roche cardiac reader

Roche Cardiac readerP O I N T O F C A R ET E S T I N G

0 4

44

636

400

1(02

)-04

/05

EN

Operator’s Manual

Roche Cardiac reader

2

On the packaging, on the identification plate of the instrument and in the manual you may encounter the following symbols, shown here with their meaning:

For in vitro diagnostic use

This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.

Please consult instructions for use

Caution (refer to accompanying documents). Please refer to safety-related notes in the Manual accompanying this instrument.

Manufacturer

Catalogue number

Store at

Last update: April 2005

ROCHE CARDIAC is a trademark of Roche.

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Table of contents

Table of contents

1 Short Guide to Using Roche Cardiac reader 7

2 Getting Started 8 2.1 Introduction 8 2.2 Safety instructions and regulatory compliance 10 2.2.1 Symbols used in the Operator’s Manual 10 2.2.2 Regulatory compliance and general safety warnings 10 2.3 About this manual 11 2.4 Roche Cardiac reader at a glance 12

3 Unpacking and Installation 13 3.1 Check for possible damage incurred during transport 13 3.2 Unpacking 13 3.3 Proper siting 13 3.4 Connection to mains supply 14 3.5 Supplementary safety notice 14

4 System Description 15 4.1 Measuring principle 15 4.2 Components and functions 15 4.2.1 Front of the instrument 15 4.2.2 Display and keypad 16 4.2.3 Back of the instrument 16 4.2.4 Power supply unit and mains supply 16

5 Software 17 5.1 Software overview 17 5.1.1 Factory default settings 17 5.2 Setup menu 17 5.2.1 Setup menu table 17 5.2.2 Selecting the language 20 5.2.3 Selecting the date format 21 5.2.4 Setting the date 21 5.2.5 Selecting the time format 22 5.2.6 Setting the time (24-hour clock) 22 5.2.7 Setting the time (12-hour clock) 23 5.2.8 Host/PC connection setting 23 5.2.9 Printer connection setting 24 5.2.10 Selecting the units of measurement 25 5.2.11 Setting the beeper frequency 25 5.2.12 Setting the patient ID 26 5.2.13 Setting the operator ID 28 5.2.14 Setting the QC transmission 30 5.2.15 Printing the Setup parameters 30 5.2.16 Internal memory functions 30


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6 Operating the Instrument 31 6.1 Switching on Roche Cardiac reader 31 6.2 Operating modes 31 6.3 Reading procedure 32 6.3.1 General 32 6.4 How to use the coding chip 32 6.4.1 Inserting the coding chip 33 6.5 Reading mode: Patient samples 33 6.5.1 Display and storage of results 35 6.5.2 Displaying and printing patient data from memory 36 6.5.3 Additional evaluation for Troponin T parameter (Cardiac T Quantitative) 37 6.6 Control readings 37 6.6.1. IQC test to check the performance of the optical system 38 6.6.2. Control measurement with liquid control 39 6.6.3 Displaying and printing control readings from memory 41 6.6.4 Retrieving and printing Instrument Quality Control (IQC) results from memory 41 6.7 Overall test time 42 6.8 Using patient identification numbers 42 6.8.1 Entering a Patient ID number via the keypad 43 6.8.2 Entering a Patient ID number via a scanner (optional) 43 6.9 Using operator identification numbers 44 6.9.1 Entering an Operator ID number via the keypad 44 6.9.2 Entering an Operator ID number via a scanner (optional) 45

7 Error Messages 46 7.1 General information on error detection and correction 46 7.2 Handling error messages 46 7.3 Error messages prior to reading 47 7.4 Error messages during reading 47 7.5 Errors with Host/PC connection on 48 7.6 Repairs 49

8 Cleaning and Maintenance 50

9 Ordering Information 51

5

Table of contents

10 Interface Assignment 52 10.1 Printer/bar code reader interface 52 10.2 Host/PC interface 52

11 System Specifications 53

12 Optional Peripheral Equipment 55 12.1 Printer 55 12.1.1 General information 55 12.1.2 Connecting an external printer 55 12.1.3 Inserting paper 56 12.1.4 Indicator lights and function keys 56 12.2 Bar code reader/scanner 57 12.2.1 General information 57 12.2.2 Connecting a bar code reader/scanner 57 12.2.3 Bar code reader / scanner configuration 58 12.3 Host/PC connection 58 12.3.1 General information 58 12.3.2 Connecting to a Host/PC 58

13 Subject Index 59

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Short Guide to Using Roche Cardiac reader

1 Short Guide to Using Roche Cardiac reader

Read this Operator’s Manual in full before attempting to operate the Roche Cardiac reader.

Wear protective gloves when operating the Roche Cardiac reader, and dispose of samples, test strips and gloves according to local regulations.

1. Switch on the instrument with the power supply unit.

The instrument must be turned on at least ten minutes before the first reading.

2. Press any key, when the instrument is in Stand-by mode.

3. Wait for the self-test to finish.

4. Open the test strip pack and take out the coding chip, and insert it as shown in Fig. 1.

5. Remove the test strip from the package, and place it into the appropriate slot of the swivel stage as shown in Fig. 2.

6. Press <Start>.

Wait until the swivel stage is in the correct position for reading.

7. When instructed in the display, apply the sample (150 µL for Troponin T, Myoglobin, D-Dimer or NT-proBNP) as shown in Fig. 3.

For handling and preparation of samples, follow the instructions in the package inserts accompanying the test strips.

8. Press <Start>.

Wait until the reading is completed and the result is displayed.

9. When the swivel stage has returned to the starting position, remove the test strip.

Fig. 1: Insert the coding chip.

Fig. 2: Insert the test strip.

Fig. 3: Applying the sample.


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2 Getting Started

2.1 Introduction

Roche Cardiac reader is an innovative instrument for the quantitative evaluation of immunoassays using the gold-labelling technique. The rapid diagnostic tests in strip format available for this instrument aim at improving the diagnosis and assessment of cardiovascular diseases (Myocardial Infarction, Heart Fai-lure, risk stratification of Acute Coronary Syndromes (ACS)). D-Dimer contributes to exclusion of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). The automated evaluation of these tests with Roche Cardiac reader combines the advantages of a rapid diagnosis with enhanced clinical interpretation of quantitative values. In addition, automated evaluation ensures standardized results, as it eliminates potential sources of error associated with visual reading. Presently Roche Cardiac reader can perform the following tests: Troponin T, Myo-globin, D-Dimer and NT-proBNP.

Refer to the package inserts accompanying the test strips for detailed information on specific tests.

Readings may be carried out directly where the blood samples are taken. Therefore, this system is ideal for use in emergency rooms or intensive therapy units. Roche Cardiac reader is rapid and easy to operate: insert an unused test strip in the test strip slot and apply the sample. After the reaction period, the instrument gives a quantitative result.

Only suitably qualified personnel must operate Roche Cardiac reader.

For indoor use only.

The Roche Cardiac reader is intended for IN VITRO diagnostic use.

9

Getting Started

The most important features of Roche Cardiac reader are as follows:

Compact bench-top instrument Easy to operate Clearly laid-out keypad Intuitive user interface with various Setup options Easy to clean instrument surface Sample and control reading modes No special sample preparation required

(use of heparinised venous blood) Memory for sample and control reading results Memory for lot-specific data Display readings available in eight languages External power supply unit with ON/OFF switch (110 V to 230 V) Entry of a patient identification code (Pat. ID) via keypad or bar

code reader (optional) Interface for bar code reader / scanner (optional) Interface for external printer (optional) Interface for laboratory or hospital electronic data processing

(EDP) systems Open system, capable of reading other parameters in the same

strip format

The instrument has six function keys and two light-emitting diodes (LEDs).

Function keys: <Set> <Paging> <Control> <Memory> <Start> <Stop>

LEDs: <Positive Result> <Power>

Results and operational status are displayed on the screen.

The results and all basic settings can be printed out if the instru-ment is connected to a printer (optional).

Fig. 4: Roche Cardiac reader with test strip in reading position.

Fig. 6: Roche Cardiac reader with a printer (optional) connected.

Fig. 5: Test signal area and application area (using Cardiac T Quantitative as an example).

Fig. 7: Display window.


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2.2 Safety instructions and regulatory compliance

2.2.1 Symbols used in the Operator’s Manual

The following symbols are used throughout the manual to highlight important instructions, and to warn the ope-rator of potential hazards.

Symbols / Explanation

Warning symbol. Indicates a potentially hazardous situation that if not avoided could result in perso-nal injury or damage to the instrument. This symbol is used only in extreme situations and, therefore, requires special attention.

Attention symbol. Indicates special problems or important information. Read the accompanying text carefully.

Note symbol. Indicates information that is useful, but not essential.

Danger sign. Indicates a potentially dangerous situation involving high electrical voltages. All safety precautions must be taken to prevent personal injury or damage to the equipment.

Danger sign. Indicates a potentially dangerous situation involving the presence of biohazardous material. All safety precautions must be taken to prevent personal injury or damage to the equip-ment.

Danger sign. Indicates a potentially dangerous situation involving the presence of moving machinery. All safety precautions must be taken to prevent personal injury or damage to the equipment.

2.2.2 Regulatory compliance and general safety warnings

This instrument was designed and manufactured in compliance with DIN EN 61010-1 “Safety require-ments for electrical equipment for measurement, control and laboratory use; part I: general require-ments”, and is in compliance with all safety specifications when it leaves the factory.

The instrument may be operated only with the power supply unit specified.

This instrument is a Protection Class I device (protective earth conductor). The mains plug may only be connected to an earthed mains power outlet. The grounding protection must not be eliminated by using an extension cable without an earthed conductor.

Any interruption of the protective earth conductor inside or outside the instrument, or disconnection of the protective earth conductor may constitute a hazard for the operator.

11

Getting Started

Only qualified service personnel must gain access to the internal components of the instrument.Any adjustments, service or repairs that have to be carried out while voltages are present on the internal com-ponents of the instrument may only be performed by suitably qualified service personnel, authorized by Roche Diagnostics and familiar with the risks involved.If it must be assumed that safe operation is no longer guaranteed, the use of the instrument must be discontinued and the instrument safeguarded against unintentional use. Only suitably qualified personnel must operate Roche Cardiac reader.

Do not place your hands in the instrument while components are in motion.

The data and information contained in this manual are accurate at the time of going to press. Any substantial changes will be incorporated in the next edition. In case of conflict between this manual and information given in package inserts, the package inserts shall take precedence.

This instrument is classified as an overvoltage installation Class II and pollution Class 2 device.

2.3 About this manual

Read the Operator’s Manual carefully and completely before you attempt to use Roche Cardiac reader. Make yourself familiar with all settings, and always keep the manual near the instrument.

The following illustration is an example showing the display of Roche Cardiac reader.

Depending on the parameter settings selected in the Setup menu, the upper line shows either the patient identification number (Pat. ID):

or the date and time:

The Pat. ID is only displayed in the upper line if it has been activated in the Setup (see 5.2.12). Otherwise the date and time are displayed. Throughout this manual “19.03.2004” and “16:25” will be used as an example for time and date.

19.03.2004 16:25

remove strip

Pat.-ID: 1234

insert strip

(The Pat. ID is 1234 in this example.)

19.03.2004 16:25

insert strip

(In this example 19.03.2004 and 16:25.)


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Fig. 1014 15 16 17

10 11 12 13

Fig. 8

1 2

653 4

2.4 Roche Cardiac reader at a glance

1) Display and keypad

2) Slot for coding chip

3) Swivel stage for test strip

4) Positioning bar

5) Integrated bar code reader

6) Coding chip (included in every test strip pack)

7) Serial interface (port) for printer

8) RS232 C interface (port) for Host/PC

9) Socket for power cable of power supply unit

10) <Power> LED (green)

11) <Positive Result> LED (red)

12) <Set> key

13) <Paging> key

14) <Control> key

15) <Start> key

16) <Memory> key

17) <Stop> key

Fig. 9987

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Unpacking and Installation

3 Unpacking and Installation

3.1 Check for possible damage incurred during transport

Roche Cardiac reader arrives in a single box. If damage is found as a result of inappropriate handling during trans-port, inform your supplier or forwarding agent immediately.

3.2 Unpacking

Open the cardboard box on the side that is marked with arrows. Remove the accessories and take out the instru-ment together with the protective foam parts at the side. Place the instrument on a level surface and remove the foam packaging. Remove the protective cover. This cover may be used as a dust cover when the instrument is not in use.

Check that the box contains all of the following items:

Roche Cardiac reader instrument Power supply unit Mains cable Power cable

3.3 Proper siting

Place the instrument on a level, stable and vibration-free surface. Do not expose Roche Cardiac reader to direct sunlight. Do not place Roche Cardiac reader near radiators and heat-emitting instruments.


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3.4 Connection to mains supply

The supplied power supply unit has a mains power inlet socket and an outlet socket for connecting Roche Cardiac reader.

Connecting Roche Cardiac reader to the power supply unit:

Ensure the plug is correctly positioned. The locking clip of the power cable must be directed downwards.

1. Connect Roche Cardiac reader and the power supply unit by means of the power cable.

2. Connect the mains cable to the power supply unit.

3. Connect the mains cable plug to the mains power outlet.

4. Turn on the power supply unit.

Do not connect Roche Cardiac reader to telephone or PC connection sockets as these may be severely damaged.

3.5 Supplementary safety notice

Connection to mains power supply

To effectively disconnect the instrument from the mains power supply, the plug of the mains cable must be removed from the power supply unit or the socket.

To ensure proper and trouble-free functioning of the instrument, the power cable must be connected so that the end with the ferrite core is facing the instrument.

The ferrite core is a high-frequency suppressor used to stop electromagnetic interference from other devices affecting signals.

Fig. 12: Connecting the power cable.

Fig. 13: Power supply unit.

Fig. 11: All components in the box.

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System Description

4 System Description

4.1 Measuring principle

Two lines (signal and control line) in the detection zone of the test strip indicate whether the analyte is present in the sample. Roche Cardiac reader detects those lines by means of a charge-coupled device (CCD) photosensor with imaging lens. The test signal (signal line) increases in intensity in proportion to the concentration of the individual analyte. Integrated system software converts the signal intensity to a quantitative result, which is then displayed on the screen. The coding chip contained in every test strip pack and a bar code on the underside of the test strip include all test and lot-specific information for automated quantitative evaluation with the instrument.


4.2 Components and functions

4.2.1 Front of the instrument

1) Swivel stage for transporting the test strips

2) Built-in bar code reader: Reads lot code and strip parameters during the automatic

transport of the test strip to the position for reading. Before reading, the instrument checks if the lot parameters for each test strip are stored. If the required lot code is not available, reading is suspended and a result is not displayed.

3) Display and keypad

4) Slot for coding chip

5) Coding chip: A coding chip is included in every test strip pack and contains

all relevant information for this lot (for example, calibration curve, parameter name, expiry date). Fig. 14: Front of the instrument.

1 2 3 4 5


16


17 18

Fig. 15: Display and keypad.

11

6 7 8 9 10

12 13

Fig. 16: Back of the instrument.

14 1615

4.2.2 Display and keypad

6) <Power> LED (green)

7) <Positive Result> LED (red)

8) <Set> key

9) <Paging> key

10) <Memory> key

11) <Start> key

12) <Control> key

13) <Stop> key

4.2.3 Back of the instrument

14) Serial interface (port) for printer /bar code reader

15) RS232 C interface (port) for Host/PC

16) Socket for power cable

4.2.4 Power supply unit and mains supply

17) Power cable to the instrument

18) Power supply unit, ON/OFF switch and mains cable. Connection to the mains supply via the power supply unit and power cable provided.

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Software

5 Software

5.1 Software overview

5.1.1 Factory default settings

The default settings are:

Language: English Date format: dd.mm.yyyy Time format: 24 hours Host/PC: no Printer: no Unit of measurement: ng/mL Beeper frequency: 1 Pat. ID: no Op. ID: no

5.2 Setup menu

5.2.1 Setup menu table

The following Setup parameters are available:

Language Date format Time format Host/PC connection Printer settings Units of measurement Beeper Pat. ID no/opt./oblig. and length of ID Op. ID no/opt./oblig. and length of ID QC transmission

The operator can change all the default settings. The selected Setup parameters can be sent to a printer (optional) if connected.


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Press <Set> to select: English,

German, Spanish, Italian, French,

Portuguese, Swedish, Japanese

Press <Set> to select:

dd.mm. yy / mm. dd. yy / yy. mm. dd

Press <Set> and <Paging>

to enter date


24h / 12h

00:00 to 23:59 or

a.m. / p.m. 01:00 to 12:59


yes /no*


yes /no

Language

Date Format

Date

Time Format

Time

Host/PC Printer

Units

Beeper

Roche Cardiac reader Setup Menu - Part 1

<Paging>

<Paging> from Ready mode

Press <Set> and <Paging>

to enter the time.

<Paging>

<Paging>

<Paging>

<Paging>

if no

<Paging> if yes<Paging>

<Paging>

<Paging>

Press <Set> to

select: yes /no

Press <Set>

to select: 0...3...8

Press <Set> to select: Units

<Set>

next parameter

Units depend on parameter.


off / Frequ. 1 / Frequ. 2

Continue next page

After last parameter press <Paging>

<Paging>

<Paging>

<Set> to change the settings in Setup

<Paging> to go to the next entry

<Stop> to exit the Setup menu

Default settings are underlined

SetupLanguage: English

SetupDate format: dd.mm.yy

SetupDate: 19.03.2004

SetupTime format: 24h

SetupTime: 16:25

SetupHost/PC: no

SetupPrinter: no

SetupBeeper: Frequ.1

SetupTrop. T Unit: ng/ml

SetupImmediate print: yes

SetupBlank lines: 3

SetupTrop. T Unit: ng/ml

Example Trop. T: ng/mL or µg/L

<Paging>

<Paging>

*If yes, the option QC active appears at the end of the Setup menu.

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Software

Patient ID

Length

Operator ID

Length

QCtransmission

Print SetupPrint only

selected

Setup

parameters

Roche Cardiac reader Setup Menu - Part 2

cont. from Setup Menu

– Part 1

Press <Set>

to select:

1.....10....16<Paging> if no <Paging>

<Paging> if no

Press <Set>

to select:

1.....5....16

If printer is connec-ted press <Set>

<Paging>

<Stop> or <Paging>

Return to Ready mode

Printout

Setup

settings

SetupPat.-ID: no

SetupOp. ID: no

Setupprint setup

SetupOp. ID length: 5

Press <Set> to select: no/opt./oblig.

<Set> if optional <Paging>

<Set> if obligatory

<Set> if optional <Paging>

<Set> if obligatory

SetupPat. ID length: 10

SetupQC active yes

<Paging> if no

Press

<Set>

to select:

yes/no

* only appears when the option Host/PC yes has been selected.

*

<Paging>

Press <Set> to select: no/opt./oblig.


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Power on and self-test

If the Roche Cardiac reader has been correctly installed, an automatic self-test is performed when the instrument is switched on. After a warm-up phase of 10 minutes the instrument goes into Ready mode if no test strip is inserted.

If the instrument fails to install correctly, contact your Roche Diagnostics service representative.

If no test strip is inserted, the display reads:

If an earlier test strip is still present, the display reads:

1. Remove the test strip.

Test strips must be removed and disposed of according to local regulations as soon as all tests are completed.

5.2.2 Selecting the language

To view the Setup menu:

1. Press <Paging>.

The display reads:

2. One of the following 8 display languages may be selected by pressing <Set>:

English, German, Spanish, Italian, French, Portuguese, Swedish or Japanese.

3. Press <Stop> to leave the Setup menu, or proceed to Selecting the date format.

19.03.2004 16:25

insert strip

19.03.2004 16:25

remove strip

Language:

English

21

Software

5.2.3 Selecting the date format

1. Press <Paging>.

The display reads:

The default setting is dd (day) - mm (month) – yyyy (year).

2. Select other date formats by pressing <Set>:

The year is only indicated by the last 2 digits in the display when you select the date format. However, once you have set the date format, the year is always displayed in full with 4 digits (e.g. 19.03.2004). See below Setting the date.

5.2.4 Setting the date

1. Press <Paging>.

The display reads:

2. Press <Set> to select the setting.

3. Press <Paging>.

The display reads:


Setup

Date format: dd.mm.yy

Setup

Date format: mm.dd.yy

Setup

Date format: yy.mm.dd

(factory setting)

Setup

Date: 19.03.2004

(First group of digits flashes.)

Setup

Date: 19.03.2004

(Second group of digits flashes.)


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5. Press <Paging>.

The display reads:


7. Press <Stop> to leave the Setup menu or proceed to Selec-ting the time format.

5.2.5 Selecting the time format

1. Press <Paging>.

The display reads:

2. Press <Set> to select the 12 or 24-hour format.

5.2.6 Setting the time (24-hour clock)

1. Press <Paging>.

The time is displayed for example:

2. Press <Set> to select the hours.

3. Press <Paging>.

The time is displayed for example:

4. Press <Set> to set the minutes.

5. Press <Stop> to leave the Setup menu, or proceed to setting the Host/PC connection.

Setup

Time format: 24h

Setup

Date: 19.03.2004

(Third group of digits flashes.)

(The minutes flash.)

Setup

Time: 16:25

Setup

Time: 16:25

(The hours flash.)

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Software

5.2.7 Setting the time (12-hour clock)

1. Press <Paging>.

The display reads for example:

2. Press <Set> to select the hours.

During the incremental 12-hour indication, the display reading automatically changes from am (before noon) to pm (after noon).

3. Press <Paging>.

The display reads for example:

4. Press <Set> to select the minutes.

5. Press <Stop> to leave the Setup menu, or proceed to setting the Host/PC connection.

5.2.8 Host/PC connection setting

1. Press <Paging>.

The display reads:

2. Press <Set> to select the Host/PC connection (no or yes)

The Host/PC connection may only be selected if the instrument is connted to DataCare or to a hos-pital computer or a PC (see Sections 7.5, 12.3.1 and 12.3.2).

The Host/PC setting automatically activates the setting QC yes (see Section 5.2.14).

3. Press <Stop> to leave the Setup menu, or proceed to setting the Printer connection.

Setup

Host/PC: no

Setup

Time: pm 04:25

(The minutes flash.)

Setup

Time: pm 04:25

(The hours flash.)


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5.2.9 Printer connection setting

Printer not connected:

1. Press <Paging>.

The display reads:

If the printer is not to be activated, or if a printer is not connected, this setting remains unchanged.

2. Press <Stop> to leave the Setup menu, or proceed to Selecting the units of measurement.

Printer connected:

To activate a printer, if connected:

1. Press <Set> to activate the printer connection.

The display reads:

2. Press <Paging>.

The display reads:

3. Press <Paging> to proceed to Selecting the units of measu-rement, or press <Set> to select “immediate print”.

If “immediate print” is selected, the result is printed immediately after reading is completed, if the printer is switched on.

4. Press <Paging>.

The display reads:

5. Press <Set> to select the number of blank lines between the results for the printout in a range of 0 to 8.

6. Press <STOP> to leave the Setup menu, or proceed to Selecting the units of measurement .

Setup

Printer: no

Setup

Printer: yes

Setup

Immediate print: no

Setup

Immediate print: yes

Setup

Blank lines: 3

(3 blank lines are selected.)

25

Software

5.2.10 Selecting the units of measurement

1. Press <Paging>.

The display reads:

2. Press <Set> to select one of the two options (ng/mL or µg/L or alternatively pg/mL or ng/L).

3. Press <STOP> to leave the Setup menu, or proceed to Setting the beeper frequency.

5.2.11 Setting the beeper frequency

1. Press <Paging>.

The beeper operates at frequency 1, and the display reads:

2. Press <Set> to select beeper frequency 2.

The beeper operates at frequency 2, and the display reads:

3. Press <Set> to turn the beeper off.

The display reads:

4. Press <Stop> to leave the Setup menu, or proceed to Setting the patient ID.

Setup

Trop. T Unit ng/ml

(Trop T is used as an example.)

Setup

Beeper: off

Setup

Beeper: Frequ.1

(Beeper activated at frequency 1.)

Setup

Beeper: Frequ.2

(Beeper activated at frequency 2.)


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5.2.12 Setting the patient ID

The operator can choose between the following options:

Pat. ID no: The system will never ask for an input of the Pat. ID

Pat . ID opt: The user has the option to input a Pat. ID

Pat. ID oblig: The system will always ask for a Pat. ID and will not proceed until an entry has been made.

1. Press <Paging>.

The display reads:

If no Patient ID is required, this setting remains.

2. Press <Stop> to leave the Setup menu, or proceed to the Setting the operator ID.

If a Patient ID is optionally required:

1. Press <Set> to activate the Patient ID setting.

The display reads:

2. Press <Paging>.

The display reads:

3. Press <Set> to select the Patient ID length in a range of 1 to 16 characters.

The Pat. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, you c an scan in information electronically. The information entered with a bar code reader / scanner can include alphabetic and numeric characters (see Sections 6.8 to 6.8.2 and 12.2.2).

4. Press <Stop> to leave the Setup menu, or proceed to Setting the operator ID.

Setup

Pat. ID length: 10

(Patient ID length setting of 10 characters.)

Setup

Pat. ID: opt.

(Patient-ID activated.)

(No patient ID entry required.)

Setup

Pat. ID: no

27

Software

If a Patient ID is obligatory:

1. Press <Set> to activate the Patient ID setting.

The display reads:

2. Press <Set> again.

The display reads:

3. Press <Paging>.

The display reads:

4. Press <Set> to select the Patient ID length in a range of 1 to 16 characters.

The Pat. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, you can scan in information electronically. The information entered with a bar code reader / scanner can include alphabetic and numeric characters (see Sections 6.8 to 6.8.2 and 12.2.2).

5. Press <Stop> to leave the Setup menu, or proceed to Setting the operator ID.

Setup

Pat.-ID: opt.

Setup

Pat.-ID: 10

Setup

Pat.-ID: oblig.


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5.2.13 Setting the operator ID

The operator can choose between the following options:

Op. ID no: The system will never ask for an input of the Operator ID

Op . ID opt: The user has the option to input an Operator ID

Op. ID oblig: The system will always ask for an Operator ID and will not proceed until an entry has been made.

1. Press <Paging>.

The display reads:

If no Operator ID is required, this setting remains.

2. Press <Stop> to leave the Setup menu, or proceed to QC active yes/no or to Printing the Setup parameters.

If an Operator ID is optionally required:

1. Press <Set> to activate the Operator ID setting.

The display reads:

2. Press <Paging>.

The display reads:

3. Press <Set> to select the length of the Operator ID in a range of 1 to 16 characters.

The Op. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, you can scan in information electronically. The information entered with a bar code reader / scanner can include alphabetic and numeric characters (see Sections 6.9., 6.9.1 and 12.2.2).


Setup

Op. ID: no

Setup

Op. ID: opt.

(Operator ID required.)

(Operator ID length setting of 5.)

Setup

Op. ID length: 5

29

Software

If an Operator ID is obligatory:

1. Press <Set> to activate the Operator ID setting.

The display reads:

2. Press <Set> again

The display reads:

3. Press <Paging>.

The display reads:

4. Press <Set> to select the length of the Operator ID in a range of 1 to 16 characters.

The Op. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, you can scan in information electronically. The information entered with a bar code reader / scanner can include alphabetic and numeric characters (see Sections 6.9., 6.9.1 and 12.2.2).


If Patient ID and Operator ID are both set to opt , press <Set> to select first the patient ID and after-wards press <paging> to select the Operator ID.

Setup

Op. ID: opt.

Setup

Op. ID: 10

Setup

Op. ID: oblig.


30

5.2.14. Setting QC transmission

The option QC active yes/no is only displayed when the Host/PC on setting was selected in the menu (see Section 5.2.8) and is set to yes as default.

1. Press <Paging> to access the QC setting.

2. Press <Set> to deactivate QC.

3. Press <Stop> to leave the Setup menu or proceed to Printing the Setup parameters.

5.2.15 Printing the Setup parameters

If the printer connection has been activated:

1. Press <Paging>.

The display reads:

2. Press <Set> to print out all Setup parameters if a printer is connected.

The instrument now leaves the Setup menu automatically.

5.2.16 Internal memory functions

Roche Cardiac reader has the following memory functions:

Automatic storage of up to 20 patient results. The oldest result is always overwritten when the memory is full.

Automatic storage of up to 20 quality control test results. The oldest result is always overwritten when the memory is full.

Automatic storage of up to 62 IQC test results. The oldest result is always overwritten when the memory is full.

Storage of up to 15 sets of lot parameters in memory. Lot-specific information is loaded via the lot-specific coding chip. The oldest set is always overwritten when the memory is full.

Ensure that all required data are downloaded or printed out regularly from Roche Cardiac reader to avoid data loss.

Setup

QC active: yes

Setup

QC active: no

Setup

print Setup

Setup

print Setup

31

Operating the instrument

6 Operating the instrument

6.1 Switching on Roche Cardiac reader

Switch on Roche Cardiac reader with the ON/OFF switch located on the power supply unit. After power-on, the instrument performs a self-test to check that all components are functioning properly.

Following the self-test it is possible to:

Enter the Setup menu and change settings. Read a lot code from a coding chip. Print findings and control results from memory.

After the warm-up phase of 10 minutes the instrument is in Ready mode.

As soon as the Roche Cardiac reader is in Ready mode it is possible to:

Insert a test strip and perform a reading.

6.2 Operating modes

The instrument must be turned on ten minutes before the first reading. It is recommen-ded to have Roche Cardiac reader connected to the mains power at all times so that it is ready to operate in emergency situations. This will not cause any damage to the instrument.

The three modes of operation are:

Ready mode Reading is in progress (“Reading is on” mode) Stand-by mode

In Ready mode, the display reads, for example:

All settings, entries, and readings are performed in Ready mode.

Reading can be broken off at any stage of operation. In Reading is on mode, two alternating messages are displayed, for example:

and

After 10 minutes of no data entry, the instrument automatically switches to Stand-by mode if no reading is in pro-gress. The display turns off, and the green Power LED lights up. Press any key to return to Ready mode.

19.03.2004 16:25

insert strip

ON/OFF switch


Reading is on 11:59

Troponin T

(Reading is in progress.)

Result in 11:59

Troponin T

(Reading will be completed in 11 minutes 59 seconds.)


32

6.3 Reading procedure

6.3.1 General

All stages of the procedure are menu-driven; the operator is prompted through all steps via the display.

When instructed in the display, insert the test strip into the appro-priate slot on the swivel stage. Press <Start> to automatically transport the test strip to the correct position for reading. The lot code (bar code) on the underside of the test strip (see Fig.19) is automatically scanned before reading starts.

When the instrument has not been used for 10 minutes, it automa-tically switches to Stand-by mode. Press any key to change from Stand-by to Ready mode.


6.4 How to use the coding chip

A coding chip (see Fig. 20) is included in every test strip pack and provides the lot-specific data that are required for evaluation of the results obtained for the test strip lot in use.

A bar code on the underside of the test strip contains informa-tion on the test parameter and lot number of that test strip (see Fig. 19). A built-in bar code reader scans this information while the test strip is transported from the starting to the reading position on the swivel stage.

The information on the inserted test strip is automatically checked against that contained in the coding chip, which was inserted in the instrument. If this does not match, the operator is instructed to insert the correct coding chip, i.e. the one supplied with the test strip pack, into the appropriate slot.

There is sufficient memory capacity for 15 lots. If a test strip of a particular lot has already been read, the lot-spe-cific information is stored in the internal lot memory. If a test strip from a known lot is inserted, the relevant data are obtained from memory, even if no coding chip, or a different coding chip is inserted in the instrument. The oldest lot data are overwritten when the memory is full.

Fig. 19: Bar code on the underside of the test strip.

Fig. 20: Coding chip.

33


Insert Coding Chip

Troponin T 8821

Lot data

read

(Lot data have been read.)

Fig. 21: Inserting the coding chip.

(Insert the coding chip with test strip lot code. In this example the parameter is Troponin T and the lot number of this batch of strips is 8821.)

19.03.2004 16:25

press <START>

Fig. 22: Inserting the test strip.

6.4.1 Inserting the coding chip

Every pack of test strips includes a lot-specific coding chip. When the instrument instructs you to insert a new coding chip, the display reads:

A 4-digit test strip lot code is displayed. The coding chip matches the strip when the lot number in the display is identical to the 4-digit lot code that is printed on the chip. For verification, the 4-digit lot number on the coding chip can be compared to the code on the test strip pack.Insert the coding chip (see Fig. 21) into the appropriate slot of the instrument until it snaps into place.

After reading the coding chip the display reads:

6.5 Reading mode: Patient samples

Reading is started in Ready mode.

1. Insert the test strip (see Fig. 22).

The display reads:


34

Apply sample

and press <START>

please wait…….

(Test strip is being checked.)

Fig. 23: Press <START>: The swivel stage transports the test strip to the reading position.

Abort reading ?

Abort <STOP> - key

Sample detection

Troponin T

(Display for Troponin T reading.)

2. Press <Start> (see Fig. 23).

The test strip is transported to the reading position.

The following message is displayed briefly:

If the test strip passes the check (and is unused, see also Section 6.5.3), the display reads:

The sample is then applied to the application area of the test strip (see Fig. 24).

If no sample is applied, the instrument emits an acoustic warning (beep) after 8 minutes.

3. Press <Stop> to turn off the beeper.

4. Press <Stop> again to break off reading.

or

Press <Start> after a sample has been applied to start rea-ding.

The display reads:

Fig. 24: Applying the sample to the application area of the test strip.

35


Reading starts as soon as the applied sample has been detected. Two alternating messages are displayed, for example:

and

At the end of the reaction time countdown, the swivel stage with the test strip moves back to the starting position, and the result is displayed, for example:

For Troponin T only, see the package insert accompanying the test strips for detailed information: Roche Cardiac reader signals a positive result through the red <Positive Result> LED indicator and

an acoustic signal. As soon as the signal intensity exceeds the threshold value, the LED turns on, even though the reaction time is still running.

Terminate reading by removing the test strip or by pressing <Stop>.

The display reads:

Reading is completed, and Roche Cardiac reader returns to Ready mode when the test strip has been removed.

6.5.1 Display and storage of results

If a result is within the defined range, a quantitative value is dis-played. For results that are outside the defined range, the display reads, for example:

For the interpretation of results, refer to the package inserts accompanying the respective test.

Test results are stored automatically. It is possible to store up to 20 results. Roche Cardiac reader overwrites the oldest result when the memory is full.

Reading is on 11:59

Troponin T

(Troponin T is being read.)

Result in 11:59

Troponin T

(Reading will be completed in 11 minutes 59 seconds.)

Reading completed

Trop. T 1.2 ng/ml

(Displayed result: 1.2 ng/mL Troponin T.)

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remove strip

(Remove the test strip.)

19.03.2004 16:25

Trop. T hi >2.0 ng/ml


36

6.5.2 Displaying and printing patient data from memory

To call up patient data from memory, the instrument must be in Ready mode.

1. Press <Memory>.

By pressing the <Memory> key, the last 20 results can be called up successively.

The display reads:

When all results have been displayed, or if no results are stored in memory, the display reads:

If no entry is made within 10 seconds, the display reads:

If the printer connection was enabled in the Setup menu, the display reads:

2. Press <Set> to start a printout,

or

Press <Stop> to return to Ready mode without printing.

A printout includes all results in the memory.

19.03.2004 16:25

Trop. T 1.2 ng/ml

(Example of the last reading.)

no entry

19.03.2004 16:25

insert strip

Result memory

<SET> print result

37


6.5.3 Additional evaluation for Troponin T parameter (Cardiac T Quantitative)

Reading a used Cardiac T Quantitative test strip

In addition to the quantitative evaluation of Troponin T, it is possible to use Roche Cardiac reader for a qualitative evaluation (that is, a yes or no statement) of a used Cardiac T Quantitative test strip. In this case, the operator observes the reaction time of Cardiac T Quantitative. For qualitative evaluation proceed as follows:

1. Place a Cardiac T Quantitative test strip for which the reaction has been completed (reaction time 15 minutes after sample application) into the slot of the swivel stage.

2. Press <Start>.

3. Wait until the swivel stage is in the correct position for reading.

4. When the test zone reading is completed, the instrument indicates whether a signal line was detected or not. The display reads either:

“Troponin T positive”: that is, Troponin T is detected in the applied sample,

or

“Troponin T negative”: that is, Troponin T is not detected in the applied sample.

A quantitative value cannot be determined subsequently for test strips that were first visually (i.e. qualitatively) evaluated outside the instrument. This qualitative reading mode can only be used for Cardiac T Quantitative test strips. If a used Cardiac M (Myoglobin), a Cardiac proBNP or a Cardiac D-Dimer test strip is inserted, the instrument displays an error message.

6.6 Control readings

Control readings are performance and function checks. There are two types of quality control tests intended for Roche Cardiac reader:

quality control tests to check the optical system of the instrument

Roche Cardiac reader IQC (REF 0 3133508196) is a set of two re-usable control strips for checking the perfor-mance of the instrument’s optical system.

quality control tests to verify system (instrument and test strips together) integrity

For checking system performance, suitable lyophilised control material for the individual test parameters can be ordered (for catalogue numbers, see Section 9).

For the preparation and handling of the control material, refer to the information leaflet of the respec-tive Roche Cardiac control.

Control readings are started when Roche Cardiac reader is in Ready mode.


38

Fig. 25: Inserting the IQC strip.

6.6.1. IQC test to check the performance of the optical system

1. Insert a IQC strip (see Fig. 25).

2. press <Control> twice

The display reads:

3. Press <Start>


During the check of the IQC strip, a break off is possible by pressing <Stop>.

The display reads:

Press <Stop> to break off the reading.

As soon as the IQC test starts, interruption is not longer possible

The display reads:

At the end of the reaction time countdown, the swivel stage with the IQC strip moves back to the starting position, and the result of the control reading is displayed, for example:

4. Remove the IQC strip to terminate the reading or Press <Stop>.

The display reads:

IQC

press <START>

Please wait…

Abort reading?

Abort <Stop>-key

IQC

Reading is on Hi

(Display when running IQC strip high for chek-king the reflectance in the upper concentration range)

IQC Hi passed

64.9 <= 70.7 <= 75.9

IQC

remove strip

(Remove the IQC strip; reading completed)

39


5. Remove IQC strip and return it to the container immediately. Keep the container closed.

Reading is completed, Roche Cardiac reader returns to Ready mode.

6.6.2 Control measurement with liquid control

1. Insert a test strip (see Fig. 25).

2. Press <Control>.

The display reads:

3. Press <Start>.


Then:

4. Apply the control solution to the application area of the test strip (see Fig. 26).

If no control solution is applied, or an applied control solution is not detected, the instrument emits a beep after 8 minutes.

5. Press <Stop> to turn off the beeper.

Control solution

Press <START>

Apply control

Trop. T

please wait…….

Fig. 26: Applying the control solution.

Abort reading?

Abort <STOP> - key


40

6. Press <Stop> again to break off the reading

or

Press <Start> to start the reading following application of control solution.

The display reads:

If a control solution is detected, reading starts, and two messages are alternately displayed:

and

At the end of the reaction time countdown, the swivel stage with the test strip moves back to the starting position, and the result of the control reading is displayed, for example:

For Troponin T control readings only: If the result is positive, the red <Positive Result> LED also lights up.

7. Remove the test strip to terminate the reading

or

Press <Stop>.

The display reads:

Test strips must be removed and disposed of according to local regulations as soon as all tests are completed.

Reading is completed; Roche Cardiac reader returns to Ready mode.

(Control solution for Trop T has been recogni-zed.)

Sample detection

Contr. sol. Trop. T

(Control reading for Troponin T is running.)

Reading is on 11:59

Contr. sol. Trop. T

(Control reading for Troponin T will be comple-ted in 11 minutes and 59 seconds.)

Result in 11:59

Contr. sol. Trop. T

Contr. sol.

Trop. T 0.1 ng/ml

(Result: 0.1 ng/mL Troponin T.)

Control solution

remove strip

(Remove test strip; reading completed.)

41


6.6.3 Displaying and printing control readings from memory

The results of control readings are stored in the internal memory of the instrument for evaluation and documen-tation, and can be displayed and printed (optional printer) via the menu.

The instrument must be in Ready mode to display the results of control readings.

1. Press <Control>.

The display reads:

2. Press <Memory>.

The last 20 results can be displayed successively, when the <Memory> key is pressed.

The display reads:

When all results have been displayed, or if no results are stored in memory, the display reads:

If no entry is made within 10 seconds, the display changes to:

If the printer connection was enabled in the Setup menu, the dis-play reads:

3. Press <Set> to start a printout.

A printout always includes all results in memory.

6.6.4 Retrieving and printing Instrument Quality Control (IQC) results from memory

Results can be retrieved from memory in the same way as non-IQC control readings described above . To do this, press the <Control> key twice. Pressing the <Set> key enables you to alternate between the qualitative “Passed” or “Failed” screen and % reflectance.

Control solution

insert strip

19.03.2004 16:25

Trop. T lo <0.1 ng/ml

(Example of the last reading.)

no entry

Control solution

insert strip

Control solution

<SET> print result

(Printer was activated in the Setup menu.)


42

6.7 Overall test time

The overall test time includes the warm-up period of the instrument (if turned off prior to reading), the preparation period (sample preparation and recognition), and the reaction time including result evaluation:

Warm-up Period

In Stand-by mode Self-test only; then immediately in Ready mode

From power on 10 minutes

Sample recognition : approx. 2 minutes

Reaction time after sample recognition including parameter-specific result evaluation

12 minutes for Troponin T

8 minutes for Myoglobin

8 minutes for D-Dimer

12 minutes for NT-proBNP

6.8 Using patient identification numbers

Patient identification numbers ensure unambiguous identification of results and patient samples. Roche Cardiac reader is designed for entering patient identification numbers (referred to as Pat. IDs). Their entry is optio-nal, that is, this function can be enabled in the Setup menu if required. A numerical Pat. ID may be entered either directly on the instrument by pressing the <Set> and <Paging> keys several times, or by means of an external bar code reader / scanner (optional). The length of the Pat. ID may consist of a minimum of one and a maximum of 16 characters.

The Pat. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, alphanumeric characters can be used.

A Pat. ID may be entered either before or during reading. When reading is completed, it is no longer possible to define a Pat. ID for that result.

If a Pat. ID is entered before reading starts, it is displayed on the screen with the result. If a printer (optional) is connected, the result is printed with the Pat. ID. The Pat. ID is stored with the corresponding result in the internal memory, and can be recalled and printed as required.

When a reading is completed, the Pat. ID is deleted automatically for the next reading.

43


6.8.1 Entering a patient ID number via the keypad

A Pat. ID may be entered either before reading starts, when the instrument is in Ready mode, or while reading is in progress.

Prerequisite:

The Pat. ID setting was enabled in the Setup menu (see Section 5.2.12).

1. Press <Set>.

The display reads:

2. Press <Set> to enter the first digit in the range from 0 to 9.

3. Press <Paging>.

The display reads:

4. Press <Set> to enter the second digit. Repeat as many times as required until the entire Pat. ID is

entered.

5. Press <Stop> to leave Pat. ID. input mode

or

press <Paging> to proceed to entering the Operator ID.

6.8.2 Entering a Patient ID number via a bar code reader / scanner (optional)

To enter the Pat. ID by using a bar code reader / scanner, the device is placed on to the Patient ID bar code. You can scan in the Pat. ID before you insert the test strip or while reading is on. When the code is scanned, a beep is emitted. The Pat. ID is automatically stored in the memory. For recommended scanner types, refer to Section 12.2.

If you scan in a bar code with more characters than you have selected in the Setup menu (e.g. you have left the default length of 10 characters in the Setup menu for Pat. ID and you scan in 13), the additional characters will be cut off. To avoid this, select the maximum length (16 characters) in the Setup menu.

Pat. ID Input

>>>>>>>>> _ <<<<<<<<<<<

(For example, a 4-digit Pat. ID was selected in the Setup menu; the first digit can now be entered.)

1st digit

Pat. ID Input

>>>>>>>>> 5_ <<<<<<<<<<<

(The first digit entered is 5; the second digit can now be entered.)

2nd digit


44

6.9 Using operator identification numbers

Operator identification numbers allow unambiguous identification of who tested particular patient samples. Roche Cardiac reader is designed for entering operator identification numbers (referred to as Op. IDs). However, if this function is not required, it may be disabled in the Setup menu. A numerical Op. ID may be entered either directly on the instrument by pressing the <Set> and <Paging> keys several times, or by means of an external bar code reader / scanner (optional). The length of the Op. ID may consist of a minimum of one and a maximum of 16 characters.

The Op. ID consists only of numbers if you enter the characters manually into Roche Cardiac reader. If a bar code reader / scanner is attached, alphanumeric characters can be used.

An Op. ID may be entered either before or during reading. When reading is completed, it is no longer possible to define an Op. ID for that result. If there is a break in testing and the instrument returns to Standby mode or if it is turned off, the current Op. ID will not be retained. It must be entered again if the same operator wishes to continue testing. To enter an Op. ID, you must first enter a Pat. ID.

If a printer (optional) is connected, the result is printed with the Op. ID. The Op. ID is always stored together with the corresponding result in the internal memory, and may be recalled and printed as required.

6.9.1 Entering an Operator ID number via the keypad

The Operator ID is entered after the Patient ID.

Prerequisite:

The Op. ID setting was enabled in the Setup menu (see Section 5.2.13).

1. Press <Paging>.

The display reads:

2. Press <Set> to enter the first digit in the range from 0 to 9.

3. Press <Paging>.

The display reads:

4. Press <Set> to enter the second digit.

5. Repeat as required until the entire Op. ID is entered.

Op. ID Input

>>>>>>>>>_ <<<<<<<<<<<

(For example, a 4-digit Operator ID was selec-ted in the Setup menu; the first digit can now be entered.)

1st digit

Op. ID Input

>>>>>>>>>4_ <<<<<<<<<<<

(The first digit entered is 4; the second digit can now be entered.)

2nd digit

45


6.9.2 Entering an Operator ID number via a bar code reader / scanner (optional)

To enter the Op. ID by using a bar code reader / scanner, the device is placed on to the Op. ID bar code. You can scan in the Op. ID before you insert the test strip or while reading is on. However, to enter an Op. ID, you must first enter a Pat. ID. When the code is scanned, a beep is emitted. The Op. ID is automatically stored in the memory. For recommended scanner types, refer to Section 12.2.

If you scan in a bar code with more characters than you have selected in the Setup menu (e.g. you have left the default length of 5 characters in the Setup menu for Op. ID and you scan in 8), the addi-tional characters will be cut off. To avoid this, select the maximum length (16 characters) in the Setup menu.


46

7 Error Messages

7.1 General information on error detection and correction

Roche Cardiac reader has been designed to be user-friendly. Follow all the instructions given in this manual to ensure error-free handling. If an error occurs, follow the instructions given below. If, after checking all options, the error persists, contact your local Roche Diagnostics service representative.

7.2 Handling error messages

There is a general distinction between major instrument errors and system errors. A major instrument error occurs when an important instrument component is defective, and reliable results can no longer be guaranteed. In this case, all reading functions are blocked and an error message is displayed, for example:

Note the displayed error code, for example 100, and contact your Roche Diagnostics service repre-sentative.

System errors may occur because of operator error or test strip–specific faults, for example:

In most cases, such system errors can be remedied by accurately observing the instructions given in the manual or by using a new test strip.

Call Service

Major Error 100

No reading poss.

Error 60

47

Error Messages

7.3 Error messages prior to reading

The table below indicates problems that may occur before a reading starts and appropriate corrective action.

Source of Error Action

Expiry date of test strip exceeded Insert new strip with a valid expiry date.

Bar code not readableCheck bar code on the underside of the test strip for soiling or scratches. Wipe with a soft cloth if appro-priate.

Unknown lot codet Check if the appropriate coding chip is inserted.

7.4 Error messages during reading

The table below indicates system errors that may occur during reading and appropriate corrective action.

Error Code Description Action

60 to 99 Evaluation of test strip not possible.

Repeat with new test strip. If the error cannot be corrected, note the error code and contact your Roche Diagnostics service repre-sentative.

The table below lists the major instrument errors that may occur.

Error Code Description Action

100 to 999 Major errors Note the error code and contact your Roche Diagnostics service representative.


48

7.5 Errors with Host/PC connection on

If the Host/PC connection was selected without a PC or the laboratory EDP system being connected to the Cardiac reader, the errors listed below may occur:

Setup menu setting

Action by Cardiac reader

Error message Action by operator

Cause of the error

Host/PC on

QC off

Cardiac reader power-on

Host/PC not ready

Check Host/PC

1. Press <Stop> to change to ready state

2. Select Setup Menu setting Host/PC off

Host/PC not connected or not ready

Host/PC on

QC on

Cardiac reader power-on

Host/PC not ready

Check Host/PC




Testing of control solution

Wait for Host/PC

Host timeout wait for Host




Removal of test strip following reading

Interface not ready

Check DC connection




Interface not ready

Memory full

1. Host/PC must be con-nected and download of results stored in the Cardiac reader be performed.


Memory full with undownloaded results

49

Error Messages

7.6 Repairs

Only suitably qualified personnel authorized by Roche Diagnostics must perform repairs, readjustments (except Setup), or other modifications to the instrument.

Do not open the instrument under any circumstances.


50

8 Cleaning and Maintenance

Roche Cardiac reader is maintenance-free in operation.

The design of the instrument minimizes contamination by samples, as the sample application area is separated from the instrument interior by means of the swivel stage.

The housing can be cleaned with commercial laboratory cleaners and disinfectants, preferably 70% alcohol, if required.

Use a non-linting cloth or a cotton bud to clean the corners.

The instrument must not be opened for cleaning.

Gloves must be worn when cleaning the instrument.

51

Ordering Information

9 Ordering Information

The catalogue numbers (REF) for ordering system components are listed below.

Item Description REF

Roche Cardiac T Quantitative 10 tests for quantitative detection of Roche Cardiac Troponin T for use with Roche Cardiac reader

1 1894307193

Roche Cardiac control Troponin T Control set for use with Roche Cardiac T Quantitative (control set for 2 x 6 function checks)

1 1937553193

Roche Cardiac M 20 tests for quantitative detection of Myoglobin for use with Roche Cardiac reader

1 1893840193

Roche Cardiac control Myoglobin Control set for use with Roche Cardiac M (control set for 2 x 6 function checks)

1 1937545193

Roche Cardiac D-Dimer 10 tests for quantitative detection of D-dimer for use with Roche Cardiac reader

1 2241528196

Roche Cardiac control D-Dimer Control set for use with Roche Cardiac D-Dimer (control set for 2 x 6 function checks)

0 3526038196

Roche Cardiac proBNP 10 tests for quantitative detection of NT-proBNP for use with Roche Cardiac reader

0 4659449190

Roche Cardiac control proBNP Control set for use with Roche Cardiac proBNP (control set for 2 x 6 function checks)

0 4533453196

Roche Cardiac reader IQC Set of two re-usable control strips for checking the performance of the instrument’s optical system

0 3133508196

Roche Cardiac pipettes 20 disposable syringe pipettes (150 µL) for blood application

1 1622889190

Printer for Roche Cardiac reader Thermal printer for use with Roche Cardiac reader 0 3136671001

Printer connection cable Cable for connecting printer to the Roche Cardiac reader (only for use with REF 0 3136671001)

0 3136680001

Printer power supply unit Power supply unit including mains cable 0 4653840001

Paper for printer Paper for thermal printer for use with REF 0 3136671001 1 1903233001


52

10 Interface assignment

10.1 Printer/bar code reader interface

Connector: D-sub, 9-pin, female

Pin assignment: Pin 1 +5V (for printer/bar code reader ) Pin 2 RxD (input Roche Cardiac reader) Pin 3 TxD (output Roche Cardiac reader) Pin 5 GND Pin 7 RDY (ready signal to bar code reader)

Electrically conductive connection between the connector shell and the coating of the housing.

10.2 Host/PC interface

Connector: D-sub, 9-pin, male

Pin assignment: Pin 2 RxD (input Roche Cardiac reader) Pin 3 TxD (output Roche Cardiac reader) Pin 5 GND

Electrically conductive connection between the connector shell and the coating of the housing. Maximum length of connecting cable is 3 m.

53

System Specifications

11 System Specifications

Contents of box: Instrument packed, with power supply unit, manual, mains cable and power cable

Measuring principle: CCD photosensor with lens, annular illumination of green LEDs (555 nm), micropro-cessor controlled evaluation of a control and signal line and display of a quantitative result

Sample volume: 150 µL

Sample material: Heparinised venous whole blood

Overall reaction time: Parameter-specific

Parameter detection: Detection of parameters and lot by means of bar code on the underside of the test strips

Measuring range: Parameter-specific

Controls: Parameter-specific control solutions Cardiac reader IQC

Languages (display): German, English, French, Spanish, Italian, Swedish, Portuguese, Japanese

Keypad: Integrated keypad with 6 function keys to operate the instrument

Display: 2-line alphanumeric display, 2 x 20 characters, for operator prompts and result display

Host/PC interfaces: Serial interface (RS232) for Host or PC connection

Printer interfaces: Serial interface (RS232) for connecting external printer and/or bar code reader

Coding chip: Contains all lot-specific data for the test strips

Memory: Data memory for storing: 20 results with date, time, Pat. ID, and Op. ID 20 control readings 62 IQC results 15 lot codes Date and time


54

Dimensions: Height 95 mmWidth 250 mmDepth 200 mm

Weight: 1.31 kg, excluding packing; instrument including power supply unit and mains cable 1.81 kg

Power supply: Universal external power supply, Model 78-095-0300 Ascom Frako Input: 110 V-240 V, 50-60 Hz, 0,4-0,2 A Output: 5 V, 2 A 12 V, 2 A

Ambient conditions:: Operation Storage temperature: +18 to +35°C -20 to +60°C relative humidity: 20 to 80% 20 to 80%

Certification marks: , UL, cUL

For further performance data, refer to the test pack inserts.

55

Optional peripheral equipment

12 Optional peripheral equipment

12.1 Printer

Peripheral equipment that is connected to the Roche Cardiac reader must conform to EN 60950 and UL 1950 for EDP equipment.

12.1.1 General information

A printer (see Fig. 27) can be connected to Roche Cardiac reader. The following printouts are available:

Setup parameters Patient results Control reading results

12.1.2 Connecting an external printer

The following multi-purpose printer, which can be ordered separa-tely, can be connected:

Printer type: DPT-6333-V.24, Roche Diagnostics, REF 0 3136671001 (see Section 9)

The external printer is connected to the printer interface of Roche Cardiac reader by means of the connecting cable, REF 0 3136680001. Connect the power supply unit, REF 0 4653840001 (see Fig. 28). The printer can be used imme-diately.

Fig. 28: Connection for power supply, printer interface

Fig. 27: Printer


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12.1.3 Inserting paper

To insert the paper, the printer must be connected to the power supply unit and switched on.

1. To remove, push the lid in the direction of the arrows marked on the lid.

2. Cut the front end of the paper into a triangular form and insert it into the slot.

3. Press <LF>. The linefeed function of the printer feeds the paper into the printer.

4. Press <LF> again to stop the linefeed function.

5. Place the paper roll in the printer and replace the lid after having passed the front end of the paper through the slot in the lid.

For detailed information, refer to the instruction manual of the printer.

12.1.4 Indicator lights and function keys

The two indicator lights on the panel of the DPT-6333 printer are the power indicator light (P) and the status indicator (SEL). The SEL indicator shows the status of the printer. The light is on when the printer is online, and off when the printer is offline. The SEL indicator flashes to indicate a problem with the printer (such as paper shortage or printer overheating). The SEL key on the printer panel is used to select the printer online while the LF key controls paper feed.

Fig. 29: Inserting the paper.

3, 4 2

Fig. 30: Installing the paper roll.

1 5

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Optional peripheral equipment

12.2 Bar code reader/scanner

12.2.1 General information

It is possible to connect a bar code reader /scanner to Roche Cardiac reader. The bar code reader/scanner can be connected either via the interface connector of the printer or directly to the printer port of the Roche Cardiac reader.

12.2.2 Connecting a bar code reader/scanner

The following bar code readers/scanners can be connected:

1. CCD reader: BCS-2060 (TR 26) BM (with release button)

This bar code reader/scanner (scan area width 60-100 mm) reads all common bar codes.

Supplier in Germany:

BÜTEMA Daten-Elektronik GmbH Pleidelsheimer Straße 31 D-74321 Bietigheim-Bissingen

2. CCD-Touch Scanner: DLC 6065-MO DH 0486 (without release button) This bar code reader/scanner (scan area width 60 mm) reads all common bar codes.

Supplier in Germany:

Datalogic GmbH Daimlerstraße 2 D-73268 Erkenbrechtsweiler

www.datalogic.com

For the addresses of distributors in other countries, contact your local Roche Diagnostics representa-tive.

Connecting a bar code reader/scanner other than the types described above to Roche Cardiac reader may lead to data transmission problems.

For more information about connecting a bar code reader/scanner, contact your Roche Diagnostics service representative.

Set the scanner to the Busy/Ready mode (see instruction manual for the scanner). In this mode, the scanner trans-mits scanned data upon receiving a request-to-send (RTS) signal from Roche Cardiac reader.

Roche Cardiac reader itself does not give an acoustic signal that Pat. IDs have been successfully received from the scanner. Therefore, the scanner must be set so that every string is acknowledged by an acoustic OK signal directly on the bar code reader. If an error occurs, the bar code reader emits an acoustic NOT-OK signal.


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12.2.3 Bar code reader / scanner configuration

The bar code reader / scanner parameters can only be modified by scanning bar code labels and not via ESC sequences obtained from Roche Cardiac reader. This means that the operator must modify the bar code reader / scanner configuration, unless the following configurations are available as default settings:

Baud rate: 9600 baud Data: 8 data bits Parity: none Stop bits: 1 Handshake: Busy/Ready mode Buzzer: signal after transmission Prefix: no prefix Suffix: CR (ASCII 13) on string entry, no suffix or ETX or LF on single character entry Length transmission: disabled Check sum: disabled Code identifier: disabled Bar code: Read all codes, if correction symbol coding is different from Pat. ID code

12.3 Host/PC connection

12.3.1 General Information

It is possible to connect a Host/PC to Roche Cardiac reader. When a reading is completed, the result, including all available information (such as date, time, Pat. ID, Op. ID), is automatically transmitted to the printer port and the Host/PC port. If the Host/PC connection is not enabled in the Setup menu, the data will appear on the PC in the same format as on the printout. If the Host/PC connection is enabled in the Setup menu, a special ASTM protocol is used. For detailed information please contact your Roche Diagnostics service representative.

12.3.2 Connecting to a Host/PC

Roche Cardiac reader is connected to a Host/PC via a standard serial port using an RS232C cable with three data lines. A special 0-modem cable is used for cable and connector. The D-sub 9-pin connector is male on both the Roche Cardiac reader and Host/PC side. Synchronization is established by means of passive software handshake (XON/XOFF). The baud rate is fixed at 9600 baud (8 bits, 1 stop bit without parity). These parameters cannot be changed. The pin assignment of the connectors is as follows:

Host/PC Roche Cardiac reader

DB 9 male DB 9 maleTxd Pin 3 Txd Pin 3Rxd Pin 2 Rxd Pin 2CTS Pin 8 CTS Pin 8RTS Pin 7 RTS Pin 7DTR Pin 4 DTR Pin 4DSR Pin 6 DSR Pin 6SG Pin 5 SG Pin 5

Pin 1 on both sides must not be connected with the shielding. Switch off the instruments before disconnecting the connectors.

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Subject Index

13 Subject Index

AAccessories . . . . . . . . . . . . . . . . . . . . . 3.2Attention symbol . . . . . . . . . . . . . . . . . 2.2.1

BBar code . . . . . . . 4.1, 6.3.1, 6.4, 6.8.2, 6.9.2, 7.3.11Bar code reader . . . . . . . . . . . . 6.8.2, 6.9.2, 12.2

CCatalogue numbers (REF) . . . . . . . . . . . . . . . 9Coding chip . . . . . . . 2.4, 4.1, 4.2, 6.4, 6.4.1, 7.3.11Control readings . . . . . . . . . . . . . . . 5.2.15, 6.6

DDanger sign . . . . . . . . . . . . . . . . . . . . 2.2.1D-Dimer . . . . . . . . . . . . . . . . . . 1.7, 2.1, 6.7, 9

EError messages . . . . . . . . . . . . . . . . . . . . 7

GGold-labelling technique . . . . . . . . . . . . . . 2.1

HHazards . . . . . . . . . . . . . . . . . . . . . . . 2.2.1Host/PC connection . . . . . . . . . . . . . . . . . 12.3Host/PC settings . . . . . . . . . . . . . . . . 5.2.8, 7.5Host/PC interfaces . . . . . . . . . . . . 10.2, 11, 12.3

IImmunoassays . . . . . . . . . . . . . . . . . . . . 2.1Internal memory functions . . . . . . . . . . . . 5.2.1IQC (Instrument Quality Control) 5.2.16, 6.6, 6.6.2, 9, 11

KKeypad . . . . . . . . . . . . . . . . . . . . . 4.2.2, 11

LLanguages . . . . . . . . . . . . . . . . . . . 2.1, 5.2.2Light-emitting diodes (LEDs ) . . . . . . . 2.1, 2.4, 11

M Measuring principle . . . . . . . . . . . . . . . 4.1, 11Memory . . . . . . . . . . . . . . . . . 5.2.16, 6.4, 11 Myocardial Ischemia . . . . . . . . . . . . . . . . 2.1Myoglobin . . . . . . . . . . . . . . . . . 1.7, 2.1, 6.7, 9

NNote symbol . . . . . . . . . . . . . . . . . . . . 2.2.1

OOperating modes . . . . . . . . . . . . . . . . . . 6.2Operator ID (Op. ID) . . . . . . . . . . . . . 5.2.12, 6.8

PPatient ID (Pat. ID) . . . . . . . . . . . . . . 5.2.12, 6.8Pin assignment . . . . . . . . . . . . . . . . . 10.1, 10.2Power supply unit . . . . . . . . . . . . 3.2, 3.4, 4.2.4Printer . . . . . . . . . . . . . . . . . . . . . . 9, 12.1Printing . . . . . . . . . . . . . 5.2.15, 6.5.2, 6.6.1, 6.6.2 Printer connection . . . . . . . . . . 2.4, 5.2.9, 9, 12.1.2Protective earth conductor . . . . . . . . . . . . 2.2.2ProBNP . . . . . . . . . . . . . . . . . . . 1.7, 2.1, 6,7, 9

QQuality control . . . . . . . . . . . . . . . . . . . . 6.6

RReady mode . . . . . . . . . . . . . . . . . . . . . 6.2Regulatory compliance . . . . . . . . . . . . . . . 2.2Repairs . . . . . . . . . . . . . . . . . . . . . . . . 7.5

SSafety instructions . . . . . . . . . . . . . . . . . . 2.2Scanner . . . . . . . . . 6.8.2, 6.9.2, 12.2, 12.2.2, 12.2.3Self-test . . . . . . . . . . . . . . . . . . . . . 6.1, 6.7Settings (default) . . . . . . . . . . . . . . . . . 5.1.1Settings (menu table) . . . . . . . . . . . . . . . 5.2.1Setup menu . . . . . . . . . . . . . . . . . . . . . 5.2Stand-by mode . . . . . . . . . . . . . . . . . . . 6.2Swivel stage . . . . . . . . . . . . . . . . . . . 6.4, 6.5

TTest signal . . . . . . . . . . . . . . . . . . . . . . 4.1Troponin T . . . . . . . . . . . . . . . 1.7, 2.1, 6.5.3, 9

UUnpacking and installation . . . . 3.1, 3.2, 3.3, 3.4, 3.5

WWarm-up time . . . . . . . . . . . . . . . 2.5.1, 6.1, 6.7Warning symbol . . . . . . . . . . . . . . . . . . 2.2.1

0088

Roche Diagnostics GmbHD-68298 Mannheim, Germanywww.roche.com

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