QA-ST

User and Service Manual

QA-ST Safety Tester

North American Version 1.2

Copyright  2004 by METRON. All rights reserved.

METRON:

USA_ ____ FRANCE________ GERMANY NORWAY______

1345 Monroe NW 30, rue Paul Claudel Gundastrasse 29 Vegamot 8
Grand Rapids, MI 49505 91000 Evry, France D-63762 Grossostheim N-7048 Trondheim
Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+49) 6026 993975 Phone: (+47) 7395 4700
Fax: (+1) 616 454 3350 Fax: (+33) 1 6078 6839 Fax: (+49) 6026 977079 Fax: (+47) 7395 4701
E-mail: [email protected] E-mail: [email protected] E-mail:[email protected] 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 jurisdic-
tions 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-ST Safety Tester 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 simulator, if the fault is due to a manufac-
turing 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-ST Safety Tester, 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-ST Safety Tester. Neither
METRON nor its local representatives will accept, nor be bound by any other form of guarantee concerning the
QA-ST Safety Tester other than this guarantee. Some jurisdictions do not allow disclaimers of expressed or im-
plied warranties in certain transactions; therefore, this statement may not apply to you.

ii
 Table of Contents

1. INTRODUCTION...............................................................................................................................1-1
1.1 Features....................................................................................................................................1-1
1.2 Specifications ............................................................................................................................1-1
1.3 General Information ..................................................................................................................1-2
2. INSTALLATION ................................................................................................................................2-1
2.1 Receipt, Inspection and Return .................................................................................................2-1
3. OPERATING QA-ST .........................................................................................................................3-1
4. QA-ST SAFETY TESTS .................................................................................................................4-1
4.1 Linearity Test of Voltmeter (Lead to Lead) ................................................................................4-1
4.2 Mains Supply Voltage ...............................................................................................................4-2
4.3 Ground Wire Resistance DC.....................................................................................................4-3
4.4 Leakage Current – Internal Case ..............................................................................................4-4
4.5 Leakage Current – External Case .............................................................................................4-5
4.6 Patient Leakage Current – Lead to Lead ..................................................................................4-6
4.7 Patient Leakage Current – Lead to Ground ..............................................................................4-7
4.8 Leakage Current – Lead to ISO ................................................................................................4-8
5. CALIBRATION..................................................................................................................................5-1
5.1 Linearity Test of Voltmeter (Lead to Lead) ................................................................................5-1
5.2 Mains Supply Voltage ...............................................................................................................5-2
5.3 Ground Wire Resistance DC.....................................................................................................5-3
5.4 Leakage Current – Internal Case ..............................................................................................5-4
5.5 Leakage Current – External Case .............................................................................................5-5
5.6 Patient Leakage Current – Lead to Lead ..................................................................................5-6
5.7 Patient Leakage Current – Lead to Ground ..............................................................................5-7
5.8 Leakage Current – Lead to ISO ................................................................................................5-8
APPENDIX A – CIRCUIT BOARD SCHEMATIC (NORTH AMERICAN VERSION).............................. A-1
APPENDIX B – ERROR REPORT FORM ............................................................................................. B-1

APPENDIX C - IMPROVEMENT SUGGESTION FORM ....................................................................... C-1

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iv
 Manual Revision Record

This record page is for recording revisions to your QA-ST User and Service Manual that have been published
by METRON AS or it’s authorized representatives. We recommend that only the management or facility rep-
resentative authorized to process changes and revisions to publications:

• make the pen changes or insert the revised pages;

• ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as superseded
and placed in a superseded document file, and;
• enter the information below reflecting that the revisions have been entered.
Rev No Date Entered Reason Signature of Person Entering Change
1.2 01.15.04 General update

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vi
 1. Introduction

This chapter describes the METRON QA-ST Safety Tester’s features

and specifications.

1.1 Features
The QA-ST is designed to quickly check electrical safety on medical
and industrial devices. It is palm-sized and very portable. The tests
can be performed manually or in step-by-step mode. The results are
displayed in a bright 4-digit LCD display.
The QA-ST performs all electrical safety tests necessary to satisfy
AAMI ESI, NFPA-99, VDE 701, VDE 751 and HEI 95. It also features
differential current measurements obtained by an internal current
clamp. This presents a new leakage current measurement technique
for convenient testing of medical equipment with a fixed power cord
(hardwired to wall, not detachable).

1.2 Specifications1

1. Line Voltage Measurement

Range: 0 - 300 V
Accuracy:± 1% reading, ± 1 digit
Resolution: 1 V L-N
2. Current Capacity
15 Amps @ 100 Volts
15 Amps @ 120 Volts
10 Amps @ 230 Volts
3. Resistance Measurement
DC-Source:
Range: 0 - 19.99 Ohms
Accuracy:± 2%reading, ± 1 digit
Resolution: 0.01 ohms
Current Source: 100 mA DC
AC-Source:
Range: 0 - 1999 mOhms
Accuracy:± 2% reading, ± 1 digit
Resolution: 1 mOhm
Current Source: 200 mA AC
4. Leakage Current
Range: 0 - 1999 µA RMS
Accuracy:DC and 25 to 1.0 kHz, ± 2% reading, ± 1 digit
1.0 kHz to 100 kHz, ± 2.5%R, ± 1 digit
100 kHz to 1 MHz, ± 5.0%R, ± 1 digit
Resolution: 1 µA
5. Input Impedance

1
For North American QA-ST Version 1.1
 1000 ohm, AAMI ES1-1993 load or
IEC 60601.1 load
6. Power Consumption
110 V (50/60) Hz = 200 mA
115 V (50/60) Hz = 200 mA
240 V (50/60) Hz = 100 mA

1.3 General Information

1. Temperature Requirements:
+15/59 to +35/95 °C/F while operating
0 to +50/122 °C/F for storage
2. Display:
Type: LCD
Numeric format: 4 characters
Display control: Keypad
3. Power: 100V/110V or 230V/240V, 50/60 Hz
4. Housing: Plastic case
5. Physical Dimensions (D x W x H):
191mm x 135mm x 45mm
7.5 in x 5.3 in x 1.8 in
6. Weight: 930 g / 2.0 lbs.

1.4 QA-ST Ordering Information

Order no:
11040: QA-ST Electrical Safety Analyzer
(Specify power supply socket.)
Standard Accessories:
11045: User/Service Manual QA-ST
17290: Test Lead (Kelvin Cable)
Various power supply socket including:
European Schuco, French Schuco, UK, Swiss,
Australian, US.
Optional Accessories:
11041: Carrying Case

1-2
 2. Installation

This chapter explains unpacking, receipt inspection, claims, and the

general procedures for QA-ST setup.

2.1 Receipt, Inspection

and Return
1. Inspect the outer box for physical damage.
2. Carefully unpack all items from the box and check to see that you
have the following items:
• QA-ST Electrical Safety Analyzer (P.N. 11040)
• User/Service Manual QA-ST (P.N. 11045)
• Test Lead (Kelvin Cable) (P.N. 17290)
• Specified power supply socket
3. If you note physical damage, or if the unit fails to function accord-
ing to specification, inform the supplier immediately. When MET-
RON or the company’s Sales Agent, is informed, measures will be
taken to either repair the unit or dispatch a replacement. The cus-
tomer will not have to wait for a claim to be investigated by the
Sales Agent. The Customer should issue a new purchase order to
ensure delivery.
4. When returning an instrument to METRON, or the Sales Agent, 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 or its Sales Agent.

2-1
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 3. Operating the QA-ST

This chapter describes the controls and terminals of the QA-ST Safety
Tester.

3-1
Binary display format:
LEAD NUMBER DISPLAY X=ON O=OFF
1 OOOX
2 OOXO
3 OOXX
4 OXOO
5 OXOX
6 OXXO
7 OXXX
8 XOOO
9 XOOX
10 XOXO

3-2
 4. QA-ST Safety Tests
This chapter describes QA-ST safety tests by function. If you are un-
familiar with the simulators’ basic operation, refer to paragraph 3.3,
Operating QA-ST.
NOTE: When the QA-ST is initially powered up, the unit will be in a de-
fault condition. At this time no measurements are being performed.

4.1 Leakage Current

(Lead to Lead)
The purpose of this test is to test for any leakage current between pa-
tient leads (applied parts).
1. Connect patient leads to the QA-ST starting with port 1, then 2
and so forth.

2. Press “Patient Current Lead to Lead”.

3. The result for Lead 1 will be displayed on the LCD display. To

test Lead 2, press “Patient Current Lead to Lead”. Observe
that the lead under test number is indicated in binary format by
the LEDs in the “Measurements” area located below the LCD
display.

4-1
4.2 Mains Supply Voltage

The purpose of this test is to have the QA-ST display the Mains Sup-
ply Voltage coming into the QA-ST. This is measured between Hot
and Neutral.
1. Press “Supply V”.

2. The value will be displayed on the LCD. The LED “ON” in the
“Measurements” box will illuminate.

4-2
4.3 Ground Wire Resistance DC
The purpose of this test is to determine if there is any DC resistance
between the cabinet of the Device Under Test (DUT) and the Mains
Supply Ground on the DUT.
1. Press “Ground Wire Res. DC”. QA-ST will display over range (1).

2. Connect the Kelvin Test Lead to the cabinet of the DUT.

3. The resistance value will be displayed on the LCD.

4-3
4.4 Leakage Current – Internal Case
The purpose of this test is to determine if there is any leakage current
between DUT Ground and Mains Supply Ground.
1. Plug in the DUT into the “Outlet Supply”.

2. Press “Leakage current Int. Case”.

3. Next, press “Outlet Supply RS” (Reversed Supply). The displayed

QA-ST value may change.

4. Then, press “Outlet Supply OG” (Open Ground). The displayed

QA-ST value may change.

4-4
4.5 Leakage Current – External Case
The purpose of this test is to determine if there is any leakage current
between DUT Enclosure (chassis) and Mains Supply Ground.
1. Connect the Kelvin Clamp to the chassis of the DUT.

2. Press “Leakage current Ext. Case”.

3. The value will be displayed on the LCD. Note the value.

4. Next, press “Outlet Supply RS” (Reversed Supply). The displayed
QA-ST value may change.

5. Then, press “Outlet Supply OG” (Open Ground). The displayed

QA-ST value may change.

4-5
4.6 Patient Leakage Current
Lead to Lead
The purpose of this test is to determine if there is any patient leakage
current between DUT Enclosure (chassis) and Mains Supply Ground.
1. Connect all patient leads to the QA-ST starting with lead 1, then
lead 2, and so forth.

2. Press “Patient leakage current – lead to lead”.

3. The result will be displayed on the LCD. Note the value.

4. Press “lead to lead” to change the patient lead number. The diode
panel will display, in binary format, the number of the actual pa-
tient lead that is under test.

4-6
4.7 Patient Leakage Current
Lead to Ground
The purpose of this test is to determine if there is any leakage current
between all the patient leads in parallel, and DUT Ground.
1. Connect all patient leads to the QA-ST starting with lead 1, then
lead 2, and so forth.

2. Press “Patient leakage current lead to GND” (Ground).

3. The value will be displayed on the LCD. Note the value.

4-7
4.8 Leakage Current - Lead to ISO
The purpose of this test is to determine the quality of isolation between
the DUT chassis and all of the patient leads in series.
1. Connect all patient leads to the QA-ST starting with lead 1, then
lead 2, and so forth.
Connect the Kelvin Clamp to the chassis of the DUT.
NOTE: All patient leads are connected internally within the QA-ST
to the same potential.

2. Press and hold “lead ISO”.

CAUTION: During the lead isolation test high voltage is present at the
patient lead connections. While there is a resistor in the test circuit,
making the risk of dangerous shock minimal, caution should be taken
to avoid contact with the patient lead inputs or conductive applied
parts during this test.

3. The results will be displayed on the LCD.

4-8
 5. Calibration

This chapter describes the QA-ST calibration by function. If you are

unfamiliar with the simulators’ basic operation, refer to paragraph 3.3,
Operating QA-ST.

5.1 Linearity Test of Voltmeter

(Lead to Lead)
The purpose of this test is to calibrate the display/voltmeter.
2. Connect a voltage source in series with an ammeter and 10KΩ
resistance as shown below.

4. Press “Patient Current Lead to Lead”.

5. Adjust the voltage source until the ammeter displays 1000µA.

Then, adjust the QA-ST potentiometer R63 (see Appendix A for
location) until the QA-ST LCD displays the same 1000µA value.

5-1
5.2 Mains Supply Voltage

The purpose of this test is to calibrate the QA-ST to display the correct
mains voltage.
3. Press “Supply V”.

4. Adjust the mains voltage with an external variable AC voltage

(VARIAC) source. Then, adjust the QA-ST potentiometer R67
(see Appendix A for location) until the QA-ST LCD displays the
same value.
5. Perform the test for tall the given values in the test protocol under
“Mains Supply Voltage: Reference”.

5-2
5.3 Ground Wire Resistance DC
The purpose of this test is to determine if there is any DC resistance
between the cabinet of the device under test, or DUT, and the Mains
Earth on the DUT.
4. Press “Ground Wire Res. DC”. QA-ST will display over range (1).

5. Connect a Kelvin Test Lead in series with an ammeter directly to

DUT Earth. QA-ST will display 102mA ± 2%.
6. Next, connect as shown in the below figure, without the ammeter
and test leads.

7. Perform the test for tall the given values in the test protocol under
“Ground Wire Resistance DC: Reference”.

5-3
5.4 Leakage Current – Internal Case
The purpose of this test is to determine if there is any leakage current
between DUT Earth and Mains Earth.
5. Connect a voltage source in series with an ammeter and 10KΩ
resistance as shown below.

6. Press “Leakage current Int. Case”.

7. Adjust the voltage until the ammeter displays the first reference
value in the test protocol. QA-ST will display the same value as
the reference ammeter. Note the value.
8. Next, press “Outlet Supply RS” (Reversed Supply). The displayed
QA-ST value will not change.

9. Then, press “Outlet Supply OG” (Open Ground). The displayed

QA-ST value will not change.

10. Perform the test for tall the given values in the test protocol under
“Leakage Current Int. Case: Reference”.

5-4
5.5 Leakage Current – External Case
The purpose of this test is to determine if there is any leakage current
between DUT Enclosure (chassis) and Mains Earth.
6. Connect a voltage source in series with an ammeter and 10KΩ
resistance as shown below.

7. Press “Leakage current Ext. Case”.

8. Adjust the voltage until the ammeter displays the first reference
value in the test protocol. QA-ST will display the same value as
the reference ammeter. Note the value.
9. Next, press “Outlet Supply RS” (Reversed Supply). The displayed
QA-ST value will not change.

10. Then, press “Outlet Supply OG” (Open Ground). The displayed
QA-ST value will not change.

7. Perform the test for tall the given values in the test protocol under
“Leakage Current Ext. Case: Reference”.

5-5
5.6 Patient Leakage Current
Lead to Lead
The purpose of this test is to determine if there is any patient leakage
current between DUT Enclosure (chassis) and Mains Earth.
5. Connect a voltage source in series with an ammeter and 10KΩ
resistance as shown below.

6. Press “Patient leakage current – lead to lead”.

7. Adjust the voltage until the ammeter displays the first reference
value in the test protocol. QA-ST will display the same value as
the reference ammeter. Note the value.
8. Press “lead to lead” to change the patient lead number. The diode
panel will display, in binary format, the number of the actual pa-
tient lead that is under test.
9. Perform the test for tall the given values in the test protocol under
“Patient Leakage Current Lead to Lead: Reference”.

5-6
5.7 Patient Leakage Current
Lead to Ground
The purpose of this test is to determine if there is any leakage current
between all the patient leads in parallel, and DUT Earth.
4. Connect a voltage source in series with an ammeter and 10KΩ
resistance as shown below.

5. Press “Patient leakage current lead to GND” (Ground).

6. Adjust the voltage source until the ammeter displays the first ref-
erence value in the test protocol. QA-ST will display the same
value as the reference ammeter. Note the value.
7. Perform the test for all the given values in the test protocol under
“Patient Leakage Current Lead to GND: Reference”.

5-7
5.8 Leakage Current - Lead to ISO
The purpose of this test is to determine the quality of isolation between
the DUT chassis and all of the patient leads in series.
4. Connect Kelvin test leads in series with an ammeter and a refer-
ence resistance to one of the patient leads (see below). Note that
all patient leads are connected internally within the QA-ST to the
same potential.

5. Press “lead ISO”.

6. Adjust the voltage source until the ammeter displays the first ref-
erence value in the test protocol. QA-ST should display the same
value as the reference ammeter. Note the value. If the ammeter
value is not the same as the reference value, adjust the mains us-
ing potentiometer R67. (See Appendix A)

7. Perform the test for tall the given values in the test protocol under
“Leakage Current to ISO: Reference”.

5-8
Appendix A - Circuit Board Schematic (North American Version)

A-1
 This page intentionally left blank.

A-2
USA ____ FRANCE________ GERMANY NORWAY______
1345 Monroe NW 30, rue Paul Claudel Gundastrasse 29 Vegamot 8
Grand Rapids, MI 49505 91000 Evry, France D-63762 Grossostheim N-7048 Trondheim
Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+49) 6026 993975 Phone: (+47) 7395 4700
Fax: (+1) 616 454 3350 Fax: (+33) 1 6078 6839 Fax: (+49) 6026 977079 Fax: (+47) 7395 4701
E-mail: [email protected] E-mail: [email protected] E-mail:[email protected] E-mail: [email protected]

From: (name) Phone:

Address: Fax:
E-mail:
Date:

Error Report
Product: Version: Serial no.:

Description of the situation prior to the error:

Description of the error:

(METRON AS internally)
Comments:

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

B-1
USA ____ FRANCE________ GERMANY NORWAY______
1345 Monroe NW 30, rue Paul Claudel Gundastrasse 29 Vegamot 8
Grand Rapids, MI 49505 91000 Evry, France D-63762 Grossostheim N-7048 Trondheim
Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+49) 6026 993975 Phone: (+47) 7395 4700
Fax: (+1) 616 454 3350 Fax: (+33) 1 6078 6839 Fax: (+49) 6026 977079 Fax: (+47) 7395 4701
E-mail: [email protected] E-mail: [email protected] E-mail:[email protected] E-mail: [email protected]

From: (name) Phone:

Address: Fax:
E-mail:
Date:

Improvement Suggestion
Product: Version:

Description of the suggested improvement:

(METRON AS internally)
Comments:

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

C-1
USA ____ FRANCE________ GERMANY NORWAY______
1345 Monroe NW 30, rue Paul Claudel Gundastrasse 29 Vegamot 8
Grand Rapids, MI 49505 91000 Evry, France D-63762 Grossostheim N-7048 Trondheim
Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+49) 6026 993975 Phone: (+47) 7395 4700
Fax: (+1) 616 454 3350 Fax: (+33) 1 6078 6839 Fax: (+49) 6026 977079 Fax: (+47) 7395 4701
E-mail: [email protected] E-mail: [email protected] E-mail:[email protected] E-mail: [email protected]