Bosch Vivalytic Instructions For Use Manual Download Page 24

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Instructions for use

Appendix

Value/

abbreviations

Description

Value/

abbreviations

Description

DHCP

Dynamic host configuration

protocol

LAN

Local area network

DMC

Data matrix code

LIS

Laboratory information system

EEE

Electric and electronic

equipment

NRTL

Nationally Recognized Test

Laboratory

European Union

PCR

Polymerase chain reaction

FAT

File allocation table

PDF

Portable document format

FCC ID

Federal Communications

Commisions ID

SSID

Service Set ID

FSC

Forest Stewardship Council

µl

Microlitre

HIS

Hospital information system

URL

Uniform ressource locator

Idendity/ Identifier

USB

Universal serial bus

Internet protocol

WEEE

Waste of electric and electronic

equipment

IVD

In vitro diagnostic

WLAN

Wireless local area network

10 Appendix

10.1 Electromagnetic compatibility

Hereby, Bosch Healthcare Solutions GmbH declares that the radio equipment type Vivalytic one is in compliance with

Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following Internet address:

www.bosch-vivalytic.com

10.2 Licence terms of end users

Please refer to www.bosch-vivalytic.com for more information about the Licence terms of end users.

11 Manufacturer

Bosch Healthcare Solutions GmbH

Stuttgarter Strasse 130

71332 Waiblingen

GERMANY

www.bosch-vivalytic.com

Made in Germany

Summary of Contents for Vivalytic

Page 1: ...Instructions for use ...

Page 2: ...est 1 Scan sample code 2 Scan cartridge code 3 Insert the sample and close cartridge lid 4 Insert cartridge The test starts automatically How to exchange the air filter 1 Shutdown turn off and unplug 2 Turn over 3 Remove used air filter 4 Insert new air filter Carefully read instructions for use The user must consult and follow the instructions for use before using Vivalytic ...

Page 3: ...scratch 2 Lid 3 Sample input 4 Cartridge code 5 Sample volume 6 Expiry date 7 Test description Overview of the icons Symbol Function Symbol Function ena Pfeil links Einen Schritt zurück enabled Bearbeiten ena Pfeil rechts Einen Schritt vor Löschen Hinzufügen enabled Suche Fenster zur Eingabe der Suchkriterien öffnen ena Schließen abbrechen enabled Exportieren Überprüfe Hinweise nabled Drucken Nutz...

Page 4: ...verything is running well ID 342 346 23 1 Progress bar 2 Test status information 3 Remaining test time 4 Sample data 5 Cancel test run 6 Test description 7 More detailed information Analyser result overview screen Result saved and submitted Cartridge is ready to eject ID 342 485 58 TEST NAME FINISH Test valid Target 1 Target 2 Target 3 DETAILS 1 Menu 2 Status 3 Information about valid invalid test...

Page 5: ...ata management and export 13 5 Menu 13 5 1 Device settings 14 5 2 User accounts and passcode 14 5 3 Network configuration 14 5 4 Configuration of order result interface HIS LIS 15 5 5 Configuration of data export to USB or network drive 16 5 6 Printer configuration 16 5 7 Software update 17 5 8 Factory reset 17 5 9 System information 17 6 Maintenance and troubleshooting 17 6 1 Shutting down the an...

Page 6: ...The test then runs automatically and the results are presented to you at the end These instructions for use together with the application specific instructions for use that come with each test will provide all the information needed to set up the system and perform a test Please consider the following notes before using Vivalytic Only operate Vivalytic if you are a healthcare professional and trai...

Page 7: ...pen the door of the analyser slot manually Do not use under conditions with high humidity extreme temperatures direct sun radiation or high exposure to dust see chapter 8 1 4 Data security information Bosch privacy statement This product stores measurement data as well as user and patient information WARNING Data protection is under the responsibility of the organisation using Vivalytic Make sure ...

Page 8: ... wait until onboarding starts automatically The analyser is for indoor use only Make sure that the power switch is accessible Make sure to leave sufficient space for adequate air circulation Do not grab or touch the scanner of the analyser 2 2 Setting up the software onboarding When you start the analyser for the first time you will be guided through a setup procedure Please follow the instruction...

Page 9: ...f user account Administrator Professional Edit own account Perform a test Manage and print measurement data Change display brightness Change language date and time Edit or reset passcode for other accounts Add delete and activate deactivate other accounts Enable disable passcode protection Configure network Configure order result interface HIS LIS Set export configuration Install and configure pri...

Page 10: ...yser please make sure you have read and understood the application specific instructions for use for the test you want to perform 3 2 Login If passcode protection is enabled the analyser requires authentication before a test can be started Welcome to Vivalytic Who are you User 2 User 3 User 1 Pro fess ional A dmi ni str ator Pro fessio nal The welcome screen opens automatically when you turn on th...

Page 11: ...nnected to an HIS LIS Alternatively enter sample data manually Scanning the cartridge Place the cartridge code DMC underneath the scanner A white light beam with a red dot indicates that scanning is in progress The test description and further data will be displayed on the screen When scanning the cartridge the analyser will check the expiry date of the cartridge It will only accept cartridges tha...

Page 12: ...the direction shown by the arrow The cartridge is drawn in and the test starts automatically Make sure to insert the same cartridge as scanned to avoid a mix up WARNING Do not try to block the door of the analyser slot Do not reach into the analyser slot 3 4 While running a test S M H 01 16 51 TEST NAME Detection Everything is running well ID 342 346 23 During a test the following information will...

Page 13: ...s please refer to the application specific instructions for use enabled Export a specific test to save the test report in PDF format enabled Print a test report of a specific test run The test report summarises the sample and test description the results and illustrations of the test run the user who started the test and information about the analyser and the cartridge enabled The results should n...

Page 14: ... run can be printed and exported see also chapter 3 5 enabled Search for jobs enabled Export all test data by pressing export on the joblist screen to save the test reports To configure export location see chapter 5 5 enabled Delete data Before deleting the data make sure that all test runs are exported WARNING Deletion of data is permanent Data cannot be recovered afterwards make sure that all te...

Page 15: ...t the type of account Administrator Professional Afterwards type in a username and a numeric passcode enabled Enable or disable passcode protection for professional accounts Only an administrator user can edit activate deactivate or delete the account of another user Professional users can only edit their own account At least one administrator account must exist When passcode protection is enabled...

Page 16: ...ng components manually Internet protocol address IP address Subnet mask Gateway Follow the instructions displayed on the screen If necessary a proxy can be configured To view the current configuration select show network configuration 5 4 Configuration of order result interface HIS LIS The analyser exchanges information with hospital and laboratory information systems HIS LIS if connected It recei...

Page 17: ...instructions displayed on the screen To view the current configuration select show export configuration 5 6 Printer configuration Log in as an administrator for access enabled In the menu select settings then select printer configuration To configure an existing printer as standard printer Select configure printer A list of configured printers will be displayed To set a standard printer mark it in...

Page 18: ... find more information about customer service Hardware revision Software revision Kernel revision Firmware revision IP address Select Open Source Software OSS to find information about the Open Source components used in this product Select OSS Written Offer to find how you can obtain the Open Source components you are entitled to Select Oracle Java Software to find information about license terms ...

Page 19: ...plug all connections on the back Grasp the analyser with both hands and turn it over its rearmost corner until it is resting on its back Open the flap on the analyser bottom and remove the used air filter Insert a new air filter into the flap with the soft surface side facing towards the interior of the analyser Afterwards close the flap 6 4 Quality control testing It is strongly recommended to pe...

Page 20: ...yser is capturing the sample code and check the distance between the scanner and the sample code Vary the distance between code and scanner hold the code closer and further away Check if the scanner is blocked or dirty If necessary clean it as described in chapter 6 2 The red light has to shine on the code Make sure the code is not damaged Make sure to use a sample with a code If it cannot be read...

Page 21: ...nter is switched on and available Check the USB connection in case of an USB printer Check if the printer and its connection is established and available in case of network or shared printer Communication test is negative for order result or export configuration Check the settings of the export or order result interface configuration and go to the troubleshooting points of network connection failu...

Page 22: ...talogue number F 09G 300 115 Weight 15 kg Display 7 inch 16 10 1024 x 600 pixel touchscreen Storage humidity 20 95 not condensing Operating air pressure range 850 1 100 hPa corresponds to 0 1 400 m above sea level Operating humidity 30 80 not condensing Operating temperature 15 30 C Electrical data 100 240 V 50 60 Hz 160 VA Storage temperature 20 60 C Instrumental safety IEC EN 61010 1 IEC EN 6101...

Page 23: ...Do not use if package is damaged WEEE separate collection for EEE Use by date YYYY MM DD Date of manufacture YYYY MM DD This way up Do no re use Contains sufficient for n tests Fragile handle with care Fuse Ethernet Liquid sample USB On Off Der Grüne Punkt Bluetooth compatible The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG Inc and any use of such marks by Bo...

Page 24: ... URL Uniform ressource locator ID Idendity Identifier USB Universal serial bus IP Internet protocol WEEE Waste of electric and electronic equipment IVD In vitro diagnostic WLAN Wireless local area network 10 Appendix 10 1 Electromagnetic compatibility Hereby Bosch Healthcare Solutions GmbH declares that the radio equipment type Vivalytic one is in compliance with Directive 2014 53 EU The full text...

Page 25: ...h Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany F 09G 300 066 Revision_04 Latest change 2020 05 29 ...

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