the instrument under test with Protective Earth open circuit (S4 = open); normal and reversed polarity using S2.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Measures patient leakage current to earth from all Applied Parts in parallel; normal and reversed polarity using S2.
Maximum leakage current Types B and BF: 100 A (Range: DC and AC up to 1 kHz). For
Type CF: 10 A (Range: DC and AC up to 1 kHz).
A-7
Measures patient leakage current to earth from all Applied Parts in parallel with one supply
lead interrupted (S1 = open); normal and reversed polarity using S2.
Maximum leakage current Types B and BF: 500 A (Range: DC and AC up to 1 kHz). For
Type CF: 50 A (Range: DC and AC up to 1 kHz).
A-8
Measures leakage current to earth from all Applied Parts in parallel with the Protective Earth
open circuit (S4 = open); normal and reversed polarity using S2.
Maximum leakage current Types B and BF: 500 A (Range: DC and AC up to 1 kHz). For
Type CF: 50 A (Range: DC and AC up to 1 kHz).
12. Test P.L.C. 4 - Patient Leakage Current: S.F.C. Mains on Applied Part
Measures leakage current to earth from Applied Part to earth caused by external mains voltage
on Applied Part, and with switch S5 open and closed.
Maximum leakage current Type BF: 5000 A (Range: DC and AC up to 1 kHz). For Type
CF: 50 A (Range: DC and AC up to 1 kHz) (100 A for CF defib paddles: IEC 601-2-4).
A-9
A-10
Measures the current flowing between one of the Applied Parts and all of the others in parallel, e.g., patient leads; normal and reversed polarity using S2.
Maximum auxiliary current Types B and BF: 10 A DC; 100 A (Range: AC 0.1 Hz up to 1
kHz). For Type CF: 10 A (Range: DC and AC up to 1 kHz).
Measures the current flowing between one of the Applied Parts and all of the others in parallel
with one supply lead interrupted (S1 = open); normal and reversed polarity using S2.
Maximum auxiliary current Types B and BF: 50 A DC; 500 A (Range: AC 0.1 Hz up to 1
kHz). For Type CF: 50 A (Range: DC and AC up to 1 kHz).
A-11
15. Test P.A.C. 3 - Patient Auxiliary Current: S.F.C. Open Earth (Ground)
A-12
Measures the current flowing between one of the Applied Parts and all of the others in parallel
with the Protective Earth open circuit (S4 = open); normal and reversed polarity using S2.
Maximum auxiliary current Types B and BF: 50 A DC; 500 A (Range: AC 0.1 Hz up to 1
kHz). For Type CF: 50 A (Range: DC and AC up to 1 kHz).
2.
Measures leakage current of the exposed metal parts of the instrument under test.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Measures the patient leakage current from the Applied Parts to the enclosure.
For Type BF and CF equipments, measures with the AP/GND switch S3 open and closed.
Maximum auxiliary current Types B and BF: 100 A (Range: DC and AC up to 1 kHz). For
Type CF: 10 A (Range: DC and AC up to 1 kHz).
A-13
3.
4.
A-14
Measures the patient leakage current from the Applied Parts to the enclosure caused by the external mains voltage on the Applied Part.
Measures the current flowing from one of the Applied Parts and all the others in parallel.
Maximum auxiliary current Types B and BF: 10 A DC; 100 A (Range: AC 0.1 Hz up to 1
kHz).
2.
Measures leakage current of the exposed metal parts of the instrument under test and between
parts of the system within the patient environment; normal and reversed polarity using S2.
Measures leakage current of the exposed metal parts of the instrument under test with Protective Earth open circuit (S4 = open), and between parts of the system within the patient environment; normal and reversed polarity using S2.
A-15
2.
A-16
Test VDE 0751-1 Test 1 - Replacement Leakage Current Fig. 9. (Ersatz - Ableitstrom nach
Bild 9)
Applicable to Classes 1 and 2, Types B, BF and CF. (For Class 1: Protective Earth conductor
is not connected.)
Measures replacement leakage current to earth from all Applied Parts and enclosure in parallel; normal and reversed polarity using S.
Test VDE 0751-1 Test 2 - Replacement Equipment Leakage Current (Ersatz - Gerteableitstrom)
Measures replacement leakage current to mains part from all Applied Parts and enclosure in
parallel, with Protective Earth wire connected.
3.
Test VDE 0751-1 Test 3 (Replacement Patient Leakage Current) (Ersatz - Patientableitstrom)
Measures replacement leakage current to mains part from all Applied Parts and enclosure in
parallel.
Maximum leakage current Type BF: 5000 A. For Type CF: 50 A (100 A for CF defib
paddles).
A-17
A-18
APPENDIX B: DIAGRAMS
Mains & EUT Connections Schematic Diagram ............................................................................ B-2
Measuring Board Component Location, Layer 1 ............................................................................ B-3
Measuring Board Component Location, Layer 2............................................................................ B-4
Measuring System Schematic Diagram Part 1 (Measuring Preparation) ........................................ B-5
Measuring System Schematic Diagram Part 2 (High Voltage Interface) ........................................ B-6
Measuring System Schematic Diagram Part 3 (High Voltage Logic) ............................................. B-7
Measuring System Schematic Diagram Part 4 (High Voltage Drives) ........................................... B-8
Measuring System Schematic Diagram Part 5 (Applied Part Matrix) ............................................ B-9
Measuring System Schematic Diagram Part 6 (Measurement Matrix) ......................................... B-10
Measuring System Schematic Diagram Part 7 (Program Amplifier and Lowpass) ...................... B-11
Measuring System Schematic Diagram Part 8 (Relay Drivers) .................................................... B-12
Microprocessor Board Component Location ................................................................................ B-13
Keypad Board Component Location ............................................................................................ B-14
Microprocessor System Schematic Diagram Part 1 (QA-90) ....................................................... B-15
Microprocessor System Schematic Diagram Part 2 (Integrated Keypad) ..................................... B-16
Microprocessor System Schematic Diagram Part 3 (CPU) .......................................................... B-17
Microprocessor System Schematic Diagram Part 4 (Memory)..................................................... B-18
Microprocessor System Schematic Diagram Part 5 (Printer and Display Interface) .................... B-19
Microprocessor System Schematic Diagram Part 6 (Series and Keypad Interface) ..................... B-20
B-1
B-2
DESCRIPTION
METRON
DRAW CAT.
Schematic diagram
DRAW NO.
E160.20.0F00.U3
PRODUCT
DATE
QA-90
PAGE
20.11.1995
1 of 1
B-3
B-4
B-5
B-6
B-7
B-8
DESCRIPTION
METRON
DRAW CAT.
E160.20.2300.U3
PRODUCT
DATE
QA-90
PAGE
17.10.1995
4 of 8
B-9
DESCRIPTION
METRON
DRAW CAT.
E160.20.2400.U3
PRODUCT
DATE
QA-90
B-10
PAGE
17.10.1995
5 of 8
B-11
B-12
B-13
B-14
DESCRIPTION
Keypad Board
METRON
DRAW CAT.
Component Location
DRAW NO.
.
PRODUCT
DATE
QA-90
PAGE
17.10.1995
1 of 1
B-15
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DESCRIPTION
METRON
DRAW CAT.
E160.20.1300.U1
PRODUCT
DATE
QA-90
PAGE
15.03.1994
6 of 6
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FRANCE
30, rue Paul Claudel
91000 Evry, France
Phone: (+33) 1 6078 8899
Fax:
(+33) 1 6078 6839
E-mail: metronfrance@infonie.fr
NORWAY
Travbaneveien 1
N-7044 Trondheim, Norway
Phone: (+47) 7382 8500
Fax:
(+47) 7391 7009
E-mail: support@metron.no
From: (name)
Address:
Phone:
Fax:
Date:
Product:
Version:
Type
Wrong results
Program stops, no reaction
Other
Description of the situation prior to the error:
Critical
Correction date:
Minor
Ref No.
Normal
C-1
C-2
FRANCE
30, rue Paul Claudel
91000 Evry, France
Phone: (+33) 1 6078 8899
Fax:
(+33) 1 6078 6839
E-mail: metronfrance@infonie.fr
NORWAY
Travbaneveien 1
N-7044 Trondheim, Norway
Phone: (+47) 7382 8500
Fax:
(+47) 7391 7009
E-mail: support@metron.no
From: (name)
Address:
Phone:
Fax:
Date:
Product:
Version:
Type
One window
Several windows
Documentation
Description of the suggested improvement:
Presentation
Options, configuration possibilities
Other
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D-2