cobas h 232 POC system Operators Manual Ver 4.0 May 2015

Manual version

Revision date

Changes

Version 1.0

2006-10

New document

Version 2.0

2009-09

Minor revisions from internal review

Version 3.0

2011-09

Update to SW 03; enhanced error messages

Version 4.0

2014-05

Added description of new OTS functionality, miscellaneous minor revisions

cobas h 232 POC system Operator’s Manual Version 4.0

0 4880889001 (04) 2014-05 EN

© 2006-2014, Roche Diagnostics GmbH. All rights reserved The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Please send questions or comments about this manual to your local Roche representative. ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. On the packaging and on the identification plate of the meter you may encounter the following symbols, shown here with their meaning: Caution, consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this instrument. Temperature limitation (Store at) Manufacturer Catalogue number

IVD

In vitro diagnostic medical device This product fulfills the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No.61010-1-04).

Laser class 1 according to IEC 60825-1 (applies only to meters with a barcode scanner, meter S/N greater than 200000) The user is fully responsible for the installation, use and upkeep of the cobas h 232 meter.

Table of Contents 1

1.1

2

2.1

3 4

5 5.1

5.2

5.3

Introduction 9 The cobas h 232 meter... 9 Test principle ... 10 Contents of the Pack ... 10 Important safety instructions and additional information... 11 Safety information... 12 Disposal of the system ... 13 General care... 13 Laser scanner ... 14 Electrical safety ... 14 Electromagnetic interference ... 14 Touchscreen... 14 Local Area Network: protection from unauthorized access ... 15 Wired network connection ... 15 The cobas h 232 POC System 16 Overview of the meter and its accessories... 16 Meter ... 16 Test strip ... 19 Handheld Base Unit ... 20 Overview of the Buttons and Icons used on Screen 21 Putting the Meter into Operation 23 Power supply... 24 Inserting the handheld battery pack... 25 Powering the meter on and off ... 27 Meter Setup 29 Settings summary... 30 Basics setup ... 35 Contrast ... 35 Language ... 37 Setting the date... 39 Setting the time... 41 Setting the display options for date and time ... 43 Sound... 45 Auto off ... 48 Data Handling setup ... 50 Connection ... 50 Computer... 51 Printer ... 52 Result memory ... 54 Result unit... 57 Result display mode ... 59 ID Setup setting ... 61 Administrator ID ... 62 Operator ID... 68 Patient ID... 71

5

Table of Contents 5.4 Lockout setup ... 73 Operator lockout... 74 Quality control (QC) settings ... 77 Quality control (QC) lockout ... 79 Instrument quality control (IQC) lockout... 80 QC result format ... 81 Custom Range Troponin T ... 82 Reset test parameters... 84 Cleaning lockout... 85 STAT test configuration ... 86 5.5 Optional Screens setup ... 88 6 Performing a Test 91 Sample material ... 92 6.1 Preparing to test ... 93 Code chip ... 93 Inserting the code chip ... 94 Test steps (overview) ... 95 Powering on the meter... 96 Logging in ... 97 6.2 Performing a test ... 100 Inserting a test strip ... 104 Displaying, confirming or adding comments to results... 109 STAT tests ... 112 7 Control Testing and Quality Control 113 7.1 Preparing to run a quality control test ... 113 7.2 Performing a quality control test ... 115 Quality control (QC) ... 115 Instrument quality control (IQC)... 121 8 Review Results 125 Reviewing test results... 125 Patient history... 127 All results... 128 Quality control (QC) results... 129 Instrument quality control (IQC) results ... 130 Maintenance history ... 131 9 Extended Functionalities 132 Data handling ... 132 Computer (Setup option)... 133 Operator lists... 134 Patient lists... 135 Barcode scanner... 136 Stored test results and comments ... 136 10 Cleaning and Disinfecting the Meter 139 Recommended cleaning/disinfecting solutions ... 140 Cleaning/disinfecting the exterior (meter housing) ... 140 Cleaning after contamination due to mispipetting... 141 Cleaning the test strip guide cover... 142 Cleaning the visible area of the test strip guide... 143

6

Table of Contents 11

Troubleshooting 145 Errors and unusual behavior without error messages ... 146 12 General Product Specifications 147 12.1 Operating conditions and technical data... 147 Technical data ... 147 Sample material ... 148 Storage and transport conditions ... 148 12.2 Further information... 148 Ordering information ... 148 Product limitations... 150 Information about software licenses ... 150 Repairs ... 150 Contact Roche... 150 13 Warranty 150 14 Appendix 151 14.1 Example of barcode symbologies ... 151 14.2 Contact Roche ... 152 15 Supplement for Observed Test Sequence 159 Observed Test Sequence (OTS) ... 159 Using the OTS function... 160 16 Index 163

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8

Introduction

1

Introduction

The cobas h 232 meter The cobas h 232 meter is an instrument for the quantitative evaluation of immunoassays using the gold-labeling technique. The rapid diagnostic tests in strip format available for this meter support efficient diagnosis and assessment of cardiovascular diseases. The evaluation of these tests with the cobas h 232 meter combines the advantages of a rapid diagnosis with enhanced clinical interpretation of quantitative values (in comparison with qualitative tests). In addition, automated evaluation provides more reliable results by eliminating the potential sources of error associated with visual reading. 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, the cobas h 232 meter is ideal for use at the point of care in emergency rooms, intensive care units and ambulances, as well as by cardiologists and general practitioners. The cobas h 232 meter is rapid and easy to operate: Insert an unused strip in the meter and apply the sample. After the reaction period, the meter provides a quantitative result; in addition, a qualitative result is provided prior to the end of some tests. The cobas h 232 meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche (available separately). The cobas h 232 meter supports data exchange via the POCT1A standard. Data management systems may have the ability to expand the security features of the meter, such as enabling operator lockouts. Data management systems may also enable data transfer to an LIS or HIS. Refer to the manuals of the Handheld Base Unit and of your DMS for technical details. Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time. You must configure the cobas h 232 meter according to your needs before initial use. Refer to Chapter 5, “Meter Setup”. Be sure to read the “Important safety instructions and additional information” section in this chapter before operating the system. For all questions about the cobas h 232 system that are not answered in this manual, contact your Roche representative (see Chapter 12). In order to expedite troubleshooting, please have ready your cobas h 232 meter, its serial number, this manual, and all related consumables when you call.

If you connect your cobas h 232 meter to a cobas IT 1000 data management system or another PC/DMS, you will not be able to print directly from the meter to a printer. In order to print out meter data, use printers connected to the respective PC/DMS.

9

Introduction Test principle Two lines (signal and control line) in the detection zone of the test strip indicate whether the analyte to be determined is present in the sample material. These lines are detected by the cobas h 232 meter with the help of an LED (lighting the detection zone) and a camera sensor (imaging the detection zone). The test signal (signal line) increases in intensity in proportion to the concentration of the respective analyte. Integrated system software converts the signal intensity to a quantitative result, which is then displayed on the screen at the end of the measurement. The accuracy of the measurement is ensured through a simple principle: Every test strip box includes a code chip that contains all test and lot-specific information in electronic format. The test strips are labelled with a barcode on their underside and are hereby assigned to a specific code chip. When you insert a test strip from a new strip lot for the first time, the meter prompts you to plug in the corresponding code chip. The information is now read from the code chip and stored for future tests. Contents of the Pack ■

cobas h 232 meter

■

Handheld power supply with cable

■

Operator’s manual in English

■

CD-ROM with operator’s manual in other languages

Optionally available (not included in the scope of delivery): ■

Roche Handheld Battery Pack (rechargeable) for temporary operation without the handheld power supply

■

Handheld Base Unit (docking station) for data transfer within a network or via USB (Universal Serial Bus) For a personal printout of the operator’s manual in your language, contact your local Roche organization (see Chapter 14).

10

Introduction

1.1

Important safety instructions and additional information

This section explains how safety-related messages and information related to the proper handling of the system are presented in the cobas h 232 Operator’s Manual. Please read these passages carefully.

The safety alert symbol alone (without a signal word) promotes awareness to hazards which are generic or directs the reader to related safety information.

WARNING

CAUTION

NOTICE

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

Indicates a hazardous situation which, if not avoided, may result in damage to the system.

Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips.

All illustrations in this manual show hands wearing gloves.

11

Introduction Safety information Operator qualification Only trained healthcare professionals may operate the cobas h 232 meter. Operators must also have received comprehensive instruction in the operation, quality control, and care of the cobas h 232 meter. Protection against infection and blood-borne pathogens WARNING

Healthcare professionals using the cobas h 232 meter to perform tests must be aware that any object coming into contact with human blood is a potential source of infection. Operators need to adhere to Standard Precautions when handling or using the cobas h 232 meter. All parts of this system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and between patients and healthcare professionals. ■

Use gloves.

■

Dispose of used syringes, tubes, pipettes, test strips, and all other materials coming into contact with blood according to your institution’s infection control policy.

■

Follow all health and safety regulations in force locally.

Allergy or injury caused by reagents and other working solutions CAUTION

12

Direct contact with reagents, detergents, cleaning/disinfection solutions, or other working solutions may cause skin irritation or inflammation. ■

Always use protective gloves.

■

Observe the cautions given in the package inserts of the reagents and cleaning/disinfection solutions.

■

If a reagent, control, or cleaning/disinfection solution comes into contact with your skin, wash it off immediately with water.

■

Follow all health and safety regulations in force locally.

Introduction Disposal of the system Infection by a potentially biohazardous instrument WARNING

The cobas h 232 meter or its components must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its components according to the appropriate local regulations. Exploding batteries

WARNING

Do not throw rechargeable batteries into an open fire. They may explode. Do not dispose of the battery pack with normal domestic waste. As a component of the cobas h 232 meter, it must be deemed as potentially biohazardous. Treat it accordingly. See safety message “Infection by a potentially biohazardous instrument” above.

General care NOTICE

Clean the meter only with the solutions recommended (see page 139). Using other solutions may result in incorrect operation and possible failure of the system. Make sure that the meter is thoroughly dried after cleaning and disinfecting.

13

Introduction Laser scanner The built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007.

WARNING

A barcode does not need to be present for the laser scanner to become active. Lasers should never be stared at directly by the human eye.

Electrical safety NOTICE

Never run the meter if the electrical power supply or the attached cable is visibly damaged. If there is any visible damage contact your local Roche service for inspections.

Electromagnetic interference Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter.

Touchscreen NOTICE

14

■

Use only your finger (even when wearing gloves) or special pens designed for use with handheld devices to touch the screen elements. Using pointed or sharp-edged objects can damage the touchscreen.

■

Do not use the system in direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the screen.

Introduction Local Area Network: protection from unauthorized access If this product is connected to a local area network, this network must be protected against unauthorized access. In particular, it must not be linked directly to any other network or the Internet. Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code. Wired network connection If connected to a local area network, the cobas h 232 Handheld Base Unit must be protected against unauthorized access by means of a strong password management. Observe your own facility guidelines on password management where available, or apply the following rules:

Characteristics of strong passwords ■

Passwords must not contain the user’s account name or parts of the user’s full name that exceed two consecutive characters.

■

Passwords must be at least eight characters in length.

■

Passwords must contain characters from at least three of the following four categories: – – – –

English uppercase alphabetic characters (A through Z) English lowercase alphabetic characters (a through z) Numeric characters (0 through 9) Non-alphabetic characters (for example, !, $, #, %)

Examples of weak passwords ■

uhxwze11 contains no upper case letter.

■

UHXW13SF contains no lower case letter.

■

uxxxxx7F contains the same character more than four times.

■

x12useridF contains a substring of the user ID longer than four characters.

To ensure that your cobas h 232 meter functions properly, observe the operating and storage conditions as given in the chapter “General Product Specifications”, starting on page 147.

15

The cobas h 232 POC System

2

The cobas h 232 POC System

2.1

Overview of the meter and its accessories

Meter A

B C D

F G H E

CLASS I LASER PRODUCT Complies with 21 CFR 1040.10

I

and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001

16

The cobas h 232 POC System

A Touchscreen Shows results, information, icons and results saved in the memory. To select an option, simply touch the button lightly. B On/Off button Press this button to power the meter on or off. C Opening for sample application Opening in the test strip guide cover that enables you to apply blood once the test strip is inserted. D Test strip guide cover Remove this cover to clean the area underneath (if it has become soiled, e.g., with blood).

E

Barcode scanner (Laser) Operator and patient IDs can be read into the meter using the integrated barcode scanner (only meter versions with a serial number greater than 200 000). F Battery compartment A cover closes the empty battery compartment if meter is operated without the Handheld Battery Pack; alternatively insert battery pack. G Tab of the battery compartment cover Used to open the battery compartment. H Meter identification plate See page 4 for symbol explanation. I Laser label For meters with a barcode scanner only.

17

The cobas h 232 POC System

J M K

N

L

O

J

Test strip guide Insert the test strip here. K Reset button Use this button to reset the meter in case of software or power-up errors. L Infrared (IR) window Supports data communication (covered by the semi-transparent rear panel). M Code chip slot Insert the code chip here.

18

N Contacts for Handheld Base Unit Used for power supply and/or charging the handheld battery pack, when the meter is docked in the Handheld Base Unit. O Connection socket for the power supply unit Here you can plug in the power supply unit provided.

The cobas h 232 POC System Test strip

R

P S

P Test area This area is evaluated by the meter via the camera. Q Sample application area The sample is applied to this area after inserting the test strip in the meter.

Q

R Barcode Assigns the strip to the corresponding code chip. The barcode is automatically read by the meter when the strip is inserted into the test strip guide. S Code chip Contains strip lot specific data.

19

The cobas h 232 POC System Handheld Base Unit U

T

V Y

X

W Z

T

Charging contacts Used for power supply and/or charging the handheld battery pack.

U Status indicator Lights up when power is connected, charge indicator. V Infrared (IR) window For communication with the meter. W Extension piece For cobas h 232 meter.

X Data ports (Ethernet/RJ45 and USB) For connecting the device to a Data Management System (DMS). Y Connection socket for the power supply unit Here you can plug in the power supply unit provided with the meter. Z Removable cover for configuration switch The switch sets the mode of operation for the Handheld Base Unit.

The Handheld Base Unit can be ordered separately. For detailed information on usage and configuration please consult the operator's manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself.

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