Manufacturer information and date of last update

Manufacturer information:
Tonic Easy Medical S.A.
Address: R. do Heroísmo, 281, Arm. 1, 4300-259 Porto, Portugal
Email: support@tonicapp.com
Website: http://www.tonicapp.io

Formal device name: Calculators & scales
Trade name: Calculadoras and scales
Basic UDI: ++G49011602A
UDI-DI: G49011600Z
UDI-PI: +$$+71.16.0/16D20240214ZF
Issuing organisation: HIBCC

Date of last update: 10.12.2025

Unique identifier: Calculadoras&escalas_EN_V1.0_10122025

  1. What are the software and hardware requirements to access the Calculators and scales module?

Compatible devices include iOS (Apple) and Android smartphones, as well as computers. An internet connection is required to use the tool, and it is recommended to keep your operating system and browser updated to the latest versions to ensure an optimal experience.

  1. Where can I access the Calculators and scales module?

You can access it through the “Calculators and Scales” section within the Tonic platform.

  1. What is the Calculators and scales model for?

The Calculators and scales module was developed to support physicians in clinical decision-making, bringing together several tools that are useful in daily clinical practice. It is not intended to replace clinical judgment, but rather to provide a practical, safe, and efficient way to perform simple medical calculations that support the physician’s decision-making process.

  1. What are the clinical benefits of the Calculators and scales module?

The module optimizes clinical care by providing efficient, standardized, and validated medical calculators and scales commonly used in clinical practice, increasing the efficiency and consistency of routine clinical calculations.

  1. How does the Calculators and scales module work? Can you give examples?

In Tonic, open the “Calculators and Scales” section and search for a calculator/scale (e.g., “CURB-65”, “BMI”, “CHA2DS2-VA”). Enter the necessary data (numerical or categorical) and select the units, if applicable. The module performs the calculation and displays the results, along with interpretation guidelines, whenever necessary.

  1. Can you give me some tips to get the highest-quality results?

Make sure that all values entered (e.g., laboratory test values, age, weight, and other clinical data) are accurate, complete, and measured correctly. Confirm the units (e.g., mg/dL or mmol/L), when applicable.
Use the calculators only for the patient population and clinical context described in the calculator instructions.
Review the bibliographic references provided in the calculator to validate their suitability for the clinical context.

  1. Can I rely on the results generated by the Calculators and scales module?

The module has been verified and validated to ensure that the calculations correspond to the expected results derived from data obtained in the medical literature. However, the module is intended to support, and not replace, your clinical judgment. The interpretation of the results should be done considering the patient’s complete clinical context.

  1. What are the limitations of the Calculators and scales module?

The module does not provide diagnoses or therapeutic decisions and should not be used as the sole basis for clinical decisions. Results depend entirely on the user’s correct data entry and its proper interpretation within the complete clinical context.

  1. What are the contraindications for using the Calculators and scales module?

The module should not be used as the sole basis for clinical decisions, as it is intended to support, not replace, clinical judgment. Additionally, it should not be used when specific patient data is unavailable or uncertain (e.g., missing laboratory results or unverified measurements). The module should not be used in emergency situations requiring immediate clinical judgment.

  1. What residual risks have been identified in using the Calculators and scales module?

Despite exhaustive design, verification, and validation processes, the following residual risks persist:

  • Misinterpretation of results: users may misinterpret the results or apply them inappropriately in clinical decision-making.
  • Data entry errors: incorrect data entry can lead to incorrect results.
  • System availability: external technical factors may temporarily affect access to the tool.
  1. What should I do if the Calculators and scales module fails?

If the tool is unavailable, ensure that the device running the tool is connected and has network access. Close and reopen the platform software to restart the tool. Report the error immediately. You can do this by sending an email to support@tonicapp.com or through the “Support and Help” button in the module’s initial window. Your feedback is very important to us.
If the problem persists, consult other reliable, properly validated alternative sources or perform the calculations manually.

  1. What is the privacy policy for the Calculators and scales module?

All data entered in the Calculators and Scales module is handled in accordance with strict privacy and security protocols to ensure the confidentiality and integrity of the information, including compliance with GDPR requirements.
For more information, please see our privacy policy: https://tonicapp.io/privacy-policy/

  1. Is there a history of my calculations?

The module can store interaction logs (e.g., usage events, calculator access, and errors) for quality assurance, monitoring, troubleshooting, and analysis purposes. It is not intended to function as a clinical record system.

  1. What should I do if a serious incident occurs related to the Calculators and scales module?

If a serious incident occurs related to the use of the tool, it is important to report it immediately to the manufacturer and the competent authority -MHRA – immediately: https://www.gov.uk/mhra. Serious incidents may include situations that cause or may cause significant harm to the health of the user or patient. This notification helps ensure the continued safety of the device and the adoption of corrective measures, if necessary.

  1. How can I access the electronic instructions for use for the Calculators and scales module?

To access the tool’s instructions for use, follow these steps:
1- Go to our website: www.tonicapp.io
2- Select your preferred language in the navigation bar
3- Scroll to the bottom of the home page
4- Click ‘Calculators and scales Instructions for Use’

If you have any difficulty, contact us at support@tonicapp.com for assistance.

To request paper instructions for use, email support@tonicapp.com with your request. The printed version of the instructions is not controlled. Please check for updates regularly by visiting the electronic instructions for use section on the website: www.tonicapp.io.

The instructions for use will be available for a period of 15 years after the last device has been placed on the market.