Bosch vivatmo pro Instructions For Use Manual

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Bosch Healthcare Solutions GmbH

Stuttgarter Straße 130

71332 Waiblingen

Germany

F09G100512_01

Latest change: March 7 2024

Bosch Healthcare Solutions GmbH

Stuttgarter Straße 130

71332 Waiblingen, Germany

Instructions for use

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Page 1 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen Germany Bosch Healthcare Solutions GmbH F09G100512_01 Stuttgarter Straße 130 Instructions for use Latest change: March 7 2024 71332 Waiblingen, Germany...
Page 2 Vivatmo Oxycap...
Page 4: Table Of Contents
Content Initial information ........................Package contents Before using Vivatmo pro Safety information Intended use/Indications for use System elements ........................Screen elements Handheld elements Disposable mouthpiece Handheld display Installation ..........................Installing the handheld Installing the basestation 3.2.1 User concept 3.2.2 Onboarding Login ©...
Page 5 Manage ............................Patient records List of measurements List of measurement orders Settings ............................General settings Ambient NO Quality control (QC) 6.3.1 QC Tester qualification 6.3.2 Performing QC System information Administrator settings 6.5.1 Device settings Instructions for use © Bosch Healthcare Solutions GmbH...
Page 6 6.5.8 Export and Backup file configuration 6.5.9 Vivasuite configuration User administration Data backup Maintenance and trouble shooting ..................Maintenance Status information handheld Reconditioning Remote Software Update Trouble shooting 7.5.1 Wrong or forgotten passcode 7.5.2 Trouble shooting handheld © Bosch Healthcare Solutions GmbH Instructions for use...
Page 7 Disposal ............................Disposing the Vivatmo pro device and the battery Disposing the mouthpiece Technical data ........................... Device data Device Performance Symbols Warranty 10 Manufacturer ..........................11 Appendix ............................ 11.1 Electromagnetic compatibility 11.2 Compliant cables 11.3 Literature 11.4 License Terms for End Users Instructions for use ©...
Page 8: Initial Information
• Instructions for use • Power supply unit with connectors • 1 rechargeable lithium-ion battery Keep these Instructions for use. For frequently used functions see chapter 3, 4, 5, 7 and 8. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 9: Before Using Vivatmo Pro
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.
Page 10: Safety Information
Initial information Safety information WARNING The following conditions can cause malfunction or disturbance to the Vivatmo pro and the dispos- able 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.
Page 11 • 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.
Page 12: Intended Use/Indications For Use
(other than asthma). Vivatmo pro should not be used in critical care, emergency care or in anesthesiology. The following conditions can infl uence correct measurement of results and shall be avoided: smoking or tobacco consumption for at least 1 hour before the mea- surement, eating or drinking at least 1 hour before the measurement, especially nitrate rich food (e. g., spinach), strenuous...
Page 13: System Elements
System elements System elements Basestation frontside Basestation backside Handheld Ethernet port Charging cradle USB ports On/Off button Power adapter port Touchscreen Instructions for use © Bosch Healthcare Solutions GmbH...
Page 14: Screen Elements
Manage patients, measurements and orders C O N T I N U E C O N T I N U E Welcome to Vivatmo pro, Jouko Kinnunen Charging status handheld battery Handheld connected M E A S U R E...
Page 15 P A T I E N T R E C O R D Releases measurement result from set of Prints the current data fi le. patient data. Delete 1 8 PPB Deletes the current entry. WWWWWWWWWWWWW WWWWWWWWWWWWW 07.04.2016 11:43 WWWWWWWWWWWWW WWWWWWWWWWWWW Instructions for use © Bosch Healthcare Solutions GmbH...
Page 16: Handheld Elements
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.
Page 17: Disposable Mouthpiece
The measurement procedure is guided by an animation on the display of the basestation or the LED on the back of the hand- held. 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.
Page 18: Handheld Display
(parts per billion) Invalid disposable mouthpiece: Use a new disposable mouth piece Attach disposable mouthpiece Measurement procedure incorrect Measuring ID Time and date of the stored measurement result Device busy Device ready for measurement © Bosch Healthcare Solutions GmbH Instructions for use...
Page 19 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.
Page 20: Installation
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 fi ngers and insert the rechargeable battery into the battery compartment. Mind the triangle marks on the battery and inside the battery compartment.
Page 21: Installing The Basestation
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 deactivat- ed.
Page 22: Onboarding
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.
Page 23: Software Setup
Installation Software setup When you start your Vivatmo pro basestation for the fi rst 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.
Page 24: Administrator Account
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.
Page 25: Login
B0:72:BF:0F:E3:66 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...
Page 26 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...
Page 27: Measure
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”.
Page 28: Measurement Using The Basestation
10:44 AM 2024/03/28 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. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 29 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. 10:44 AM 2024/03/28 10:44 AM 2024/03/28 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 30 The measurement was successful. dispose the mouthpiece, see “8.2 Disposing the mouthpiece”. Please remove the mouthpiece. 10:44 AM 2024/03/28 3. Select the x to leave the Result screen. The Patient File screen opens. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 31 VISUALIZATION screen and the animation on the screen indicates that the has disappeared. Then press the Enter-button to star t a new regeneration process is ongoing. measurement. The display depends on the selected visualization, see “ Visualization and regeneration” in 4.1. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 32: Measurement Stand-Alone With The Handheld
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.
Page 33 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. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 34: Displaying Stored Measured Values
Possible interpretation of results according ATS Guideline 2011 and ATS guideline 2021, see chapter “11.3 Literature”. 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.
Page 35: Manage
Search patients, see “Searching patients”. *1976/09/20 PID 123123123 Yue Ying Lung • Edit patient data, see “Editing patients”. *2001/02/21 PID 123456789 • Delete patient data, see “Deleting patients”. 10:44 AM 10:44 AM 2024/03/28 2024/03/28 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 36 3. Select the Firstname, Lastname and Date of Birth if required, change content on the selected screen and confi rm with DONE. . ? 1 2 3 D o n e 4. The gender of the patient can be changed in a drop-down menu. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 37 3. Confi rm with DONE. A list opens that shows all patients that correspond to your search criteria. . ? 1 2 3 D o n e D o n e D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
Page 38 09: 55 AM 9 PPB 10:44 AM 2024/03/28 Deleting patients 1. In the patient list, select the Delete button. You are asked to confi rm before a patient fi le is deleted. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 39: List Of Measurements
PID: 109876876 patient record system. 2 024/02/13 unassigned 29 ppb 07:25 AM The patient is added to the list of patients on the Vivatmo pro basestation. 10:44 AM 2024/03/28 Page 1 / 3 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 40: Settings
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. G E N E R A L Welcome to Vivatmo pro, Jouko Kinnunen Welcome to Vivatmo pro, Jouko Kinnunen...
Page 41: General Settings
1. Select General Settings to change display settings. General Select Display. Language Display 10:44 AM 2024/03/28 2. Select the point and move it to set the brightness. Display Language Brightness 10:44 AM 2024/03/28 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 42: Ambient No
When the ambient NO measurement is done, you see the result on the screen. Ambient Measurement last measurement : 2024/03/12 - 07:02 AM 18 PPB The measurement was successful. 10:44 AM 2024/03/28 © Bosch Healthcare Solutions GmbH Instructions for use...
Page 43: Quality Control (Qc)
Quality control (QC) External QC tests are used to control the measurements of the Vivatmo pro handheld in comparison to reference concentra- tions of nitric oxide (NO). The system documents the tester who performs the QC tests by the user login.
Page 44: Qc Tester Qualification
The moving mean value is recalculated when the QC tester performs a new QC-measurement with- in 7 days. The qualification of a QC tester expires after 60 days. Then the qualification is suspended and the QC tester needs to qualify again, according to the qualification procedure. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 45 When the qualifi cation procedure is passed, the qualifi cation status of the QC tester is changed to Qualifi ed. The qualifi ed QC tester can perform the defi ned NO reference measurement test. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 46: Performing Qc
In the list, you see all users with their QC status. Your account is highlighted Administrator and can be selected. Konsta Haapakoski Qualified Professional If no user management is enabled only the administrator is shown in the list. Oona Pakarinen-Kattilakoski Professional 10:44 AM 2024/03/28 QC ! © Bosch Healthcare Solutions GmbH Instructions for use...
Page 47 10:44 AM 2024/03/28 QC ! QC-measurement QC tester The second reference QC-measurement is performed by a qualifi ed QC tester. For the QC tester qualifi cation procedure, see “6.3.1 QC Tester qualifi cation”. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 48: System Information
Hardware Revision 749e813d9bab... Software Revision 1.8.0 Kernel Revision 4.4.35 Firmware Revision V02.00.134 SVN Revision 230 Open Source Sovtware (OSS) OSS Written Offer License Terms for End Users 10:44 AM 2024/03/28 © Bosch Healthcare Solutions GmbH Instructions for use...
Page 49: Administrator Settings
The Device Settings screen opens for changing Language, Date and Time, Language Auto-Lock or Factory Reset. Factory Reset resets all stored data and settings. Language Date and Time Auto-Lock Factor y Reset 10:44 AM 2024/03/28 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 50: Setting The Language
2. Enter year, month and day. Enter the time and select AM or PM. Y Y Y Y M M D D 3. Confi rm with DONE. 4. Select the CONTINUE button to confi rm your settings. D o n e © Bosch Healthcare Solutions GmbH Instructions for use...
Page 51: Setting Auto-Lock
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. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 52: Quality Control (Qc) Settings
• by time: select daily, weekly, bi-weekly or Select Inter val • by number of performed measurements: select After x measurements. daily Select the Arrow Right button. weekly bi-weekly after x measurements © Bosch Healthcare Solutions GmbH Instructions for use...
Page 53 QC settings. Status Inter val after x measurements 10. Check your QC confi guration. Level 0 11. Confi rm with SAVE to save the QC confi guration. QC Tester S A V E Instructions for use © Bosch Healthcare Solutions GmbH...
Page 54: Printer Configuration
4. On the Select Printer screen, select the desired printer. HP 550 PCS 5. Select the Right Arrow to move to the Select Printer Driver screen. D O N E 6. Select the printer driver. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 55: Assigning The Handheld
3. Select the x button to close the list. 6.5.4 Assigning the handheld 1. On the Administration screen, select Network/Interfaces. Network/ Interfaces Language Assign Handheld Network Order/ Result Interface Location for Export / Backup Vivasuite Configuration 10:44 AM 2024/03/28 Instructions for use © Bosch Healthcare Solutions GmbH...
Page 56 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.
Page 57: Release The Handheld
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. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 58: Network Configuration
6.5.6 Network confi guration 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.
Page 59 Settings Supported confi guration of an ethernet connection 1. Plug in the ethernet cable in the ethernet port on the rear of the Vivatmo pro Network Configuration basestation. Select Your Networksetup 2. On the Network screen, select Confi gure Network.
Page 60 8. On the next screen, enter the WLAN Password of your WLAN. 9. Select the Right Arrow or confi rm with DONE to leave the screen. WPA2 10. Confi rm with SAVE. D O N E © Bosch Healthcare Solutions GmbH Instructions for use...
Page 61 5. Enter the IP-Address of your network and the Subnet Mask of your network. Network Configuration 6. Enter the Gateway ID. Enter IP … IP- Address 7. Select the Right arrow or confi rm with DONE to leave the screen. D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
Page 62 4. Follow steps 4 to 8 of “Supported installation of a WLAN connection”. 5. Follow step 5 to 8 of “Manual ethernet confi guration”. After a successful confi guration, the Network Confi guration screen is displayed. 6. Confi rm with SAVE. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 63: Order/Result Interface
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 net- work is confi gured. The interface standards GDT (German Data Transfer) and HL7 (Health Level 7) are supported.
Page 64 ://example/vivatmo/inbox If you delete the inbox and the outbox, the order button disappears from the home screen. Outbox smb ://example/vivatmo/outbox Username Praxis-admin-1 Password •••••••••• Communication Test Positive S A V E © Bosch Healthcare Solutions GmbH Instructions for use...
Page 65: Export And Backup File Configuration
Select Expor t and Backup Drive the storage of the export and backup fi les on USB or network drive. End the location path always with “/”-symbol. Network D O N E Instructions for use © Bosch Healthcare Solutions GmbH...
Page 66: Vivasuite Configuration
Vivasuite is the digital Vivatmo ecosystem allowing use of services such as device management and remote software up- date. Vivasuite runs in the Bosch managed Cloud and applies highest standards regarding IT security and data privacy. The Vivasuite service is not available in all countries. Ask your local distributor.
Page 67 1. Vivatmo pro: On the Network/Interfaces screen, select Vivasuite Vivasuite Configuration Confi guration. Language 2. Vivatmo pro: Select Disconnect. You are asked to confi rm before device gets Connection Status Connected disconnected. D I S C O N N E C T...
Page 68: User Administration
E N A B L E Add new user For adding a new user, follow the confi guration wizard: 1. On the User Accounts screen, select the + ADD NEW USER button. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 69 Enter 4-digit passcode Passcode step 3/4 • an 8 digit passcode for an administrator account. 5. Repeat the passcode. 6. Confi rm with DONE. The user is successfully added. D o n e Instructions for use © Bosch Healthcare Solutions GmbH...
Page 70: Deleting User Accounts
When lock is open, the user access is enabled. Deleting user accounts 1. On the User Accounts screen, select the user you want to delete. 2. Select the Delete button. The account is deleted. © Bosch Healthcare Solutions GmbH Instructions for use...
Page 71: Data Backup
The backup procedures might take up to 5 minutes. Maintenance and trouble shooting Maintenance WARNING Fractures in the housing and ingress of spray, moisture or liquid may cause malfunction to the Vivatmo pro and disposable mouthpiece. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 72: Cleaning And Disinfecting
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 % alco- hol, e.g., Caviwipes1 (Metrex), Mikrobac Tissues (Bode Chemie GmbH) or mikrozid uni-...
Page 73: Reconditioning
Reconditioning Vivatmo pro performs an automatic stability check with the fi rst 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 basestation and the handheld.
Page 74: Remote Software Update
Remote Software Update When the Vivatmo pro is connected to Vivasuite (see “6.5.9 Vivasuite confi guration”) new software updates will automatically be available on the device. The device administrator always has full control over new software updates. A notifi cation informs about the availablitiy of a new software update and the administrator can perform the software update whenever it fi ts the schedule.
Page 75: Trouble Shooting
C O N T I N U E The system needs at least 1 administrator login. If the administrator passcode is forgotten, Vivatmo pro needs to be reset by a service technician. Instructions for use © Bosch Healthcare Solutions GmbH...
Page 76: Trouble Shooting Handheld
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”.
Page 77 Solution 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 conditions. range. When transporting the device from one place to another, a stabilization period of at least 20 minutes should be observed before use.
Page 78: Disposal
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.
Page 79: Technical Data
ME device with external supply, tested according to EN 60601-1, IP20 for basic safety Wireless charging Charging w/ constant current up to 220 mA followed by constant voltage up to 4.2 V stopping when fully charged Instructions for use © Bosch Healthcare Solutions GmbH...
Page 80 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) © Bosch Healthcare Solutions GmbH Instructions for use...
Page 81: Device Performance
Linearity Three Vivatmo pro devices were tested on linearity as part of a study on accuracy. A range of contrived FeNO concentrations (in total, nine NO concentrations and a negative control) from 3 ppb to 330 ppb were tested to determine linearity. The data showed that the test is linear within the claimed range of 5–300 ppb NO, with a slope of 1.0 ±...
Page 82 Within-device precision = estimate of variation between test runs and days The precision and repeatability for Vivatmo pro is claimed to be a standard deviation of ≤ 5 ppb for readings ≤ 50ppb, and a CV of ≤ 10 % for readings > 50 ppb and ≤ 160ppb, and a CV of ≤ 15 % for readings > 160 ppb. The precision/repeatability testing performed confirmed that the precision/repeatability performance of Vivatmo pro fell within these specifications.
Page 83: Acceptance Criteria
Analytical Accuracy Three Vivatmo pro devices were tested at nine NO concentrations between 3 and 330 ppb NO with two test runs and two replicates per device per run. The data showed that mean Vivatmo pro results were within 5 ppb for NO concentrations ≤...
Page 84 Two clinical precision studies were performed with a total of 143 subjects (65 children and 78 adults). In the first study Participants were asked to obtain two Vivatmo pro measurements in two visits each for a total of N = 88 Vivatmo pro evalua- tions with 2 measurements.
Page 85 For those with elevated initial FeNO levels > 30 ppb for adults and > 25 ppb for children (total n = 95),there was a fall in mean FeNO measured by Vivatmo pro in patients with elevated FeNO levels for combined adult and pediatric treatment populations.
Page 86: Symbols
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 GmbH Instructions for use...
Page 87: Warranty
Direct current 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.
Page 88: Appendix
FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installa- tion. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with © Bosch Healthcare Solutions GmbH Instructions for use...
Page 89 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.
Page 90: Compliant Cables
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. The following list shows cables, transducers, and other applicable accessories with which Bosch Healthcare Solutions claims EMC compliance.
Page 91: License Terms For End Users
Appendix 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 “6.4 System information”. Instructions for use © Bosch Healthcare Solutions GmbH...