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© Bosch Healthcare Solutions GmbH

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Instructions for use

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6.3.1  QC Tester qualification

For the tester qualification, you have to meet the following criteria:
•  Over 18 years of age.
•  No ongoing cold or known airway disease.
•  Non-smoker.
•  Expected stable FeNO values below 50 ppb. 

To qualify as tester, you must complete the following steps:
•  Perform 4 measurements within 7 days, not more than one qualification measurement per day.
•  The QC-measurement on the fourth day must be within accepted range of 5 ppb ± 3 x standarddeviation,  at least ± 3 ppb 

from the mean value.

The moving mean value is recalculated when the QC tester performs a new QC-measurement within  

7 days.
The qualification of a QC tester expires after 30 days. Then the qualification is suspended and the  

QC tester needs to qualify again, according to the qualification procedure.

Summary of Contents for vivatmo pro

Page 1: ...Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany F09G100512_04 Latest change draft Instructions for use ...

Page 2: ...Oxycap ...

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Page 4: ...e contents 6 1 2 Before using Vivatmo pro 7 1 3 Safety information 8 1 4 Intended use Indications for use 10 2 System elements 11 2 1 Screen elements 12 2 2 Handheld elements 14 2 3 Disposable mouthpiece 15 2 4 Handheld display 16 3 Installation 18 3 1 Installing the handheld 18 3 2 Installing the basestation 19 3 2 1 User concept 19 3 2 2 Onboarding 20 ...

Page 5: ...tion 26 4 2 Measurement stand alone with the handheld 30 5 Manage 33 5 1 Patient records 33 5 2 List of measurements 37 5 3 List of measurement orders 37 6 Settings 38 6 1 General settings 38 6 2 Ambient NO 39 6 3 Quality control QC 40 6 3 1 QC Tester qualification 41 6 3 2 Performing QC 43 6 4 System information 45 6 5 Administrator settings 46 6 5 1 Device settings 46 ...

Page 6: ...Assigning the handheld 52 6 5 5 Release the handheld 54 6 5 6 Network configuration 55 6 5 7 Order result interface 60 6 5 8 Export and Backup file configuration 62 6 5 9 Vivasuite configuration 63 6 6 User administration 65 6 7 Data backup 68 7 Maintenance and trouble shooting 68 7 1 Maintenance 68 7 2 Status information handheld 69 7 3 Reconditioning 70 7 4 Remote Software Update 71 ...

Page 7: ... Trouble shooting handheld 73 8 Disposal 75 8 1 Disposing the Vivatmo pro device and the battery 75 8 2 Disposing the mouthpiece 75 9 Technical data 76 9 1 Device data 76 9 2 Device Performance 79 9 3 Symbols 80 9 4 Warranty 81 10 Manufacturer 82 11 Appendix 82 11 1 Electromagnetic compatibility 82 11 2 Compliant cables 84 11 3 Literature 84 11 4 License Terms for End Users 85 ...

Page 8: ...lish English English English English 1 Initial information 1 1 Package contents Vivatmo pro basestation Handheld device Instructions for use Power supply unit with connectors 1 rechargeable lithium ion battery Keep these Instructions for use For frequently used functions see chapter 3 4 5 7 and 8 ...

Page 9: ...eld the disposable mouthpiece and the mouthpiece pouch before use If you notice any damage do not use the device or accessories WARNING Do not use any defective devices or accessories to avoid malfunction or hazardous situations If you need any support or have additional questions including information about data privacy please contact your distribution partner or visit the Bosch Vivatmo website a...

Page 10: ... range smoke or tobacco consumption Adjacent or stacked use close to other systems If adjacent or stacked use is necessary observe normal operation of the Vivatmo pro Use of mobile phones and other devices even if compliant with CISPR emission requirements Ingress of moisture or liquid Immerse the device or disposable mouthpiece into water or other liquids More than 10 hours nonstop usage with a f...

Page 11: ...nal network isolator certified to EN 60601 1 Modifications of the system can lead to endangerments and result in the warranty becoming invalid Data security and protection Vivatmo pro shall not be used in unprotected networks or work environments Data protection is under the responsibility of the organization using Vivatmo pro and can be supported by the use of credentials on your network When con...

Page 12: ...ment of FeNO by Vivatmo pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti inflammatory pharmacological therapy as an indication of therapeutic effect in pa tients with elevated FeNO levels FeNO measurements are to be used as an adjunct to established clinical assessments Vivatmo pro is suitable for children approximately 7 ...

Page 13: ...e System elements English English English English English English English 2 System elements Basestation frontside 1 Handheld 2 Charging cradle 3 On Off button 4 Touchscreen Basestation backside 1 Ethernet port 2 USB ports 3 Power adapter port 1 1 4 2 3 2 3 ...

Page 14: ...rement orders from electronic patient record system 2 Manage patients measurements and orders 3 Charging status handheld battery 4 Handheld 4 C O N T I N U E connected 4 C O N T I N U E disconnected 5 Start measurement 6 Settings menu logout You see the basestation homescreen when the installation is complete see 3 Installation Screen elements Element Function Element Function Help Opens the Help ...

Page 15: ...comment to the current patient data file 4 I N U E Add new user patient Opens the screen for the data input of a new user patient Search Opens a window for entering search criteria 4 C O N T I N U E Pencil Opens the current data file for editing 1 8 PPB 07 04 2016 11 43 P AT I E N T R E C O R D QC QC Quality Control QC status Shows the QC status 4 C O N T I N U E Export Exports the current data fi...

Page 16: ...ate and deactivate the device ENTER button Press this button to start the regeneration or to confirm selection ARROW buttons Press these buttons to change the settings and to access stored measuring data Breath intensity display Feedback during the measurement Yellow Caution the breath intensity is too weak Blue The breath intensity is right Red Warning the breath intensity is too strong Procedure...

Page 17: ... disposable mouthpiece is needed Regular disposable mouthpiece Oxycap The regular Vivatmo pro disposable mouthpiece must be attached for performing all measurements except of QC Level 0 measurements as described below The outside of the regular disposable mouthpiece is transparent The disposable mouthpiece chemically prepares the test sample Human breath is cleaned from contaminants and stabilized...

Page 18: ...1 9 2 3 4 5 6 7 8 1 Measured value 2 Concentration of nitric oxide NO in exhaled breath in ppb parts per billion 3 Invalid disposable mouthpiece Use a new disposable mouth piece 4 Attach disposable mouthpiece 5 Measurement procedure incorrect 6 Measuring ID 7 Time and date of the stored measurement result 8 Device busy 9 Device ready for measurement ...

Page 19: ... handheld is connected to the Vivatmo pro basestation The icon disappears when the Vivatmo pro handheld is used as a stand alone device without the Vivatmo pro basestation The audio sound is activated The icon appears when audio sound is activated Battery icon displayed The battery charge is low Recharge the handheld device as soon as possible Battery icon blinking The battery charge is too low to...

Page 20: ...wo fingers and insert the rechargeable battery into the battery compartment Mind the triangle marks on the battery and inside the battery compartment 3 Apply the battery cover 4 Remove protective cap and place the handheld on the basestation cradle for charging Charge before first use The recharging time for a completely exhausted battery is about 12 hours As long as the LED is blinking blue the h...

Page 21: ...in compliance with the national or local regulations for battery disposal see 8 1 Disposing the Vivatmo pro device and the battery 3 2 Installing the basestation 3 2 1 User concept User accounts protect your patient data by access control to the system When the user management is activated the access is protected by the user name and a numeric passcode You can use Vivatmo pro also when the user ma...

Page 22: ...Configure network see 6 5 6 Network configuration Configure HL7 or GDT interfaces see 6 5 7 Order result interface Manage user accounts see 6 6 User administration 3 2 2 Onboarding WARNING Only use the Vivatmo pro basestation with the provided low voltage power supply unit Attempted use with other power sources may cause irreparable damage and invalidate the warranty Avoid connection of the Vivatm...

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Page 24: ...unt to use Vivatmo pro Remember this access code carefully The reset of the administrator account can only be done by service personnel US ER ACCOUNT S Maintain a high security standard and raise comfort by enabling individual user accounts on your device Note you can always add users later N O T N O W E N A B L E 4 User administration 1 Select ENABLE to activate the user administration 2 Create a...

Page 25: ... When you select the NOT NOW button the user identification will be deactivated Language Vivatmo pro 1234567890 Vivatmo pro 0987654321 Handheld S C A N F O R H A N D H E L D S NAME MAC ADDRESS Assign handheld 1 Select the CONTINUE button to set up and install the handheld To assign the handheld press SCAN FOR HANDHELDS For details see 6 5 4 Assigning the handheld 2 On the screen select the FINISH ...

Page 26: ...unt from the user list F O R G O T Oona Pakarinen Kattilakoski Profe ssional Hi Jouko Kinnunen please enter your passcode 1 2 3 4 5 6 7 8 0 9 2 Enter your passcode Professionals use a 4 digit passcode administrators an 8 digit passcode If you forgot your passcode see 7 5 1 Wrong or forgotten passcode O O P AT I E N T S A N D R E S U LT S S TA R T N E W M E A S U R E M E N T M A N A G E M E A S U R...

Page 27: ... flames for example gas range smoke or from tobacco consumption Disposable mouthpiece shall be handled with care for correct measurement results Use only disposable mouthpieces approved for this device and from intact and unopened pouches that are not expired See the expiration date on the pouch Store in outer package Do not clean the disposable mouthpiece Take care to use regular disposable mouth...

Page 28: ...andheld is switched on and connected to the basestation the bluetooth symbol on the handheld finished blinking the handheld connected icon is shown 2 On the Home screen select the MEASURE button New measurement Release handheld from basestation and firmly attach a new mouthpiece 3 On the handheld display the Disposable mouthpiece icon flickers Open the pouch and attach the disposable mouthpiece fi...

Page 29: ...IZATION screen select the button for the visualization you want to use either the fish or the scale The visualization helps the patient to control the strength of the breath during the measurement On the lower part of the screen you can observe the handheld regenerating and preparing the measurement Exhale 10s 5 When the preparation process is finished you have to start the measurement within 60 s...

Page 30: ... mouthpiece like blowing into a recorder or cooling a hot drink The breath control visualization helps the patient to stay within the dotted lines for the entire duration On the display you see the remaining time to the end of the measurement Having performed the measurement the Result screen opens 18 PPB The measurement was successful Please remove the mouthpiece Inhalation through the disposable...

Page 31: ...the ASSIGN TO PATIENT button The patient list is opened 2 Select the dedicated patient from the list 3 Measurements assigned to a patient can be unassigned by the UNASSIGN button Failed measurement MEASUREMENT FAILED Please wait until the clock symbol on the handheld display has disappeared Then press the Enter button to start a new measurement In case your measurement failed the MEASUREMENT FAILE...

Page 32: ...mo pro handheld in the cradle of the Vivatmo pro basestation 1 Use the ON OFF button to activate your Vivatmo pro handheld You see all screen icons and the system performs a brief self test Then the software version installed on the handheld is shown shortly After the self test the handheld shows the audio icon on the handheld is activated the bluetooth connection is not activated The Bluetooth ic...

Page 33: ...ift the handheld to your mouth pro 7 Exhale softly through the disposable mouthpiece like cooling a hot drink while observing the LED side of the handheld The color of the LED provides feedback on the correct breathing strength yellow caution too weak blue correct red warning too strong Successful measurement The LED flashes blue and the result appears on the display All results are automatically ...

Page 34: ... 3 B The measurement failed because the start was not performed within 60 seconds after the regeneration Repeat the measurement see 4 2 Measurement stand alone with the handheld start at point 4 Displaying stored measured values Your Vivatmo pro handheld automatically stores up to 1 000 measured FeNO values identified by time date and measuring ID The measured values are stored in descending order...

Page 35: ...nnected to the basestation 5 1 Patient records Manage PID 123123123 Joel Linnasalo 1976 09 20 PID 123456789 Yue Ying Lung 2001 02 21 ADD NEW PATIENT PATIENT S MEASUREMENT S ORDERS On the Manage screen select the PATIENTS tab In the PATIENTS tab you can perform the following View patient file and start new measurement see Viewing patient file Add new patients see Adding patients Search patients see...

Page 36: ...C see 6 3 Quality control QC 3 Select NEW MEASUREMENT to perform a measurement with the patient see 4 1 Measurement using the basestation 4 Select the Arrow to leave the patient file Adding patients Patient ID Enter ID Add Patient 1 6 Z X C V B N M 1 2 3 Done A S D F G H J K L W E R T Y U I O P Q 1 On the PATIENTS tab select ADD NEW PATIENT The Add Patients screen opens Entering a alphanumeric pat...

Page 37: ...nder S A V E Paula Hendrikson 1967 12 08 Female 5 Confirm all entries with SAVE Searching patients Search for Nikol Browse Patients Z X C V B N M 1 2 3 Done A S D F G H J K L W E R T Y U I O P Q 1 On the PATIENTS tab select the Search button The Browse screen opens 2 Enter name or patient ID 3 Confirm with DONE A list opens that shows all patients that correspond to your search criteria ...

Page 38: ...55 Joel Linnasalo 1976 09 20 PID 123123123 N E W M E A S U R E M E N T ME A SUREMENT S GR APH 1 In the patient list select the patient you want to edit The Patient File screen opens 2 Select the Pencil button to edit the patient data 3 Follow the wizard step by step to edit the data Deleting patients 1 In the patient list select the Delete button You are asked to confirm before a patient file is d...

Page 39: ... the pages using the arrow buttons bottom right 3 If you perform a measurement without having selected a patient you can select a measurement result and assign the result to a patient see page 29 5 3 List of measurement orders Nikola Matějková 1987 11 07 PID 123456788 Manage PATIENT S MEASUREMENT S ORDERS PID 123123123 Joel Linnasalo 1976 09 20 Yue Ying Lung 2001 02 21 PID 123456789 1 On the Manag...

Page 40: ...t P AT I E N T S A N D R E S U LT S S TA R T N E W M E A S U R E M E N T M A N A G E M A N A G E Welcome to Vivatmo pro Jouko Kinnunen AMBIENT N O GENERAL PERFORM QC INFORMATION ADMINIS TRATION LOGOUT 1 On the Home screen select the Settings menu 6 1 General settings Setting the display Language Display General 1 Select General Settings to change display settings Select Display 2 Select the point ...

Page 41: ...MENT screen opens 2 Turn on the handheld 3 Attach a new mouthpiece see 4 1 Measurement using the basestation Please leave handheld in one place during measurement Ambient Measurement last measurement 2018 03 12 07 02 4 Lay down the handheld in a way that the device has good access to the ambient air 5 Select the RUN MEASUREMENT button On the screen you see that the ambient NO measurement is runnin...

Page 42: ...for the QC are done only by administrators 6 5 2 Quality Control QC settings Vivatmo pro supports QC for 2 reference concentrations Level 0 Level 0 is performed with a specific white Level 0 disposable mouthpiece see 2 3 Disposable mouthpiece A comparative test is performed for a concentration below 5 ppb which is below the detection limit Defined NO with QC tester The comparative test is performe...

Page 43: ...y as tester you must complete the following steps Perform 4 measurements within 7 days not more than one qualification measurement per day The QC measurement on the fourth day must be within accepted range of 5 ppb 3 x standarddeviation at least 3 ppb from the mean value The moving mean value is recalculated when the QC tester performs a new QC measurement within 7 days The qualification of a QC t...

Page 44: ... opens and the actual user is highlighted and can be selected 2 Select the QUALIFY button Passed 2016 04 07 11 43 Passed 2015 10 07 13 16 Jeppe M Gregersendan Expired N A Q U A L I F Y QC Measurements 3 Perform a regular measurement After the measurement the result can be Qualify Status during first 3 measurements of QC tester qualification Passed Result is within acceptance range of the mean of t...

Page 45: ...formed first with Level 0 and then with defined NO with QC tester or with the selected reference QC measurement only Start QC measurement Language QC Tester Konsta Haapakoski Professional Qualified Oona Pakarinen Kattilakoski Professional Jeppe M Gregersendan Administrator Qualified 1 In the Settings menu select PERFORM QC The QC Tester screen opens only if QC tester is activated In the list you s...

Page 46: ...ld device from the basestation and attach a Level 0 mouthpiece C O N T I N U E Level 0 Measurement 0 PPB The measurement was successful Last measurement 2018 03 12 07 02 3 Perform the measurement see 4 1 Measurement using the basestation When the result is 0 ppb the Level 0 QC test was successful If the result is 5 ppb or higher the Level 0 QC test failed Repeat the measurement and take care to us...

Page 47: ...asurement using the basestation When the result is in the acceptance range of the QC testers mean the QC test is passed The QC test is passed when all reference measurements defined in the QC settings are successfully peformed 6 4 System information Language Hardware Revision Rev 1 0 1 Software Revision Rev 2541 Kernel Version 4 4 38 Firmware Version 1 1 25 Open Source Software System Information ...

Page 48: ...nistration Data Backup Administration settings are activated only if you are logged in as administrator 1 Log in as administrator 2 In the Settings menu select ADMINISTRATION 6 5 1 Device settings Language Language Date and Time Auto Lock Factory Reset Device Settings 1 On the Administration screen select Device Settings The Device Settings screen opens for changing Language Date and Time Auto Loc...

Page 49: ...age 1 On the Device Settings screen select Language 2 Select the desired language Setting date and time The time format is dd mm yyyy hh mm 0 24 h Date and Time 1 2 M M Y Y Y Y M M H H D o n e 1 2 3 4 5 6 7 8 9 0 1 On the Device Settings screen select Date and Time 2 Enter day month year and the time 3 Confirm with DONE 4 Select the CONTINUE button to confirm your settings ...

Page 50: ...g in again after an automatic lockoff You can set the interval according to the needs in the clinical environment 1 On the Device Settings screen select Auto Lock 2 Select and hold the blue point and move it to the desired Auto Lock time Factory reset Factory reset removes all stored measurements from the basestation and all data of patients and users Date and time are reset and no handheld will b...

Page 51: ...ow QC Configuration to display the current settings Select Status QC Configuration Quality Control off 2 Select Configure Quality Control 3 Select ON OFF to activate or deactivate the QC mode For further information see 6 3 Quality control QC 4 Select the Arrow Right button to move to the next screen Select Interval QC Configuration Daily Weekly Bi Weekly After x measurements 5 Select the interval...

Page 52: ...r on 7 After selecting the interval select the Arrow Right button Quality control is recommended with both Level 0 and QC Tester reference controls 8 Select activation or deactivation of this control methods QC Configuration on Status After x measurements Interval on Level 0 on QC Tester S A V E 9 Select the Arrow Right button to move to the next screen The QC Configuration screen opens with an ov...

Page 53: ...d 2 Select Add new printer Select Interface Printer Configuration USB Network Shared Done 3 Select the desired printer interface USB Network Shared Select the Right Arrow to move to the Select Printer screen Select Printer Printer Configuration HP 500 PCL HP 510 PCL HP 550 PCS Do ne Printing data is transmitted unencrypted 4 On the Select Printer screen select the desired printer 5 Select the Righ...

Page 54: ...onfirm with SAVE to save the printer configuration The list of printers is shown Elements in the list of printers 1 Mark a printer to select your standard printer 2 Select the Delete button to delete a printer from the list 3 Select the x button to close the list 6 5 4 Assigning the handheld Language Assign Handheld Network Order Result Interface Export Location Network Interfaces Vivasuite Config...

Page 55: ... is active you see the message No handhelds available 6 Compare the number of the Vivatmo pro handheld in the list with the serial number beneath the symbol on the handle of the handheld 7 From the list select the Vivatmo pro handheld which shall be installed with your Vivatmo pro basestation 8 The Configuring device screen opens The handheld and the basestation connect automatically The Vivatmo p...

Page 56: ...dheld button If you want dispose of the old handheld clear the memory and take out the battery 1 Keep the ENTER button and the Arrow right button pressed for 3 seconds The Clear memory icon is selected 2 Use the Arrow buttons to select the check mark 3 Press the ENTER button to confirm the clear memory An animation is shown while the Clear memory icon flashes 4 Press the ENTER button to return to ...

Page 57: ...er credentials shall be used in accordance with the local data security policies Data is transmitted unencrypted Language Networktype WLAN DHCP enabled SSID BHCS Securityprotocol WPA2 Password Network Details 1 On the Network Interfaces screen select Network 2 If a network access is configured already select Show Network Configuration The Network Details are Networktype WLAN or Ethernet DHCP Dynam...

Page 58: ...lect Networksetup Network Configuration Networktype Ethernet DHCP enabled Do ne 1 Plug in the ethernet cable in the ethernet port on the rear of the Vivatmo pro basestation 2 On the Network screen select Configure Network 3 Select the Networktype Ethernet in the drop down menu 4 Enable DHCP Network Configuration Ethernet Networktype enabled DHCP S A V E 5 Confirm with SAVE ...

Page 59: ...Configure Network 2 Select the Networktype WLAN 3 Enable DHCP 4 On the Set network SSID screen enter the name of the WLAN 5 Select the Right Arrow or the DONE button to leave the screen Select Securityprotocol Network Configuration WEP WPA WPA2 Done 6 Select the security protocol activated in your WLAN 7 Select the Right Arrow button to leave the screen 8 On the next screen enter the WLAN Password...

Page 60: ...t port of the basestation 2 On the Network screen select Configure Network Select Networksetup Network Configuration Networktype Ethernet DHCP enabled Done enabled disabled Select 3 Select the Networktype Ethernet 4 Disable DHCP IP Address Enter IP Network Configuration Done 1 2 3 4 5 6 7 8 9 0 5 Enter the IP Address of your network and the Subnet Mask of your network 6 Enter the Gateway ID 7 Sele...

Page 61: ...rityprotocol Password S A V E 8 Confirm with SAVE Manual WLAN configuration 1 On the Network screen select Configure Network The Network Configuration screen opens 2 Select the Networktype WLAN 3 Disable DHCP 4 Follow steps 4 to 8 of Supported installation of a WLAN connection 5 Follow step 5 to 8 of Manual ethernet configuration After a successful configuration the Network Configuration screen is...

Page 62: ...lt Interface Order Result Interface active Protocol GDT Credentials yes Done 1 On the Administration screen select Network Interface 2 On the Network and Interface screen select Order Result Interface You can select Configure Interface to change the settings Show Interface Configuration to display the current settings Select Configure Interface to change settings 3 Activate the Order Result Interf...

Page 63: ...W E R T Y U I O P Q 9 Enter the user name required to access the data from the EPR system 10 Confirm with DONE to move to the next screen 11 Enter the password required to access the data from the EPR system 12 Confirm with DONE Order Result Interface GDT Protocol smb example vivatmo inbox Inbox Location smb example vivatmo outbox Outbox Location active Order Result Interface Praxis admin 1 Userna...

Page 64: ...itted unencrpyted The backup file is stored encrypted and can be imported to the same basestation only For configuration follow the configuration wizard Language Configure Export Backupfile Show Configuration Export Backupfile Configuration 1 On the Administration screen select Network and Interfaces 2 On the Network and Interfaces screen select Location for Export Backup Select Export and Backup ...

Page 65: ... not available in all countries Ask your local distributor A registration to Vivasuite and pairing of your device is required Your device must be connected to an internet enabled network To connect Vivatmo pro to Vivasuite perform the following steps C O N N E C T N O W Connect your device to our connectivity solution and benefit from vauable add on services Registration is required to download th...

Page 66: ...res after 60 min PAIR DEVICE Z244 4 Vivasuite Click Add device 5 Vivasuite Enter the pairing code shown on the Vivatmo pro 6 Vivatmo pro Confirmation screen is shown To disconnect Vivatmo pro from Vivasuite perform the following steps Language Connection Status Connected Vivasuite Configuration D I S C O N N E C T 1 Vivatmo pro On the Network Interfaces screen select Vivasuite Configuration 2 Viva...

Page 67: ...e disabled by the button C O N T I N U E USER ADMINIS TRATION Maintain a high security standard and raise comfort by enabling individual user accounts on your device Note you can always add users later N O T N O W E N A B L E When USER ADMINISTRATION is not enabled in the setup procedure the User Accounts screen opens to ENABLE individual user accounts By disabling the User Administation the user ...

Page 68: ...Administrator Professional Username Enter Username Professional Account Z X C V B N M 1 2 3 Done A S D F G H J K L W E R T Y U I O P Q 2 4 3 Enter the name of the user Passcode Enter 4 digit Passcode Professional Account 3 4 Done 1 2 3 4 5 6 7 8 9 0 4 Enter the respective passcode a 4 digit passcode for a professional user an 8 digit passcode for an administrator account 5 Repeat the passcode 6 Co...

Page 69: ...2 Select the Pencil button 3 Enter your changes to user name and passcode 4 Confirm with DONE Enable Disable user account 1 On the User Accounts screen select the user you want to enable disable 4 I N U E 2 Select the Enable Disable user button When lock is open the user access is enabled Deleting user accounts 1 On the User Accounts screen select the user you want to delete 2 Select the Delete bu...

Page 70: ...ion mechanism the Backup data can be imported to the same basestation only The import of the backup overwrites the data stored on the basestation Language Create Backup Import Backup Data Backup 1 On the Administration screen select Data Backup 2 Select between Create Backup Import Backup The backup procedures might take up to 5 minutes 7 Maintenance and trouble shooting 7 1 Maintenance WARNING Fr...

Page 71: ...mikrozid universal wipes Schülke Mayr GmbH or with a soft cloth moistened with soap cleaning agents Carefully wipe around openings 3 For disinfecting repeat step 2 with alcohol disinfectant wipes with maximum 30 alcohol following the wipe manufacturer s instructions for disinfecting 7 2 Status information handheld Your handheld 234094758 is connected Successful measurements QC Status valid 29 Meas...

Page 72: ...rts the reconditioning 1 The wrench symbol on the handheld and the basestation indicates that the reconditioning process is on going The remaining reconditioning time is shown in minutes 2 The handheld beeps and blinks 3 times blue when reconditioning is finished 3 Dispose mouthpiece after reconditioning The reconditioning takes between 7 and 90 minutes and cannot be interrupted The wrench symbol ...

Page 73: ...e software update whenever it fits the schedule Updates can only be installed by Admins Bosch Healthcare Solution This update might take up to 15 minutes Rev 2 3 0 improves overall security of this device and solves a touch button bug Following tests were added ABC Vivalytic Reviosion 2 3 0 New update available Revision 2 2 0 Installed I N S TA L L N O W 1 A Notification is shown when a new softwa...

Page 74: ... E Please contact an administrator or your service to reset your passcode C O N T I N U E If you forgot your passcode 1 Select the FORGOT button A screen opens and tells you to ask your administrator to reset your passcode 2 Select the CONTINUE button to return to the user list The system needs at least 1 administrator login If the administrator passcode is forgotten Vivatmo pro needs to be reset ...

Page 75: ...4 1 Measurement using the basestation Measurement procedure is incorrect breathing was too strong too weak or time limit after regeneration was exceeded Repeat the measurement see 4 2 Measurement stand alone with the handheld Permissible number of measurement trials reached soon measurements still possible See display for number of remaining measurement trials Order new Vivatmo pro handheld see 7 ...

Page 76: ...g the device from one place to another a stabilization period of at least 20 minutes should be observed before use Battery is too weak for measurement Place the device on the basestation for charging System self test failed Make sure the battery is sufficiently charged by positioning the handheld on the basestation for at least 2 hours Take out and re insert the battery of the handheld if the erro...

Page 77: ...l Turn in the device for recycling in order to promote the sustainable reuse of material resources in compliance with EU directive 2012 19 EU The used measuring unit should be recycled in compliance with the local recycling program for electronic equipment Dispose of used batteries in compliance with the national local regulations for the disposal of batteries separated from the device in complian...

Page 78: ... 2 000 m above sea level Storage and transport temperature humidity air pressure 5 C to 27 C 10 to 60 relative humidity between uses 780 hPa to 1 100 hPA Data transfer Ethernet 10 100MB WLAN 2 4 GHz b g n internal Bluetooth Smart low energy 2 4 GHz Basestation Catalogue number F09G100168 Display basestation 7 inch 16 10 1024 x 600 pixel touchscreen Weight 1350 g Dimensions 265 x 213 x 160 mm Elect...

Page 79: ...0 ppb 10 for 50 ppb 15 for 160 ppb expressed as the upper lower confidence limit of 95 Precision for 10 second measurement mode 5 ppb below 50 ppb 10 for 50 ppb 15 for 160 ppb expressed as one standard deviation for replicate measurements with the same instrument Memory capacity 1 000 measurements Maximum ambient NO concentration 100 ppb Power source handheld Customized rechargeable Li ion battery...

Page 80: ...t 170 g Dimensions 4 0 cm x 5 4 cm x 22 4 cm Lifetime At least 5 000 measurement trials Useful life of rechargeable battery At least 40 measurement trials when fully charged Disposable Mouthpiece accessory Disposable mouthpiece single time use Measurement limited to 5 measurement trials within 15 minutes Useful life of disposable mouthpiece Limited by expiration date Vivatmo pro can contain follow...

Page 81: ...8E8B712E469 0 999 1 04 1 88 ppb E8E8B714CC4D 0 995 1 01 0 63 ppb E8E8B710F568 0 996 1 01 0 62 ppb E8E8B711FDEE 0 995 1 00 1 53 ppb Analytical Precision A nested components of variance design with 20 testing days two runs per day and two replicate measurements per run for each concentration was used Evaluations were done according to CLSI guideline EP05 Repeatability describes the variation within ...

Page 82: ...number Manufacturer address Catalogue number The IVD product meets the requirements of applicable European directives Applied part type B as per EN 60601 1 Read instructions for use carefully In vitro diagnostic medical device 98 79 EEC IVD Directive Caution read IFU regarding warnings Keep dry Warning to avoid a hazard Information IP Protection class Bluetooth compatible Date of expiration YYYY M...

Page 83: ...quipment as to electrical shock fire and mechanical hazards only in accordance with ANSI AAMI EN60601 1 2005 C1 2009 A2 2010 A1 2012 IEC60601 1 6 2010 A1 2013 CAN CSA C22 2 No 60601 1 2014 60601 1 6 2011 A1 2015 The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by Bosch Healthcare Solutions GmbH is under license 9 4 Warranty The statut...

Page 84: ... Economic Development Canada s licence exempt RSS standard s 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 L émetteur récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d Innovation Sciences et Dével...

Page 85: ...ed 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 turning the equipment off and on the user is encouraged to try to correct the interference by o...

Page 86: ...r or the user of Vivatmo pro should assure that it is used in such an environment Medical devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities It is recommended that all equipment used near the Vivatmo pro device comply with the medical electromagnetic compatibility standard and to check before use that no interference is eviden...

Page 87: ...ATS ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide Am J Respir Crit Care Med 2005 171 912 30 2 Dweik RA Boggs PB Erzurum SC et al Official ATS clinical practice guideline interpretation of exhaled nitric oxide levels FENO for clinical applications Am J Respir Crit Care Med 2011 184 602 15 11 4 ...

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