P O I N T O F T E S T I N G

C A R E

Roche Cardiac reader

Operators Manual

0 4446364001(02)-04/05 EN

Roche Cardiac reader

On the packaging, on the identication 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 fulls 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.

Table of contents

Table of contents
1 2 Short Guide to Using Roche Cardiac reader Getting Started 2.1 Introduction 2.2 Safety instructions and regulatory compliance 2.2.1 Symbols used in the Operators Manual 2.2.2 Regulatory compliance and general safety warnings 2.3 About this manual 2.4 Roche Cardiac reader at a glance Unpacking and Installation 3.1 Check for possible damage incurred during transport 3.2 Unpacking 3.3 Proper siting 3.4 Connection to mains supply 3.5 Supplementary safety notice System Description 4.1 Measuring principle 4.2 Components and functions 4.2.1 Front of the instrument 4.2.2 Display and keypad 4.2.3 Back of the instrument 4.2.4 Power supply unit and mains supply Software 5.1 Software overview 5.1.1 Factory default settings 5.2 Setup menu 5.2.1 Setup menu table 5.2.2 Selecting the language 5.2.3 Selecting the date format 5.2.4 Setting the date 5.2.5 Selecting the time format 5.2.6 Setting the time (24-hour clock) 5.2.7 Setting the time (12-hour clock) 5.2.8 Host/PC connection setting 5.2.9 Printer connection setting 5.2.10 Selecting the units of measurement 5.2.11 Setting the beeper frequency 5.2.12 Setting the patient ID 5.2.13 Setting the operator ID 5.2.14 Setting the QC transmission 5.2.15 Printing the Setup parameters 5.2.16 Internal memory functions 7 8 8 10 10 10 11 12 13 13 13 13 14 14 15 15 15 15 16 16 16 17 17 17 17 17 20 21 21 22 22 23 23 24 25 25 26 28 30 30 30

Roche Cardiac reader

Operating the Instrument 6.1 Switching on Roche Cardiac reader 6.2 Operating modes 6.3 Reading procedure 6.3.1 General 6.4 How to use the coding chip 6.4.1 Inserting the coding chip 6.5 Reading mode: Patient samples 6.5.1 Display and storage of results 6.5.2 Displaying and printing patient data from memory 6.5.3 Additional evaluation for Troponin T parameter (Cardiac T Quantitative) 6.6 Control readings 6.6.1. IQC test to check the performance of the optical system 6.6.2. Control measurement with liquid control 6.6.3 Displaying and printing control readings from memory 6.6.4 Retrieving and printing Instrument Quality Control (IQC) results from memory 6.7 Overall test time 6.8 Using patient identication numbers 6.8.1 Entering a Patient ID number via the keypad 6.8.2 Entering a Patient ID number via a scanner (optional) 6.9 Using operator identication numbers 6.9.1 Entering an Operator ID number via the keypad 6.9.2 Entering an Operator ID number via a scanner (optional) Error Messages 7.1 General information on error detection and correction 7.2 Handling error messages 7.3 Error messages prior to reading 7.4 Error messages during reading 7.5 Errors with Host/PC connection on 7.6 Repairs Cleaning and Maintenance Ordering Information

31 31 31 32 32 32 33 33 35 36 37 37 38 39 41 41 42 42 43 43 44 44 45 46 46 46 47 47 48 49 50 51

8 9

Table of contents

10

Interface Assignment 10.1 Printer/bar code reader interface 10.2 Host/PC interface System Specications Optional Peripheral Equipment 12.1 Printer 12.1.1 General information 12.1.2 Connecting an external printer 12.1.3 Inserting paper 12.1.4 Indicator lights and function keys 12.2 Bar code reader/scanner 12.2.1 General information 12.2.2 Connecting a bar code reader/scanner 12.2.3 Bar code reader / scanner conguration 12.3 Host/PC connection 12.3.1 General information 12.3.2 Connecting to a Host/PC Subject Index

52 52 52 53 55 55 55 55 56 56 57 57 57 58 58 58 58 59

11 12

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Short Guide to Using Roche Cardiac reader

Short Guide to Using Roche Cardiac reader

Read this Operators 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 rst reading.
Fig. 1: Insert the coding chip.

2. 3. 4.

Press any key, when the instrument is in Stand-by mode. Wait for the self-test to nish. Open the test strip pack and take out the coding chip, and insert it as shown in Fig. 1. Remove the test strip from the package, and place it into the appropriate slot of the swivel stage as shown in Fig. 2. Press <Start>.
Fig. 2: Insert the test strip.

5.

6.

Wait until the swivel stage is in the correct position for reading. 7. When instructed in the display, apply the sample (150 L 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. 3: Applying the sample.

Roche Cardiac reader

2
2.1

Getting Started
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 Failure, risk stratication 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, Myoglobin, D-Dimer and NT-proBNP.

Refer to the package inserts accompanying the test strips for detailed information on specic 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 qualied personnel must operate Roche Cardiac reader.

For indoor use only.

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

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-specic data Display readings available in eight languages External power supply unit with ON/OFF switch (110 V to 230 V) Entry of a patient identication 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

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

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

The instrument has six function keys and two light-emitting diodes (LEDs). Function keys: <Set> <Control> <Start> <Paging> <Memory> <Stop>

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

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 instrument is connected to a printer (optional).

Fig. 7: Display window.

Roche Cardiac reader

2.2 Safety instructions and regulatory compliance

2.2.1 Symbols used in the Operators Manual

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

Symbols / Explanation Warning symbol. Indicates a potentially hazardous situation that if not avoided could result in personal 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 equipment.

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 requirements for electrical equipment for measurement, control and laboratory use; part I: general requirements, and is in compliance with all safety specications when it leaves the factory.

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

10

Getting Started

Only qualied 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 components of the instrument may only be performed by suitably qualied 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 qualied 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 conict between this manual and information given in package inserts, the package inserts shall take precedence. This instrument is classied as an overvoltage installation Class II and pollution Class 2 device.

2.3

About this manual Read the Operators 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.

19.03.2004 remove strip

16:25

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

Pat.-ID: insert strip

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

1234

or the date and time: 19.03.2004 insert strip

(In this example 19.03.2004 and 16:25.)

16:25

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.

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Roche Cardiac reader

2.4 1) 2) 3) 4) 5) 6)

Roche Cardiac reader at a glance Display and keypad Slot for coding chip Swivel stage for test strip Positioning bar Integrated bar code reader Coding chip (included in every test strip pack)
Fig. 8

7) 8) 9)

Serial interface (port) for printer RS232 C interface (port) for Host/PC Socket for power cable of power supply unit

Fig. 9

10 10) 11) 12) 13) 14) 15) 16) 17) <Power> LED (green) <Positive Result> LED (red) <Set> key <Paging> key <Control> key <Start> key <Memory> key <Stop> key
Fig. 10

11

12

13

14

15

16

17

12

Unpacking and Installation

3
3.1

Unpacking and Installation

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 transport, 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 instrument 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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Roche Cardiac reader

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.

Fig. 11: All components in the box.

1.

Connect Roche Cardiac reader and the power supply unit by means of the power cable. Connect the mains cable to the power supply unit. Connect the mains cable plug to the mains power outlet. Turn on the power supply unit.

2. 3. 4.

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

Fig. 12: Connecting the power cable.

Fig. 13: Power supply unit.

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.

14

System Description

4
4.1

System Description
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-specic information for automated quantitative evaluation with the instrument. Refer to the package inserts accompanying the test strips for detailed information on specic tests.

4.2 4.2.1 1) 2)

Components and functions Front of the instrument

Swivel stage for transporting the test strips 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. Display and keypad Slot for coding chip 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).

3) 4) 5)

Fig. 14: Front of the instrument.

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Roche Cardiac reader

4.2.2 6) 7) 8) 9)

Display and keypad

10

<Power> LED (green) <Positive Result> LED (red) <Set> key <Paging> key

10) <Memory> key 11) <Start> key

Fig. 15: Display and keypad.

12) <Control> key 13) <Stop> key

11 12

13

4.2.3

Back of the instrument

14

15

16

14) Serial interface (port) for printer /bar code reader 15) RS232 C interface (port) for Host/PC 16) Socket for power cable

Fig. 16: Back of the instrument.

4.2.4

Power supply unit and mains supply

17

18

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.

Fig. 17: Power supply unit.

16

Software

5
5.1 5.1.1

Software
Software overview Factory default settings

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

5.2 5.2.1

Setup menu 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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Roche Cardiac reader

Roche Cardiac reader Setup Menu - Part 1

<Set> <Stop>

to change the settings in Setup to exit the Setup menu

<Paging> to go to the next entry

<Paging> from Ready mode

Default settings are underlined

Setup Language:
<Paging>

English

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

Language

Setup Date format:

dd.mm.yy

Date Format

<Paging>

Setup Date:

19.03.2004
<Paging>

Press <Set> and <Paging> to enter date

Date

Setup Time format:

<Paging>

24h

Press <Set> to select: 24h / 12h

Time Format

Setup Time:
<Paging>

16:25

00:00 to 23:59 or a.m. / p.m. 01:00 to 12:59

Time

Setup Host/PC:
<Paging>

no

Press <Set> to select: yes /no*

Press <Set> and <Paging> to enter the time.

Host/PC

Setup Printer:
if no

no

Press <Set> to select: yes /no

<Paging> if yes

Setup Immediate print:

<Paging>

yes

Press <Set> to select: yes /no

Printer

<Paging>

<Paging>

Setup Blank lines:

Press <Set> to select: 0...3...8

<Paging>

Press <Set> to select: Units

Setup Trop. T Unit: ng/ml
<Paging> <Set>

Setup Trop. T Unit:

ng/ml

Units

After last parameter press <Paging>

Setup Beeper:
<Paging>

Units depend on parameter.

Example Trop. T: ng/mL or g/L

next parameter

Frequ.1

Press <Set> to select: off / Frequ. 1 / Frequ. 2

Beeper

Continue next page

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

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Software

Roche Cardiac reader Setup Menu - Part 2

cont. from Setup Menu Part 1
<Set> <Set> if obligatory

if optional

<Paging>

Setup Pat.-ID:
<Paging> if no

no

Setup Pat. ID length: Press <Set> to select: no/opt./oblig.

<Paging>

10

Press <Set> to select: 1.....10....16

Patient ID Length

<Set>

if obligatory

<Set>

if optional

<Paging>

Setup Op. ID:

<Paging> if no

no

Setup Op. ID length: Press <Set> to select: no/opt./oblig.

Operator ID
5 Press <Set> to select: 1.....5....16

Length

<Paging> if no

Press <Set> to select: yes/no

Setup QC active
<Paging>

<Paging>

yes

QC transmission

Setup print setup

<Stop> or <Paging>

If printer is connected press <Set>

Printout
Setup

Print only selected Setup parameters

Print Setup

settings

Return to Ready mode

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

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Roche Cardiac reader

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:

19.03.2004 insert strip

16:25

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

19.03.2004 remove strip

16:25

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>. Language: English

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.

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Software

5.2.3 1.

Selecting the date format

Press <Paging>. Setup Date format:

(factory setting)

The display reads:

dd.mm.yy

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

2.

Select other date formats by pressing <Set>:

Setup Date format: Setup Date format: yy.mm.dd mm.dd.yy

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 1.

Setting the date

Press <Paging>. Setup Date:

(First group of digits ashes.)

The display reads:

19.03.2004

2. 3.

Press <Set> to select the setting. Press <Paging>. Setup Date: 19.03.2004

The display reads:

(Second group of digits ashes.)

4.

Press <Set> to select the setting.

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Roche Cardiac reader

5.

Press <Paging>.

Setup Date:
(Third group of digits ashes.)

The display reads:

19.03.2004

6. 7.

Press <Set> to select the setting. Press <Stop> to leave the Setup menu or proceed to Selecting the time format.

5.2.5 1.

Selecting the time format

Press <Paging>. Setup Time format: 24h

The display reads: 2. Press <Set> to select the 12 or 24-hour format.

5.2.6 1.

Setting the time (24-hour clock)

Press <Paging>. Setup Time:

(The hours ash.)

The time is displayed for example: 2. Press <Set> to select the hours.

16:25

3.

Press <Paging>. Setup Time:

(The minutes ash.)

The time is displayed for example:

16:25

4. 5.

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

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Software

5.2.7 1.

Setting the time (12-hour clock)

Press <Paging>. Setup Time: pm 04:25

The display reads for example:

2.

Press <Set> to select the hours.

(The hours ash.)

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

3.

Press <Paging>. Setup Time: pm

(The minutes ash.)

The display reads for example:

04:25

4. 5.

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

5.2.8 1.

Host/PC connection setting

Press <Paging>. Setup Host/PC: no

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 hospital 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.

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Roche Cardiac reader

5.2.9

Printer connection setting

Printer not connected: 1. Press <Paging>. Setup Printer: 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. no

The display reads:

Printer connected: To activate a printer, if connected: 1. Press <Set> to activate the printer connection. Setup Printer: 2. Press <Paging>. Setup Immediate print: no yes

The display reads:

The display reads:

3.

Press <Paging> to proceed to Selecting the units of measurement, or press <Set> to select immediate print. Setup Immediate print: yes

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

4.

Press <Paging>. Setup Blank lines:

(3 blank lines are selected.)

The display reads:

5. 6.

Press <Set> to select the number of blank lines between the results for the printout in a range of 0 to 8. Press <STOP> to leave the Setup menu, or proceed to Selecting the units of measurement .

24

Software

5.2.10 Selecting the units of measurement 1. Press <Paging>. Setup Trop. T Unit
(Trop T is used as an example.)

The display reads:

ng/ml

2. 3.

Press <Set> to select one of the two options (ng/mL or g/L or alternatively pg/mL or ng/L). Press <STOP> to leave the Setup menu, or proceed to Setting the beeper frequency.

5.2.11 Setting the beeper frequency 1. Press <Paging>. Setup Beeper:

(Beeper activated at frequency 1.)

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

Frequ.1

2.

Press <Set> to select beeper frequency 2. Setup Beeper:

(Beeper activated at frequency 2.)

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

Frequ.2

3.

Press <Set> to turn the beeper off. Setup Beeper: off

The display reads:

4.

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

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Roche Cardiac reader

5.2.12 Setting the patient ID The operator can choose between the following options: Pat. ID no: Pat . ID opt: Pat. ID oblig: The system will never ask for an input of the Pat. ID The user has the option to input a Pat. ID The system will always ask for a Pat. ID and will not proceed until an entry has been made.

1.

Press <Paging>. Setup Pat. ID:

(No patient ID entry required.)

The display reads:

no

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. Setup Pat. ID:
(Patient-ID activated.)

The display reads:

opt.

2.

Press <Paging>. Setup Pat. ID length:

(Patient ID length setting of 10 characters.)

The display reads:

10

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.

26

Software

If a Patient ID is obligatory: 1. Press <Set> to activate the Patient ID setting. Setup Pat.-ID: 2. Press <Set> again. The display reads: Setup Pat.-ID: 3. Press <Paging>. Setup Pat.-ID: 10 oblig. opt.

The display reads:

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.

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Roche Cardiac reader

5.2.13 Setting the operator ID The operator can choose between the following options: Op. ID no: Op . ID opt: Op. ID oblig: The system will never ask for an input of the Operator ID The user has the option to input an Operator ID The system will always ask for an Operator ID and will not proceed until an entry has been made.

1.

Press <Paging>. Setup Op. ID: no

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. Setup Op. ID:
(Operator ID required.)

The display reads:

opt.

2.

Press <Paging>. Setup Op. ID length:

(Operator ID length setting of 5.)

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

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Software

If an Operator ID is obligatory: 1. Press <Set> to activate the Operator ID setting. Setup Op. ID: 2. Press <Set> again Setup Op. ID: 3. Press <Paging>. Setup Op. ID: 10 oblig. opt.

The display reads:

The display reads:

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). 5. Press <Stop> to leave the Setup menu, or proceed to QC active yes/no or to Printing the Setup parameters. If Patient ID and Operator ID are both set to opt , press <Set> to select rst the patient ID and afterwards press <paging> to select the Operator ID.

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Roche Cardiac reader

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. Setup QC active: 2. Press <Set> to deactivate QC. Setup QC active: 3. Press <Stop> to leave the Setup menu or proceed to Printing the Setup parameters. Setup print Setup no yes

5.2.15 Printing the Setup parameters If the printer connection has been activated: 1. Press <Paging>. Setup The display reads: print Setup

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-specic information is loaded via the lot-specic 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.

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Operating the instrument

6
6.1

Operating the instrument

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 ndings and control results from memory.

Fig. 18: Power supply unit. ON/OFF switch

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 rst reading. It is recommended 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: 19.03.2004 insert strip 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: Reading is on Troponin T
(Reading is in progress.)

16:25

11:59

and

Result in Troponin T

11:59

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

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

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Roche Cardiac reader

6.3 6.3.1

Reading procedure 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 appropriate 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 automatically switches to Stand-by mode. Press any key to change from Stand-by to Ready mode.

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

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

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-specic 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 information 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.

Fig. 20: Coding chip.

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 sufcient memory capacity for 15 lots. If a test strip of a particular lot has already been read, the lot-specic 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.

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Operating the instrument

6.4.1

Inserting the coding chip

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

Insert Coding Chip Troponin T 8821

(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.)

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 4digit lot code that is printed on the chip. For verication, 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.

Fig. 21: Inserting the coding chip.

After reading the coding chip the display reads:

Lot data read

(Lot data have been read.)

6.5

Reading mode: Patient samples

Reading is started in Ready mode. 1. Insert the test strip (see Fig. 22).

Fig. 22: Inserting the test strip.

The display reads:

19.03.2004 press <START>

16:25

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Roche Cardiac reader

2.

Press <Start> (see Fig. 23).

The test strip is transported to the reading position.

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

The following message is displayed briey: please wait.

(Test strip is being checked.)

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

Apply sample and press <START>

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

3. 4.

Press <Stop> to turn off the beeper. Press <Stop> again to break off reading. or Press <Start> after a sample has been applied to start reading. Abort reading ? Abort <STOP> - key

The display reads:

Sample detection Troponin T

(Display for Troponin T reading.)

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Operating the instrument

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

Reading is on Troponin T
(Troponin T is being read.)

11:59

Result in and Troponin T

11:59

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

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:

Reading completed Trop. T 1.2 ng/ml

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

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:

19.03.2004 remove strip

(Remove the test strip.)

16:25

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 dened range, a quantitative value is displayed. For results that are outside the dened range, the display reads, for example:

19.03.2004 Trop. T hi

16:25 >2.0 ng/ml

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.

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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:

19.03.2004 Trop. T
(Example of the last reading.)

16:25 1.2 ng/ml

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

no entry

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

19.03.2004 insert strip

16:25

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

Result memory <SET> print result

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.

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Operating the instrument

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. Press <Start>. Wait until the swivel stage is in the correct position for reading. 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 rst 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.

2. 3. 4.

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 performance of the instruments 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 leaet of the respective Roche Cardiac control. Control readings are started when Roche Cardiac reader is in Ready mode.

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Roche Cardiac reader

6.6.1. IQC test to check the performance of the optical system 1. Insert a IQC strip (see Fig. 25).

Fig. 25: Inserting the IQC strip.

2.

press <Control> twice IQC press <START>

The display reads:

3.

Press <Start>

The following message is displayed briey: Please wait During the check of the IQC strip, a break off is possible by pressing <Stop>. The display reads: Abort reading? Abort <Stop>-key Press <Stop> to break off the reading. As soon as the IQC test starts, interruption is not longer possible The display reads: IQC Reading is on Hi

(Display when running IQC strip high for chekking the reectance in the upper concentration range)

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:

IQC 64.9 <= 70.7

Hi passed <= 75.9

4.

Remove the IQC strip to terminate the reading or Press <Stop>. IQC remove strip
(Remove the IQC strip; reading completed)

The display reads:

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Operating the instrument

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>. Control solution Press <START>

The display reads:

3.

Press <Start>.

The following message is displayed briey: please wait.

Then:

Apply control Trop. T

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.

Fig. 26: Applying the control solution.

5.

Press <Stop> to turn off the beeper.

Abort reading? Abort <STOP> - key

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Roche Cardiac reader

6.

Press <Stop> again to break off the reading or Press <Start> to start the reading following application of control solution.

The display reads:

Sample detection Contr. sol. Trop. T

(Control solution for Trop T has been recognized.)

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

Reading is on Contr. sol.

11:59 Trop. T

(Control reading for Troponin T is running.)

and

Result in Contr. sol.

11:59 Trop. T

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

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:

Contr. sol. Trop. T

(Result: 0.1 ng/mL Troponin T.)

0.1 ng/ml

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:

Control solution remove strip

(Remove test strip; reading completed.)

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.

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Operating the instrument

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 documentation, 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>. Control solution insert strip

The display reads:

2.

Press <Memory>.

The last 20 results can be displayed successively, when the <Memory> key is pressed. The display reads: 19.03.2004 Trop. T lo
(Example of the last reading.)

16:25 <0.1 ng/ml

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

no entry

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

Control solution insert strip

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

Control solution <SET> print result

(Printer was activated in the Setup menu.)

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 % reectance.

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Roche Cardiac reader

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 From power on Sample recognition : approx. 2 minutes Reaction time after sample recognition including parameter-specic result evaluation 12 minutes for Troponin T 8 minutes for Myoglobin 8 minutes for D-Dimer 12 minutes for NT-proBNP Self-test only; then immediately in Ready mode 10 minutes

6.8

Using patient identication numbers

Patient identication numbers ensure unambiguous identication of results and patient samples. Roche Cardiac reader is designed for entering patient identication numbers (referred to as Pat. IDs). Their entry is optional, 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 dene 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.

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Operating the instrument

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>. Pat. ID Input >>>>>>>>> _ <<<<<<<<<<<
1st digit

The display reads:

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

2.

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

3.

Press <Paging>. Pat. ID Input >>>>>>>>> 5_

2nd digit

The display reads:

<<<<<<<<<<<

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

4.

Press <Set> to enter the second digit. Repeat as many times as required until the entire Pat. ID is entered. Press <Stop> to leave Pat. ID. input mode or press <Paging> to proceed to entering the Operator ID.

5.

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.

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Roche Cardiac reader

6.9

Using operator identication numbers

Operator identication numbers allow unambiguous identication of who tested particular patient samples. Roche Cardiac reader is designed for entering operator identication 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 dene 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 rst 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>. Op. ID Input >>>>>>>>>_ 2. Press <Set> to enter the rst digit in the range from 0 to 9. <<<<<<<<<<<
1st digit

The display reads:

(For example, a 4-digit Operator ID was selected in the Setup menu; the rst digit can now be entered.) 2nd digit

3.

Press <Paging>. Op. ID Input >>>>>>>>>4_

The display reads:

<<<<<<<<<<<

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

4. 5.

Press <Set> to enter the second digit. Repeat as required until the entire Op. ID is entered.

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Operating the instrument

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 rst 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 additional characters will be cut off. To avoid this, select the maximum length (16 characters) in the Setup menu.

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Roche Cardiac reader

7
7.1

Error Messages
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:

Call Service Major Error 100 Note the displayed error code, for example 100, and contact your Roche Diagnostics service representative.

System errors may occur because of operator error or test stripspecic faults, for example:

No reading poss. Error 60

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.

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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 Expiry date of test strip exceeded Bar code not readable Unknown lot codet

Action Insert new strip with a valid expiry date. Check bar code on the underside of the test strip for soiling or scratches. Wipe with a soft cloth if appropriate. 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 60 to 99

Description Evaluation of test strip not possible.

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

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

Error Code 100 to 999

Description Major errors

Action Note the error code and contact your Roche Diagnostics service representative.

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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 Host/PC on QC off

Action by Cardiac reader Cardiac reader power-on

Error message Host/PC not ready Check Host/PC

Action by operator 1. Press <Stop> to change to ready state 2. Select Setup Menu setting Host/PC off 1. Press <Stop> to change to ready state 2. Select Setup Menu setting Host/PC off 1. Press <Stop> to change to ready state 2. Select Setup Menu setting Host/PC off 1. Press <Stop> to change to ready state 2. Select Setup Menu setting Host/PC off 1. Host/PC must be connected and download of results stored in the Cardiac reader be performed. 2. Select Setup Menu setting Host/PC off

Cause of the error Host/PC not connected or not ready

Host/PC on QC on

Cardiac reader power-on

Host/PC not ready Check Host/PC

Host/PC not connected or not ready

Testing of control solution

Wait for Host/PC Host timeout wait for Host

Host/PC not connected or not ready

Removal of test strip following reading

Interface not ready Check DC connection Interface not ready Memory full

Host/PC not connected or not ready

Memory full with undownloaded results

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Error Messages

7.6

Repairs

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

Do not open the instrument under any circumstances.

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Roche Cardiac reader

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.

50

Ordering Information

Ordering Information

The catalogue numbers (REF) for ordering system components are listed below. Item Roche Cardiac T Quantitative Description 10 tests for quantitative detection of Roche Cardiac Troponin T for use with Roche Cardiac reader Control set for use with Roche Cardiac T Quantitative (control set for 2 x 6 function checks) 20 tests for quantitative detection of Myoglobin for use with Roche Cardiac reader Control set for use with Roche Cardiac M (control set for 2 x 6 function checks) 10 tests for quantitative detection of D-dimer for use with Roche Cardiac reader Control set for use with Roche Cardiac D-Dimer (control set for 2 x 6 function checks) 10 tests for quantitative detection of NT-proBNP for use with Roche Cardiac reader Control set for use with Roche Cardiac proBNP (control set for 2 x 6 function checks) Set of two re-usable control strips for checking the performance of the instruments optical system 20 disposable syringe pipettes (150 L) for blood application Thermal printer for use with Roche Cardiac reader Cable for connecting printer to the Roche Cardiac reader (only for use with REF 0 3136671001) Power supply unit including mains cable Paper for thermal printer for use with REF 0 3136671001 REF 1 1894307193

Roche Cardiac control Troponin T

1 1937553193

Roche Cardiac M

1 1893840193

Roche Cardiac control Myoglobin

1 1937545193

Roche Cardiac D-Dimer

1 2241528196

Roche Cardiac control D-Dimer

0 3526038196

Roche Cardiac proBNP

0 4659449190

Roche Cardiac control proBNP

0 4533453196

Roche Cardiac reader IQC

0 3133508196

Roche Cardiac pipettes

1 1622889190

Printer for Roche Cardiac reader Printer connection cable

0 3136671001 0 3136680001

Printer power supply unit Paper for printer

0 4653840001 1 1903233001

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Roche Cardiac reader

10
10.1

Interface assignment
Printer/bar code reader interface D-sub, 9-pin, female Pin 1 Pin 2 Pin 3 Pin 5 Pin 7 +5V (for printer/bar code reader ) RxD (input Roche Cardiac reader) TxD (output Roche Cardiac reader) GND RDY (ready signal to bar code reader)

Connector: Pin assignment:

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

10.2

Host/PC interface D-sub, 9-pin, male Pin 2 Pin 3 Pin 5 RxD (input Roche Cardiac reader) TxD (output Roche Cardiac reader) GND

Connector: Pin assignment:

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

52

System Specications

11

System Specications
Instrument packed, with power supply unit, manual, mains cable and power cable CCD photosensor with lens, annular illumination of green LEDs (555 nm), microprocessor controlled evaluation of a control and signal line and display of a quantitative result 150 L Heparinised venous whole blood Parameter-specic Detection of parameters and lot by means of bar code on the underside of the test strips Parameter-specic Parameter-specic control solutions Cardiac reader IQC German, English, French, Spanish, Italian, Swedish, Portuguese, Japanese Integrated keypad with 6 function keys to operate the instrument 2-line alphanumeric display, 2 x 20 characters, for operator prompts and result display Serial interface (RS232) for Host or PC connection Serial interface (RS232) for connecting external printer and/or bar code reader Contains all lot-specic data for the test strips 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

Contents of box: Measuring principle:

Sample volume: Sample material: Overall reaction time: Parameter detection:

Measuring range: Controls:

Languages (display): Keypad: Display: Host/PC interfaces: Printer interfaces: Coding chip: Memory:

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Roche Cardiac reader

Dimensions:

Height 95 mm Width 250 mm Depth 200 mm 1.31 kg, excluding packing; instrument including power supply unit and mains cable 1.81 kg 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 Operation +18 to +35C 20 to 80% Storage -20 to +60C 20 to 80%

Weight:

Power supply:

Ambient conditions:: temperature: relative humidity: Certication marks: , UL, cUL

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

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Optional peripheral equipment

12
12.1

Optional peripheral equipment

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

Fig. 27: Printer

12.1.2 Connecting an external printer The following multi-purpose printer, which can be ordered separately, 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 immediately.
Fig. 28: Connection for power supply, printer interface

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Roche Cardiac reader

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. Cut the front end of the paper into a triangular form and insert it into the slot. Press <LF>. The linefeed function of the printer feeds the paper into the printer. Press <LF> again to stop the linefeed function. 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.

3, 4

2.

3.

Fig. 29: Inserting the paper.

4. 5.

Fig. 30: Installing the paper roll.

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 ofine. The SEL indicator ashes 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.

56

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: BTEMA Daten-Elektronik GmbH Pleidelsheimer Strae 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 Daimlerstrae 2 D-73268 Erkenbrechtsweiler www.datalogic.com

For the addresses of distributors in other countries, contact your local Roche Diagnostics representative.

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 transmits 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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Roche Cardiac reader

12.2.3 Bar code reader / scanner conguration The bar code reader / scanner parameters can only be modied 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 conguration, unless the following congurations are available as default settings: Baud rate: Data: Parity: Stop bits: Handshake: Buzzer: Prex: Sufx: Length transmission: Check sum: Code identier: Bar code: 9600 baud 8 data bits none 1 Busy/Ready mode signal after transmission no prex CR (ASCII 13) on string entry, no sufx or ETX or LF on single character entry disabled disabled disabled 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 xed 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 DB 9 male Txd Pin 3 Rxd Pin 2 CTS Pin 8 RTS Pin 7 DTR Pin 4 DSR Pin 6 SG Pin 5

Roche Cardiac reader DB 9 male Txd Pin Rxd Pin CTS Pin RTS Pin DTR Pin DSR Pin SG Pin

3 2 8 7 4 6 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
A

Subject Index
O
Operating modes . . . . . . . . . . . . . . . . . . 6.2 Operator ID (Op. ID) . . . . . . . . . . . . . 5.2.12, 6.8

Accessories . . . . . . . . . . . . . . . . . . . . . 3.2 Attention symbol . . . . . . . . . . . . . . . . . 2.2.1

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

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

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

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

Q
Quality control . . . . . . . . . . . . . . . . . . . . 6.6

E
Error messages . . . . . . . . . . . . . . . . . . . . 7

R
Ready mode . . . . . . . . . . . . . . . . . . . . . 6.2 Regulatory compliance . . . . . . . . . . . . . . . 2.2 Repairs . . . . . . . . . . . . . . . . . . . . . . . . 7.5

G
Gold-labelling technique . . . . . . . . . . . . . . 2.1

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

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

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

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

K
Keypad . . . . . . . . . . . . . . . . . . . . . 4.2.2, 11

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

U
Unpacking and installation . . . . 3.1, 3.2, 3.3, 3.4, 3.5

W
Warm-up time . . . . . . . . . . . . . . . 2.5.1, 6.1, 6.7 Warning symbol . . . . . . . . . . . . . . . . . . 2.2.1

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

N
Note symbol . . . . . . . . . . . . . . . . . . . . 2.2.1

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Roche Diagnostics GmbH D-68298 Mannheim, Germany www.roche.com www.diavant.com www.roche-diagnostics.com/npt