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Bosch Healthcare Solutions GmbH Stuttgarter Strae 130 71332 Waiblingen Germany F09G100512_04 Latest change:
draft Bosch Healthcare Solutions GmbH Stuttgarter Strae 130 71332 Waiblingen, Germany Instructions for use Oxycap This page is intentionally left blank. Content 1 Initial information ............................................................................................................................6 2 System elements .......................................................................................................................... 11 3 Installation ...................................................................................................................................... 18 2 1.1 Package contents 1.2 Before using Vivatmo pro 1.3 Safety information 1.4 Intended use/Indications for use 2.1 Screen elements 2.2 Handheld elements 2.3 Disposable mouthpiece 2.4 Handheld display 3.1 Installing the handheld 3.2 Installing the basestation 3.2.1 User concept 3.2.2 Onboarding 6 7 8 10 12 14 15 16 18 19 19 20 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 3.3 Login 4 Measure ........................................................................................................................................... 25 4.1 Measurement using the basestation 4.2 Measurement stand-alone with the handheld 5 Manage ............................................................................................................................................. 33 6 Settings ............................................................................................................................................ 38 5.1 Patient records 5.2 List of measurements 5.3 List of measurement orders 6.1 General settings 6.2 Ambient NO 6.3 Quality control (QC) 6.3.1 QC Tester qualification 6.3.2 Performing QC 6.4 System information 6.5 Administrator settings 6.5.1 Device settings 3 23 26 30 33 37 37 38 39 40 41 43 45 46 46 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 6.5.2 Quality Control (QC) settings 6.5.3 Printer configuration 6.5.4 Assigning the handheld 6.5.5 Release the handheld 6.5.6 Network configuration 6.5.7 Order/result interface 6.5.8 Export and Backup file configuration 6.5.9 Vivasuite configuration 6.6 User administration 6.7 Data backup 7.1 Maintenance 7.2 Status information handheld 7.3 Reconditioning 7.4 Remote Software Update 4 7 Maintenance and trouble shooting ......................................................................................... 68 49 51 52 54 55 60 62 63 65 68 68 69 70 71 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 8 Disposal ........................................................................................................................................... 75 8.1 Disposing the Vivatmo pro device and the battery 8.2 Disposing the mouthpiece 9 Technical data ................................................................................................................................ 76 10 Manufacturer ................................................................................................................................. 82 11 Appendix ......................................................................................................................................... 82 7.5 Trouble shooting 7.5.1 Wrong or forgotten passcode 7.5.2 Trouble shooting handheld 9.1 Device data 9.2 Device Performance 9.3 Symbols 9.4 Warranty 11.1 Electromagnetic compatibility 11.2 Compliant cables 11.3 Literature 11.4 License Terms for End Users 5 72 72 73 75 75 76 79 80 81 82 84 84 85 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Initial information 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 6 Keep these Instructions for use. For frequently used functions see chapter 3, 4, 5, 7 and 8. Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Initial information 1.2 Before using Vivatmo pro Welcome to Vivatmo pro, the measurement system to support a monitoring of respiratory diseases. Please consider the following before using Vivatmo pro:
Take enough time to carefully read the instructions for use before using the measurement system. You must understand the functions, warnings, displays, and operations for safe and reliable use. Inspect the basestation, the handheld, 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 at www.vivatmo.com. Have your serial number of your handheld or your basestation available when you contact the service center. You find the twelve digit code on your Vivatmo pro handheld, next to the symbol bottom of the device. at the Bosch privacy statement: This product stores the measurement data and personal information of patients. 7 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Initial information 1.3 Safety information WARNING The following conditions can cause malfunction or disturbance to the Vivatmo pro and the disposable mouthpiece:
High humidity, extreme temperature (see 9.1 Device data). Direct sun radiation or high exposure to dust or volatile substances, e.g., disinfectants or nail polish remover. Places that are subject to vibration or shock, or near hot surfaces. Rooms with open flames, gas 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 frequency above 10 measurement trials/hour. Use the device for a maximum of 10 hours nonstop and allow a break of 10 hours before restarting to avoid system overload. When you disconnect the device from the power line, first remove the plug from the wall outlet, then disconnect the cable from the device to avoid contact to line voltage. 8 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish WARNING The assembly of Vivatmo pro and modifications during the actual service life require evaluation to the requirements of the applied standard. Changes or modifications made to this equipment not expressly approved by Bosch Healthcare Solutions may void the FCC authorization to operate this equipment. Only connect printers and computers that comply with EN 60950-1, EN 60601-1 or EN 61010-1 standards, or that bear the UL or CSA mark. Connect ethernet port only to networks with galvanic isolation certified to EN 60601-1 or use an external 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 connecting the basestation to the local area network consider that data is transmitted unencryptedly with the risk of unprotected access to patient data. Setup, changes and reconfigurations to the network or connected devices is under the responsibility of the organization using the system and might introduce new risks. Delete personal data on the basestation and handheld prior to disposal or service returns. Bluetooth is activated as long as the basestation is power supplied. Initial information 9 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 1.4 Intended use/Indications for use Vivatmo pro Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement 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 7-17 years, and adults 18 years and older. Testing using the Vivatmo pro should only be done in a point- of-care healthcare setting under professional supervision. Vivatmo pro should not be used in critical care, emergency care or in anesthesiology. Initial information 10 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 2 System elements Basestation frontside Basestation backside 1 2 3 4 1 Handheld 2 Charging cradle 3 On/Off button 4 Touchscreen 1 2 3 1 Ethernet port 2 USB ports 3 Power adapter port System elements 11 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish System elements 2.1 Screen elements Elements of the basestation homescreen Welcome to Vivatmo pro M E A S U R E M A N A G E S T A R T N E W M E A S U R E M E N T P A T I E N T S A N D R E S U LT S 4 Screen elements Element Function 6 5 4 12 1 Measurement orders from electronic patient record system 4 4 2 Manage patients, measurements and orders C O N T I N U E C O N T I N U E 3 Charging status handheld battery 1 2 3 4 Handheld connected disconnected 5 Start measurement 6 Settings menu/logout You see the basestation homescreen when the installation is complete, see 3 Installation. C O N T I N U E 4 Help Opens the Help screen. Arrow left Moves one screen backward. Element Function Close Closes the current file. Arrow right Moves one screen forward. 4 C O N T I N U E C O N T I N U E Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Element Function Element Function 4 C O N T I N U E 4 4 C O N T I N U E C O N T I N U E 4 4 4 C O N T I N U E Orientation beads Shows the current step during the installation procedure. View trials / Reconditioning active Shows the number of measuring trials. C O N T I N U E 4 Comment Adds a comment to the current patient data file. C O N T I N U E 4 Search Opens a window for entering search criteria. C O N T I N U E 4 Quality Control (QC) status Shows the QC status. N E W M E A S U R E M E N T C O N T I N U E P A T I E N T R E C O R D Unassign measurement result Releases measurement result from set of patient data. P A T I E N T R E C O R D WWWWWWWWWWWWW 1 8 PPB WWWWWWWWWWWWW 07.04.2016 11:43 WWWWWWWWWWWWW WWWWWWWWWWWWW C O N T I N U E 4 C O N T I N U E 4 Joel Linnasalo
* 10.01.2000, m PID 123123123 C O N T I N U E 1 8 PPB 07.04.2016 11:43 System elements User Administration Disable access control by user accounts. Enable/Disable user Enables or disables access for user in user management. Add new user/patient Opens the screen for the data input of a new user/patient. Pencil Opens the current data file for editing. Export Exports the current data file. Print Prints the current data file. Delete Deletes the current entry. 13 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishQC QC ! QC System elements 2.2 Handheld elements On the handheld, you see the following operating elements:
p r o 14 Disposable mouthpiece: Interface to breathe into the Vivatmo pro handheld. Display: Shows current and stored measuring data and device messages. ON/OFF button: Activate 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:
Procedure correct: Blue blinking. Procedure failed: Red blinking. Warning, the breath intensity is too strong. When the handheld is placed on the basestation blue blinking light indicates that battery is charging. Battery compartment Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish The measurement procedure is guided by an animation on the display of the basestation or the LED on the back of the handheld. Synchronize measurement results of stand-alone measurements with the Vivatmo pro handheld by placing the switched on Vivatmo pro handheld in the cradle of the Vivatmo pro basestation. 2.3 Disposable mouthpiece To perform a measurement with the Vivatmo pro system a disposable mouthpiece is needed. System elements 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 to guarantee reliable test results. QC Level 0 disposable mouthpiece Level 0 Quality Control (QC) measurement is performed with a specific Level 0 disposable mouthpiece, see 6.3.2 Performing QC. A comparison measurement is performed for a concentration below 5 ppb. The outside of the Level 0 disposable mouthpiece is white. 15 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish System elements 2.4 Handheld display 1 2 9 16 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 8 Device busy 7 Time and date of the stored measurement result 9 Device ready for measurement 3 4 5 6 7 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Handheld symbols Icon Function Reconditioning active. Regeneration in progress. Ambient NO measurement in progress. The memory is cleared. The Vivatmo pro 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:
Battery icon blinking:
No battery icon displayed: The battery charge is sufficient. The battery charge is low. Recharge the handheld device as soon as possible. The battery charge is too low to perform measurements. System elements 17 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Installation 3 Installation Install the handheld. Install the basestation. Before you start using your Vivatmo pro perform the following steps:
3.1 Installing the handheld To install the handheld, insert the rechargeable battery. 1. Open the battery compartment on the back of the Vivatmo pro handheld. 2. Hold the handling tab with two 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 handheld is charging. 5. Press the ON/OFF button to turn on the handheld. You see all screen icons and the system performs a brief self-test. Then the software version on the handheld is shown. 6. Turn off the device before you replace the battery. 18 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish WARNING After 5 minutes of inactivity, the handheld will turn off automatically. The stored measured values and the date, time setting will remain stored in the memory for 5 minutes when the rechargeable battery might need to be changed. Remove the battery if you are not using the device for a prolonged period of time. Do not touch the battery contacts to avoid electrical short. Dispose of the used battery in compliance with the national or local regulations for battery disposal, see 8.1 Disposing the Vivatmo pro device and the battery. 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 management is deactivated. Vivatmo pro supports 2 levels of user access:
3.2 Installing the basestation 3.2.1 User concept Professionals can:
Perform measurements, see 4 Measure. Manage patient data and measurement orders, see 5 Manage. Change display, see 6.1 General settings. Perform Ambient NO measurement, see 6.2 Ambient NO. Perform QC-measurement, see 6.3.2 Performing QC. Export and print. Installation 19 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Installation Administrators can additionally:
Change QC settings, see 6.5.2 Quality control (QC). Change language, see Setting the language in 6.5.1. Change time and date, see Setting date and time in 6.5.1. Activate/de-activate auto-lock, see Setting Auto-Lock in 6.5.1. Install printers and export locations, see 6.5.3 Printer configuration and 6.5.8 Export and Backup file configuration. Change Vivatmo pro handheld used with the basestation, see 6.5.5 Release the handheld. 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. 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 Vivatmo pro basestation to a multiple socket-outlet to prevent interference by other devices. 1. Connect the jackplug from the power supply unit into the power adapter port on the rear of the Vivatmo pro basestation. 2. Plug the suitable adapter for your country firmly on the power supply unit. 3. Plug the main plug into a suitable socket. The Vivatmo pro basestation starts automatically. 3.2.2 Onboarding WARNING 20 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Software setup When you start your Vivatmo pro basestation for the first time, you will be guided through a setup procedure of 5 simple steps, which helps you to enter all the required settings. 1. Switch on the basestation, by pressing the ON/OFF button. The Region screen is displayed. Region and Language Please select region of use 1. Select a region. USA Rest of World Lorem ipsum Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, cons ectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. The region selection defines the functionality approved for the region. The Language screen is displayed. 2. Select a language. The Date and Time screen opens. Date and Time 1. Set up date and time. For details, see Setting date and time in 6.5.1. 2. Confirm with DONE after successful setting. The Administrator Account screen opens. 1 2 5 8 0 Date and Time 1 2
. 1 0
. 2 0 1 9 1 3
5 5 1 4 7 3 6 9 D o n e Installation 21 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Installation 3 A D M I N I S T R AT O R A C C O U N T C O N T I N U E Administrator account As administrator you can add or edit user accounts and change system settings. 2. Select the CONTINUE button after the successful addition of an administrator. 1. Create an administrator account. For details, see Add new user in 6.6. The User administration screen opens. You need at least one administrator account to use Vivatmo pro. Remember this access code carefully. The reset of the administrator account can only be done by service personnel. 4 U S E R A C C O U N T S User administration 1. Select ENABLE to activate the user administration. Maintain a high security standard and raise comfor t by enabling individual user accounts on your device. Note: you can always add users later. 2. Create a new user by entering a user name and a passcode. For details, see 3.2.1 User concept and Add new user. N O T N O W E N A B L E user accounts. 3. Select CONTINUE after successful addition of a user and see the list of 4. Select the Arrow to leave the list. 5. On the next screen, select the CONTINUE button. The Handheld screen opens. 22 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish When you select the NOT NOW button, the user identification will be deactivated. You can activate or deactivate user accounts within the settings as well. Using the Vivatmo pro without the user management is only recommended when you do not use patient records. When you select the NOT NOW button, the user identification will be deactivated. Handheld Language S C A N F O R H A N D H E L D S Vivatmo pro Vivatmo pro 1234567890 0987654321 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 button.The setup procedure is completed. 3.3 Login When user accounts are enabled, Vivatmo pro demands authentication on the system. You have to login before you can start using the system. Installation 23 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishNAMEMAC-ADDRESS Installation The Welcome screen opens automatically, when you turn on the basestation. You see the list of all users. Welcome to Vivatmo. Who are you?
1. Select your account from the user list. Konsta Haapakoski Jouko Kinnunen Oona Pakarinen-
Kattilakoski 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. The Home screen opens. Select the MEASURE button to start a measurement, see 4 Measure. Select the MANAGE button to manage the data, see 5 Manage. Hi Jouko Kinnunen, please enter your passcode. Oona Pakarinen-
Kattilakoski F O R G O T 1 4 7 3 6 9 2 5 8 0 Welcome to Vivatmo pro , Jouko Kinnunen M E A S U R E M A N A G E S T A R T N E W M E A S U R E M E N T O O P A T I E N T S A N D R E S U LT S 24 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishProfessionalAdministratorProfessionalProfessional 4 Measure WARNING If the Vivatmo pro device has been stored in warm and humid environment or not been in use for a longer time, reconditioning may be required and starts automatically during first measurement. Therefore per-
form a test measurement every day before using the device with the patient, see 7.3 Reconditioning. Following conditions can influence correct measurement results and shall be avoided:
Smoking or tobacco consumption for at least 1 hour before the measurement. Eating or drinking at least 1 hour before the measurement, especially nitrate rich food
(e.g. spinach). Strenuous exercise. or from tobacco consumption. Rooms with high air pollution, high ambient NO or open flames, for example gas range, smoke, 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 mouthpieces with transparent cover. The use of Level 0 disposable mouthpieces with white cover and a 0 on the disposable pouch leads to 0 ppb measurements. Always check your Vivatmo pro basestation, handheld, and the disposable mouthpiece for damages before using to avoid injury or malfunction. Leakage at the disposable fitting may lead to a lower measurement result. A mouthpiece can be used for one patient measurement only. In case of an unsuccessful measurement note that at most 5 attempts possible with 1 mouthpiece. Use the mouthpiece within 15 minutes after opening its pouch. Measure 25 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Measure 4.1 Measurement using the basestation Welcome to Vivatmo pro, Jouko Kinnunen M E A S U R E M A N A G E S T A R T N E W M E A S U R E M E N T O O P A T I E N T S A N D R E S U L T S New measurement Release handheld from basestation and firmly attach a new mouthpiece. 1. Ensure that your handheld 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. 3. On the handheld display, the Disposable mouthpiece icon flickers. Open the pouch and attach the disposable mouthpiece firmly in a way that it fits securely on the device. On the handheld display, the Disposable mouthpiece icon stops blinking. 26 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Attaching the mouthpiece The Vivatmo pro disposable mouthpiece cleans and stabilizes the breath sample from contaminants to guarantee reliable test results. Use the disposable mouthpiece directly after opening the pouch. Visualization and regeneration V I S U A L I Z AT I O N Handheld is regenerating 7 4. On the VISUALIZATION 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. 5. When the preparation process is finished, you have to start the measurement within 60 seconds. According to your selection, the respective visualization is shown. The regeneration may last up to 100 seconds and is needed to guarantee reliable results. To stop the regeneration, remove the mouthpiece from the handheld. Measure 27 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishExhale!10s Measure Measuring When you assist a person with the measurement, pay attention to the following steps:
1. The patient should sit in a relaxed position, inhale deeply through the mouth and lift the handheld to the mouth. WARNING The patient should avoid inhalation through the nose to exclude influence of nasal NO-concentrations. 2. Exhalation should be performed through the disposable 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. Inhalation through the disposable mouthpiece is without harm but not recommended. When the regeneration is done, start the measurement within 60 seconds. Before the next FeNO determination, you must remove and dispose the mouthpiece, see 8.2 Disposing the mouthpiece. 3. Select the x to leave the Result screen. The Patient File screen opens. 18 PPB The measurement was successful. Please remove the mouthpiece. 28 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish810s Unassigned Result N E W M E A S U R E M E N T 1 8 PPB 07.04.2016 11:43 The result 5 ppb -LO- or <5 ppb represents a result below the lower detection limit of the device. The result 300 ppb - HI- or >300 ppb represents a result above the upper detection limit of the device. When performing a measurement without selecting a patient before, the result is shown as unassigned. You can assign the measurement to a patient immediately or later from the list of measurements:
1. Select 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 M E A S U R E M E N T F A I L E D Please wait until the clock symbol on the handheld display has disappeared. Then press the Enter-button to star t a new measurement. In case your measurement failed, the MEASUREMENT FAILED screen opens. 1. The screen might show being busy to prepare the next measurement. Wait until the clock icon on the handheld stops blinking. Press the ENTER button on the handheld and the measurement procedure starts again with the VISUALIZA-
TION screen and the animation on the screen indicates that the regeneration process is ongoing. The display depends on the selected visualization, see Visualization and regeneration in 4.1. Measure 29 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishASSIGN TO PATIENTNOTEQC 4.2 Measurement stand-alone with the handheld Stand-alone measurements can be used when the handheld has no connection to the basestation. The handheld must be out of range of the basestation or the basestation must be switched off. The measurement procedure is guided by the handheld display and the LED on the upper side. Synchronize measurement results of stand-alone measurements with the Vivatmo pro handheld by placing the switched on Vivatmo 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 icon is blinking, as the handheld is not connected to the basestation. 2. Attach a new disposable mouthpiece. 3. The handheld device might be busy. Wait until the clock icon stops blinking. Press the ENTER button to start the regeneration cycle. While the handheld is regenerating, segments of the display will be animated to indicate the handheld is preparing the measurement. Measure 30 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 4. When the display shows the Breathing icon, start the measurement procedure within 60 seconds. The LED on the back of the device turns blue. 5. Turn the device display downwards, so that you can see the LED at the back of 6. Sit in a relaxed position, inhale deeply through your mouth and lift the handheld the device. to your mouth. 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:
blue:
red:
warning, too strong caution, too weak correct Successful measurement: The LED flashes blue and the result appears on the display. All results are automatically stored on the device. Failed measurement: The LED flashes red and the Exhalation failed icon appears on the display, see Failed measurement. 8. Remove the mouthpiece. 9. Discard the mouthpiece, see 8.2 Disposing the mouthpiece. Measure 31 p r o Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Measure Failed measurement A) The measurement failed because the exhalation through the device was excessively weak or strong:
The LED flashes red, you hear an audio signal, and the screen shows Repeat the measurement, see 4.2 Measurement stand-alone with the that the exhalation failed. handheld, start at point 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 To retrieve the 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 starting with the latest. Press the Arrow left button to show older measured values. Press the Arrow right button to scroll to the more recent values. Press the Enter button to exit the view. 32 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish In the Manage menu, you can manage the following data records:
Data records can be managed without a handheld connected to the basestation. 5 Manage 5.1 Patient records 5.2 Measurements 5.3 Measurement orders 5.1 Patient records Manage P AT I E N T S A D D N E W P AT I E N T 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 Searching patients. Edit patient data, see Editing patients. Delete patient data, see Deleting patients. Manage 33 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishPID 123123123Joel Linnasalo*1976-09-20 PID 123456789Yue Ying Lung*2001-02-21MEASUREMENTSORDERS N E W M E A S U R E M E N T 1. From the patient list, select a patient. The patient file is displayed and shows the last measurements. 2. Select MEASUREMENTS or GRAPH of the last measurements. The validity of the QC is displayed with the results. For further information on QC, see 6.3 Quality control (QC). 3. Select NEW MEASUREMENT to perform a measurement with the patient, see 11 PPB 8 PPB 9 PPB 4.1 Measurement using the basestation. 4. Select the Arrow to leave the patient file. 1. On the PATIENTS tab, select + ADD NEW PATIENT. The Add Patients screen opens. Entering a alphanumeric patient ID is mandatory, all other entries are optional. 2. Select the patient ID (PID) from the list, change content on the Patient ID screen and confirm with DONE. ? 1 2 3 D o n e on the selected screen and confirm with DONE. 3. Select the the firstname, lastname and date of birth if required, change content 4. The gender of the patient can be changed in a drop-down menu. Manage Viewing patient file Joel Linnasalo
* 1976-09-20 PID 123123123 M E A S U R E M E N T S 2016-04-07 11 :43 2015-10-07 13: 16 2015-06-21 09: 55 Adding patients Add Patient Q W E R T Y U I O P A S D F G H J K L Z X C V B N M
. 34 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishGRAPHPatient IDEnter ID 1/6 Add Patient 5. Confirm all entries with SAVE. Patient ID Firstname Lastname Date of Birth Gender AB1234567 Paula Hendrikson 1967-12-08 Female S A V E Searching patients Browse Patients Nikol Q W E R T Y U I O P A S D F G H J K L Z X C V B N M
. ? 1 2 3 D o n e 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. Manage 35 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSearch for N E W M E A S U R E M E N T The Patient File screen opens. 1. In the patient list, select the patient you want to edit. 2. Select the Pencil button to edit the patient data. 3. Follow the wizard step-by-step to edit the data. 11 PPB 8 PPB 9 PPB 1. In the patient list, select the Delete button. You are asked to confirm before a patient file is deleted. Manage Editing patients Joel Linnasalo
* 1976-09-20 PID 123123123 M E A S U R E M E N T S 2016-04-07 11 :43 2015-10-07 13: 16 2015-06-21 09: 55 Deleting patients 36 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishGRAPH 5.2 List of measurements Manage M E A S U R E M E N T S Page 1 / 3 Page 1 / 3 1. On the Manage screen, select the MEASUREMENTS tab. Here you can view all measurements in chronological order. 2. The measurements are displayed in pages of 10 measurement results. Change 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 Manage O R D E R S 1. On the Manage screen, select the ORDERS list. The list of measurement orders opens. 2. Select a patient to perform a measurement, see 4.1 Measurement using the basestation. When the measurement is done, the result is send back to the electronic patient record system. The patient is added to the list of patients on the Vivatmo pro basestation. Manage 37 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishPATIENTSORDERS17.01.201815:47unassigned29 ppb17.01.201815:36Mary SmithPID MS7891145 ppb17.01.201814:26Joel Linnasalo PID JL7891011 ppbNikola Matjkov*1987-11-07PID 123456788PATIENTSMEASUREMENTSPID 123123123Joel Linnasalo*1976-09-20 Yue Ying Lung*2001-02-21PID 123456789 The access to settings depends on the login as professional or administrator, see 3.2.1 User concept. 1. On the Home screen, select the Settings menu. 1. Select General Settings to change display settings. Select Display. 2. Select the point and move it to set the brightness. Settings 6 Settings Welcome to Vivatmo pro, Jouko Kinnunen A M B I E N T N O G E N E R A L P E R F O R M Q C I N F O R M AT I O N M A N A G E A D M I N I S T R AT I O N S T A R T N E W M E A S U R E M E N T L O G O U T M A N A G E P A T I E N T S A N D R E S U LT S 6.1 General settings Setting the display General Language Display 38 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 6.2 Ambient NO Ambient Measurement Ambient NO measurement may help to interpret FeNO measurement results. To perform an ambient NO measurement:
1. In the Settings menu, select AMBIENT NO. The AMBIENT MEASUREMENT screen opens. Release handheld from basestation and firmly attach a new mouthpiece. 2. Turn on the handheld. 3. Attach a new mouthpiece, see 4.1 Measurement using the basestation. 4. Lay down the handheld in a way that the device has good access to the Ambient Measurement ambient air. Please leave handheld in one place during measurement. 5. Select the RUN MEASUREMENT button. On the screen, you see that the ambient NO measurement is running. When the ambient NO measurement is done, you see the result on the screen. Ambient Measurement 18 PPB The measurement was successful. Please remove the mouthpiece. Settings 39 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishlast measurement: 2018-03-12 - 07:02last measurement: 2018-03-12 - 07:02 Settings 6.3 Quality control (QC) External QC tests are used to control the measurements of the Vivatmo pro handheld in comparison to reference concentrations of nitric oxide (NO). The system documents the tester who performs the QC tests by the user login. QC is recommenended weekly or after 50 measurements if Vivatmo pro is used in a clinical environment. Commitment, frequency and reference measurements to be performed are dependent on the local quality control standards of the operating organization. The settings 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 performed by a qualified QC tester with a FeNO concentration below 50 ppb. For this test a regular transparent disposable mouthpiece is used. QC with defined NO is performed by users who have the QC tester qualification. A minimum of 1 individual needs to qualify, 2 are recommended, see below. When QC for the Vivatmo pro is invalid or failed, the measurements are stored with the QC status in the patient data. 40 P A T I E N T R E C O R D 1 8 PPB 07.04.2016 11:43 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishQC QC ! 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. Settings 41 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Settings Qualification procedure QC Tester Language Jeppe M. Gregersendan Expired N/A Q U A L I F Y QC-Measurements 2016-04-07 11 :43 2015-10-07 13: 16 Passed Passed 42 Note: In the QC settings, the QC Tester control must be activated, see 6.5 Administrator settings. Perform the following steps:
1. In the Settings menu, select PERFORM QC. The QC Tester screen opens and the actual user is highlighted and can be selected. 2. Select the QUALIFY button. 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 the last 3 measurements. Failed: Result is outside acceptance range of the mean of the last 3 measurements. When the qualification procedure is passed, the qualification status of the QC tester is changed to Qualified. The qualified QC tester can perform the defined NO reference measurement test. Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishKonsta HaapakoskiProfessionalQualifiedOona Pakarinen-KattilakoskiProfessionalJeppe M. GregersendanAdministratorQualifiying1/3 Passed 6.3.2 Performing QC QC provides 2 reference measurement tests:
1. Level 0 2. Defined NO with QC tester Start QC-measurement QC Tester Language In the 6.5.2 Quality Control (QC) settings, QC can be restricted to 1 QC reference measurement only. Dependant on the QC settings, QC is performed first with Level 0 and then with defined NO with QC tester, or with the selected reference QC-measurement only. 1. In the Settings menu, select PERFORM QC. The QC Tester screen opens (only if QC tester is activated). In the list, you see all users with their QC status. Your account is highlighted and can be selected. If no user management is enabled only the administrator is shown in the list. Settings 43 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishKonsta HaapakoskiProfessionalQualifiedOona Pakarinen-KattilakoskiProfessionalJeppe M. GregersendanAdministratorQualified If Level 0 QC is configured perform the following steps:
1. Select your user name and select the PERFORM QC button
(only if QC tester is activated). 2. Release the handheld device from the basestation and attach a Level 0 mouthpiece. 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 use a new Level 0 mouthpiece. When the Level 0 QC test still fails, contact the service. The second reference QC-measurement is performed by a qualified QC tester. For the QC tester qualification procedure, see 6.3.1 QC Tester qualification. Settings QC test Level 0 Jeppe M. Gregersendan Exp. Date 2018-09-10 25 PPB P E R F O R M Q C QC-Measurements 2016-04-07 11 :43 2015-10-07 13: 16 2015-06-21 09: 55 Passed Passed Passed Level 0 Measurement 0 PPB The measurement was successful. C O N T I N U E QC-measurement QC tester 44 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishLast measurement: 2018-03-12 07:02 Jeppe M. Gregersendan Exp. Date 2018-09-10 25 PPB P E R F O R M Q C QC-Measurements 2016-04-07 11 :43 2015-10-07 13: 16 2015-06-21 09: 55 Passed Passed Passed 6.4 System information System Information Language Hardware Revision Software Revision Kernel Version Firmware Version Open Source Software Rev. 1.0.1 Rev. 2541 4.4.38 1.1.25 1. Select your user name. You can see your datasheet with the list of your last QC-Measurements. 2. Select the PERFORM QC button. 3. Attach a regular transparent disposable mouthpiece. 4. Perform the measurement, see 4.1 Measurement 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. 1. In the Settings menu, select INFORMATION. The System information screen opens. Find the versions of the used software components might needed in case of service. 2. Select Open Source Software to find information and a written offer concerning open source software components used in the product. Settings 45 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Settings 6.5 Administrator settings Administration Language Device Settings Quality Control (QC) settings Printer Configuration Network/Interfaces User Administration Data Backup 6.5.1 Device settings Device Settings Language Language Date and Time Auto-Lock Factor y Reset 46 Administration settings are activated only if you are logged in as administrator. 1. Log in as administrator. 2. In the Settings menu, select ADMINISTRATION. 1. On the Administration screen, select Device Settings. The Device Settings screen opens for changing Language, Date and Time, Auto-Lock or Factory Reset. Factory Reset resets all stored data and settings. Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Setting the language Language Language English Espaol 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
1 4 7 3 6 9 2 5 8 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. Settings 47 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishMMYYYYMMHHDone Time 5 min You can set the interval according to the needs in the clinical environment. When Auto-Lock is activated, the system shuts down to save energy and protect patient data. The user needs to log in again after an automatic lockoff. 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 removes all stored measurements from the basestation and all data of patients and users. Date and time are reset and no handheld will be connected afterwards. Use factory reset prior to disposal or service returns only. Settings Setting Auto-Lock Auto-Lock Language Factory reset 48 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 6.5.2 Quality Control (QC) settings Quality Control (QC) Configure Quality Control Language Show QC Configuration 1. On the Administration screen, select Quality Control (QC) Settings. You can select:
Configure Quality Control to change the settings. Show QC Configuration to display the current settings. QC Configuration 2. Select Configure Quality Control. Quality Control off 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. QC Configuration 5. Select the interval to perform the quality control by time: select daily, weekly, bi-weekly or by number of performed measurements: select After x measurements. Select the Arrow Right button. Daily Weekly Bi-Weekly After x measurements Settings 49 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect StatusSelect Interval QC Configuration 6. Enter the number of measurements to be performed before next quality control. 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. 9. Select the Arrow Right button to move to the next screen. The QC Configuration screen opens with an overview of the current QC settings. After x measurements 10. Check your QC configuration. 11. Confirm with SAVE to save the QC configuration. QC Configuration QC Configuration S A V E on on on on on Settings 10 25 50 100 Level 0 QC Tester Status Inter val Level 0 QC Tester 50 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect Number of MeasurementsSelect Controls 6.5.3 Printer configuration Printer Configuration Printer Configuration USB Network Shared HP 500 PCL HP 510 PCL HP 550 PCS D o n e D o n e 1. On the Administration screen, select Printer Configuration. The List of Printers screen opens. The standard printer is highlighted. 2. Select Add new printer. 3. Select the desired printer interface:
USB Network Shared Select the Right Arrow to move to the Select Printer screen. Printing data is transmitted unencrypted. 4. On the Select Printer screen, select the desired printer. 5. Select the Right Arrow to move to the Select Printer Driver screen. 6. Select the printer driver. Settings 51 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect InterfaceSelect Printer The Printer Configuration screen is displayed. 7. Confirm 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. 1. On the Administration screen, select Network/Interfaces. Settings Printer Configuration Interface Printer Name Printer Driver USB HP 500 PCL xyz.ppd S A V E 6.5.4 Assigning the handheld Network/Interfaces Language Assign Handheld Network Order/Result Interface Export Location Vivasuite Configuration 52 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Handheld Language S C A N F O R H A N D H E L D S Vivatmo pro Vivatmo pro 1234567890 0987654321 2. On the Network screen, select Assign Handheld. 3. Turn on your handheld. 4. Select SCAN FOR HANDHELDS. 5. Wait until the scan procedure is completed. You see the list of active handhelds. If no handheld 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. automatically. 8. The Configuring device screen opens.The handheld and the basestation connect The Vivatmo pro handheld and the Vivatmo pro basestation show the same date and time now. If QC is activated, perform a QC-measurement after assigning a new handheld. The basestation software stores the QC status of the handheld with each measurement. Settings 53 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishNAMESERIAL NUMBER Settings 6.5.5 Release the handheld In case another handheld was installed before, it is disconnected by tapping the Release Handheld 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 the main screen. 5. Switch off the handheld. 54 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 6.5.6 Network configuration Vivatmo pro can be connected to a local area network to receive measurement orders, send back measurement results, export patient related measurement data, or use a network printer. Vivatmo pro supports Ethernet and Wireless via WLAN connection. Vivatmo pro shall not be used in unprotected networks. Data security using user credentials shall be used in accordance with the local data security policies. Data is transmitted unencrypted. Network Details Language 1. On the Network/Interfaces screen, select Network. 2. If a network access is configured already, select Show Network Networktype DHCP SSID Securityprotocol Password WLAN enabled BHCS WPA2 Configuration. The Network Details are:
Networktype: WLAN or Ethernet DHCP: Dynamic Host Configuration Protocol When DHCP is enabled, the device supports the configuration of the network. SSID: Service Set Identifier Shows the name of the WLAN network. Securityprotocol: Shows the security protocol used for your system. Password: Shows the network password. Settings 55 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Supported configuration of an ethernet connection Network Configuration Vivatmo pro basestation. 1. Plug in the ethernet cable in the ethernet port on the rear of the 2. On the Network screen, select Configure Network. 3. Select the Networktype Ethernet in the drop down menu. 4. Enable DHCP. Network Configuration 5. Confirm with SAVE. Ethernet enabled D o n e Ethernet enabled S A V E Settings Networktype DHCP Networktype DHCP 56 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect Networksetup Supported installation of a WLAN connection Network Configuration 1. On the Network screen, select Configure Network. 2. Select the Networktype WLAN. Q W E R T Y U I O P 3. Enable DHCP. A S D F G H J K L 4. On the Set network SSID screen, enter the name of the WLAN. Z X C V B N M
. 5. Select the Right Arrow or the DONE button to leave the screen. ? 1 2 3 WEP WPA WPA2 Network Configuration 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 of your WLAN. 9. Select the Right Arrow or confirm with DONE to leave the screen. 10. Confirm with SAVE. D o n e Settings 57 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSSIDEnter SSID DoneSelect Securityprotocol 1. Plug in the ethernet cable in the ethernet port of the basestation. 2. On the Network screen, select Configure Network. Network Configuration 3. Select the Networktype Ethernet. 4. Disable DHCP. Network Configuration 6. Enter the Gateway ID. 5. Enter the IP-Address of your network and the Subnet Mask of your network. 7. Select the Right arrow or confirm with DONE to leave the screen. Settings Manual ethernet configuration Network Language Configure Network Show Network Configuration Networktype DHCP Ethernet enabled enabled disabled D o n e 1 4 7 3 6 9 2 5 8 0 58 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect NetworksetupSelectIP-AddressEnter IP Done Network Configuration 8. Confirm with SAVE. Networktype DHCP IP-Address Subnet Mask Gateway SSID Securityprotocol Password S A V E Ethernet enabled
. . . . . . . BHCS WPA2 Manual WLAN configuration 2. Select the Networktype WLAN. 3. Disable DHCP. 1. On the Network screen, select Configure Network. The Network Configuration screen opens. 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 displayed. 6. Confirm with SAVE. Settings 59 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Vivatmo pro can receive measurement orders from and send results to an electronic patient record system (EPR), if the network is configured. The interface standards GDT (German Data Transfer) and HL7 are supported. To configure the interface to your patient management system follow the installation wizard:
Order/Result Interface 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 Interface. The system keeps the interface settings when de-activated. 4. Select the Arrow Right button to move to the next screen. Select the desired protocol standard: HL7 or GDT. 5. Select Yes for Credentials when the Order/Result Interface is access controlled by user name and password. Settings 6.5.7 Order/result interface Order/Result Interface Protocol Credentials active GDT yes D o n e 60 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect Setup Order/Result Interface inbox for incoming measurement orders. 6. In accordance to IT definitions in your organization, define the location for the Q W E R T Y U I O P A S D F G H J K L 8. Confirm with DONE. Z X C V B N M
. When credentials are required, follow steps 9 to 13. 7. Repeat the procedure for the location of the outbox. Order/Result Interface 9. Enter the user name required to access the data from the EPR system. 10. Confirm with DONE to move to the next screen. Q W E R T Y U I O P 11. Enter the password required to access the data from the EPR system. A S D F G H J K L 12. Confirm with DONE. Z X C V B N M
. ? 1 2 3
. ? 1 2 3 The settings for the ORDER/RESULT INTERFACE are displayed including the result of a Communication Test. 13. Check the data and confirm with SAVE when the data are correct. On your home screen, you see the order button, see 2.1 Screen elements. If you delete the inbox and the outbox, the order button disappears from the home screen. Order/Result Interface Order/Result Interface Protocol active GDT Inbox Location smb://example/vivatmo/inbox Outbox Location smb://example/vivatmo/outbox Username Password Communication Test Praxis-admin-1 Positive S A V E Settings 61 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishInboxEnter Inbox Location DoneUsernameEnter Username Done Settings 6.5.8 Export and Backup file configuration You can export data from patient records (see 5.1 Patient records) or backup the entire measurement and patient data (see 6.7 Data backup) to a defined storage location. The storage location can rather be a USB drive or a network drive. Export files of a patient can be identified by the time stamp and the patient name. Export data are transmitted unencrpyted. The backup file is stored encrypted and can be imported to the same basestation only. For configuration follow the configuration wizard:
Export-/Backupfile Configuration Configure Export-/Backupfile Language Show Configuration 1. On the Administration screen, select Network and Interfaces. 2. On the Network and Interfaces screen, select Location for Export/Backup. Export-/Backupfile Configuration 3. Select Configure Export/Backup File to change the settings. 4. In accordance to IT definitions in your organization, define the location for the storage of the export and backup files on USB or network drive. End the location path always with /-symbol. USB Network 62 D o n e Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect Export and Backup Drive Export-/Backupfile Configuration 5. Select CSV or PDF as export format. The settings for the Location for Export/Backup are displayed. 6. Check the data and confirm with SAVE button when the data are correct. PDF CSV D o n e 6.5.9 Vivasuite configuration Vivasuite is the digital Vivatmo ecosystem allowing use of services such as device management and remote software update. Vivasuite runs in the Bosch IoT Cloud and applies highest standards regarding IT security and data privacy. The Vivasuite service is 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:
CONNECT WITH VIVASUITE account. 1. Vivasuite: Register an account on www.bosch-vivasuite.com and log into your Connect your device to our connectivity solution and benefit from vauable add-on ser vices. Registration is required to download the newest software updates to your device. C O N N E C T N O W 2. Vivatmo pro: On the Administration Screen select Network/Interfaces. On the Network/Interfaces screen, select Vivasuite configuration. 3. Vivatmo pro: Click through introduction and configure your network connection
(for details see 6.5.6 Network configuration) until devices show screen with the pairing code. Settings 63 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect File Format (Export only) Settings Visit our website at www.Bosch-Vivasuite.com from a destop, tablet or smar tphone. Create an account to pair your device with the following pairung code :
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:
1. Vivatmo pro: On the Network/Interfaces screen, select Vivasuite Connection Status Connected 2. Vivatmo pro: Select Disconnect. You are asked to confirm before device gets Vivasuite Configuration Language D I S C O N N E C T Configuration. disconnected. 64 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishCode expires after 60 min 4 C O N T I N U E 6.6 User administration User Accounts Language A D D N E W U S E R 1. On the Administration screen, select User Administration. Access control by user accounts can be disabled by the button
. U S E R A D M I N I S T R AT I O N Maintain a high security standard and raise comfor t 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 settings are kept for later use. See also 3.2.1 User concept. Add new user For adding a new user, follow the configuration wizard:
1. On the User Accounts screen, select the + ADD NEW USER button. Settings 65 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishOona Pakarinen-KattilakoskiProfessionalKonsta HaapakoskiProfessionalJeppe M. GregersendanAdministrator Settings Administrator Professional Q W E R T Y U I O P A S D F G H J K L Z X C V B N M
. ? 1 2 3 1 4 7 3 6 9 2 5 8 0 66 New User Account 2. Select the desired user type, see 3.2.1 User concept:
Administrator Professional D o n e Professional Account 3. Enter the name of the user. Professional Account 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. Confirm with DONE. The user is successfully added. Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishSelect Usertype1/4UsernameEnter Username Done2/4PasscodeEnter 4-digit Passcode 3/4Done C O N T I N U E 4 4 Editing and reset user accounts 1. On the User Accounts screen, select the user you want to edit. C O N T I N U E 3. Enter your changes to user name and passcode. 2. Select the Pencil button. 4. Confirm with DONE. 4 C O N T I N U E Enable/Disable user account Deleting user accounts 1. On the User Accounts screen, select the user you want to enable/disable. 2. Select the Enable/Disable user button. When lock is open, the user access is enabled. 1. On the User Accounts screen, select the user you want to delete. 2. Select the Delete button. The account is deleted. Settings 67 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Data backup stores the entire measurement and patient data encrypted at the defined storage location, see 6.5.8 Export and Backup file configuration. Due to the encryption mechanism the Backup data can be imported to the same basestation only. The import of the backup overwrites the data stored on the basestation. 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 Fractures in the housing and ingress of spray, moisture or liquid may cause malfunction to the Vivatmo pro and disposable mouthpiece. Maintenance and trouble shooting 6.7 Data backup Data Backup Language Create Backup Import Backup 7.1 Maintenance WARNING 68 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish The Vivatmo pro is easy to maintain. Clean the device in accordance with the hygienic standards of your organization. Maintenance and trouble shooting Cleaning and Disinfecting 1. Turn off the device. Wash hands thoroughly with soap and water. 2. Wipe the entire Vivatmo pro with alcohol disinfectant wipes with maximum 30 % alcohol, e.g., Caviwipes1 (Metrex), Mikrobac Tissues (Bode Chemie GmbH) or mikrozid universal wipes (Schlke & 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 manufacturers instructions for disinfecting. 7.2 Status information handheld 4 C O N T I N U E Your handheld 234094758 is connected 29 Successful measurements QC Status valid 4755 Measurement trials left 01.01.2018 Latest QC date The number of measurement trials you can perform with one Vivatmo pro handheld is limited. 1. Slide up the handheld connected icon to view the number of trials left. 2. If required, change the handheld, see 6.5.4 Assigning the handheld. 69 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Maintenance and trouble shooting 7.3 Reconditioning Vivatmo pro performs an automatic stability check with the first measurement of the day: If the Vivatmo pro device has been stored in a warm and humid environment or has not been in use for a longer time, the wrench symbol may appear on the bases-
tation and the handheld. Reconditioning is required to provide consistent measurement performance. In this case the wrench symbol appears during the regeneration process on the screen and the device automatically starts 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 is shown during all activities:
If E-6 and the blinking battery symbol appear during reconditioning, remove the mouthpiece and place the handheld on the basestation for 2-3h for charging. Re-attach the mouthpiece afterwards to continue reconditioning. Change the disposable mouthpiece if the Invalid mouthpiece screen appears during reconditioning. If you push the ON/OFF button, OFF appears as long as the reconditioning is active. 70 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Maintenance and trouble shooting 7.4 Remote Software Update When the Vivatmo pro is connected to Vivasuite (see 6.5.9 Vivasuite configuration) new software updates will automatically be available on the device. The device administrator always has full control over new software updates. A notification informs about the availablitiy of a new software update and the administrator can perform the software update whenever it fits the schedule. New update available Vivalytic Reviosion 2.3.0 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 I N S T A L L N O W 1. A Notification is shown when a new software update is available. 2. Select the notification icon on the dashboard and select the New Software Update notification. start the Software Update. automatically. 3. Carefully read the Release Notes on the Details Screen. Press Install Now to 4. When the Software Update is completed the basestation will restart 71 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglishUpdates can only be installed by AdminsRevision 2.2.0Installed Maintenance and trouble shooting 7.5 Trouble shooting 7.5.1 Wrong or forgotten passcode F O R G O T P A S S C O D E Please contact an administrator or your ser vice 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 by a service technician. 72 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 7.5.2 Trouble shooting handheld Display Description Solution Maintenance and trouble shooting Regeneration is ongoing. Battery is almost empty. Wait for the purging to be completed. Do not remove the mouthpiece. Charge the handheld on the basestation cradle, see 3.1 Installing the handheld. Disposable mouthpiece is not valid. Exchange the mouthpiece and take a new one from the package, see 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 7.2 Status information hand-
held. Number of permissible measurement trials reached. Device does not perform any measurements after maximum number of permissible tests is reached. Connect a new Vivatmo pro handheld and dispose of the old one, see chapter 8.1 Disposing the Vivatmo pro device and the battery. 73 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Maintenance and trouble shooting Display Description Solution Humidity in device too high. Check ambient conditions and take a new mouthpiece. Ambient temperature and air pressure
(altitude) is outside the specified range. Use the Vivatmo pro in a location with permissible ambient conditions. Battery is too weak for measurement. Place the device on the basestation for charging. When transporting the device from one place to another, a stabilization period of at least 20 minutes should be observed before use. System self-test failed. Regeneration 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 error persits and/or change the battery. If the error persists, contact your distribution partner. Press the ENTER button to repeat the regeneration. If the errors persists, contact your distribution partner. 74 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 8 Disposal 8.1 Disposing the Vivatmo pro device and the battery Delete data on your device prior to disposal or service returns ,see 6.5.1 Factory Reset and 6.5.5 Release the handheld. For the purpose of disposal, please separate this device from other waste to prevent possible harm to the environment or human health from uncontrolled waste disposal. 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 compliance with the European directive 2006/66/EC). 8.2 Disposing the mouthpiece The mouthpiece is a single-use product. It contains small quantities of potassium permanganate KMnO4. Use a new mouthpiece for each measurement and dispose of the used one in contaminated patient waste. Disposal 75 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Technical data 9 Technical data 9.1 Device data Model Applied part Data transfer Basestation Display basestation Weight Dimensions Electrical safety Wireless charging 76 Operating conditons temperature / humidity
+15 C to +27 C / 15 % to 60 % relative humidity (non-condensing) Vivatmo pro Type B as per EN 60601-1 for handheld and disposable mouthpiece when attached Air pressure range 780 hPa to 1,100 hPa, corresponds to 0 - 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 Ethernet 10/100MB, WLAN 2.4 GHz b/g/n; internal: Bluetooth Smart (low energy), 2.4 GHz Catalogue number F09G100168 7 inch 16:10, 1024 x 600 pixel touchscreen 1350 g 265 x 213 x 160 mm ME device with external supply, tested according to EN 60601-1, IP20 for basic safety Charging w/ constant current up to 220 mA followed by constant voltage up to 4.2 V stopping when fully charged Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Technical data Power supply (accessory) Model type Input voltage Output power range Output voltage Handheld Measuring range Linearity UE electronic UE36LCP-240150SPA or DONGGUAN UES36LCP-240150SPA 100 240 VAC, 1.0 A, 50 60 Hz
< 25 W 24 V Catalogue number F09G100078 8 ppb to 300 ppb r2 0.99, slope 1.00 0.05 , intercept +/- 5 ppb Accuracy for 10 second measurement mode Precision for 10 second measurement mode 5 ppb below 50 ppb, 10 % for 50 ppb, 15 % for 160 ppb expressed as the upper/lower confidence limit of 95%
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 Electrical safety Customized rechargeable Li-ion battery F09G100314, 3.6 V, battery: accessory; compartment lid: detachable part ME device with internal supply, tested according to EN 60601-1, IP20 for basic safety Maximum surface temperature 58 C, touch time < 60 seconds Electromagnetic emissions CISPR 11 Group 1 (battery operated) 77 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Electromagnetic immunity IEC 61000-4-2, IEC 61000-4-3 (battery operated), IEC 61000-4-8 Chemical field-effect transistor Bluetooth Smart (low energy), 2.4 GHz frequency band 170 g 4.0 cm x 5.4 cm x 22.4 cm 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 following substances of the actual candidate list of the EU REACH regulation 1907/2006 in a concentration above 0.1 %: Lead-monoxide. Technical data Sensor Data transfer Weight Dimensions Lifetime 78 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish 9.2 Device Performance Linearity Device E8E8B712E469 E8E8B714CC4D E8E8B710F568 E8E8B711FDEE Analytical Precision R^2 0.999 0.995 0.996 0.995 Four Vivatmo pro devices were tested as part of the linearity study. Nitric oxide (NO) was mixed in a balance gas of air to obtain NO concentration levels between 8 to 300 ppb. The data showed that the test is linear across this range. The results are listed in the table below. Slope 1.04 1.01 1.01 1.00 Intercept
-1.88 ppb 0.63 ppb 0.62 ppb 1.53 ppb 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 one run. Precision describes the variation between runs and days. Device 124480 124710 136720 Repeatibility Within-device Precision 25 ppb 50 ppb 200 ppb 25 ppb 50 ppb 200 ppb 1.47 1.22 1.42 1.88 1.77 1.83 3.21%
3.33%
3.16%
1.98 1.83 1.87 2.48 2.67 2.70 5.66%
6.50%
6.43%
Technical data 79 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Technical data 9.3 Symbols 80 Temperature range Application range air pressure Application range humidity Serial number Manufacturer address Catalogue number The IVD product meets the requirements of applicable European directives. Read instructions for use carefully Applied part type B as per EN 60601-1 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 Date of manufacture YYYY-MM-DD Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Batch number For single use only Electrical safety class II Direct current Regulatory compliance mark Australia For Prescription Use E514097 Medical - General medical equipment 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 statutory provisions on warranty rights in consumer goods sales in the country of purchase shall apply. Technical data 81 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Manufacturer 10 Manufacturer Bosch Healthcare Solutions GmbH Stuttgarter Str. 130 71332 Waiblingen, Germany E-Mail: info@vivatmo.com Internet: www.vivatmo.com 11 Appendix 11.1 Electromagnetic compatibility Important information regarding electromagnetic compatibility (EMC) This device complies with Part 15 of the FCC Rules and contains license-exempt transmitter(s)/receiver(s) that comply with In-
novation, Science and Economic Development Canadas 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. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes: (1) lappareil ne doit pas produire de brouillage, et (2) lappareil doit accepter tout brouillage radiolectri-
que subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 82 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish This radio transmitter (ISED certification number: 25982-VMPHH1 and 25928-VMPBS1) has been approved by Industry Canada to operate with the antenna types listed with the maximum permissible gain indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device. Le prsent metteur radio (ISED certification number: 25982-VMPHH1 and 25928-VMPBS1) a t approuv par Industrie Can-
ada pour fonctionner avec les types dantenne numrs ci-dessous et ayant un gain admissible maximal. Les types dantenne non inclus dans cette liste, et dont le gain est suprieur au gain maximal indiqu, sont strictement interdits pour lexploitation de lmetteur. RF Exposure Information: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Caution: Any changes or modications to this device not explicitly approved by manu-
facturer could void your authority to operate this equipment. Vivatmo pro complies with EN60601-1-2:2015 with the objective to avoid insecure product situations. This standards regulate the levels of immunity against electromagnetic interferences and the maximum electromagnetic emission values for medical equipment. Vivatmo pro manufactured by the company complies with the standard guidance and manufacturers declaration electromagnetic emissions EN60601-1-2:2015 both in terms of immunity and of emissions and does therefore not need any service and maintenance regarding EMC and ESD over lifetime. Vivatmo pro basestations with a date of manufacture before 1st November 2018 comply with EN 61326-1:2013 for EMC. For manufacturers declaration regarding EMC see www.vivatmo.com. Appendix 83 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish Appendix WARNING Note that portable and mobile HF communication systems may interfere with this device. Do not staple or use the device close to mobile phones or other devices generating electrical or electromagnetic fields. This could result in malfunction of the medical device and may create a potentially insecure situ-
ation. Portable RF communication devices (including peripherals such as antenna cables and external antennas) are not to be used closer than 30 cm next to any part of the Vivatmo pro system. The Vivatmo pro is intended for use in professional healthcare facility environment. The customer 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 evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system. 11.2 Compliant cables WARNING 84 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish The following list shows cables, transducers, and other applicable accessories with which Bosch Healthcare Solutions claims EMC compliance. Ethernet cable, 3 m, shielded USB cable, 3 m, shielded 11.3 Literature Supplied accessories do not affect EMC compliance.
[1]
[2]
ATS & ERS: 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. 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 License Terms for End Users The following License Terms apply to your use of a BOSCH Vivatmo pro device (the Bosch Product) wherein Java Runtime Environment are embedded, see www.vivatmo.com. Appendix 85 Bosch Healthcare Solutions GmbHInstructions for useEnglishEnglishEnglishEnglishEnglishEnglishEnglish
1 2 | Internal Photos | Internal Photos | 927.31 KiB | October 05 2021 / April 03 2022 | delayed release |
1 2 | External Photos | External Photos | 532.39 KiB | October 05 2021 / April 03 2022 | delayed release |
1 2 | ID Label Location Info | ID Label/Location Info | 246.47 KiB | October 05 2021 |
Vivatmo pro Handheld device Label Location of FCC and IC ID Label position on Vivatmo pro Handheld device
1 2 | FCC Confidentiality Request | Cover Letter(s) | 235.16 KiB | October 05 2021 |
CONFIDENTIALITY REQUEST for Certification Service in USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 2021-05-19 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commission's Rules (47 C.F.R.) and Section 552(b) (4) of the Freedom of Information Act, we requests confidentiality for the following products:
FCC ID Model name 2AVQ9VMPHH1 Vivatmo pro (Handheld) For the product stated above, we request that the following information be held confidential;
Exhibits Long-Term Short-Term Short-Term Confidentiality Confidentiality Confidentiality Days External Photos &X 180 Internal Photos X 180 Block Diagram xX]
Schematics, Parts List hs]
Test Setup Photos xX 180 Users Manual Xx 180 Operational Descriptions i]
The long-term confidentiality exhibits contain our trade secrets and proprietary information that could be of benefit to our competitors. The short-term confidentiality on the basis of ensuring that business sensitive information remains confidential until the actual marketing of our new device. If you have any questions, please feel free to contact me at the address shown below. nero,
(Signed) Name / Title: Markus Thiirsam; CTO Company: Bosch Healthcare Solutions GmbH Address: Stuttgarter StraRe 130, 71332 Waiblingen, Germany Phone: +49 711 81158301 Fax: +49 711 811-58276 E-Mail: Markus. Thuersam@de.bosch.com
1 2 | Test Setup Photos 15B | Test Setup Photos | 409.76 KiB | October 05 2021 / April 03 2022 | delayed release |
1 2 | Test Setup Photos BLE | Test Setup Photos | 552.08 KiB | October 05 2021 / April 03 2022 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-10-05 | JAB - Part 15 Class B Digital Device | Original Equipment | |
2 | 2402 ~ 2480 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2021-10-05
|
||||
1 2 | Applicant's complete, legal business name |
Bosch Healthcare Solutions GmbH
|
||||
1 2 | FCC Registration Number (FRN) |
0029215837
|
||||
1 2 | Physical Address |
Stuttgarter Str. 130
|
||||
1 2 |
Waiblingen, N/A
|
|||||
1 2 |
Germany
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@cetecom.com
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2AVQ9
|
||||
1 2 | Equipment Product Code |
VMPHH1
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
M******** T********
|
||||
1 2 | Telephone Number |
+49 1********
|
||||
1 2 | Fax Number |
+49 7********
|
||||
1 2 |
M******@de.bosch.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 04/03/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | JAB - Part 15 Class B Digital Device | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | System for quantitative measurement of fractional nitric oxide (FeNO) in human breath | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power listed is peak conducted. This device is certified for portable use. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
CETECOM GmbH
|
||||
1 2 | Name |
N******** J****
|
||||
1 2 | Telephone Number |
+49 2********
|
||||
1 2 | Fax Number |
+49 2********
|
||||
1 2 |
n******@cetecom.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0010000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC