COMPLETE USER GUIDE
"1 minute for my heart"

01. My equipment

02. User guide

04. Indications

05. Precautions

07. Lab results entry

08. Data visualization

09. History logs

10. Notify of an absence

11. My healthcare team

12. Settings

01. MY EQUIPMENT:

• Tablet and charger 
•  A blood pressure monitor consisting of a main unit and a cuff 
• A scale
• A set of batteries 
• A quick user guide 
• The packaging box and its insert should be kept for occasional transport or when returning the equipment. 

03. INTENDED USE :

 "1 Minute For My Heart" is a software as a medical device intended for the telemonitoring of patients suffering from chronic heart failure through the collection, analysis, storage, and visualization of health data. The patient application enables the collection of your data for processing by the Newcard algorithm. 

Eligibility criteria:

Patients suffering from chronic heart failure, regardless of the type and etiology of the disease, who meet one of the following two conditions: 

1. Hospitalization within the past 12 months for a heart failure flare-up; 
2. OR currently in NYHA class 2 or higher. 

04. INDICATIONS :

Blood pressure and weight measurement are daily by default. 

The frequency of your measurements can be adapted by your cardiologist if needed. 

It should ideally be taken at rest, to ensure a reliable transcription of the data. 

 The connected tablet must be placed on a table and the scale on a flat, hard floor (no carpet or rugs). When taking your weight measurement, please make sure to set your tablet down before stepping onto the scale, so as not to distort the accuracy of your data. 

 Also ensure you have a chair to sit on while taking your blood pressure. 

Technical specifications / prerequisites :

An internet connection is required to use the application. The tablet provided by Newcard is equipped with a 4G SIM card, providing internet access. 

05. PRECAUTIONS :

This device is for personal use only. 

 The Newcard service is not an emergency service; it is not intended to replace interventions by healthcare professionals. If you have any medical questions or if your condition suddenly worsens, please contact a healthcare professional or call your local emergency services. 

THE KIT IS A LOAN GRANTED TO YOU BY NEWCARD FOR THE DURATION OF YOUR TELEMONITORING. AT THE END OF YOUR MONITORING, YOU ARE REQUIRED TO RETURN THE DEVICE PROVIDED TO YOU AS SOON AS POSSIBLE AND IN THE SAME CONDITION IN WHICH YOU RECEIVED IT. 

Preventive and routine maintenance operations: 

Newcard may modify or adapt the NEWCARD application or the General Terms and Conditions of Use. In this case, an update on your part may be required. In accordance with the Terms of Use, this update must be carried out promptly. 

Residual risks :

The software has no direct physical contact with the patient and poses no mechanical, electrical or biological risk. The residual risks identified are of a technical or software nature; although rare, they may, in certain situations, have an indirect impact on patient care. The main residual risks associated with the use of this software are described below.

• Appropriate technical and organisational measures have been put in place to ensure the platform remains available. Despite these controls, there remains a residual risk that the platform may be temporarily unavailable until it is restored (in the event of an internet connection failure, a technical error, etc.).
  
  

• The platform incorporates mechanisms designed to ensure the reliability of the alerts it generates. Nevertheless, a residual risk of alert errors—including, in particular, false positives, false negatives, duplicates or alerts not being displayed—cannot be entirely ruled out.
  
  

• Despite the controls in place, errors may occur in the transmission of patient measurements (failure to transmit data, or data that is inaccurate or unreliable).
  
  

• Newcard has implemented appropriate cybersecurity measures to ensure the security of all data transmitted. However, a residual risk of loss, alteration or unauthorised access to this data cannot be entirely ruled out. In any event, Newcard is committed to safeguarding users’ privacy and complying with applicable data protection regulations, in particular the GDPR.

06. MEASUREMENTS :

1. Turn on your tablet by pressing the small button on the right. 
2. Tap the NEWCARD icon on the screen. 
3. Tap "Take my measurements". The date of your next measurement is shown as an indication.
   
   
   
   
4. Please follow the instructions displayed on your tablet and click on "Continue demo" 
5.  Sit down and relax. Place the cuff around your left arm and adjust it.
   The red band on the cuff must be positioned over the inside of the elbow crease. 
   
6.  Place your left arm on a table with the palm of your hand facing upward. 
7.  Press the "Start / Stop" button on the blood pressure monitor.
   The cuff will inflate and then deflate. When the cuff is completely deflated, press the "M/" button. 
   
   

8.  You can still enter your blood pressure and heart rate manually by tapping "Enter my data manually". Your blood pressure and heart rate will be displayed on the tablet. Tap "Continue" 
   

9. Step onto your scale.
10. When the measurement is displayed, tap "Continue".
     You can always manually enter your weight by selecting "Enter my data manually".
    
    
11.  Answer the question: I feel the same as usual / I don't feel as well as yesterday.
    
12.  If you feel worse than yesterday, select the symptom(s) or discomfort(s) you are experiencing. 
    
    
    
    

13. Tap "Continue". Your data has been successfully sent. Select "Home screen". 
    

14. Turn off the tablet: press the power button for three seconds. A pop-up will appear: select "Shut down".

     

    07. LAB RESULTS ENTRY :

    When your cardiologist prescribes lab tests, you can enter your results into your tablet as soon as you receive them. You can only enter one lab test report per day. In the application, you can enter the date of your test and scroll through the different tabs to fill in the values shown on your lab report. 

    Lab tests are divided into tabs: 

    Biochemistry, Cardiology parameters, Hematology, and a photo of the report to make entering your results easier. 

    Your lab data will appear directly on your cardiologist's platform, where they can review it and access a dated history of your results. 

     

    1. Upon receipt of your results, you can enter them into the NEWCARD application.

    Tap: "+ Lab tests" then "Start". 

    

2. Set the date of your analysis report. To do this, select the date directly with the key or click on the calendar button to open the calendar. After selecting the correct date, tap "Continue".

3. In the application, lab tests are divided into 4 steps to make data entry easier. You will find the following sections: "Biochemistry", "Cardiology parameters", "Hematology", "Photos", and "Send". To move to the next section, tap "Continue". 

4. Each tab contains a list of fields you can complete. To scroll through the list, touch the screen and swipe up. 

Fill in the data for which you have information on your lab report. Tap the field you want to complete. The numeric keypad will appear: enter your data by tapping the corresponding numbers. When you have entered all the data you have for a category, tap "Continue" to move to the next section. 

5. Tap "Add a photo", then "Take a photo". Allow the application to access the camera. Position your results and tap "Take a photo" to capture the image. Once the photo is taken, confirm it by tapping "Continue". You can add more photos by tapping the "+". If you are not satisfied with the photo, tap "Retake photo" to try again. 

6. Once the data is entered and the photo is uploaded, you can still edit the fields. If everything looks correct, tap "Send to". 

7. Your data has been sent. Select "Home screen".  
     Turn off the tablet: press and hold the power button for three seconds. A window will open: tap "Power off". 

8. VIEWING STATISTICS :

You can access your clinical data history in the form of tables and graphs.
If you want to view your data, tap "Data" at the bottom of the home screen.

You can access your weight charts.

To return to the start, tap "Home". 

Turn off the tablet: press and hold the power button for three seconds. A window will open: tap "Power off". 

9. HISTORY LOGS :

You can also view your measurement and lab test history by scrolling down on the home screen. In the "Measurements" tab, you will find the history of your weight, blood pressure, or heart rate. 

 In the "Lab tests" tab, you can access your lab report history. Select the date you want and tap the arrow to open the lab report you entered. 

To return to the start, tap "Home". Turn off the tablet: press and hold the power button for three seconds. A window will open: tap "Power off". 

10. NOTIFY OF AN ABSENCE :

1. On the home screen, tap "Report an absence". 

2. Select the reason for your absence by tapping "Personal reason", "Hospitalization for heart condition", or "Other hospitalization". 

3. Specify your absence by selecting your departure and return dates, then tap "Send my absence". 

4. Your absence has been successfully sent. Return to the home screen by tapping "Home screen". 

11. MY HEALTHCARE TEAM :

In the "Contacts" tab on the home screen, you will find the Newcard support number and any other useful contacts. To return to the start, tap "Home". 

12. SETTINGS :

 In the "Settings" tab, you will find your connected devices, your phone number, your social security number, the option to change your password and use a PIN code, the Legal Terms of Use of the application, and the regulatory information regarding the device (the electronic label) and its version.