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Roche Diagnostics

9115 Hague Road, PO Box 50457Indianapolis, IN 46250-0457 USATel. + 1-317-521-2000

Software Bulletin

TP-00495 V305/30/19

Firmware Updates — Accu-Chek® Inform II Blood Glucose System, CoaguChek® XS Pro System, and CoaguChek XS Plus System

Updates were made to pages 12, 13 and 25 of this Software Bulletin. Changes are marked by black bars in the margins.

Introduction ___________________________________________________________________________________

These instructions provide guidance on obtaining device firmware to upgrade your Accu-Chek Inform II, CoaguChek XS Pro, and CoaguChek XS Plus systems to address cyber security vulnerabilities communicated in Analyzer Bulletin TP-00355. As the U.S. Regulatory Agency for cyber security, the Department of Homeland Security also published Medical Advisory ICSMA-18-310-01 for informational purposes1. The firmware provided, following the instructions in this Software Bulletin, addresses all identified vulnerabilities noted in Analyzer Bulletin TP-00355 and ICSMA-18-310-01. In TP-00355, Roche offered suggested customer actions to help increase the cyber security of your network. Roche is pleased to announce firmware updates for your Accu-Chek Inform II, CoaguChek XS Pro, and CoaguChek XS Plus systems. These updates are not mandatory but Roche recommends that customers update their meter systems.

1 Department of Homeland Security Medical Advisory ICSMA-18-310-01, https://ics-cert.us-cert.gov/advisories/ICSMA-18-310-01

Product Catalog Number

Firmware Version Now Available

Accu-Chek Inform II meter 0506031100103.06.00

(serial numbers < UU14000000)

Accu-Chek Inform II meter with RF card 0506030300104.03.00

(serial numbers > UU14000000)

Accu-Chek Inform II Base Unit (BU) 0506029000103.01.04

(serial number > UU41000000)

Accu-Chek Inform II Base Unit Hub (BUH) 0588876000103.01.04

(serial numbers > UU59000000)

CoaguChek XS Plus Meter Care Kit 0502153700103.01.06

(serial numbers > UQ0000000)

CoaguChek XS Pro Meter Kit 0553019916003.01.06

(serial numbers > U70000000)

Handheld Base Unit (HBU) for CoaguChek XS Pro and CoaguChek XS Plus systems

0480565816003.01.04

(serial numbers > UU00000000)over...

þ Accu-Chek Inform IIþ CoaguChek XS Plusþ CoaguChek XS Pro

https://ics-cert.us-cert.gov/advisories/ICSMA

TP-00495 V3 page 2 of 42

Table of Contents ________________________________________________________________________________

Use this Table of Contents to determine the appropriate instructions for downloading the updated firmware and subsequently updating the individual meters.

Description Page(s)

How to Determine Your Current Accu-Chek® Inform II Firmware Version 3-4

How to Determine Your Current CoaguChek® XS Plus Meter Firmware Version 5

How to Determine Your Current CoaguChek XS Pro Meter Firmware Version 6

Minimum Data Management System (DMS) Version Requirements 7

General Instructions for Downloading Firmware Version Updates 7

Downloading the Firmware File from the Roche Firmware Portal 8-13

Downloading the Firmware to the cobas IT 1000 DMS 14-15

Updating Meters Via the cobas IT 1000 DMS 16-22

RALS™ Customers: Downloading the Firmware to the RALS Web3 and RALS Notebook v3.0 DMS

23

RALS Customers: Updating the Meters via the RALS Web3 or RALS Notebook v3.0 DMS 23

Updating the CoaguChek Handheld Base Unit (HBU), Accu-Chek Inform II Base Unit (BU), and Accu-Chek Inform II Base Unit Hub (BUH)

24-26

Installing HosPOC Update Tool Version 10.0 27-28

Installing the Roche HBU/BU Control Panel Version 03.00.01 Firmware and USB Drivers 29-32

Performing Accu-Chek Inform II Meter Firmware Upgrades with HosPOC Update Tool Version 10.0

33-36

Performing CoaguChek XS Plus and CoaguChek XS Pro Meter Firmware Upgrades with HosPOC Update Tool Version 10.0

37-41

n Local Administrative Rights may be required from your facility’s IT Department for these procedures. The following steps will modify a medical device within your hospital’s facility. Roche recommends that you adhere to your facility’s standards and security policies prior to making any changes. In addition, you may need assistance from your IT Department to make the recommended updates.

n Screen shots throughout this Software Bulletin are provided for illustrative purposes. Your screen may appear slightly different.

TP-00495 V3page 3 of 42

How to Determine Your Current Accu-Chek® Inform II Firmware Version ______________________________

There are two ways to determine the firmware version of your meter(s):

1. View the device list in your DMS to determine the firmware versions in your facility or

2. Determine the firmware version at the device level. The following instructions show how todetermine firmware version at the device level:

To determine the firmware version on your Accu-Chek Inform II meter, go to Diagnostics view to find information about the system. For instructions, refer to the Accu-Chek Inform II Operator’s Manual version 6.0, section 10.5 Diagnostics view. Once you have determined the firmware version, follow the instructions in the next table.

The Accu-Chek Inform II meter, catalog number 05060311001, serial number begins with “UU13.”

The Accu-Chek Inform II meter, catalog number 05060303001, serial number begins with “UU14.”

Go to Table of Contents

TP-00495 V3 page 4 of 42

How to Determine Your Current Accu-Chek® Inform II Firmware Version, continued ___________________

Product Catalog Number Serial Number

If the diagnostics screen displays

firmware version...Then refer to

Accu-Chek Inform II meter

05060311001serial numbers

beginning with UU1303.03.01 or greater

the enclosed instructions for updating the meter firmware


05060303001serial numbers

beginning with UU1404.01.02 or less

Software Bulletin 16-168, Accu-Chek Inform II Blood Glucose Meter Firmware Version 04.01.02 – Important Information and Actions Required

c The Accu-Chek Inform II meter battery must be charged to a minimum of 40% prior to initiating the firmware upgrade.


TP-00495 V3page 5 of 42

How to Determine Your Current CoaguChek® XS Plus Meter Firmware Version ________________________




After displaying the Roche logo, the meter briefly displays the Init (initialization) screen. The screen shows which firmware version is currently running on your meter. (The Init screen shown below is for illustration purposes only - version numbers on your meter may differ.) Refer to the CoaguChek XS Plus Operator’s Manual version 7.0, section 3, “Putting the Meter into Operation.”

• If the displayed firmware version is 02.02.00 or greater, refer to the instructions in the section of thisbulletin titled Updating Meters Via the cobas IT 1000 DMS for updating the CoaguChek XS PlusMeter firmware.

• If the displayed firmware version is less than 02.02.00, please contact Roche Technical Support at1-800-428-4674.

c The CoaguChek XS Plus meter battery must be charged to a minimum of 15% prior to initiating the firmware upgrade.


TP-00495 V3 page 6 of 42

How to Determine Your Current CoaguChek® XS Pro Meter Firmware Version _________________________




After displaying the Roche logo, the meter briefly displays the Init (initialization) screen. The screen shows which firmware version is currently running on your meter. (The Init screen shown below is for illustration purposes only - version numbers on your meter may differ.) Refer to the CoaguChek XS Pro Operator’s Manual version 4.0, section 3, “Putting the Meter into Operation.”

• If the displayed firmware version is 02.02.00 or greater, refer to the instructions in this SoftwareBulletin on updating the CoaguChek XS Plus Meter firmware.

• If the displayed firmware version is less than 02.02.00, please contact Roche Technical Support at1-800-428-4674.

c The CoaguChek XS Pro meter battery must be charged to a minimum of 15% prior to initiating the firmware upgrade.


TP-00495 V3page 7 of 42

Minimum DMS Version Requirements _____________________________________________________________

The minimum DMS version requirements to enable features on the Accu-Chek® Inform II meters follow:

Data Management System Minimum System Version Minimum Driver Version

cobas IT 1000 2.04 PCommunicator 1.12.13

cobas IT 1000 for meter TLS encryption

2.04 To Be Determined

RALS™ Web3 5.13 N/A

RALS Notebook 2.5 N/A

RALS Notebook 3.0 N/A

To obtain an update of your cobas IT 1000 DMS, contact the Roche Support Network Customer Support Center at 1-800-526-2272. A Roche Support Network (RSN) Clinical Solutions Engineer will contact you within three (3) business days to discuss the update process.

To obtain an update of your RALS Web3 DMS, contact RALS Technical Support at 1-877-627-7257. For other POCT1-A DMS solutions, contact your DMS vendor to determine the minimum version and to obtain the DMS update.

For any DMS not mentioned in the table above, HosPOC Update Tool version 10.0 will be available to update your Accu-Chek Inform II, CoaguChek® XS Plus, and CoaguChek XS Pro meters.

General Instructions for Downloading Firmware Version Updates ____________________________________

You will need to download the needed firmware version(s) from the Roche Firmware Portal to one of the following:

• a server with the cobas IT 1000 or RALS Web3 application installed,• a computer/workstation with access to the cobas IT 1000 or RALS Web3 application installed, or• a computer/workstation with internet access and the ability to save files to a USB storage device

(e.g., flash drive) that is not a RALS Notebook v3.0 laptop.

Firmware update files have been grouped together for ease of retrieval. As a result, individual firmware version files must be extracted from the downloaded folder prior to updating individual meters.

After downloading the needed firmware version(s) to one of the options listed above, you will need to update the individual meters.

The Accu-Chek Inform II Base Unit, Base Unit Hub, and CoaguChek Handheld Base Unit can be updated via an ethernet connection using File Transfer Protocol (FTP) or USB connection to a computer containing the needed firmware version.


TP-00495 V3 page 8 of 42

Downloading the Firmware File from the Roche Firmware Portal _____________________________________

Work with your IT Department to perform the following steps 1 through 14.

1. Go to the Roche Diagnostics website at diagnostics.roche.com.

2. Click on the Account icon at the top right of the page next to your country.

3. If you do not have an account, click Register and complete the information.

4. Check your email and follow the provided instructions to complete your registration.Note: you will be asked to supply your Customer Account Number. Go to step 7 on the next page.

5. If you already have a diagnostics.roche.com account, click Login.

6. Log in using your credentials.


usdiagnostics.roche.com

TP-00495 V3page 9 of 42

Downloading the Firmware File from the Roche Firmware Portal, continued ___________________________

7. Click on Products.

8. Click on Point of Care.

9. For all Accu-Chek® Inform II and CoaguChek® updates, scroll down to Accu-Chek Inform IISystem and click Learn more.

10. Scroll down the page and click Resources.


TP-00495 V3 page 10 of 42


11. Click Login in the Firmware Downloads section.

12. You will be presented with a Terms and Conditions agreement to use the firmware files. Read theTerms and Conditions; acknowledge them by clicking I agree to the Terms & Conditions. Youwill be directed to a page containing the firmware files and this Software Bulletin.

13. Follow the instructions in this bulletin to determine which firmware files are needed to upgrade yourAccu-Chek® Inform II and CoaguChek® XS systems. Download all firmware in the device- specificfolder on the firmware portal for your upgrades as noted in the tables on the following pages.

14. Follow the instructions in this Software Bulletin to perform the update(s).


TP-00495 V3page 11 of 42


Product Serial Number

FirmwareFirmware for DMS: cobas IT 1000Minimum

VersionEnding Version

Accu-Chek® Inform II meter

UU13xxxxxx

03.04.xx 03.06.00 POCTUpdate_aci2_3@@b_0304@@_030600.zip

03.05.00 03.06.00 POCTUpdate_aci2_3@@b_030500_030600.zip

03.03.01 03.06.00 POCTUpdate_aci2_3@@b_0303@@_030600.zip

UU14xxxxxx

04.00.0x 04.01.02 POCTUpdate_aci2_4.@@_04000@_040102.zip

04.01.xx 04.03.00 POCTUpdate_aci2_4.@@_0401@@_040300.zip

04.02.xx 04.03.00 POCTUpdate_aci2_4.@@_0402@@_040300.zip


FirmwareFirmware for DMS:

RALS™ Web3 and RALS Notebook version 3.0Minimum Version

Ending Version


UU13xxxxxx

03.04.xx 03.06.00 POCTUpdate_aci2_3@@b_0304@@_030600.zip

03.05.00 03.06.00 POCTUpdate_aci2_3@@b_030500_030600.zip

03.03.01 03.06.00 POCTUpdate_aci2_3@@b_0303@@_030600.zip

UU14xxxxxx

04.00.0x 04.01.02 POCTUpdate_aci2-RALS_4@@@_04000@_040102.zip

04.01.xx 04.03.00 POCTUpdate_aci2-RALS_4@@@_0401@@_040300.zip

04.02.xx 04.03.00 POCTUpdate_aci2-RALS_4@@@_0402@@_040300.zip

Product Serial Number Step*

FirmwareFirmware for DMS: HosPOC Udate ToolMinimum



UU13xxxxxx

1 03.04.xx 03.06.00 POCTUpdate_aci2_3@@b_0304@@_030600.zip

2 03.05.00 03.06.00 POCTUpdate_aci2_3@@b_030500_030600.zip

3 03.03.01 03.06.00 POCTUpdate_aci2_3@@b_0303@@_030600.zip

UU14xxxxxx

1 04.00.0x 04.01.02 POCTUpdate_aci2_4.@@_04000@_040102.zip

2 04.01.xx 04.03.00 POCTUpdate_aci2_4.@@_0401@@_040300.zip

3 04.02.xx 04.03.00 POCTUpdate_aci2_4.@@_0402@@_040300.zip

*Using the HosPOC Update Tool, upgrades must be performed stepwise. Depending on the starting version of the meter,starting at Step 1 may not always be necessary.


03.04.xx

_030600.zip

b_030500_030600.zip

_030600.zip

mailto:_04000@_040102.zip

04.01.xx

_040300.zip

04.02.xx

_040300.zip

03.04.xx

_030600.zip

b_030500_030600.zip

_030600.zip

mailto:_04000@_040102.zip

04.01.xx

_040300.zip

04.02.xx

_040300.zip

03.04.xx

_030600.zip

b_030500_030600.zip

_030600.zip

mailto:_04000@_040102.zip

04.01.xx

_040300.zip

04.02.xx

_040300.zip

TP-00495 V3 page 12 of 42



FirmwareFirmware for DMS: cobas IT 1000Minimum


CoaguChek® XS Plus meter

All**

02.02.00 03.01.00POCTUpdate_ccxspro_34@a_0202@@_030100.zip

and POCTUpdate_ccxspro_35@a_0202@@_030100.zip

03.00.xx 03.01.00POCTUpdate_ccxspro_34@a_0300@@_030100.zip




CoaguChek XS Pro meter

All

02.0x.00 03.00.00 POCTUpdate_ccxspro_3@@a_020@00_030000.zip







**The “ccxspro” files are correct for the CoaguChek XS Plus meters using cobas IT 1000.


FirmwareFirmware for DMS: RALS™ Web3Minimum


CoaguChek XS Plus meter

All

02.02.00 03.01.00POCTUpdate_ccxsplus_34@a_0202@@_030100.zip

and POCTUpdate_ccxsplus_35@a_0202@@_030100.zip

03.00.xx 03.01.00POCTUpdate_ccxsplus_34@a_0300@@_030100.zip


03.01.xx 03.01.06POCTUpdate_ccxsplus_34@a_0301@@_030106.zip



All

02.0x.00 03.00.00 POCTUpdate_ccxspro_3@@a_020@00_030000.zip








_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

_030100.zip

_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

_030100.zip

_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

TP-00495 V3page 13 of 42


Product Serial Number Step*

FirmwareFirmware for DMS: HosPOC Update ToolMinimum


CoaguChek® XS Plus meter

All

1 02.0x.xx 03.00.00 ICIUpdate_ccxsplus_3@@a_020@00_030000.zip

2 02.02.00 03.01.00ICIUpdate_ccxsplus_34@a_0202@@_030100.zip

and ICIUpdate_ccxsplus_35@a_0202@@_030100.zip

3 03.00.xx 03.01.00ICIUpdate_ccxsplus_34@a_0300@@_030100.zip


4 03.01.xx 03.01.06ICIUpdate_ccxsplus_34@a_0301@@_030106.zip



All

1 02.0x.xx 03.00.00 ICIUpdate_ccxspro_3@@a_020@00_030000.zip

2 02.02.00 03.01.00ICIUpdate_ccxspro_34@a_0202@@_030100.zip

andICIUpdate_ccxspro_35@a_0202@@_030100.zip

3 03.00.xx 03.01.00ICIUpdate_ccxspro_34@a_0300@@_030100.zip

and ICIUpdate_ccxspro_35@a_0300@@_030100.zip

4 03.01.xx 03.01.06ICIUpdate_ccxspro_34@a_0301@@_030106.zip

and ICIUpdate_ccxspro_35@a_0301@@_030106.zip

*Using the HosPOC Update Tool, upgrades must be performed stepwise. Depending on the starting version of the meter,starting at Step 1 may not always be necessary.

Product Step***Firmware

Firmware for Local Computer ConnectionMinimum Version

Ending Version

Base Unit, Base Unit Hub, and Handheld Base Unit

1 03.xx.xx 03.01.01 hbm-blknrfap-uds-build-03.01.01.update

2 03.01.01 03.01.04 hbm-ap-uds-build.03.01.04.update

3 04.00.00 04.01.00 hbm-blknrfapzz-uds-build-04.01.00.update

*** Once the firmware download is complete, the file will appear in the location you have designated.


02.0x.xx

mailto:a_020@00_030000.zip

_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

02.0x.xx

mailto:a_020@00_030000.zip

_030100.zip

_030100.zip

03.00.xx

_030100.zip

_030100.zip

03.01.xx

_030106.zip

_030106.zip

03.xx.xx

hbm-blknrfap-uds-build-03.01.01.update

hbm-ap-uds-build.03.01.04.update

TP-00495 V3 page 14 of 42

Downloading the Firmware to the cobas IT 1000 DMS ______________________________________________

w Remove the meter (Accu-Chek® Inform II or CoaguChek® XS Plus or CoaguChek XS Pro meter) to be updated from the patient care area and place it in a Base Unit (Accu-Chek Inform II meter) or Handheld Base Unit (CoaguChek XS Plus or CoaguChek XS Pro meter) prior to performing the firmware update. Interrupting the firmware upgrade process will cause the upgrade to fail.

PCommunicator version 1.12.13 for the cobas IT 1000 application is required to access all Accu-Chek Inform II firmware version 04.03.00 features and is scheduled to be available in the 1st quarter of 2019.

The PCommunicator version needed to enable TLS encryption for Accu-Chek Inform II firmware version 03.06.00 with the cobas IT 1000 application will be available in the future.

Step Action

1Log in to the server where the cobas IT 1000 application is installed.

You may need to contact your facility’s IT Department to gain access to your cobas IT 1000 Server.

2

Once on the cobas IT 1000 server, navigate to your Local Disk (C:) drive.

Create two (2) new folders on the local disk (C:) drive of the cobas IT 1000 server and name the folders as follows:• Accu-Chek Inform II – “ACI2FW_Upgrade”• CoaguChek XS Plus and CoaguChek XS Pro – “CCXSFW_Upgrade”

The created folder name must match for the following steps to work as instructed. Your existing/new folder should look like the picture below.


TP-00495 V3page 15 of 42

Downloading the Firmware to the cobas IT 1000 DMS, continued ____________________________________

Step Action

3Log in with administrative rights onto the server where the cobas IT 1000 application is installed.

You may need to contact your facility’s IT Department to gain access to your cobas IT 1000 Server.

4

Retrieve your download of the Accu-Chek® Inform II firmware update and move the new firmware file into the folder titled “C:\ACI2FW_Upgrade\”

Retrieve your download of the CoaguChek® XS Plus and CoaguChek XS Pro firmware update and move the new firmware file into the folder titled “C:\CCXSFW_Upgrade\”

c DO NOT change the name of the .zip file.DO NOT unzip the file.


C:\ACI2FW_Upgrade\

C:\CCXSFW_Upgrade\

TP-00495 V3 page 16 of 42

Updating Meters Via the cobas IT 1000 DMS ______________________________________________________

Multiple firmware files are being made available. Roche suggests that all files be added to the cobas IT 1000 DMS. During the update of each meter, the meter will work with the cobas IT 1000 application to determine which file is needed for upgrade. Note that multiple upgrade cycles may be needed to obtain the end desired firmware version.

Step Action

1 Log in to the cobas IT 1000 application. If you have multiple cobas IT 1000 sites, select the site where you will be updating the Accu-Chek® Inform II, CoaguChek® XS Plus, or CoaguChek XS Pro meters.

2 In the Menu tree along the left side, select Instruments, then Configuration.


TP-00495 V3page 17 of 42

Updating Meters Via the cobas IT 1000 DMS, continued ____________________________________________

Step Action

3 A. From the Instruments – Configuration screen, click the Add button on the bottom right.

B. When the Copy Configuration window opens, select your facility’s primary meter deviceconfiguration. Click OK.

C. The details of your copied configuration will now be editable. Depending on the firmware versionon your individual device, there is potential for the update(s) to occur via an iterative process (i.e., eachdevice updates sequentially from the oldest to the newest firmware version.) In the Details section, createa unique name in the “Configuration ID” and “Description” fields using the information in the followingtable. Click OK to save.

D. In the Configuration screen, select the configuration created in the previous step. Click theDevice Conf button.

• Accu-Chek® Inform II meter – Go to > Device Configuration > User and change the ID Validation Mode to “None.”

• CoaguChek® XS Plus and CoaguChek XS Pro meter – Go to > Device Configuration > DeviceSetup > ID Setup and remove the check mark for Operator List.


TP-00495 V3 page 18 of 42


Step Action

3, cont’d E. For Accu-Chek® Inform II meter: Select “Patient” from the Device Configuration menu and change thefollowing:

• Patient confirmation – None

• ID Validation Mode – None

• Uncheck the “Patient List” check box, if checked

Click OK when finished to save all changes.

For CoaguChek® XS Plus and CoaguChek XS Pro meters: While viewing “ID Setup” within the “Device Setup” section, change the Patient ID setting to “No.” Select “Server Setup” from the Device Configuration menu and remove the check mark for Patient List. Click OK when finished to save all changes.

After saving your changes, return to the main Instruments > Configuration screen.


TP-00495 V3page 19 of 42


Step Action

3, cont’d F. Double-click Upgrade Configuration to open the Details window.In the Details section, enter the Firmware File Path in the Firmware File Path field using the informationin the following table:

w It is highly recommended that you remove the device from its working location and perform the upgrade in a non-patient care area or office to avoid any use of the instrument during this time.

Return the device to your facility’s previous configuration following completion of the upgrade.

w The Accu-Chek® Inform II meter can use wireless connectivity for the upgrade. However, it is highly recommended that the meter remain docked during the upgrade process to avoid full battery discharge.

Interrupting the firmware upgrade process, including disruption due to battery discharge, will cause the upgrade to fail.


TP-00495 V3 page 20 of 42


Step Action

4 In the Menu on the left side, select Instruments > Instrument Assignment.

5 Double-click the desired meter to display the details. In the Configuration drop-down, select the needed firmware file for update.

Click OK to save.


TP-00495 V3page 21 of 42


Step Action

6 Dock the meter in a base unit to initiate communication with the cobas IT 1000 server. If the meter is in the base unit, remove the meter and return it to the base unit to initiate the update process. The meter will complete the normal communication with the server and then you will see “Updating Firmware” on the front of the meter.

Accu-Chek® Inform II meter – The meter will complete several communications with the cobas IT 1000 server, and you will see different messages on the meter screen. Leave the meter on the dock until the meter screen is idle for at least 10 seconds.

For the Accu-Chek Inform II meter, firmware updates can be completed faster via wireless connectivity.

For CoaguChek® XS Plus and CoaguChek XS Pro meters, the meter will complete

communication with the cobas IT 1000 server in order to obtain the firmware update file.

Pay close attention to the meter for completion of the update cycle!

CoaguChek XS Plus and CoaguChek XS Pro meters – Leave the meter on the dock until you no longer see the communication icon and/or “I-005 The meter is docked” message for at least 10 seconds. Power the meter off and back on using the power button. A screen displaying the message “Firmware update in progress” will appear while the meter is processing the update file. (Verify the time and date along with Connection settings and correct them if necessary.)

7 For Accu-Chek Inform II meter, following update completion, confirm the meter firmware version on the meter’s Diagnostics screen. If the Diagnostics screen does not display the firmware version to which you just updated, repeat step 6.

For CoaguChek XS Plus and CoaguChek XS Pro meters, following update completion, confirm the meter firmware version on the meter’s Init screen that displays when the meter is first powered on. If the Init screen does not display the firmware version to which you just updated, repeat step 6.


TP-00495 V3 page 22 of 42


Step Action

8 Assign updated devices back to their previous configuration on the Instrument Assignment screen.

w Reset the user configuration on your device(s) according to your facility’s previous configuration to avoid unauthorized users from accessing the device.

Dock the meter to re-synchronize with the cobas IT 1000 server.

9 Run quality controls (QC) on the upgraded meter.

(After the update, the Accu-Chek® Inform II meter will force the user to run QC prior to running any patient tests.)

10 Repeat Steps 6-10 for additional firmware versions or to upgrade additional meters.

For questions regarding the upgrade process on the Accu-Chek Inform II meter, contact Roche Technical Support at 1-800-440-3638.

For questions regarding the upgrade process on the CoaguChek® XS Plus or CoaguChek XS Pro meters, contact Roche Technical Support at 1-800-428-4674.


TP-00495 V3page 23 of 42

RALS™ Customers: Downloading the Firmware to the RALS Web3 and RALS Notebook v3.0 DMS _______

1. Multiple firmware files are being made available. Roche suggests that all files be added to the RALSWeb3 or RALS Notebook v 3.0 DMS. During the update of each meter, the meter will work with theRALS Web3 or RALS Notebook v 3.0 DMS to determine which file is needed for upgrade. Note thatmultiple upgrade cycles may be needed to obtain the end desired firmware version.

2. Download the required firmware versions from the Roche Firmware Portal.

3. Once the firmware download is complete, the file will appear in your designated location.

RALS Customers: Updating the Meters via the RALS Web3 or RALS Notebook v3.0 DMS _______________

Refer to the RALS DMS Operator’s Manual to:

1. Load the firmware into the RALS DMS and

2. Update your Accu-Chek® Inform II Blood Glucose meters.

n Contact RALS Technical Support prior to upgrading firmware of Accu-Chek Inform II meter(s) with serial number in UU13xxxxxx - < UU14000000 range.


TP-00495 V3 page 24 of 42

Updating the CoaguChek® Handheld Base Unit (HBU), Accu-Chek® Inform II Base Unit (BU), and Accu-Chek Inform II Base Unit Hub (BUH) ________________________________________________________

n Devices may be updated via ethernet using the File Transfer Protocol (FTP) or USB connection to a computer containing the needed firmware. For assistance, contact your IT Department. If you have additional questions, contact Roche Technical Support at 1-800-440-3638 (Accu-Chek Inform II Base Unit or Base Unit Hub) or at1-800-428-4674 (CoaguChek Handheld Base Unit).

1. Note the position of the “USB Configuration Switch.” Switch the “USB Configuration Switch” toposition 1 (Configuration) on the HBU, BU, or BUH. In this switch position, the HBU/BU/HBUacts as a removable disk on the USB port.

2. Connect the Handheld Base Unit (HBU), Base Unit (BU), or Base Unit Hub (BUH) to yourcomputer using the USB cable.

3. Using Windows® File Explorer, navigate to the local drive as shown below. The drive letter maydiffer based on what drive letter assignments are available in your computer. Select the drive for thebase unit by double-clicking. The root directory for the connected base unit is now displayed.


TP-00495 V3page 25 of 42

Updating the CoaguChek® Handheld Base Unit (HBU), Accu-Chek® Inform II Base Unit (BU), and Accu-Chek Inform II Base Unit Hub (BUH), continued ______________________________________________

4. Determine the firmware version of the CoaguChek Handheld Base Unit (HBU), Accu-Chek InformII Base Unit (BU), or Base Unit Hub (BUH). If the HBU/BU/BUH is configured, you will need theuser name and password to log in.

5. The HBU/BU/BUH writes the firmware version numbers and the hardware identity number to thefile “status.log” accessible via USB removable disk during each start up of the HBU/BU/BUH.

6. Determine the version(s) of firmware needed.

A. If the firmware version is less than 03.01.01, your firmware will need to be updated to version03.01.01 prior to further update.

1. Download the firmware version 03.01.01 file titled,hbm-blknrfap-uds-build-03.01.01.update and save it in a folder on the computer or otherlocal mass storage device you will use for the upgrade.

B. If the firmware version is 03.01.01 or greater but less than firmware version 03.01.04, thefirmware can be updated to version 03.01.04.

1. Download the firmware version 03.01.04 file titled hbm-ap-uds-build.03.01.04.updateand save it in a folder on the computer or other local mass storage device you will use for theupgrade.

7. Make a copy of the decompressed and downloaded new firmware in your temporary folder on thecomputer or other local mass storage device.

A. If updating to firmware version 03.01.01, then copy the file titledhbm-blknrfap-uds-build-03.01.01.update to the root directory of the base unit.

B. If updating to firmware version 03.01.04, then copy the file titledhbm-ap-uds-build.03.01.04.update to the root directory of the base unit.

C. If updating to firmware version 04.01.00, then copy the file titledhbm-blknrfapzz-uds-build-04.01.00.update to the root directory of the base unit.


status.log





TP-00495 V3 page 26 of 42

Updating the CoaguChek® Handheld Base Unit (HBU), Accu-Chek® Inform II Base Unit (BU), and Accu-Chek Inform II Base Unit Hub (BUH), continued ______________________________________________

8. If user access control is enabled for the base (i.e., user authentication is required to makeconfiguration changes), a valid user name and password will need to be saved to the BASEConf.xmlfile in order for the device to process the update file.

For example:

9. Open the file status.log or BASEConf.xml to verify that the latest entry for the firmware version iscorrect.

n If the removable disk drive still contains the update file, an error described in the file “update.log” occurred and the firmware was not successfully updated. Reset the device by disconnecting and reconnecting the power supply and repeat steps 6-8.

10. To resume routine operation, set the USB Configuration switch to the position 1 (Configuration).See the diagram in step 1 on page 24 of this Software Bulletin.


BASEConf.xml

status.log

BASEConf.xml

update.log

TP-00495 V3page 27 of 42

Installing HosPOC Update Tool Version 10.0 _______________________________________________________

1. Using your computer, access the download location for the files or insert the local mass storagedevice provided to you by Roche Diagnostics to perform the firmware upgrade on your Accu-Chek®Inform II, CoaguChek® XS Plus, and CoaguChek XS Pro meters.

2. Open the HosPOC Update Tool v 10.0 Installation folder within the HosPOC Update Toolfolder located on the media or download location.

3. Double click the Setup.exe file.

n RALS™ Notebook Customers: The HosPOC Update Tool version 10.0 firmware should be installed on a non-RALS Notebook computer.

n You must be logged in as an Administrator on the computer to which the HosPOC Update Tool version 10.0 will be installed.

n If the User Account Control prompt displays, click Yes to proceed with the installation.

4. Click Ok.


Setup.exe

TP-00495 V3 page 28 of 42

Installing HosPOC Update Tool Version 10.0, continued _____________________________________________

5. Confirm the default installation path of the application and then click the installation button.

6. Click Continue.

7. Allow the installation process to complete; then, click Ok on the following screen.

8. The HosPOC Update Tool v 10.0 can now be located in the Start menu of your computer.


TP-00495 V3page 29 of 42

Installing the Roche HBU/BU Control Panel Version 03.00.01 Firmware and USB Drivers ______________

Only devices intended for use in the United States can be upgraded.

1. Disconnect the Accu-Chek® Inform II Base Unit(s) or CoaguChek® XS Handheld Base Unit(s)connected via USB from the computer on which the Roche HBU/BU Control Panel v 03.00.01firmware and USB drivers will be installed.

n Roche HBU/BU Control Panel version 03.00.01 firmware and USB drivers will not install properly if Accu-Chek Inform II Base Unit(s) or CoaguChek XS Handheld Base Unit(s)remain connected via USB to the computer.

2. Using your computer, access the download location for the required files or insert the local massstorage device provided to you by Roche Diagnostics to perform the firmware upgrade on yourAccu-Chek Inform II, CoaguChek XS Plus, and CoaguChek XS Pro meter(s).

3. Open the Roche HBU-BU Control Panel v 03.00.01 folder located in your download location ormedia.

4. Double click the ROCHE HBU-BU USB Install (03-00-01) file.

n In order to install the application, you must be logged in as an Administrator for the PC on which the Roche HBU/BU Control Panel version 03.00.01 and USB drivers will be installed.

n If the User Account Control prompt displays, click Yes to proceed with the installation.

5. Click Next.


TP-00495 V3 page 30 of 42

Installing the Roche HBU/BU Control Panel Version 03.00.01 Firmware and USB Drivers, continued ____

6. Review and accept the terms of the License Agreement and click Next.

7. Click Next.

n The Destination Folder can remain as the default folder listed unless otherwise instructed by your IT department.


TP-00495 V3page 31 of 42


8. Click Install.

n For RALS™ Notebook or RALS Web3 customers, keep the default settings for the Preferences section.

n For cobas IT 1000 customers, enter the IP address or host name for your cobas IT 1000 server in the DMS IP-address/host name field and the port number (Default port = 3333) in the DMS port number field.

9. Allow the installation program to complete; then, click Next when prompted.


TP-00495 V3 page 32 of 42


10. Depending on your computer system, a reboot may be required. If so, click Finish and allow thecomputer to reboot.

If a reboot is not required, click Finish.

11. Reconnect any Accu-Chek® Inform II Base Unit(s) or CoaguChek® XS Handheld Base Unit(s)previously connected to your computer via USB connection. The Roche HBU/BU Control Panel isnow installed and the icon can be located in the System Tray of your Desktop.


TP-00495 V3page 33 of 42

Performing Accu-Chek® Inform II Meter Firmware Upgrades with HosPOC Update Tool Version 10.0 ____

1. Ensure HosPOC Update Tool v 10.0 and Roche HBU/BU Control Panel v 03.00.01 firmware andUSB drivers are installed on the computer.

For assistance:

For assistance installing the HosPOC Update Tool version 10.0, refer to the Installing HosPOC Update Tool Version 10.0 instructions on pages 27-28 of this Software Bulletin. Contact Roche Technical Support via email at [email protected] or via phone at 1-800-440-3638 if additional firmware upgrade assistance is needed.

For assistance installing the Roche HBU/BU Control Panel version 03.00.01 firmware and USB drivers, refer to the Installing Roche HBU/BU Control Panel Version 03.00.01 Firmware and USB Drivers instructions on pages 29-32 of this Software Bulletin. Contact Roche Technical Support via email at [email protected] or via phone at 1-800-440-3638 if additional firmware upgrade assistance is needed.

2. Using your computer, access the download location for the required files or insert the local massstorage device provided to you by Roche Diagnostics to perform the firmware upgrade on yourAccu-Chek Inform II meter(s).

3. Start the HosPOC Update Tool version 10.0 firmware.

4. Select the appropriate instrument to update by clicking the Instrument Selection device button;then, selecting the appropriate meter, communication device, and COM port.

The CoaguChek® Pro II and cobas h 232 shown in the image above are not approved for use in the United States.


mailto:[email protected]


TP-00495 V3 page 34 of 42

Performing Accu-Chek® Inform II Meter Firmware Upgrades with HosPOC Update Tool Version 10.0, continued ______________________________________________________________________________________

For assistance:

The COM port for the USB-connected base can be identified in the Roche HBU/BU Control Panel firmware. With the Accu-Chek Inform II Base Unit in USB mode (configuration switch in position 3), the COM port should be listed along with the Accu-Chek Inform II Base Unit serial number and a mode of “POCT1-A.” Contact Roche Technical Support via email at [email protected] or via phone at 1-800-440-3638 for assistance determining the COM port. COM ports are assigned by the computer and may not reflect the same COM port as depicted in the images contained in this Software Bulletin.

n Only devices intended for use in the US can be upgraded.

5. Confirm selection by clicking the check mark .


6. Click Update Instrument Firmware.



TP-00495 V3page 35 of 42


7. Click on the Open File button ; then, select the appropriate compressed (zipped) devicefirmware update file for the new firmware version by navigating to the file storage location and clickOpen.

8. Once the appropriate update file has been selected and accepted by the HosPOC Update Tool, clickOk; then, click Start.

9. The HosPOC Update Tool will give prompts to dock and re-dock the device as it validates thecurrent firmware version, uploads the desired update file, and validates the successful upgrade to thedesired firmware version.

n Ensure that the device has ≥ 40% battery charge before starting the upgrade process.

n Follow the prompts as directed by the tool. Do not disturb the device while it goes through the upgrade process unless prompted.

10. Once the HosPOC Update Tool has validated the success of the firmware upgrade, perform QCtesting.

11. Go to the Diagnostics section under Main Menu 2 to verify that the updated firmware version islisted.


TP-00495 V3 page 36 of 42


12. Repeat steps 7-11 for additional firmware versions or to upgrade additional meters.

13. Once the available meters have been upgraded, click Exit .

14. Click Close to exit the program.


TP-00495 V3page 37 of 42

Performing CoaguChek® Plus and CoaguChek Pro Meter Firmware Upgrades with HosPOC Update Tool Version 10.0 ____________________________________________________________________________________

Only devices intended for use in the United States can be upgraded.

1. Ensure HosPOC Update Tool v 10.0 and Roche HBU/BU Control Panel v 03.00.01 firmware andUSB drivers are installed on the computer.

For assistance:

For assistance installing the HosPOC Update Tool version 10.0, refer to the Installing the HosPOC Update Tool Version 10.0 instructions on pages 27-28 of this Software Bulletin. Contact Roche Technical Support via email at [email protected] or via phone at 1-800-428-4674 if additional firmware upgrade assistance is needed.

For assistance installing the Roche HBU/BU Control Panel Version 03.00.01 firmware and USB drivers, refer to the Installing the Roche HBU/BU Control Panel Version 03.00.01 Firmware and USB Drivers instruction on pages 29-32 of this Software Bulletin. Contact Roche Technical Support via email at [email protected] or via phone at 1-800-428-4674 if additional firmware upgrade assistance is needed.

2. Using your computer, access the download location for the required files or insert the local massstorage device provided by Roche Diagnostics to perform the firmware upgrade on your CoaguChekPlus and CoaguChek Pro meter(s).

3. Start HosPOC Update Tool v 10.0 firmware.

4. Select the appropriate instrument to update by clicking the Instrument Selection device button;then, selecting the appropriate meter, communication device, and COM port.





TP-00495 V3 page 38 of 42

.

Performing CoaguChek® Plus and CoaguChek Pro Meter Firmware Upgrades with HosPOC Update Tool Version 10.0, continued __________________________________________________________________________

For assistance:

The COM port for the USB-connected base can be identified in the Roche HBU/BU Control Panel firmware. With the CoaguChek XS Handheld Base Unit in Serial mode (configuration switch in position 2), the COM port should be listed along with the CoaguChek XS Handheld Base Unit serial number and a mode of “Serial.” Contact Roche Technical Support via email at [email protected] or via phone at 1-800-440-3638 for assistance determining the COM port if needed. COM ports are assigned by the computer and may not reflect the same COM port as depicted in the images contained in this Software Bulletin.

5. Confirm selection by clicking .


6. Click Update Instrument Firmware.



TP-00495 V3page 39 of 42


7. Click on the Open File button ; then, select the appropriate compressed (zipped) devicefirmware update file for the new firmware version by navigating to the file storage location and clickOpen.

n Depending on the data of manufacture, your meter may have one of two hardware versions, “Hardware Version 34” or “Hardware Version 35.” The availability of the two hardware versions is due to manufacturing changes and does not affect the functionality of the device.

To determine which hardware version to select for the firmware update file, select a desired firmware update file from the “Hardware Version 34” folder. If the file is incompatible, the HosPOC Update Tool will display an error message indicating that the firmware update file was not compatible with the device. If this happens, select “Ok” and proceed to the firmware update file for “Hardware Version 35.” Contact Roche Technical Support via email at [email protected] or via phone at 1-800-428-4674 for further upgrade assistance.



TP-00495 V3 page 40 of 42


8. Once the appropriate update file has been selected and accepted by the HocPOC Update Tool, clickOk; then, click Start.

9. The HosPOC Update Tool will give prompts to dock and re-dock the device as it validates thecurrent firmware version, uploads the desired update file, and validates the successful upgrade to thedesired firmware version.

n The computer mode should be “Inactive” in order to perform firmware upgrade on device. Contact Roche Technical Support via email at [email protected] or via phone at 1-800-428-4674 for additional firmware upgrade assistance if needed.

n Ensure that the device has ≥ 15% battery charge in order to undergo the upgrade process.

n Follow the prompts as directed by the tool. Do not disturb the device while it goes through the upgrade process unless prompted.



TP-00495 V3page 41 of 42


10. Once the firmware update file has been uploaded to the meter, the HosPOC Update Tool will give aprompt to power the meter off; then, back on. This is necessary for the meter to process the updatefile. A Firmware Update progress bar will display to indicate the process of the firmware upgrade.

11. Power the meter off and back on to confirm the updated firmware version on the INIT screen.

12. Once the HosPOC Update Tool has validated the success of the firmware upgrade, perform QCtesting.

13. Repeat Steps 7-12 for additional firmware versions or to upgrade additional meters.

14. Once the available meters have been upgraded, click Exit .

15. Click Close to exit the program.


TP-00495 V3 page 42 of 42

Actions Required ________________________________________________________________________________

• Consider implementing the Suggested Customer Actions as described in Analyzer Bulletin TP-00355.• Determine your facility’s need to update meters and base units to address cyber security

vulnerabilities.• Obtain the new firmware following the instructions outlined in this Software Bulletin.• Discard any previous versions of this Softare Bulletin.• File this Software Bulletin for future reference.

Questions ______________________________________________________________________________________

Please contact Roche Technical Support via email at [email protected] or at the following telephone numbers if you have questions about the information contained in this Software Bulletin.

Product Catalog Number Support Number

Accu-Chek® Inform II meter 05060311001

1-800-440-3638Accu-Chek Inform II meter with RF card 05060303001

Accu-Chek Inform II Base Unit (BU) 05060290001

Accu-Chek Inform II Base Unit Hub (BUH) 05888760001

CoaguChek® XS Plus Meter Care Kit 05021537001

1-800-428-4674CoaguChek XS Pro Meter Kit 05530199160

Handheld Base Unit (HBU) for CoaguChek XS Pro and CoaguChek XS Plus systems

04805658160

ACCU-CHEK, ACCU-CHEK INFORM, COAGUCHEK, COBAS, and COBAS H are trademarks of Roche.RALS is a trademark of Abbott.All other product names and trademarks are the property of their respective owners.


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