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 at the bottom of the device.
Initial information 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.
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• 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.
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 orders from electronic patient record system Manage patients, measurements and orders C O N T I N U E Welcome to Vivatmo pro C O N T I N U E Charging status handheld battery Handheld M E A S U R E...
System elements Handheld elements On the handheld, you see the following operating elements: 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.
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.
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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.
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.
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.
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.
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Installation 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.
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The User administration screen opens. C O N T I N U E 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.
0987654321 2. On the screen, select the FINISH button.The setup procedure is completed. Login When user accounts are enabled, Vivatmo pro demands authentication on the system. You have to login before you can start using the system. Instructions for use...
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The Home screen opens. Select the MEASURE button to start a measurement, see “4 Measure”. • Welcome to Vivatmo pro, Jouko Kinnunen Select the MANAGE button to manage the data, see “5 Manage”. • M E A S U R E...
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”.
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). Welcome to Vivatmo pro, Jouko Kinnunen 2. On the Home screen, select the MEASURE button. M E A S U R E...
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Measure 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 4. On the VISUALIZATION screen, select the button for the visualization you want to use, either the fish or the scale.
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.
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Repeat the measurement, see “4.2 Measurement stand-alone with the handheld”, start at point 4. Displaying stored measured values Your Vivatmo pro handheld automatically stores up to 1,000 measured FeNO values, identified by time, date and measuring ID. The measured values are stored in descending order starting with the latest.
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.
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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.
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.
Settings 6.5.7 Order/result interface 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: 1.
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.
Maintenance and trouble shooting The Vivatmo pro is easy to maintain. Clean the device in accordance with the hygienic standards of your organization. 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...
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.
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.
Vivatmo pro handheld, see “7.2 Status information hand- possible. held”. Number of permissible measurement Connect a new Vivatmo pro handheld and dispose of the old trials reached. Device does not perform one, see chapter “8.1 Disposing the Vivatmo pro device and the any measurements after maximum battery”.
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Humidity in device too high. Check ambient conditions and take a new mouthpiece. Ambient temperature and air pressure Use the Vivatmo pro in a location with permissible ambient (altitude) is outside the specified range. conditions. When transporting the device from one place to another, a stabilization period of at least 20 minutes should be observed before use.
Disposal Disposal 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.
Linearity 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.
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. Warranty The statutory provisions on warranty rights in consumer goods sales in the country of purchase shall apply.
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– 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.
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.
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. Instructions for use...
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