Metron QA-IDS Service manual

Q A - I D S

U s e r & S e r v i c e M a n u a l

Q A - I D S I n f u s i o n P u m p T e s t e r

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Copyright  1998 by METRON. All rights reserved.

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: [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 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-IDS Infusion Pump 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 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-IDS Infu­sion Pump 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-IDS Infusion Pump Tester. Neither METRON nor its local representatives will accept, nor be bound
by any other form of guarantee concerning the QA-IDS Infusion Pump Tester 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. Centronix is a registered trade­mark of Centronix Corporation. Microsoft is a registered trademark and Windows is a trademark of Microsoft
Corporation.

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Table of Contents

MANUAL REVISION RECORD............................................................................................5

1. INTRODUCTION..................................................................................................................7

1.1 QA-IDS Features .........................................................................................................................7

1.2 Specifications................................................................................................................................7

1.3 General Information......................................................................................................................8

2. INSTALLATION...................................................................................................................9

2.1 Receipt, Inspection and Return.....................................................................................................9

2.2 Setup............................................................................................................................................10

2.3 Power ..........................................................................................................................................10

2.4 PRO-Soft QA-IDS.......................................................................................................................10

3. OPERATING QA-IDS........................................................................................................13

3.1 Control Switches and Connections.............................................................................................13

3.2 Key Pad Functions.....................................................................................................................14

3.3 Menu and Function Keys............................................................................................................14

3.4 Display Menus and Messages ...................................................................................................15

3.5 Printing Test Reports.................................................................................................................20

3.6 Operator Maintenance................................................................................................................22

4. INFUSION PUMP TESTING.............................................................................................23

4.1 Introduction................................................................................................................................23

4.2 Test Preparation..........................................................................................................................23

4.3 Occlusion Pressure/ Bolus Volume Testing ..............................................................................25

4.4 Infusion Flow Rate and Volume Testing....................................................................................26

5. CONTROL AND CALIBRATION....................................................................................29

5.1 Required Test Equipment...........................................................................................................29

5.2 Adjusting the Display Contrast ..................................................................................................29

5.3 Testing Power Supply to IDS.....................................................................................................29

5.4 Testing Pressure Gauge Accuracy..............................................................................................30

5.5 Testing Flow Rate Accuracy.....................................................................................................30

5.6 Checking the Battery Backup.....................................................................................................31

6. COMPONENT FUNCTIONS AND PARTS....................................................................33

6.1 Theory of Operation....................................................................................................................33

6.2 Power Supply..............................................................................................................................33

6.3 Printer Output..............................................................................................................................33

6.4 Serial Port...................................................................................................................................34

6.5 Microprocessor............................................................................................................................34

6.6 Pressure Gauge............................................................................................................................34

6.7 Pump............................................................................................................................................34

6.8 Stepper Motor/Drivers................................................................................................................34

6.9 Control Panel...............................................................................................................................35

6.10 Component Parts......................................................................................................................35

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APPENDIX A: DIAGRAMS......................................................................................39

Processor board Component Location...........................................................................................41

6.10.1 Processor board Schematic Diagram 1 ...............................................................................42

6.10.2 Processor board Schematic Diagram 2 (Digital Part) .......................................................43

6.10.3 Processor board Schematic Diagram 3 (CPU) ..................................................................44

6.10.4 Processor board Schematic Diagram 4 (Memory) ............................................................45

6.10.5 Processor board Schematic Diagram 5 (RS232C and Printer) .........................................46

6.10.6 Processor board Schematic Diagram 6 (Digital Outputs) .................................................47

6.10.7 Processor board Schematic Diagram 7 (Digital Inputs) ....................................................48

6.10.8 Processor board Schematic Diagram 8 (A/D) ...................................................................49

6.10.9 Processor board Schematic Diagram 9 (Stepper Motor and Drivers) ..............................50

6.10.10 Processor board Schematic Diagram 10 (Pressure Sensor and Temperature) ................51

6.10.11 Processor board Schematic Diagram 11 (Main Part) ......................................................58

6.10.12 Processor board Schematic Diagram 12 (Keyboard, Pressure Sensor and Pump Index)

..........................................................................................................................................................59

APPENDIX B: ERROR REPORT FORM, QA-IDS.........................................................62

APPENDIX C: SUGGESTION FORM, QA-IDS...............................................................65

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Manual Revision Record

This record page is for recording revisions to your QA-IDS User and Service Manual that have
been published by METRON or its authorized representatives. We recommend that only the man­agement or facility representative authorized to process changes and revisions to publications:

• make the pen changes or insert the revised pages;

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

superseded and placed in a superseded document file, and;

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

Rev No Date Entered Reason Signature of Person Entering Change

0 - Initial Release

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1.1 QA-IDS Features

1. Introduction

This chapter describes the Metron’s QA-IDS Infusion Pump Tester’s
features and specifications.

METRON’s QA-IDS Infusion Pump Tester is a precision instru­ment, designed for use by trained service technicians, for testing all
types of infusion pumps according to International Electrotechnical
Commission (IEC) Draft Standard 62.D (IEC 601.2.24). Tests in­clude:

• volumetric tests

• bolus tests

• occlusion alarm tests

QA-IDS is capable of detecting a minimum volume variation of one
microliter in a range of 0.10 milliliter per hour (ml/hr) to 1000.0
ml/hr. Flow measurements are taken every 30 seconds, so that the
measurements are independent of the infusion pump’s flow rate.

Test results, shown in the QA-IDS's LCD display, can be printed out
directly, or transferred to a PC via the PRO-Soft QA-IDS test auto­mation software. PRO-Soft lets you design test protocols, remotely
control the QA-IDS, and store the test results.

1.2 Specifications

1. Flow Rate

Flow Range 0.10 ml/hr - 1000.0 ml/hr

Min. volume detection 0.72 µl

Display resolution 0.01 ml/hr

2. Time Interval to Achieve ± % Accuracy of Reading

1000 ml/hr 100 ml/hr 10 ml/hr

0.5% 0.6 sec 0.5% 6 sec 0.5% 52 sec

1.0% 0.3 sec 1.0% 3 sec 1.0% 26 sec

1.5% 0.2 sec 1.5% 2 sec 1.5% 18 sec

3. Pressure Generation

Range: - 200 to + 600 mmHg

Accuracy:

- 200 to + 200 mmHg: ± 10 mmHg

+ 201 to + 600 mmHg: ± 20 mmHg

4. Occlusion Alarm Test

Measurement Range: - 400 to +1500 mmHg.

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Accuracy:

- 400 to + 500 mmHg: ± 10 mmHg

+ 501 to + 1500 mmHg: ± 2% of reading

Maximum Input Pressure: 2500 mmHg

5. Bolus Test

Accuracy: ± 20 µl

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

Display control 7 function keys and a keypad

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.

Mechanical Specifications

Housing Metal case

Height 13.5 cm / 5.31 in.

Width 23.5 cm / 9.25 in.

Depth 24.5 cm / 9.65 in.

Weight 4.30 kg / 9.48 lbs.

Printer Port Centronics Interface

Standard Accessories

User and Service Manual QA-IDS (P/N 15035)

Additional Accessories

Carrying case (P/N 15100)

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

PRO-Soft QA-IDS software (P/N 15200)

PRO-Soft QA-IDS DEMO (P/N 15201)

User Manual PRO-Soft QA-IDS (P/N 15205)

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.

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2.1 Receipt, Inspection

and Return

2. Installation

This chapter explains unpacking, receipt inspection and claims, and
the general procedures for QA-IDS setup.

1. Inspect the outer box for damage.

2. Carefully unpack all items from the box and check to see
that you have the following items:

• QA-IDS Infusion Pump Tester (P/N 15000)

• User and Service Manual QA-IDS (P/N 15035)

3. If you note physical damage, or if the unit fails to function
according to specification, inform the supplier immedi­ately. When METRON AS or the company’s representa­tive, is informed, measures will be taken to either repair the
unit or dispatch a replacement. The customer will not have
to wait for a claim to be investigated by the supplier. The
customer should place a new purchase order to ensure de­livery.

4. When returning an instrument to METRON AS, or the
company representative, fill out the address label, describe
what is wrong with the instrument, and provide the model
and serial numbers. If possible, use the original packaging
material for return shipping. Otherwise, repack the unit us­ing :

• a reinforced cardboard box, strong enough to carry the

weight of the unit.

• at least 5 cm of shock-absorbing material around the unit.

• nonabrasive dust-free material for the other parts.

Repack the unit in a manner to ensure that it cannot shift in the

box during shipment.

METRON’s product warranty is on page ii of this manual. The
warranty does not cover freight charges. C.O.D. will not be ac­cepted without authorization from METRON A.S or its represen­tative.

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2.2 Setup

1. Equipment connection is as shown in the typical setup be­low.

2. If PRO-Soft QA-IDS is being used, attach an RS-232 (null
modem/data transfer configured) cable to the 9-pin D-sub
outlet port located at the rear of the QA-IDS. Do not attach
the printer cable to the QA-IDS. See below. However, if
you are not using PRO-Soft QA-IDS, and are sending di­rectly to a printer for printouts, attach the printer cable to
the 25-pin outlet port .

Some RS-232C cables are

NO T E

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-IDS. Refer
to the PRO-Soft QA-IDS
Users Manual for more in­formation.

2.3 Power

2.4 PRO-Soft QA-IDS

Main On/Off Switch. QA-IDS should remain off for at least 5 sec­onds before switching on again, in order to allow the test circuits to
discharge fully.

PRO-Soft QA-IDS is a front-end test automation and presentation
tool for METRON's QA-IDS Infusion Pump Tester. It allows you to
conduct the same tests, but by remote control via an IBM-com­patilbe PC/XT with MS Windows (Version 3.1 or later).

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PRO-Soft QA-IDS has its

NO T E

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.

Each of the QA-IDS 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 infusion device being tested at
your facility.

Sequences can then be used independently, or can be attached to a
checklist, written procedure, and equipment data in the form of a
test “Protocol.” The equipment data can be entered manually into
the protocol, or it may be retrieved by PRO-Soft from the QA-MAP
program or other equipment files. Protocols can be created easily for
each infusion pump in your inventory, and stored for use. Test pro­tocols with results can be printed, or stored on disk, and the results
of testing can be sent back to the equipment database to close a
work order and update the service history.

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3.1 Control Switches and Connections

Front Panel

3. Operating QA-IDS

This chapter explains the operating controls, switches and menus of
the QA-IDS, details how to use them in testing, and provides in­structions for printing reports, and operator maintenance.

1. Key Pad 11 alphanumeric keys, used to enter information.

2. Function Keys F1-F4 are used to select the functions shown in the

3 LCD Display Shows messages, test results and function menus.

4 Inlet Inlet connection for infusion set.

5. Drain Connection for drainage tube.

6. Upgrade Keys Special function keys for firmware upgrade.

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.

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Rear Panel

3.2 Key Pad Func-

tions

7. Power Switch Turns power ON and OFF.

8. Mains QA-IDS Mains connection for test instrument.

9. Printer Outlet Port 25 pin D-sub. Centronic output.

10. RS-232 Serial Port 9-pin D-sub

The alphanumeric keys comprise both numbers and letters. Hold the
key in and it moves automatically from character to character.

3.3 Menu and Function Keys

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The QA-IDS uses displays, function keys and a keypad to provide
flexibility and control over operations. The top three lines in the dis­play are used for messages, status and results. The menu bar is
shown at the bottom of the display. Function keys are numbered
from F1 to F7.

A function/menu is selected by pressing that key which is directly
below/to the right of the menu unit shown in the display.

3.4 Display Menus and Messages

1. Startup Screen. The following screens will be displayed
in sequence for the first two seconds after the QA-90 has
been switched ON.

2. Main Menu

This window offers the following functions:

• Press Occlusion Test (F5) to go to the Occlusion Test

Setup Screen. See paragraph 3.4.5 below.

• Press Flow Measurement (F6) to go to the Flow Measure-

ment Test Setup Screen. See paragraph 3.4.6 below.

• Press Equipment Code (F7) to record the code or name of

the device under test. Press Enter (↵ ) to store.

3. PRIME (F1). When PRIME (F1) is pressed, the follow­ing display will appear:

• Press GO BACK (F2) to return to the main menu.

4. SETUP (F3)

This function is used for entering general information in con­nection with the test. Three main displays are shown below.

• Press Operator (F6) to record the operator’s name or ini-

tials.

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• Press Establishment (F5) to record the establishment.

• Press MAIN MENU (F4) to return to the main menu.

• Press MORE (F1) and the following display will appear:

• Press Serial no (F7) to record the serial number of the QA-

IDS being used.

• Press Reference Unit (F6) to select the reference unit, as

follows:

mmHg mBar kg/cm

cmH2O kPa inHg PSI

2

inH2O

• Press Alarm After Test (F5) and select Yes or No.

• Press GO BACK (F2) to return to the previous display.

• Press MAIN MENU (F4) to return to the main menu.

• Press MORE (F1) and the following display will appear:

• Press Language (F7) to select the language used for the

testing.

• Press Date (F6) to set the day/month/year.

• Press Time (F5) to set the hour/minute/second.

• Press GO BACK (F2) to return to the previous display.

• Press MAIN MENU (F4) to return to the main menu.

5. Occlusion Test (F5)

The Occlusion Alarm Test is used to protect the patient. An Oc­clusion Pressure Alarm will be activated if the pressure inside
the administration set extends preset levels. The three main test
displays are shown below.

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• Press Flow Set (F7) to set the preset value of the infusion

pump.

• Press Alarm Prsr (F6) to set the preset pump value.

• Press START (F2) to start the Occlusion Test, and the fol-

lowing display will appear:

The following parameters are displayed:

Prsr: The pressure in the connction tube. Measurement results

Time: The time from test start until alarm activation. Measure-

Bolus: The volume expansion within the tube when the infusion

display: max. value > instantaneous measured value >
mean value in mmHg.

ment results display: max. time > elapsed time > mean
time in minutes/seconds.

pump alarm activates. Measurement results display: max.
bolus > last executed calculation after STOP is pressed >
mean bolus in milliliters.

• Press GO BACK (F4) to return to the previous menu.

• Press STOP (F2) to stop the test.

• Press START (F2) to return to the previous menu.

• Press GO BACK (F4) to return to the previous display.

6. Flow Measurement (F6)

This function is used for entering flow information in connec­tion with the test. There are four main displays, shown below:

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The following parameters are displayed:

Flow Set: This value is the preset value of the infusion pump. All er-

Press Set: This function enables you to enter + (positive) or - (nega-

dT: Interrogation time, or time between two measurements.

ror calculations of the flow measurement are related to
this value. If the Flow Set value is not entered correctly,
this may cause a poor presentation with incorrect overall
errors.

tive) backpressure into the system. Operation range is
from -200 to +600 mmHg.

Average value during the test interval is displayed. Rec­ommended dT from IEC is 30 sec, and this is the mini­mum value to be selected on the QA-IDS. Maximum dT is
600 sec. or 10 minutes. Default value is 30 sec.

• Press Flow Set (F7) to set the preset value of the infusion

pump.

• Press Press Set (F6) to set the relevant + or - backpressure

into the system.

• Press dT (F5) to set the interrogation time, or time between

two measurements.

• Press PR HDR (F3) to print a header.

• Press MAIN MENU (F4) to return to the Main Menu.

• Press MORE (F1) and the following screen will appear:

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The following parameters are displayed:

Test Time: This is the preset time for a test. Maximum testing time

is 24 hours. Default value is 1 hour.

Delay Time: This is the delay before the first measuring.

• Press Test Time (F7) to set the actual time of the test.

• Press Delay Time (F6) to set the delay before the first mea-

surement.

• Press MORE (F5) to return to the previous display.

• Press PR HDR (F3) to print a header.

• Press MAIN MENU (F4) to return to the Main Menu.

• Press START (F2) to start flow measurement, and the

Flow Measurement 1 display will appear:

The following parameters are displayed:

Mean Flow: The flow of the liquid volume in infusion pump every

Cum. Volume: The cumulative volume from start of the test.

Time Left: The remaining time before the test is finish.

second displayed in ml/h and %.

• Press STOP (F2) to return to the Flow measurement setup.

• Press MORE (F1) and the Flow Measurement 2 display

will appear.

The following parameters are displayed:

Inst. Flow: Instantaneous Flow shows: max. value > mean value

Inst. Flow: Instantaneous Flow shows: max. value > mean value

Prsr: The pressure in the connection tube.

> minimum value in %.

> minimum value in ml/h.

• Press STOP (F2) to return to the previous display.

• Press MORE (F1) to return to the Flow Measurement

Setup.

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