cobas h 232 Operator's Manual

cobas h 232

Operator’s Manual

Manual version Revision date Changes

Version 1.0 2016-10 New document with country-specific

information on Cleaning and Disinfection
(based on International Operator’s Manual
0 7469101001 (02) 2016-06 EN).

Version 1.1 2017-11 Update: Added Super Sani-Cloth Germicidal

Disposable Wipes as recommended disinfect­ing agent; minor editorial revisions.

cobas h 232

Operator’s Manual

Version 1.1

0 7886594001 (02) 2017-11 EN-CAN

© 2006-2017, 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.

The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.

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

On meters with WLAN capability:

For other WLAN certifications, see label on bottom of battery compartment and addendum for
information on WLAN registration.

The user is fully responsible for the installation, use and upkeep of the cobas h 232 meter.

In vitro diagnostic medical device

Global Trade Item Number

This product fulfills the requirements of the European Directives 98/79/EC on in
vitro diagnostic medical devices and 1999/5/EC on radio and telecommunications
terminal equipment (R&TTE).

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).

This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry
Canada

5

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Table of Contents

1 Introduction 11

1.1 Important safety instructions and additional information......................................................... 14

1.2 Overview of the meter and its accessories..................................................................................... 24

1.3 Overview of the Buttons and Icons used on Screen................................................................... 31

2 Putting the Meter into Operation 35

2.1 Installing or replacing the battery pack........................................................................................... 36

3 Meter Setup 43

3.1 Basics setup ............................................................................................................................................... 49

3.2 Data Handling setup ............................................................................................................................... 64

3.3 ID Setup setting ........................................................................................................................................ 82

The cobas h 232 meter................................................................................................................. 11

Test principle ..................................................................................................................................... 13

Contents of the Pack ...................................................................................................................... 13

Safety information ........................................................................................................................... 15

Disposal of the system .................................................................................................................. 17

Battery pack ....................................................................................................................................... 17

General care....................................................................................................................................... 19

Electrical safety ................................................................................................................................ 19

Electromagnetic interference ...................................................................................................... 20

Touchscreen....................................................................................................................................... 20

Local Area Network: protection from unauthorized access ............................................ 20

Wireless connectivity ...................................................................................................................... 22

Radiofrequency radiation exposure information.................................................................. 22

Meter ................................................................................................................................................... 24

Power supply...................................................................................................................................... 27

Test strip.............................................................................................................................................. 29

Handheld Base Unit ........................................................................................................................ 30

Removing the battery pack .......................................................................................................... 37

Installing the battery pack ............................................................................................................ 38

Powering the meter on and off................................................................................................... 41

Settings summary............................................................................................................................. 44

Contrast ............................................................................................................................................... 49

Language ............................................................................................................................................ 51

Setting the date................................................................................................................................. 53

Setting the time................................................................................................................................. 55

Setting the display options for date and time ....................................................................... 57

Sound.................................................................................................................................................... 59

Auto off ................................................................................................................................................ 62

Connection ........................................................................................................................................ 64

QR Code .............................................................................................................................................. 65

Computer............................................................................................................................................. 68

Printer ................................................................................................................................................... 69

Result memory .................................................................................................................................. 71

Result units......................................................................................................................................... 75

Result display mode........................................................................................................................ 78

Diagnostics......................................................................................................................................... 80

Administrator ID ............................................................................................................................... 83

Operator ID......................................................................................................................................... 89

Patient ID............................................................................................................................................. 93

7

Table of Contents

3.4 Lockout setup............................................................................................................................................ 96

3.5 Optional Screens setup ....................................................................................................................... 112

4 Performing a Test 115

4.1 Preparing to test .................................................................................................................................... 117

4.2 Performing a test................................................................................................................................... 126

5 Control Testing and Quality Control 141

5.1 Preparing to run a quality control test .......................................................................................... 143

5.2 Performing a quality control test..................................................................................................... 144

6 Review Results 155

7 Extended Functionalities 163

Operator lockout............................................................................................................................... 97

Quality control (QC) settings .................................................................................................... 100

Quality control (QC) lockout ..................................................................................................... 102

Instrument quality control (IQC) lockout.............................................................................. 104

QC result format ............................................................................................................................ 105

Custom Range Troponin T......................................................................................................... 106

Reset test parameters.................................................................................................................. 108

Cleaning lockout............................................................................................................................ 109

STAT test configuration .............................................................................................................. 110

Sample material ............................................................................................................................ 117

Code chip ......................................................................................................................................... 118

Inserting the code chip .............................................................................................................. 119

Test steps (overview) ................................................................................................................... 120

Powering on the meter................................................................................................................ 122

Logging in ........................................................................................................................................ 123

Inserting a test strip .................................................................................................................... 130

Displaying, confirming or adding comments to results.................................................. 136

Displaying the test result as QR code ................................................................................... 139

STAT tests ........................................................................................................................................ 140

Quality control (QC) ..................................................................................................................... 144

Instrument quality control (IQC).............................................................................................. 152

Reviewing test results.................................................................................................................. 155

Patient history................................................................................................................................. 157

All results.......................................................................................................................................... 158

Quality control (QC) results....................................................................................................... 159

Instrument quality control (IQC) results ............................................................................... 160

Maintenance history .................................................................................................................... 161

Data handling ................................................................................................................................. 163

Computer (Setup option)............................................................................................................ 164

Software updates ......................................................................................................................... 164

Operator lists................................................................................................................................... 165

Patient lists....................................................................................................................................... 166

Barcode scanner............................................................................................................................ 167

Stored test results and comments .......................................................................................... 167

8

Table of Contents

8 Maintenance and Care 169

8.1 Conditions for storage and shipping ............................................................................................. 169

8.2 Cleaning and disinfecting the meter ............................................................................................. 171

9 Troubleshooting 179

10 General Product Specifications 183

10.1 Operating conditions and technical data..................................................................................... 183

10.2 Further information............................................................................................................................... 185

11 Warranty 187
A Appendix 189

A.1 Working with barcodes....................................................................................................................... 189

A.2 Operator and patient ID barcode masks...................................................................................... 190

A.3 Example of barcode symbologies ................................................................................................... 191

A.4 Supported characters in 2D barcodes .......................................................................................... 193

B Appendix 195

B.1 Option: Wireless network (WLAN) ................................................................................................. 195

C Supplement for Observed Test Sequence 201

D Contact Roche 205

Storage.............................................................................................................................................. 169

Shipping............................................................................................................................................ 170

Difference between cleaning and disinfecting.................................................................. 171

When should the meter be cleaned and disinfected? .................................................... 171

What to clean and disinfect?.................................................................................................... 171

Recommended cleaning/disinfecting agents..................................................................... 173

Cleaning after contamination due to mispipetting........................................................... 174

Cleaning the meter....................................................................................................................... 175

Disinfecting the meter................................................................................................................. 177

Errors and unusual behavior without error messages .................................................... 180

Meter reset ...................................................................................................................................... 182

Technical data................................................................................................................................ 183

Sample material............................................................................................................................. 184

Storage and transport conditions ........................................................................................... 184

Ordering information ................................................................................................................... 185

Product limitations........................................................................................................................ 187

Information about software licenses .................................................................................... 187

Repairs .............................................................................................................................................. 187

Preliminary note............................................................................................................................. 195

Background..................................................................................................................................... 195

Technical implementation.......................................................................................................... 196

RF specific functionalities and effective performance claims...................................... 198

Observed Test Sequence (OTS) ............................................................................................. 201

Using the OTS function............................................................................................................... 202

Index 207

9

Table of Contents

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10

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) by
means of wireless communication (if the meter is equipped with WLAN functionality) or through
the Handheld Base Unit from Roche Diagnostics (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.

11

Introduction

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 3, “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 “Contact Roche” on page 205). 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.

12

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

■ Power adapter

■ Universal Battery Pack

■ Battery compartment cover

■ Torx screw driver for mounting the battery compartment cover

■ Operator’s Manual in English

■ Quick Reference Guide

■ CD-ROM with operator’s manual in other languages

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

■ 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 A).

13

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.

Indicates a hazardous situation which, if not avoided, could result in death

WARNING

CAUTION

or serious injury.

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

NOTICE

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.

Illustrations in this manual show two different kinds of hands:

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

Hand without glove Hand with glove

14

Safety information

WARNING

Introduction

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.

QC and IQC Lockouts

QC and IQC lockouts are disabled by default. For routine confirmation of
system reliability it is strongly recommended to enable this feature. See
QC recommendations on page 142.

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. Wear a new pair of clean gloves for testing each patient.

■ Wash hands thoroughly with soap and water before putting on a new

pair of gloves and performing the next patient test.

■ 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.

15

Introduction

Allergy or injury caused by reagents and other working solutions

CAUTION

WARNING

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 con-

tact with your skin, wash it off immediately with water.

■ Follow all health and safety regulations in force locally.

Avoidance of electrical shock, fire, and explosions

■ Only use Roche Diagnostics original accessories (cables, power

supply units, battery packs, and spare parts). Third-party cables,
power supply units, and battery packs can cause the battery pack to
explode or the meter to become damaged.

■ Do not use loose power sockets or damaged power supply units,

cables, plugs, or battery packs.

■ Do not short circuit the power supply unit, the handheld base unit

contacts, or the battery pack.

■ Do not drop the cobas h 232 meter, the power supply unit, or the

battery pack and protect these against shaking and vibrations.

16

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. Always remove the battery pack before thermal
disinfection.

Battery pack

The meter contains a rechargeable battery pack that begins charging as soon as the power
adapter is connected or the meter is placed on an active Handheld Base Unit (i.e., one connected
to a power adapter).

NOTICE

Use only the specially designed battery pack provided by Roche
Diagnostics. Using any other type of battery may damage the system.

17

Introduction

WARNING

Possible hazards posed by the lithium-ion battery pack

Damaged or swollen lithium-ion (Li-ion) battery packs can overheat,
catch fire, or leak. Immediately cease use of cobas h 232 meters with
damaged or swollen Li-ion battery packs. Under no circumstances
recharge meters with damaged or swollen Li-ion battery packs by placing
them in the handheld base unit or connecting them to the power adapter.

Overheating can cause the battery pack to catch fire or explode.

■ Never throw the battery pack or the meters onto a fire. Do not dis-

mantle, compress, or pierce the battery pack as this could cause an
internal short circuit that leads to overheating.

■ Do not place either the battery pack or the cobas h 232 meter on or

in heating appliances, such as a microwave, conventional oven, or
radiator.

■ Avoid prolonged exposure to direct sunlight, e.g., when the meter is

docked in the Handheld Base Unit. Keep this in mind when position­ing the Handheld Base Unit.

Battery fluid or materials leaking from damaged battery packs can irritate
your skin or cause burns due to high temperatures.

■ Avoid contact with leaking battery fluid. In the event of accidental

contact with the skin, rinse with water. If you get battery fluid in your
eye(s), you should also seek medical attention.

Handle and dispose of battery packs with care.

Extreme temperatures reduce the charging capacity and usage period of the meter and the
battery pack.

18

Introduction

Observe the following general safety instructions for handling the battery pack:

Disposal of used battery packs

Do not dispose of the battery pack with normal domestic waste. Dispose
of used battery packs in accordance with applicable local regulations and
directives and your facility’s guidelines on the disposal of electronic waste
equipment.

■ When storing or disposing of the battery pack, use the manufacturer's original packaging.

Save or download data from the meter prior to replacing the battery pack to prevent loss of
data (see Chapter 7).

■ Always power the meter off before removing the battery pack.

■ When the Battery Low warning is displayed, the meter must be returned as soon as pos-

sible to the Handheld Base Unit or connected to the power adapter for recharging.

■ When the battery capacity is too low for further tests, the meter must be returned imme-

diately to the Handheld Base Unit or connected to the power adapter for recharging.

General care

NOTICE

Electrical safety

NOTICE

Clean the meter only with the solutions recommended (see page 173).
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.

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

19

Introduction

Electromagnetic interference

The meter fulfills the IEC 61326-2-6 requirements for emitted interference and interference
immunity.

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

Electrostatic discharges may cause malfunction of the meter.

Touchscreen

NOTICE

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.

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.

■ If you use a customized data management system solution, ensure that sensitive data

transmitted via the POCT1-A interface is protected by appropriate security measures.

■ Ensure that the instrument is protected against unauthorized physical access and theft.

■ Do not use shared user or operator accounts on meter, DMS and network.

■ Whether working in a wired or wireless environment, use a strong password for user or

operator accounts on the meter, DMS, and network. Observe your own facility guidelines
on password management where available, or apply the rules for strong passwords, see
“Characteristics of strong passwords” below.

20

Introduction

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 183.

21

Introduction

Wireless connectivity

If the meter is equipped with WLAN functionality:

Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to
the data management system without the need to return the meter to the Handheld Base Unit.
This feature must be configured by the system administrator. Observe the guidelines of your
facility for using wireless local area network connections. For a description of the cobas h 232
meter’s ability to connect to Wireless Local Area Networks (WLAN, Wi-Fi), see appendix B.

Radiofrequency radiation exposure information

Glossary:

■ “FCC” stands for “Federal Communications Commission” (USA).

■ “RF” stands for “radio frequency”

■ “RSS” stands for “Radio Standards Specification” (Canada).

■ “WLAN” stands for “Wireless Local Area Network”

The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from micro­wave ovens, heaters, and other noncommunication devices. While these types of devices usually
pose no threat of interference as they are low-powered devices, the possibility exists that some
industrial high power systems may wipe out any attempted communication use of a WLAN.
Therefore, perform a site survey and interference analysis with a spectrum analyzer to view the
entire spectrum, looking for signals that might not only be within the frequency range of the
intended WLAN but also could be near or at the same frequency and cause interference.

Roche Diagnostics supports industry wireless standards and recommends using
products that have Wi-Fi certification. This certification tests products to the 802.11

industry standards for basic connectivity, security, authentication, Quality of
Service (QoS), interoperability and reliability. The Wi-Fi CERTIFIED logo is an assurance that the
Wi-Fi Alliance has tested a product in numerous configurations and with a diverse sampling of
other devices to ensure compatibility with other Wi-Fi CERTIFIED equipment that operates in the
same frequency band. The Wi-Fi Alliance network of independent test labs conducts inter­operability testing programs to ensure that wireless devices work together and support secure
connections.

22

Introduction

The cobas h 232 system complies with FCC radiation exposure limits set forth for an uncon­trolled environment. This equipment should be installed and operated with minimum distance of
20 cm (8 inches) between the radiator and your body.

This transmitter must not be co-located or operated in conjunction with any other antenna or
transmitter.

Changes or modifications made to this equipment not expressly approved by Roche Diagnostics
may void the FCC authorization to operate this equipment.

This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
Operation is subject to the following two conditions:

(1) this device may not cause harmful interference,

and

(2) this device must accept any interference received, including interference that may cause
undesired operation.

The cobas h 232 system complies with the emission and immunity requirements described in
EN 61326-2-6. It has been designed and tested to CISPR 11 Class B.

This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful inter­ference to radio or television reception, which can be determined by powering the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:

■ Reorient or relocate the receiving antenna.

■ Increase the separation between the equipment and receiver.

■ Connect the equipment into an outlet on a circuit different from that to which the receiver

is connected.

■ Consult the dealer or an experienced radio/TV technician for help.

This Class B digital apparatus complies with Canadian ICES-003.

23

Introduction

1.2 Overview of the meter and its accessories

Meter

B

C

D

A

E

F

G

I

24

H N

Introduction

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).

* To determine if your meter has this function compare the REF number on the meter identifica­tion plate to the corresponding ordering information (list of REF numbers) on page 186.

E Barcode scanner

Operator and patient IDs can be read into
the meter using the integrated barcode
scanner. *

F Battery compartment cover

Remove to insert the battery pack.

G Meter identification plate

See page 5 for symbol explanation.

H Wireless LAN label

If the meter supports wireless connectivity:
This label displays registration numbers
that are specific to the meter RF hard­ware. *

25

Introduction

I

K L M

J

I Test strip guide

Insert the test strip here.

J Infrared (IR) window

Supports data communication with the
(optional) Handheld Base Unit. Covered
by the semi-transparent rear panel.

K Connection socket for power adapter

Plug in the power adapter here.

26

L Code chip slot

Insert the code chip here.

M Charging terminals

Used for power supply and/or charging
the battery pack when the meter is
docked in the (optional) Handheld Base
Unit.

Power supply

N O

Introduction

N Universal Battery Pack

Powers the device.

The meter can be operated with the rechargeable battery pack only or together with the power
adapter or the (optional) Handheld Base Unit, which both charge the battery pack when inserted.
Insert the battery pack even when always using the power adapter or the Handheld Base Unit.
This ensures that you will not lose the date and time settings if the power goes out. Results are
retained in the memory together with the corresponding date and time, as well as all other set­tings, even when no battery pack is inserted.

In general, it is not recommended to detach the external power supply or undock the meter from
the Handheld Base Unit during a measurement. When the meter is connected to an external
power supply and the battery level is low, measurements cannot be completed if the external
power supply is detached. In this case a message is displayed not to remove the external power
supply.

To save power, the meter can automatically power itself off or go into standby mode, if no
buttons are pressed or new test strips are inserted. When the meter powers itself off, all test
results obtained up to that point remain in memory and the settings are retained (see “Auto off”
in the chapter entitled “Data Handling setup” on page 62).

O Power adapter

Powers the device and charges the
battery pack.

27

Introduction

Main Menu

04/19/2016

09:15 am

Patient Test

Control Test

Review Results

Setup

Logout

Dispose of used battery packs in an environmentally responsible manner
in accordance with applicable local regulations and directives. See
“Infection by a potentially biohazardous instrument” on page 17.

During battery operation, the meter always
displays the power level of the battery pack.
The battery icon is divided into four segments
which correspond to the battery power level.

When replacing the battery pack, insert the
new battery pack within 24 hours of removing
the old one. Otherwise you may need to re­enter date and time.

28

Test strip

Introduction

R

P

Q

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.

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.

29

Introduction

Handheld Base Unit

U

T

T Charging contacts

Used for power supply and/or charging
the 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, optional.

W

V

X

X Data ports (Ethernet/RJ45 and USB)

For connecting the device to a Data
Management System (DMS).

Y Connection socket for the

power adapter

Here you can plug in the power adapter of
the Handheld Base Unit.

Z Removable cover for configuration

switch

The switch sets the mode of operation for
the Handheld Base Unit.

Y

Z

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.

30

Introduction

1.3 Overview of the Buttons and Icons used on Screen

The buttons and icons that appear during normal operation are shown here, along with a general
explanation. Error messages and the description of the icons linked to them are provided in a
separate chapter. See “Troubleshooting” starting on page 179.

Button/Icon Meaning

OK, save setting

Cancel, discard setting

Return (to previous menu)

Decrease/increase a numeric value or
Scroll through lists that are too long to be displayed at once

Inactive button; value cannot be further decreased/increased or
End of list in this direction is reached

Return to the Main Menu screen

List of tests of an individual patient

Scroll through stored results

Print displayed result (via infrared interface to corresponding printer)

Display test result as QR code

Add a comment

Operator logout

Operator login

Operator must wait until the meter has completed an action.

Insert test strip

Remove test strip

Test strip warming up

Apply sample (the time left to apply sample is counted down in the
screen alongside the required sample amount)

31

Introduction

Button/Icon Meaning

Apply QC sample (the time left to apply sample is counted down in the
screen alongside the required sample amount)

QC

am

pm

Insert code chip

Open test strip guide cover for cleaning

Battery status:

• If the battery pack still has its full charge, all segments are lit

• Individual segments disappear one by one as the battery pack
becomes weaker

• When there is no segment remaining, you can no longer perform
a test. You can, however, still access the meter’s memory

Operation with power adapter

Time between midnight and noon (in 12-hour time format)

Time between noon and midnight (in 12-hour time format)

Marks an information message

Marks an error message or a warning
(see Chapter 9 “Troubleshooting”)

Room or meter temperature is outside the acceptable range.

32

QC!

The test strip guide cover is open.

In a QC lockout condition, this icon indicates that one or more
parameters are locked, while others still can be measured.

Introduction

The following icons may appear when using the meter in conjunction with a data management
system (DMS).

Infrared interface is enabled (for communication with the computer
and/or printer)

Communication is taking place via WLAN

An OTS request is pending

Cleaning/Disinfection necessary

33

Introduction

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34

Putting the Meter into Operation

2 Putting the Meter into Operation

Before using the meter for the first time, perform the following steps:

1 Install the battery pack (see page 38)

2 Connect the power adapter to charge the battery pack

3 Set the current date and time as well as the appropriate display format (see Chapter “Meter

Setup” starting on page 43)

4 Enter the settings of choice (language, quality controls – where necessary, user

administration, etc.)

If the meter has no date/time settings (either because you are powering on the meter for
the first time or because the battery pack was removed from the meter for more than 24
hours), you cannot perform a test. In that case powering on the meter takes you immediately
to the Setup mode, where you must set the date and time.

35

Putting the Meter into Operation

2.1 Installing or replacing the battery pack

When shipped, the battery pack is not installed in the meter.

Unused battery packs lose their charge over time and have to be recharged before they can
be used. After installing a new battery pack, the meter should be charged overnight before
testing. Please note that the battery pack will only reach full capacity once it has been fully
emptied and charged several times.

Whenever the meter is placed on an active Handheld Base Unit or powered by the power
adapter, the icon is displayed. This icon shows that power is available and the meter
can be charged if necessary.

Make sure that the permitted temperature range for charging the battery pack (12-32 °C or
54-90 °F) is maintained during installation and initial setup.

36

Removing the battery pack

Putting the Meter into Operation

1 If a battery pack is already installed, make

sure that the meter is powered off.

Always disconnect the external power supply
before removing the battery pack.

2 Place the meter face down on a level sur-

face.

3 Use the starshaped Torx screw driver

(delivered with the cobas h 232 product
pack/kit) to remove the four screws hold­ing the battery compartment cover in
place.

4 Remove the battery compartment cover

from the meter. The battery pack now vis­ible is connected to the meter by a plug.

5 Carefully lift the battery pack and remove

the plug connector.

Disposal of used battery packs

Do not dispose of the battery pack with normal domestic waste. Dispose
of used battery packs in accordance with applicable local regulations and
directives and your facility’s guidelines on the disposal of electronic waste
equipment.

37

Putting the Meter into Operation

Installing the battery pack

1 Loosen the screws on the battery com-

partment cover until they are protruding
about 4-5 mm (2/10 in).

Always disconnect the external power supply
before inserting the battery connector plug.

2 Hold the battery pack in your hand, with

the wires and the plug pinched between
your thumb and index finger.

3 Plug the connector plug into the socket

and make sure it is fully inserted.

4 Place the battery pack inside the battery

compartment as shown.

To position the battery pack correctly, always
align the ridges on the side of the battery pack
with the ridges on the inside of the battery
compartment.

Preferably use the battery pack that was
shipped with the meter. When the battery
pack is installed, the meter checks if battery
pack and meter are compatible.

38

Putting the Meter into Operation

5 Place the cover on the battery compart-

ment. Make sure that the plug connector
wires do not get pinched between meter
and cover.

6 Tighten all four screws until snug (do not

overtighten).

39

Putting the Meter into Operation

After inserting a new battery pack, the meter should be charged overnight before testing.

The meter powers on automatically and the
Roche logo is displayed. If the meter does not
start up automatically, the battery pack may
be empty. In this case either a red battery
symbol or a charging symbol is displayed.
When the battery pack is charged sufficiently,
the meter starts up automatically.

7 If the meter has been without power for

too long, you have to re-enter the date
and time settings. After you have entered
the correct information, confirm each
screen with .

Year:

Set Date

2016

40

Month:

Day:

04/19/2016

1

1

Hour:

Minutes:

04/19/2016

Set Time

3

49

AM PM

Powering the meter on and off

Putting the Meter into Operation

1 Power the meter on by pressing the

button.

You can also power on the meter directly by
connecting the power adapter or by placing
the meter on the Handheld Base Unit.

2 To power the meter off after use, press the

button for approximately 1 second.

41

Putting the Meter into Operation

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42

Meter Setup

3 Meter Setup

Buttons are screen prompts that cause something to happen when touched. In this manual the
names of all buttons are either shown as bold text or as the icon used on the button (e.g., for
OK ).

When text refers to other screen elements (e.g., Menu titles), these are written in italics. These
screen elements are not active.

You can open any displayed function by
touching (or tapping) the button for it with
your finger (or a special pen for this purpose).
“Tap” means: Touch the button, then remove
your finger from the touchscreen. The next
screen appears once you remove your finger.

Main Menu

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Patient Test

Control Test

Review Results

Setup

09:15 am

Data Handling

Optional Screens

04/19/2016

Setup

Basics

ID Setup

Lockout

1 Touch Setup to call up the Setup menu.

2 Select the group of settings of choice

(see the Settings summary following this
section).

For a description of the buttons and icons
used on screen see page 31.

43

Meter Setup

Settings summary

The diagram below gives an overview of the setup areas that can be accessed on the meter.

Setup

Basics

Data

Handling

ID Setup

Lockout

Optional

Screens

Connection

Administrator ID

Operator

Lockout

LanguageContrast

Result

Memory

QC Settings

Date/Time

Result Units

Operator ID

Sound

Result Display

Mode

Cleaning

Lockout

Auto Off

Diagnostics

Patient ID

STAT Test

Confi g.

44

Start Info

Result Login

Result

Confi rmation

Meter Setup

Group

Basics Contrast

Subgroup Setting

Language

Date/Time

Sound (Beeper)

Auto Off

Values

*

0 – 10 (5*)

Dansk

Deutsch

English *

Español

Français

Italiano

Nederlands

Norsk

Português

Svenska

An installable language

Date 01/01/2011 *

Time 12:00 am *

Date formats Day.Month.Year (31.12.2011)

Month/Day/Year (12/31/2011) *

Year-Month-Day (2011-12-31)

Time formats 24-hour time format (24H)

12-hour time format (12H),
with am/pm *

Volume Off

Low

Medium *

High

Key Click Enable

Disable *

[minutes] Off

1 … 10 (default: 5 min *)

15, 20, 25, 30

40, 50, 60

* Default settings are labelled with an asterisk (*).

45

Meter Setup

Group

Data Handling Connection

ID Setup Administrator ID

Subgroup Setting

Result Memory

Result Units

Result Display Mode

Diagnostics Software

Operator ID (with DMS and list

Patient ID

Values

*

QR Code

Off *

Computer

Printer

Result Display Filter All results *

Current Op. Res.

Result Storage
Mode

Select DD Res. Unit g/mL *

Select TT Res. Unit ng/L *

Wireless Setup

available on meter)

(No list available on
meter)

No results deletion *

Delete oldest result

ng/mL

mg/L

g/L

pg/mL

ng/mL

g/L

Static *

Flashing

Display of existing settings
and parameters only

Blank (off) *

None *

List

Hidden List

None *

Optional

Required

Scan Only

None

Optional *

Required

Hidden List

* Default settings are labelled with an asterisk (*).

46

Meter Setup

Group

Lockout Operator Lockout (only if “Operator ID”

Subgroup Setting

option is enabled)

QC Settings

Cleaning Lockout

STAT Test Config.

QC Lockout New Lot: Yes/No *

IQC Lockout No *

QC Result Format Pass/Fail *

Custom Range
Trop T

Reset Test Param. Do Reset

Values

*

No *

Daily

Weekly

Monthly

Every 3 months

Every 6 months

Yearly

No *

Daily

Weekly

Monthly

Daily

Weekly

Monthly

Value

Value & Pass/Fail

Default Range*

Custom Range

No Reset *

No *

Daily

Weekly

Monthly

Enable

Disable *

* Default settings are labelled with an asterisk (*).

47

Meter Setup

Group

Optional screens Start Info

* Default settings are labelled with an asterisk (*).

Subgroup Setting

Result Login

Result Confirmation

Values

Enable

Disable *

Enable

Disable *

Enable

Disable *

*

48

Meter Setup

3.1 Basics setup

The Basics setup area contains the basic options for changing the user interface.

Contrast

Use the Contrast menu to adjust the display to your ambient light conditions and make it easier
to read.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Contrast.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

04/19/2016

49

Meter Setup

Contrast:
(0-10)

04/19/2016

Select Contrast

5

4 Touch or to change the contrast in

a range from 0 to 10.

■ Contrast “0” makes the screen very dark.

■ Contrast “10” makes the screen very light.

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

50

Language

Use this setting to select the language for all displays (that contain text).

Meter Setup

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Language.

The current language setting is highlighted
(white type on a blue background). You can
select either:

■ Dansk

■ Deutsch

■ English

■ Español

■ Français

■ Italiano

■ Nederlands

■ Norsk

■ Português

■ Svenska

An optional language can be installed upon
request (either directly at the plant or later by
an authorised Roche Diagnostics service
technician).

51

Meter Setup

Select Language

Français

Nederlands

Português

04/19/2016

Italiano

Norsk

4 Touch or to display the language

of choice on the screen.

If the arrow is just an outline , you
have reached the end of the list in the respec­tive direction.

5 Touch the button to select the language of

choice. Your selection is now highlighted.

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

52

Setting the date

Use this menu to set the date of the meter.

Meter Setup

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Date/Time.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

04/19/2016

53

Meter Setup

Setup - Date/Time

Date/Time Format

04/19/2016

Date

Time

Year:

Month:

Day:

04/19/2016

Set Date

2016

4 From the Setup-Date/Time menu, touch

Date to set the date.

5 Touch or to set the year, then the

month, then the day.

1

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically

1

returns to the previous screen.

If the Set Date menu appeared automatically
after powering the meter on, you must touch

to complete the date setting. The Set Time

menu will then be displayed next.

7 In the Setup-Date/Time menu, touch

to return to the Setup-Basics menu or
touch Time to move to the time setting.

54

Setting the time

Use this menu to set the time of the meter.

Meter Setup

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Date/Time.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

04/19/2016

55

Meter Setup

Setup - Date/Time

Date/Time Format

04/19/2016

Date

Time

Hour:

Minutes:

04/19/2016

Set Time

49

3

AM PM

4 From the Date/Time menu, touch Time to

set the time.

5 Touch or to set the hours, then the

minutes.

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

If the Set Time menu appeared automatically
after leaving the Set Date menu, you must
touch to complete the time setting. The
Main Menu will then be displayed next.

7 Touch to return to the Setup-Basics

menu or touch Date/Time Format to
move to the display options.

56

Setting the display options for date and time

Select your preferred format for the date and time display.

Meter Setup

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Date/Time.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

57

Meter Setup

Setup - Date/Time

Date/Time Format

04/19/2016

Date

Time

Select Date Format

Date DD.MM.YYYY

MM/DD/YYYY

YYYY-MM-DD

Time 24H 12H

04/19/2016

4 From the Setup-Date/Time menu screen,

touch Date/Time Format to set the dis­play format.

The current settings are highlighted (white
type on a blue background). You can select
one of the following display formats for the
date:

■ Day.Month.Year, e.g., 31.12.2011

■ Month/Day/Year, e.g., 12/31/2011

■ Year-Month-Day, e.g., 2011-12-31

You can also select one of the following dis­play formats for the time:

■ 24H (24-hour time format), e.g., 14:52

■ 12H (12-hour time format, supplemented

by am/pm), e.g., 2:52 pm

5 Touch the button with the display format

of choice for the date and time. Your
selection is now highlighted.

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

58

7 Touch to return to the Setup-Basics

menu.

Meter Setup

Sound

The cobas h 232 meter can display information visually and alert you to special circumstances
with a beep sound. When the Sound is activated, the meter beeps when:

■ it is powered on

■ it detects a test strip

■ pre-heating of the test strip is complete and you need to apply a sample

■ it detects a blood sample

■ the test is completed and the results are displayed (a long beep)

■ an error occurs (three short beeps)

■ the power adapter is connected when the meter is on

■ a barcode is scanned successfully (short beep)

■ the barcode scanner is disabled (two short beeps)

■ a positive test result can be expected, while the measurement still is in progress (a long

beep)

■ a test result requires operator confirmation and the meter will soon power off automati-

cally (three short beeps)

We recommend that you keep the Sound (beeper) activated at all times.

You can also activate a Key Click. When the Key Click is activated, the meter clicks briefly every
time a button is touched, facilitating the input of information.

59

Meter Setup

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 From the Setup-Basics menu, touch

Sound.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

60

Meter Setup

04/19/2016

Setup - Sound

Volume

Key Click

04/19/2016

04/19/2016

Select Volume

Off

Low

Medium

High

Key Click

Enable

Disable

4 From the Setup-Sound menu, touch

Volume to set the volume level of the

beeper.

The current setting is highlighted (white type
on a blue background). You may select from
the following options:

■ Off

■ Low

■ Medium

■ High

5 Touch Key Click in the Setup-Sound

menu to turn the key click on or off.

You may select from the following options:

■ Enable

■ Disable

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

7 Touch to return to the Setup-Basics

menu.

61

Meter Setup

Auto off

You can set up your meter so that it powers itself off automatically if it has not been used (no
buttons touched or tests run) for a preselected time period. Use this feature to save power and
extend the time of usage before having to recharge the battery pack.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Basics.

3 In the Setup-Basics menu, touch Auto

Off.

Setup - Basics

Contrast

Language

Date/Time

Sound

Auto Off

If connected to the power adapter or the Handheld Base Unit, the meter goes into standby
mode instead of powering off if it has not been used for 10 minutes. Furthermore the meter
can perform a maintenance reboot on a regular basis. The latter will only occur during meter
inactivity.

62

Meter Setup

Set Auto Off Time

Minutes:

04/19/2016

You may select from the following options:

■ Off (meter never powers itself off)

■ Time until meter powers itself off:

5

1…10, 15, 20, 25, 30, 40, 50, 60 minutes

4 Touch or to select the time of

choice in minutes or to deactivate the
feature.

5 Touch to save this setting, or touch

to exit this menu without saving any
changes.
The display automatically returns to the
previous screen.

6 Touch to return to the Setup menu.

63

Meter Setup

3.2 Data Handling setup

Connection

In the Connection menu you can configure the data exchange with external devices. The meter
can be connected either to a computer or a printer. In addition to this direct data output, test
results may also be encoded as QR codes, which can be scanned to be used with other applica­tions.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Data

Handling.

3 From the Setup-Data Handling menu,

touch Connection.

Setup - Data Handling

Connection

Result Memory

Result Units

Result Display Mode

Diagnostics

64

QR Code

Meter Setup

Select Connection

04/19/2016

QR Code

Off

Computer

Printer

QR Code

Show QR code:

Plain Text

Coded Data

URL Transmission

04/19/2016

On Off

4 From the Select Connection menu, touch

QR Code.

5 Touch On to enable, or touch Off to disa-

ble QR code display. Your selection is now
highlighted.

■ If you have enabled this feature, select the

style of the QR code to be displayed:

■ Plain Text

Use this option to scan the result into a PC
hosted application (e.g. electronic medi­cal record). In order to do so, you need an
external 2D barcode scanner attached to
your PC. Once scanned, the test result and
related meta-information (e.g. date, time,
comments) will appear as plain text in
your PC application.

■ Coded Data

Use this option to scan the result into a
smartphone or tablet app, or a PC hosted
application.

■ URL Transmission

Use this option to upload the result to a
web based service (e.g. such as an elec­tronic health record, etc.). For this option
further parameters (URL, encryption key)
must be set.

65

Meter Setup

Ensure that your environment for reading QR codes (QR code reader, operating system, text
processing application) is appropriate for your language. Disregard may lead to unpredictable
behavior of your receiving component (PC, mobile device).

For the options Coded Data and URL Transmission dedicated software programs or apps are
required in order to use this feature. If you are a customer or a 3rd party IT provider, and you
are interested to use this feature, contact your local Roche Diagnostics representative for
additional information.

QR Code

Show QR code:

Plain Text

Coded Data

URL Transmission

04/19/2016

On Off

URL Transmission

Encryption Key

04/19/2016

URL

URL

ABCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

. / 123

6 Touch Plain Text, Coded Data or

URL Transmission, depending on the

intended use. Your selection is now
highlighted.

If you have selected URL Transmission, the

button will become active. Use this button

to set the additional parameters.

7 Touch to open the URL Transmission

menu.

8 Touch URL to enter the URL to which the

test result data will be uploaded (note: the
URL will be provided by your specialized
service provider).

■ Use to switch to input of numbers.

■ Use to switch back to input of text.

■ Use to backspace and correct

123

ABC

a mistake.

9 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

66

Meter Setup

URL Transmission

Encryption Key

04/19/2016

URL

Encryption Key

Key:

JD5G29F6U8V2WC4L

Serial No.:

KQ0327832

Note: The encryption key
and the serial number are
required to decrypt QR code
messages from this meter.
Ensure they are available on
the target system.

04/19/2016

10 Touch Encryption Key to display the

Encryption Key menu.

The Encryption Key menu displays two types
of information which are required in order to
identify and decode the transmitted test
result. This information is required by the IT
system, to which the test result is transmitted
via the defined URL.

■ Key

This key is auto-generated by the meter
and is required to decrypt the QR code
information.

■ Serial No.

The meter's serial number is required to
map the test result to the encryption key.

Touch the New button, if you want the
meter to generate a new encryption key.

11 Touch twice to return to the QR Code

menu.

12 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

The Encryption Key information needs to be exchanged once with your specialized service pro-
vider prior to using the URL transmission method. Contact your specialized service provider in
order to exchange this information.

67

Meter Setup

Computer

The cobas h 232 meter can connect with a computer or host system running appropriate soft­ware (that is, a DMS must be installed). To use this connectivity feature, however, you need the
optional Handheld Base Unit or the meter must be configured for wireless communication. If no
wireless communication is configured, the connection is established in two steps.

■ The meter connects to the Handheld Base Unit via infrared.

■ The Handheld Base Unit is either connected to a single computer (via USB) or to a net-

work/host system (via Ethernet).

The option Computer (when activated) can be used together with a DMS to set up:

■ operator lists, or

■ patient lists (lists of patients to be tested)

This eliminates the need for manual entry of these data. In addition, you can transfer test results
stored in the meter to other systems for archiving or further evaluation. The option Computer
controls the meter’s ability to communicate with a computer or a network.

Select Connection

QR Code

13 From the Select Connection menu, touch

Computer. Your selection is now high-

lighted.

Off

Computer

Printer

04/19/2016

14 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

Extended data handling functionality is dependent on the capabilities of the particular Data
Management System (DMS) being used and may vary.

68

Meter Setup

Printer

The meter can connect directly with three different infrared printers. The Handheld Base Unit
cannot be used for this purpose.

The option to print is displayed in a test result as well as directly after a test and when calling up
stored results. Using the settings you enter here, you can activate or deactivate the meter‘s ability to
print.

Connection to a printer can only be established via infrared.

Enabling the connection to a printer disables the connection to a computer (and vice versa).

Select Connection

04/19/2016

QR Code

Off

Computer

Printer

04/19/2016

Select Printer

Citizen CMP-10

GeBE GPT-437x

Zebra MZ320

15 From the Select Connection menu, touch

Printer. Your selection is now high-

lighted.

16 Touch to confirm the selection. The

next screen allows you to choose the type
of printer you are using.

17 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the Setup-Data Handling menu.

69

Meter Setup

Pat. Test - Result

PID111SCHULZM457Pat:
SCHULZ, MANFRED
JONES, TOM

Op:

proBNP PB1234

Par:

04/19/2016 10:17

620

04/19/2016

Code:

pg/mL

To print :

■ Align the meter with the IR printer

■ At any test or memory screen,

touch .

The printer icon only appears if the printer
function is activated. Otherwise it is not
displayed.

Note: (Only applies if you are working with the
meter in a language other than English.) With
the exception of information you have entered
(such as patient ID and name, operator ID,
comments), the printout will be in English.

70

Meter Setup

Result memory

Result memory settings allow to apply a Result Display Filter and to set the Result Storage Mode
(see page 73).

All results recorded by the meter (patient results and quality controls) are stored automatically.
Use the Sel. Res. Display Filter menu to select whether to display results (when calling up the
Memory function) for all existing tests or only those from the current operator.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Data

Handling .

3 From the Setup-Data Handling menu,

touch Result Memory.

Setup - Data Handling

Connection

Result Memory

Result Units

Result Display Mode

Diagnostics

71

Meter Setup

Setup - Result Memory

Result Display Filter

Result Storage Mode

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Sel. Res. Display Filter

All Results

Current Op. Res.

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4 From the Setup-Result Memory menu,

touch Result Display Filter to select the
results to display.

The current setting is highlighted (white type
on a blue background). You may select from
the following options:

■ All Results

■ Current Op(erator) Res(ults)

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

6 Touch to return to the Setup-Data

Handling menu.

72

Meter Setup

The Sel. Res. Storage Mode menu tells the meter what to do when the memory is full.

The meter memory can store a maximum of 2000 patient tests, 500 liquid controls, and 200
instrument quality controls.

In case of a full memory, you can choose between:

■ No Result Deletion. This prevents data from being deleted inadvertently, but may (in case

of a full memory) lead to the situation that you cannot perform a new measurement. Fur­ther measurements will only be possible if stored data are transferred to the data man­agement system (DMS) or you allow automatic deletion.

■ Del. Oldest Result. Based on the 1st in/1st out principle, the oldest result will be auto-

matically deleted when necessary. This is the only option if the meter is used without a
DMS (i.e. no data will be transferred and archived).

The option No Result Deletion is available only when you are using a DMS. For more details
see “Extended Functionalities”, starting on page 163. If you are not working with a DMS, this
option is set to Del. Oldest Result.

However, you only can select between these two options, if the meter is used together with a
DMS and the Computer connection is enabled. In this case data stored in the meter are flagged,
as soon as they have been transferred to the computer. Now the meter is allowed to delete those
flagged data when necessary, even if you have selected the No Result Deletion option.

73

Meter Setup

Setup - Result Memory

Result Display Filter

Result Storage Mode

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Sel. Res. Storage Mode

No Result Deletion

Del. Oldest Result

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7 From the Setup-Result Memory menu,

touch Result Storage Mode to select
your storage mode.

You may select from the following options:

■ No Result Deletion

■ Del(ete) Oldest Result

8 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

9 Touch to return to the Setup-Data

Handling menu.

74

Meter Setup

Result units

The result unit setting applies to the result display of D-Dimer and Troponin T tests only.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Data

Handling.

3 From the Setup-Data Handling menu,

touch Result Units.

Setup - Data Handling

Connection

Result Memory

Result Units

Result Display Mode

Diagnostics

75

Meter Setup

Setup - Result Units

DD Result Units

TT Result Units

04/19/2016

Select DD Res. Unit

04/19/2016

µg/mL

ng/mL

mg/L

µg/L

4 From the Setup-Result Units menu, touch

DD Result Units.

5 From the Select DD Res. Unit menu, select

the unit to be used for the D-Dimer result
display.

The current setting is highlighted (white type
on a blue background). You may select from
the following options:

■ g/mL

■ ng/mL

■ mg/L

■ g/L

6 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

76

Meter Setup

Setup - Result Units

DD Result Units

TT Result Units

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Select TT Res. Unit

04/19/2016

ng/L

pg/mL

ng/mL

µg/L

7 From the Setup-Result Units menu, touch

TT Result Units.

8 From the Select TT Res. Unit menu, select

the unit to be used for the Troponin T
result display.

The current setting is highlighted (white type
on a blue background). You may select from
the following options:

■ ng/L

■ pg/mL

■ ng/mL

■ g/L

9 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

10 Touch to return to the Setup-Data

Handling menu.

77

Meter Setup

Result display mode

Test results may be displayed either with a static or a flashing display, the latter visually indicat­ing that the measurement process has been finished. Once a result is available, the display starts
flashing. Depending on the settings, this may be either a quantitative or qualitative result screen
or an operator login screen.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Data

Handling.

3 From the Setup-Data Handling menu,

touch Result Display Mode.

Setup - Data Handling

Connection

Result Memory

Result Units

Result Display Mode

Diagnostics

78

Meter Setup

Select Res. Display Mode

Static

Flashing

04/19/2016

4 From the Select Res. Display Mode menu,

select your display mode.

The current setting is highlighted (white type
on a blue background). You may select from
the following options:

■ Static

■ Flashing

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

6 Touch to return to the Setup-Data

Handling menu.

79

Meter Setup

Diagnostics

Under Diagnostics, you will find information about the system, such as software version and
wireless configuration details. The Diagnostics menu contains functions relevant for installation,
maintenance and troubleshooting purposes. In case of technical problems the firmware version
(Build) is an important information for the Roche Diagnostics customer support.

The diagnostics screens shown here are for illustration purposes only. The Information shown on
your meter may differ.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Data

Handling.

3 From the Setup-Data Handling menu,

touch Diagnostics.

Setup - Data Handling

Connection

Result Memory

Result Units

Result Display Mode

Diagnostics

80

Meter Setup

Diagnostics

Software

Wireless Setup

04/19/2016

Wireless Setup

Wireless Setup - Network

Use DHCP:

Use DNS:

SSID:

WLAN:
MAC:

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Enabled

Disabled

cobas h 232

01 23 45 67 89 AB

Wireless Setup

Wireless Setup - Connection

DMS Name:

DMS Port Number:

DMS IP Address:

RF Security:

04/19/2016

Software

Build:

Boot:

Kernel:

RootFS:

App:

MM-BL:

MM-FW:

04/19/2016

POCTServer

4711

0.0.0.0

WPA2-PSK (AES)

Wireless Setup

Wireless Setup - Test

RF activated:
Associated:
Authenticated:
Confi gured IP:

192.168.0.123

IP:

255.255.255.0

Subnet:
Gateway:
DNS:
Contacted DMS:
Connected to DMS:
Completed:

04.00.00

06.03.00

06.03.00

06.03.00

04.00.00

03.00.00

03.00.00

Test

4 From the Diagnostics menu, touch the

button of the diagnostics screen you want
to display.

5 Use and to toggle between the

Wireless Setup screens.

6 In either diagnostics screen, touch to

return to the Diagnostics menu.

Note: The Wireless Setup button is only
available if the meter is equipped with WLAN
functionality.

04/19/2016

81

Meter Setup

3.3 ID Setup setting

Use the ID Setup menu to enter settings for user management and patient management. These
settings are optional and set to Off/Inactive by default; the meter can be operated without these
settings.

There are three types of identification used with the meter:

■ System Administrator: The administrator has special rights to enter certain meter set-

tings and is the only one who can enter and change these settings. It is not necessary for
administrator identification to be activated to use the cobas h 232 meter. However, it
might be desired or necessary, depending on the regulatory environment and the site of
use.

■ Operator: The Operator ID is assigned to persons who use the meter to run tests. If you

want to use Operator IDs, you have several options:

– You may use Operator IDs to restrict the use of the meter to qualified personnel or a

predefined group of users. In this case an operator list created on a DMS must be trans­ferred to the meter, enabling you to select an Operator ID when logging in. For more
details see “Data handling”, starting on page 163.

– You may use Operator IDs for informational purposes only, in order to assign stored

measurement results to the users who performed the test. In this case Operator IDs may
directly be entered on the meter (by keypad or scanner), with or without an operator list
being available.

■ Patient: The Patient ID is assigned to the person, whose test results are recorded. You

can either:

– block input of a unique Patient ID (in this case, every test is simply numbered in

consecutive order)

– allow a unique Patient ID as optional, or

– require a unique Patient ID for every test. Patient lists created on a DMS can also be trans-

ferred to the meter, enabling you to select Patient IDs for a test from these lists. For more
details see “Data handling”, starting on page 163.

Operator IDs can be selected from a list (if available) or read by the barcode scanner. If pass­words were created, they must be entered via the onscreen keypad. Patient IDs can be entered
by using the onscreen keypad or the barcode scanner.

82

Meter Setup

Administrator ID

In the default setting, the meter is not protected with an Administrator ID, and all setup options
are accessible to every user. If you set up an Administrator ID, the following setup areas are auto-
matically reserved only for the administrator (i.e., the person who knows the password):

■ Screen: Date/Time

■ Data Handling

■ ID Setup

■ Quality control and the associated lockouts

■ Optional screens

The setup of an Administrator ID does not limit or alter the usage of the meter for measurements
in any way. Furthermore setting up the Administrator ID has no impact on the usage of
Operator IDs. Only the setup options as listed above are tied to administrator access.

When you enter an Administrator ID, this ID must be entered from this point forward before
any future IDs can be set up (anywhere in the ID Setup menu). The Administrator ID must also
be entered before you can delete or change the Administrator ID.

If you forget the Administrator ID, the meter setup may be unlocked via the external data man-
agement system (e.g., cobas IT 1000). If you don’t use such a system and need to reset the
Administrator ID, contact your Roche representative (see Chapter 10).

83

Meter Setup

If an Administrator ID has not been set up
yet:

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 From the Setup-ID Setup menu, touch

Administrator ID.

Setup - ID Setup

Administrator ID

Operator ID

Patient ID

84

Meter Setup

Enter Administrator ID

****|

A

BCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

Enter Administrator ID

123

****|

01

56789

234

ABC

4 Using the onscreen keypad, enter the

Administrator ID of choice (or the pass­word provided by Roche Diagnostics).
The ID can consist of up to 20 alpha­numeric characters.

Alphanumeric characters are any combi­nation of A - Z and 0 - 9. Additionally “.”
(period), or “-” (hyphen) may be used.

Pay close attention to the buttons you press,
because the characters are not displayed on
the screen. Asterisks are displayed instead (as
if entering a password on a computer).

5 Use to switch to the input of

123

numbers.

6 Use to switch back to the input of

ABC

text.

7 Use to backspace and correct a

mistake.

8 Touch to save this Administrator ID, or

touch to exit this menu without saving
any changes.

85

Meter Setup

Repeat Administrator ID

****|

A

BCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

123

9 Enter the Administrator ID again (the

onscreen keypad is automatically dis­played again) to confirm the first entry.

Touch to save this entry, (the
Administrator ID is now set), or

Touch to exit this menu, the
Administrator ID is not set and is therefore
still inactive.

The display automatically returns to the Setup-ID Setup menu. After you exit the Setup menu,
only an authenticated administrator may set up any further IDs.

86

Meter Setup

Changing an existing Administrator ID:

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

****|

Setup - ID Setup

Administrator ID

Operator ID

Patient ID

Enter Administrator ID

A

BCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

123

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 Using the onscreen keypad, enter the

valid Administrator ID.

The ID Setup is displayed. The Adminis-
trator ID button is highlighted, which
means an Administrator ID is active.

4 Touch Administrator ID and use the

onscreen keypad to enter a new ID of
choice (enter it twice).

04/19/2016

87

Meter Setup

Disabling an existing Administrator ID:

Main Menu

04/19/2016

Setup - ID Setup

Administrator ID

Patient Test

Control Test

Review Results

Setup

04/19/2016

Operator ID

Patient ID

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

****|

Optional Screens

Enter Administrator ID

A

BCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

123

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 Using the onscreen keypad, enter the

valid Administrator ID.

The ID Setup is displayed. The Adminis-
trator ID button is highlighted, which
means an Administrator ID is active.

4 Touch Administrator ID.

5 Touch to close the onscreen keypad

without entering an ID number.

The Administrator ID has been deleted
and therefore deactivated. The Adminis-
trator ID button is no longer highlighted.

04/19/2016

88

Enter Administrator ID

A|BCDE

FGHI J

KLMNO

QRS T

P

UVWX Y

Z

123

Meter Setup

Operator ID

In the default setting, the Operator login is not activated. You can either activate or deactivate
Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be

displayed and measurements can be performed. Without a list, operators can log in directly by
entering their operator name. This setup menu allows you to select whether or not an operator
login is possible or required.

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

Setup - ID Setup

Administrator ID

Operator ID

Patient ID

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 From the Setup-ID Setup menu, touch

Operator ID.

You may select from the following options:

■ Off (Operator ID cannot be entered)

■ Optional (Operator ID can be entered,

but is not required)

■ Required (An Operator ID must be

entered)

■ Scan Only (An Operator ID must be

scanned)

89

Meter Setup

Setup - ID Setup

Administrator ID

04/19/2016

Operator ID

Patient ID

Select Operator ID

Scan Only

04/19/2016

Off

Optional

Required

4 Touch the button with the setting of

choice. Your selection is now highlighted.

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen or (depend­ing on the option you selected) proceeds
to the next screen.

The entries for the option Off are now
completed. For the options Optional and
Required, continue by selecting the input
format.

90

Max. Length:

04/19/2016

Operator ID

Alphanum.

Numeric

20

Meter Setup

6 Select the form for input of the Operator

ID.

You may select from the following options:

■ Alphanum. (alphanumeric)

Enter any combination of A - Z and 0 - 9.
Additionally “.” (period), or “-” (hyphen)
may be used.

■ Numeric

Enter numbers only, e.g., “3387”

■ Max. Length

Enter the maximum number of characters
(1 … 20) the Operator ID can have.

7 Touch the button with the form of choice

for setting up the Operator ID. Your selec­tion is now highlighted.

8 Touch or to set the number of

characters (length) of choice.

9 Touch to save this setting, or touch

to exit this menu without saving any
changes.

The meter automatically returns to the
Setup-ID Setup menu.

91

Meter Setup

If you want to create a list of Operator IDs from which you can select an operator, additional
software (a data management system) and a WLAN connection or the Handheld Base Unit
are required (for more details see “Data handling”, starting on page 163).

With an Operator list being transferred to the meter, the Operator ID options are different from
the options in “standalone” mode.

Main Menu

Review Results

04/19/2016

Select Operator ID

Hidden List

Patient Test

Control Test

Setup

04/19/2016

None

List

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

Setup - ID Setup

Administrator ID

Operator ID

Patient ID

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 From the Setup-ID Setup menu, touch

Operator ID.

You may select from the following options:

■ List (Operator ID must be selected from

the list or scanned using the barcode
scanner)

■ None (Operator ID cannot be entered or

selected)

■ Hidden List (Operator ID must be

entered using the barcode scanner or the
onscreen keypad)

4 Touch the button with the setting of

choice. Your selection is now highlighted.

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen.

04/19/2016

92

Meter Setup

Patient ID

Patient IDs help you to assign stored results to individual patients. In the default setting, input of
Patient IDs is set to No. This means that a consecutive number is assigned to each test. However,

you can require that a Patient ID must be entered or make it optional.

If you want to create a list of Patient IDs from which you can select a patient for testing, addi-
tional software (a data management system) and a WLAN connection or the Handheld Base
Unit are required (see page 163).

Main Menu

04/19/2016

Patient Test

Control Test

Review Results

Setup

04/19/2016

09:15 am

Setup

Basics

Data Handling

ID Setup

Lockout

Optional Screens

04/19/2016

Setup - ID Setup

Administrator ID

Operator ID

Patient ID

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch ID Setup.

3 From the Setup-ID Setup menu, touch

Patient ID.

You may select from the following options:

■ Off (Patient ID cannot be entered)

■ Optional (Patient ID can be entered, but

is not required)

■ Required (The operator must enter the

Patient ID)

■ Hidden List (Only available when work-

ing with a DMS. The list will not be shown.
The operator needs to enter the Patient ID
manually or via barcode scan.)

93

Meter Setup

Setup - ID Setup

Administrator ID

04/19/2016

Operator ID

Patient ID

Select Patient ID

04/19/2016

Off

Optional

Required

Hidden List

4 Touch the button with the setting of

choice. Your selection is now highlighted.

5 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically
returns to the previous screen or (depend­ing on the option you selected) proceeds
to the next screen.

The entries for the option Off are now
completed. For the options Optional and
Required, continue by selecting the input
format.

94

Max. Length:

04/19/2016

Patient ID

Alphanum.

Numeric

20

Meter Setup

6 Select the form for input of the Patient ID

before each test.

You may select from the following options:

■ Alphanum. (alphanumeric)

Enter any combination of A - Z and 0 - 9.
Additionally “.” (period), or “-” (hyphen)
may be used.

■ Numeric

Enter numbers only, e.g., “3387”

■ Max. Length

Enter the maximum number of characters
(1 … 20) the Patient ID can have.

7 Touch the button with the form of choice

for the Patient ID. Your selection is now
highlighted.

8 Touch or to set the number of

characters (length) of choice.

9 Touch to save this setting, or touch

to exit this menu without saving any
changes.

The display automatically returns to the
Setup-ID Setup menu.

95

Meter Setup

3.4 Lockout setup

The Lockout menu contains the options for quality control tests that the operator is required to
perform at specified intervals or based on specific triggers. This is a list of the available lockout
options:

■ Operator Lockout

■ QC Settings, containing

– New Lot Lockout
– QC Lockout
– IQC Lockout
– Custom Range Trop T

■ Cleaning Lockout

■ STAT Test Config. (overriding a lockout in an emergency situation)

If the quality control test is not performed as required or if the result is outside the target value
range, the meter, parameter or test strip lot is locked from further use. Lockouts can also be set
up on an operator-specific basis, i.e., each operator must perform the corresponding quality con­trol tests at specified intervals.

A quality control test must be completed successfully before the meter is made available again
(either to the operator or in general) for testing.

The option of setting up lockouts for operators is available only when the meter is set up for
operator logins (see page 89) and operator lists are stored in the meter.

In case of an emergency, there may not be the time to first complete the required quality control
test if a lockout has been triggered and the meter is "locked". For such cases you may set up so­called STAT Tests (STAT = Short TurnAround Time). This option allows to perform a limited
number of tests when an operator lockout or QC lockout is in force. However, once the defined
number of STAT tests has been performed, further use of the meter is no longer possible (for the
affected test parameter or operator), unless the required quality control test is successfully
completed.

STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed a
quality control test (New Lot Lockout).

96

Meter Setup

Operator lockout

To perform a test with the meter, the individual steps must be performed properly. Quality control
tests can be performed on a regular basis by every operator to ensure these steps are performed
properly. By activating the operator lockout, operators are required to perform regular quality
control tests.

Main Menu

04/19/2016

Setup - Lockout

Operator Lockout

Cleaning Lockout

STAT Test Confi g.

04/19/2016

Patient Test

Control Test

Review Results

Setup

QC Settings

09:15 am

Optional Screens

04/19/2016

Setup

Basics

Data Handling

ID Setup

Lockout

1 From the Main Menu, touch Setup to

open the meter settings.

2 From the Setup menu, touch Lockout.

3 From the Setup-Lockout menu, touch

Operator Lockout.

If this button appears in gray (inactive),
the option Operator ID is deactivated.

97

Meter Setup

4 Select the time interval of choice in which

the required quality control tests must be
performed.

You may select from the following options:

■ No (deactivated)

■ Daily

■ Weekly

■ Monthly

■ Every 3 or 6 months

■ Yearly

Select Operator Lockout

No

Daily

Weekly

Monthly

Every 3 Months

04/19/2016

5 Touch or to display the option of

choice on the screen. If the arrow is just an
outline , this means no other
options are available in the direction indi­cated.

6 Touch the button to select the time interval

of choice. Your selection is now high­lighted.

7 Touch to save this setting, or touch

to exit this menu without saving any
changes.

If you selected No, Operator Lockout is
deactivated.

98

Meter Setup

Select Operator Lockout

No of Levels

One Level

Two Levels

04/19/2016

8 Quality control tests may include one or

two levels. Select the number of levels
which must be performed (not applicable,
if you selected No).

9 Touch to save this setting, or touch

to exit this menu without saving any
changes. The display automatically returns
to the Setup-Lockout menu.

99

Meter Setup

Quality control (QC) settings

QC Settings define that operator-independent quality control tests must be run on a regular
basis. Lockouts may be triggerd by selectable time periods, and lockouts may be triggered by
certain events. The QC Settings menu contains the following options:

■ QC Lockout (time-based), with the additional option of a New Lot Lockout (applies every

time a new test strip lot is used)

■ IQC Lockout (time-based)

■ Custom Range Trop. T (customize the QC Range in accordance with applicable local

guidelines)

■ QC Result Format (select the format for QC result displays)

■ Reset Test Param. (reset all test parameters, including code chip data and QC lockouts)

100