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Privacy Policy

RESPONSIBLE FOR THE TREATMENT
The company responsible for the processing of your data under this Privacy Policy is:

SIBEL, SAU
NIF: A08628174
Address: C / Rosselló, 500 – ground floor 08026 BARCELONA (Barcelona)
Email address: froca@sibelgroup.com
Web: www.sibelmed.es www.somnibel.eu/
Telephone: 934335452
Registered in the Mercantile Registry of Barcelona, ​​on Sheet 47.194, Folio 33, Book 3684, Registration 1st

At SIBEL, SAU, we recognize the importance of protecting your personal information and we are committed to treating it responsibly and in accordance with data protection laws.

This privacy policy aims to regulate all aspects related to the treatment of data of the different users who browse or provide their personal data through the different forms located on the web.

Personal information

A personal data is the information that identifies you or makes you identifiable. Through the web, in the boxes established for this purpose we collect the personal data that the user communicates to us: Name, surname, email, telephone, postal address, population, etc.

The user’s visit to the web does not imply that he has to provide any information about his personal data. However, if they are provided, the data will be treated in a lawful manner, subject at all times to the principles and rights set forth in the RGPD 2016/679 of April 27, 2016 and the LOPDGDD 3/2018 of December 5.

Purpose, duration and legitimacy of the treatment:

The data provided by the user will be treated for the following purposes:

Address the request or request made by the user through the contact form located on the web. We collect and process the user’s personal data in order to process and manage your request, a query or any request you make through this form. We will keep these data for the time necessary to comply with your request and for the time established by law with a minimum duration of 3 years.

The basis of legitimation of the data processing will be the consent granted by the user when selecting the acceptance box of our privacy policy before sending the request. The user has the right to revoke his consent at any time without affecting the legality of the treatment based on the consent prior to its withdrawal.

Improve your experience when browsing the web. We will keep these data as long as the user does not revoke their consent to their treatment by deleting cookies and during the time established by law with a minimum duration of 3 years.

The legitimate basis to improve your experience when browsing the web is the consent granted by the user when accepting cookies. The user has the right to revoke his consent at any time without affecting the legality of the treatment based on the consent prior to its withdrawal.

Manage our social networks and send information about our activities and products. We will keep these data as long as the user does not revoke their consent to their treatment and for the time established by law with a minimum duration of 3 years.

The legitimate basis to manage our social networks and send you our activities and news, is the consent you give us for it. The user has the right to revoke his consent at any time without affecting the legality of the treatment based on the consent prior to its withdrawal.

Transfer or communication of personal data

Your data will not be communicated or transferred to third parties unless there is any legal obligation or to those companies of the group for administrative and internal management purposes.

Data update

It is important that in order for us to keep the personal data updated, the user informs us whenever there has been any modification in them, otherwise, we are not responsible for their veracity.

The user guarantees that the personal data provided is truthful guaranteeing that all the information provided corresponds to the real situation, which is updated and accurate, being obliged to communicate any changes.

Third Party Data

If the user provides third-party data for any purpose to SIBEL, SAU, guarantees that he has obtained this data in a lawful manner, that he has previously informed those affected, obtaining his consent to communicate them and that the information provided is accurate and truthful.

Mandatory nature of the requested information

All our forms have an asterisk (*) in the mandatory data. If the user does not provide these fields, or does not check the acceptance box of the privacy policy, the sending of the information will not be allowed.

Rights of the interested parties:

You have the right to access your data and to obtain confirmation about your treatment, as well as a copy of the personal data subject to processing. You have the right to update them and request the rectification of the data that is inaccurate or request the deletion when the data is not necessary for the purposes for which they were collected. You can request the limitation in the processing of your data and oppose the processing thereof revoking your consent, as well as exercising the right to data portability. Similarly, you have the right not to be subject to decisions based solely on the automated processing of your personal data. You can exercise your rights by contacting us C / Rosselló, 500 bajo – 08026 BARCELONA (Barcelona). Email: lopd@sibelgroup.com

If you believe that your rights have not been properly addressed, you have the right to file a complaint with the Spanish Agency for Data Protection www.aepd.es

Data processing of Minors

Who provides the data through the forms on this website and accepts their treatment declares to be over 14 years of age, being prohibited access and use of the portal to minors of that age. If at any time, the Responsible detects that a child under 14 has provided personal data, we will proceed to cancel them. Likewise, parents or guardians may in any case go to SIBEL, SAU to block the access account of minors in their care who had registered falsifying their identity.

Cookies Treatment:
A cookie is a small file that is downloaded and stored on the user’s computer when it accesses a web page. Cookies allow the web, among other things, to store and retrieve information about the browsing habits of the user or their equipment and, depending on the information they contain and the way they use their equipment, they can be used to recognize the user .

The user has the option to prevent the generation of cookies, by selecting the corresponding option in their browser program. You can get more information by reading our Cookies Policy.

+00 00 000 00 00

DATOSPIR TOUCH

Description

The DATOSPIR touch spirometer has been designed by the RDI department of SIBEL, S.A.U. with the collaboration of the Pneumology Department of the “Hospital de la Santa Creu i Sant Pau de Barcelona” and the Biophysics and Bioengineering Unit of the University of Barcelona, fulfilling the standardization criteria of the ATS/ERS TASK FORCE 2005 & SEPAR.

Homologacio_isalut

The W20s Spirometry Software allows the interoperability with

SIbel_HL7

CONTACT FORM
More info Price Other
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I give my consent to SIBEL, SAU for sending information as well as the transfer of my data to the companies of the group.

Main Features

  • High resolution color touchscreen.
  • Internal printer.
  • Rechargeable battery.
  • 3 operating modes: Primary Care, Occupational Health or Diagnostic.
  • Spirometry quality control program: quality grades for tests, accuracy verification, and calibration program.
  • Modules: SpO2, MIP-MEP, Sniff and electronic weather station
  • Database with more than 3000 tests with graphs
  • Tests: FVC, VC, MVV, Bronchodilation,
  • Bronchoconstriction.
  • Simultaneous F/V and V/T graphs.
  • Adult and pediatric incentive graphs.
  • On-screen help.
  • Integrated temperature sensor.
  • Connectivity via USB, BLUETOOTH, or ETHERNET*.
  • Interoperability compatible with HL7 (spirometry CDA)**.
  • Suitable for telemedicine.
  • PIN available (In compliance with the European standards for data protection, 95/46/EC).

*Ethernet: Connectivity to the Internet for sending tests by e-mail and for remote data monitoring. **HL7: Health Level Seven is an international standard for the interoperability of health information systems. (With W20s software) CDA: Clinical Document Architecture.

Connectivities

  • USB
  • Ethernet
  • HL7
  • Bluetooth

Parameters

FVC / Bronchodilation FVC (l) FEV1 (l) FEV1/FVC (%) PEF (l/s) FEF50%(l/s) FEF25-75% (l/s) FEV6 (l) FEV1/FEV0.5 (-) PEFT Vext (l) FIVC (l) FIF50% FEF50/FIF50 QC Grades FEV.5 (l) FEV3 (l) FEV.5/FVC (%) FEV3/FVC (%) FEV1/VC (%) FEV1/FEV6 (%) FEV1/PEF (%) FEV1/FIV1 (-) PEF/PIF (-) FEF25% (l/s) FEF75% (l/s) FEF75-85% (l/s) FET25-75 (s) FET100 (s) FIV1 (l) FIV1/FIVC (%) PIF (l/s) MTT (s) MVVInd (l/min) COPD Index (%) Lung age (years) VC VC (l) TV (l) ERV (l) IRV (l) IC (l) Ti (s) Te (s) Tt (s) Ti/Tt (%) MVV MVV (l/min) Br./min (Br/min) Bronchoconstriction FVC (l) FEV1 (l) PEF (l/s) FEF25-75% (l/s) PDx Sp02 Maximum SpO2 (%) Average SpO2 (%) Minimum SpO2 (%) SpO2 Std Dev (%) Maximum PR (BPM) Average PR (BPM) Minimum PR (BPM) PR Std Dev (BPM) CT90 (%) CT80 (%) CT70 (%) ODI-4 ODI-3 ODI-2 Test time (hh:mm:ss)

Operating Modes

Occupational Health Mode (OC): Intended for occupational health clinics and insurance companies. Performs FVC and bronchodilation tests quick and easy for early detection of work-related lung diseases. Primary Care Mode (PC): Intended for Primary Care centers. Performs the main tests with interactive help in order to obtain spirometries with similar quality to the ones performed at a specialized center (Spirometry quality control). Helps to detect and follow-up most common respiratory diseases such as Asthma or COPD. Diagnostic Mode (DG): Intended for Pulmonary Function Laboratories specialized in lung diseases, providing the highest spirometry test control. It is the most complete mode that includes Bronchoconstriction Test, Occupational Health and Primary Care modes among other options.

Technical Specifications

  • Flow transducer: Fleisch, turbine or disposable (Lilly)
  • Measurement range (BTPS): Flow 0 ± 16 l/s; Volume 0 to 10 l
  • Accuracy (BTPS): Flow 5% or 200 ml/s; Volume: 3% or 50ml (ATS/ERS)
  • Dynamic resistance:
  • Display: 640 x 480 px and 5.7 inch high resolution color VGA touchscreen
  • Printer: 112 mm thermal graphic printer
  • Rechargeable battery: Ni-Mh 10.8V 2500mAh. Duration 1.5h approx.
  • No. of maneuvers per patient: 8 FVC, 8 VC, 8 MVV
  • Operating Temperature-Humidity: 5 to 40ºC. < 85% (without condensation)
  • Power supply: 100 to 240V, 50 to 60Hz
  • Power: 30W
  • Dimensions: 195 x 270 x 100 mm
  • Weight: 1.7 kg
  • Storage temperature: -20ºC to 70ºC
  • Directive: 93/42/CEE on Medical Devices, Class IIa Product
  • Standards: EN ISO 13485:2016+AC:2016, EN ISO 9001:2015, EN ISO 14971:2012, EU 2016/679, EN 60601-1:2006 +AC:2010+A11:2012+A1:2013+AC:2014, EN 60601-1-2:2015, EN ISO 10993-1: 2009+AC: 2010, EN 60601-1-6:2010+A1:2015, EN 62366:2008+A1:2015, EN ISO 26782:2009+AC:2009, EN ISO 23747:2015, EN 62304:2006+AC:2008+A1:2015, EN ISO 80601-2-61:2011, EN 60721:1995, EN 60068:1999, EN 1041:2008, EN ISO15223-1:2016, EN 980:2008.

Transducer

  • Fleisch
  • Turbine
  • Disposable

References

  • SEPAR
  • ERS
  • KNUDSON
  • CRAPO ZAPLETAL
  • MORRIS AUSTRIA GUTIERREZ
  • CASTRO-PEREIRA
  • POLGAR-WENG
  • HANKINSON – NHANES III
  • PEREZ – PADILLA
  • CRUZ-MORALES
  • GOLSHAN
  • GARCIA RIO
  • CANDELA
  • THAI 2000
  • PLATINO

Quality control program

Spirometry quality control program:

  • DATOSPIR touch includes an automatic function for spirometry quality control, based on the recommendations of the National Lung & Health Education Program (NLHEP).
  • QC Prompts: Helps the technician to provide good instructions to the patient in order to obtain high quality spirometry tests. At the end of a maneuver, an on-screen notification will inform of its acceptability.
  • QC Grades: At the end of the test, a quality grade from A to F will be shown to indicate the reliability of the results, according to the NLHEP criteria.

Accuracy verification program:

ATS/ERS 2005 recommends to check periodically volume spirometers.

In order to check that the transducer is measuring correctly, the spirometer includes a simple verification procedure, to be performed in a few seconds if required.