METRON QA-90 Guida alla risoluzione dei problemi

QA-90

User & Service Manual

QA-90 Electrical Safety Analyzer

P/N 11025

V.3.13

METRON:

USA ____ FRANCE________ NORWAY ____

1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1

Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, Norway

Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+47) 7382 8500

Fax: (+1) 616 454-3350 Fax: (+33) 1 6078 6839 Fax: (+47) 7391 7009

E-mail: support.us@metron-biomed.com E-mail: [email protected] 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 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-90 Electrical Safety Analyzer will substantially conform to published specifi-

cations 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 Safe-

ty Analyzer, even if advised of the possibility of such damages. METRON or its local representatives are not re-

sponsible 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 jurisdic-

tions 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.

iii

Table of Contents

MANUAL REVISION RECORD .........................................................................................................V

1. INTRODUCTION ................................................................................................................... 1-1

1.1 QA-90 Features...................................................................................................................1-1

1.2 Specifications......................................................................................................................1-1

1.3 General Information............................................................................................................1-3

2. INSTALLATION..................................................................................................................... 2-1

2.1 Receipt, Inspection and Return...........................................................................................2-1

2.2 Setup...................................................................................................................................2-2

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

2.4 PRO-Soft QA-90.................................................................................................................2-2

3. OPERATING QA-90............................................................................................................... 3-1

3.1 Control Switches and Connections .....................................................................................3-1

3.2 Key Pad Functions..............................................................................................................3-3

3.3 Function of The Bar Code Reader ......................................................................................3-3

3.4 Menu and Function Keys....................................................................................................3-4

3.5 Display Menus and Messages.............................................................................................3-4

3.6 Measurements with Several Modules in Manual Mode....................................................3-10

3.7 Storing Setup Parame- ters in Flash Memory....................................................................3-11

3.8 Upgrading the QA-90 Software Program..........................................................................3-13

3.9 Cleaning the QA-90..........................................................................................................3-15

4. EXAMPLE TEST MEASUREMENTS ................................................................................. 4-1

4.1 Test Lead Calibration..........................................................................................................4-1

4.2 Connecting an Instrument without Patient Inputs ...............................................................4-2

4.3 Connecting an Instrument with Patient Inputs ....................................................................4-3

4.4 Power Cable Test................................................................................................................4-6

4.5 Current Measurement Test (Dual Lead)..............................................................................4-7

4.6 Voltage Measurement Test (Dual Lead).............................................................................4-9

4.7 Resistance Measurement (Dual Lead)...............................................................................4-11

4.8 Connecting Auxiliary Power Source / Isolating Transformer ...........................................4-12

5. CONTROL AND CALIBRATION........................................................................................ 5-1

5.1 Required Test Equipment ...................................................................................................5-1

5.2 Preparation and Adjustments..............................................................................................5-1

5.3 Calibration ..........................................................................................................................5-5

5.4 Other Calibration Procedures............................................................................................5-11

5.5 Calibration Constants........................................................................................................5-14

6. COMPONENT FUNCTIONS AND PARTS......................................................................... 6-1

6.1 Theory of Operation............................................................................................................6-1

6.2 Measuring System...............................................................................................................6-2

6.3 Microprocessor System.......................................................................................................6-3

6.4 Component Parts.................................................................................................................6-4

APPENDIX A: IEC 601.1, UL 2601.1 AND VDE 0751 TESTING ................................................A-1

A.1 Classification of Equipment...............................................................................................A-1

A.2 Tests on Mains Powered Class 1 & 2 Equipment According To IEC 601.1/UL 2601.1 ...A-4

A.3 Tests on Internally Powered Equipment According To IEC 601.1/UL 2601.1 ...............A-13

A.4 System Tests Based on IEC 601.1/UL 2601.1.................................................................A-15

A.5 Tests According To VDE 0751-1, 10/1990.....................................................................A-16

APPENDIX B: DIAGRAMS..............................................................................................................B-1

Mains & EUT Connections Schematic Diagram ............................................................................B-3

Measuring Board Component Location Layer 1.............................................................................B-4

Measuring Board Component Location Layer 2.............................................................................B-5

Measuring System Schematic Diagram Part 1 (Measuring Preparation).......................................B-6

Measuring System Schematic Diagram Part 2 (High Voltage Interface).......................................B-7

Measuring System Schematic Diagram Part 3 (High Voltage Logic)............................................B-8

Measuring System Schematic Diagram Part 4 (High Voltage Drivers).........................................B-9

Measuring System Schematic Diagram Part 5 (Applied Part Matrix) .........................................B-10

Measuring System Schematic Diagram Part 6 (Measurement Matrix)........................................B-11

Measuring System Schematic Diagram Part 7 (Program Amplifier and Lowpass).............................B-12

Measuring System Schematic Diagram Part 8 (Relay Drivers)...................................................B-13

Microprocessor Board Component Location................................................................................B-14

Keypad Board Component Location ............................................................................................B-15

Microprocessor System Schematic Diagram Part 1 (QA-90)......................................................B-16

Microprocessor System Schematic Diagram Part 2 (Integrated Keypad)....................................B-17

Microprocessor System Schematic Diagram Part 3 (CPU) .........................................................B-18

Microprocessor System Schematic Diagram Part 4 (CPU) .........................................................B-19

Microprocessor System Schematic Diagram Part 5 (Printer and Display Interface)...........................B-20

Microprocessor System Schematic Diagram Part 6 (Series and Keypad Interface)............................B-21

APPENDIX C: ERROR REPORT FORM, QA-90.........................................................................C-1

APPENDIX D: SUGGESTION FORM, QA-90...............................................................................D-1

Manual Revision Record

This record page is for recording revisions to your QA-90 User and Service Manual that have been

published by METRON or its authorized representatives. We recommend that only the management

or facility representative authorized to process changes and revisions to publications:

•make the pen changes or insert the revised pages;

•ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as su-

perseded and placed in a superseded document file, and;

•enter the information below reflecting that the revisions have been entered.

Rev No

Date Entered

Reason

Signature of Person Entering Change

0 - Initial Release

3.13-1

4-26-01

General update

Symbols Used In This Manual

Caution (Refer to accompanying documents) (See NOTE)

Caution, Risk of Electrical Shock (see NOTE)

Earth (ground) TERMINAL

1-1

1. Introduction

This chapter describes the QA-90 Electrical Safety Tester’s 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 ex-

ecutes 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 ex-

port formatted data to any other database or equipment management

program. Individual test sequences may be compiled to satisfy na-

tional 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, ÖVE 0751, UL 544, HEI 95, HEI 158 among others.

1.2 Specifications 1. Voltage Measurement

Measurements may be obtained in the following ways:

•Between leads 1 and 2 (in the power contact).

•Between lead 1 and ground (in the power contact).

•Between lead 2 and ground (in the power contact).

•Between input/output E+ and E- (floating inputs/outputs).

Range

0 - 400V true RMS.

Resolution 0.1V

Accuracy

DC - 100 Hz, 1% of full scale +1 LSD

100 Hz-10 kHz, 2% of scale +1 LSD

No. of Tests

4 or multiple (LSD = least significant digit)

2. Current Consumption

1-2

The current measurement may be executed in lead no. 1 (live).

Range 1

0 - 1000 mA RMS (@ <250VAC)

Resolution

1 mA

Accuracy

2% of full scale

1 LSD

No. of Tests 1 or multiple

Range 2

1 - 16A RMS (@ <250VAC)

Resolution

1 mA

Accuracy ±

1% of full scale

1 LSD

No. of Tests

1 or multiple

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

0 - 2000 mOhm

Resolution

1 mOhm

Accuracy ±

2% of full scale

1 LSD

No. of Tests

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: 500VDC through a 130 kOhm limiting resistor.

No. of Tests: 1, 2 or multiple

Range

1 - 50 mOhm

Resolution 1 mOhm

Accuracy

±2% of full scale ±1 LSD

Range

51 - 200 mOhm

Resolution

1 mOhm

Accuracy

2% of full scale

1 LSD

5. Leakage Currents

All measurements can be performed with a IEC 601.1 filter (patient equiva-

lent), 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

No. of Tests: 4

Enclosure leakage current

No. of Tests: 6 or multiple

1-3

The following leakage currents are measured for each module:

Patient leakage current

No. of Tests: 6

Mains on applied part leakage current

No. of Tests: 2

Patient Auxiliary current

No. of Tests: 6

Floating dual lead measurement of

leakage currents

No. of Tests: Multiple

In one test run a maximum of 11 modules with different protection classes

may be tested.

6. Accuracy

Range 1

0- 100 µA

Resolution

1 µA

Accuracy

2% of full scale

1 LSD

Range 2

100- 1000 µA

Resolution

1 µA

Accuracy

2% of full scale

1 LSD

Range 3

1,0 - 10,0 mA

Resolution

1 µA

Accuracy

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 vol-

tage, delivered through a limiting resistor of 47 kOhm.

1.3 General Information Temperature Requirements

+15°C to +35°C when operating

0°C to +50°C in storage

Display

Type

LCD graphic display

Alphanumeric format

4 lines, 40 characters

Data Input/ Output (2)

Parallel printer port (1); Bi-directional

RS -232C (1) for computer control

Power

From 110 VAC to 240 VAC, 47/ 63 Hz

3900 VA

Do not exceed 16 Amps of current at

any voltage within the operating range.

Installation Category II

Fuses

Two 16 Amp, 250V slow blow fuses

1-4

Mechanical Specifications

Housing Metal case

Height 13.2 cm 3.9 in.

Width 34.2 cm 9.8 in.

Depth 30.5 cm 11.0 in.

Weight 5.8 kg 4.1 lbs.

Standard Accessories

User and Service Manual QA-90 (P/N 11025)

Additional Accessories

Carrying Case (P/N 11100)

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

Bar Code Reader (P/N 11400)

Isolating transformer 400VA (P/N 11401)

Isolating transformer 800VA (P/N 11410)

Test unit (ESA) (P/N 11402)

E input measuring cable (2m) (P/N 11411)

E input measuring cable (5m) (P/N 11415)

Clamp - crocodile type (P/N 11412)

PRO-Soft QA-90 software (P/N 11200)

PRO-Soft QA-90 DEMO (P/N 11201)

User/Service Manual PRO-Soft QA-90 (P/N 11225)

Storage

Store in the carrying case in dry surroundings within the tem-

perature range specified. There are no other storage require-

ments.

Periodic Inspection

The unit should be calibrated every 12 months.

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