Safety information

This page shows the safety information of Medixine Suite 10.0 in English. If you wish to see the information in other supported languages, please select your preferred language below:

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	Medixine Suite 11 Remote monitoring platform
	Medixine Oy  Keilaranta 17 C  02150 Espoo, Finland

	Medical device		CE Mark
	Manufacturer		Consult instructions for use
	Version number		Caution
	Unique Device Identification

Intended purpose

Medixine Suite is a communication and monitoring platform for healthcare professionals and
patients enabling remote patient monitoring. It is intended to transfer, store, and monitor data from
manual input or from supported monitoring devices and identify in the collected data deviations
from the normal range. It is intended to be used for chronic or acute illnesses or conditions for non-emergency situations and non-critical patients

Limitations 

Medixine Suite is not intended to predict and respond to life-threatening changes in a patient’s condition. The device is not intended to be used for emergency situations and for critical patients. The collected data should not be used for time-critical decisions to avoid death, long-term disability, or other serious deterioration of health. 

Patient target group 

The intended patient population of Medixine Suite are patients that have a long-term condition that can be managed at least mostly at home and patients that are suspected of having a long-term condition which involves a diagnostic period that can be performed at least mostly remotely. 

Common factors of these patients are: 

• They can benefit from remote vital signs monitoring and/or remote communication with clinicians. 
• They have a long-term condition or illness that is treated or being diagnosed. 
• They are not in a critical state. 

Intended users: 

Patient users

People comfortable with taking measurements. On top of this, people who are comfortable using digital services can also log in to Medixine Suite and access the communication tools and questionnaires.
Limited users: People who are uncomfortable with technology and children under 12 are suggested to use Medixine Suite only with measurement devices or use Medixine Suite assisted by another person.

Healthcare professionals

Professionals who have a clinical degree and confidence and proficiency in using browser-based software. 

Administrators

Employees of the organization who are experienced in doing configurations and administration with browser-based software. 

Clinical benefits:

Medixine Suite enables remote follow-up and visibility for healthcare professionals to the status and measurement history of their patients, which can lead to improved treatment or aid in disease management. 

Verification of suitability

Before using Medixine Suite, verify that the software and measurement devices are suitable for the intended purpose, patient target group also considering the specified limitations for use and limited users. 

Warnings and precautions 

General 

Ensure that you have been instructed in how to use the system safely as part of the remote care
processes.
Installing the system incorrectly may cause the system to malfunction which can cause hazardous nsituations leading to harm for patients. Follow the instructions in this document closely for installation and verification of installation.
Check that the content (trackers, questionnaires, schedules, links, and documents) used in portal
programs is carefully selected by a qualified professional. This person should also ensure consistency by confirming consistent settings for all patients assigned to the specific portal program, making sure it’s well-suited for its intended purpose.
When overriding colours, make sure the accessibility requirements for colour contrast are met.

For healthcare organization users and device administrators 

Install the device hub only on Android devices approved by the manufacturer or thoroughly tested
with all Bluetooth devices.

Observe, that some patients might share the same name or date of birth. To avoid selecting the wrong patient, it’s recommended to use stable personal identifiers in addition to the name, such as date of birth, and the personal identity code.

Ensure that any measurement limits used for remote monitoring of patients are appropriate for the patient’s condition and state.

Make sure you assign the correct program to the right patient. Make sure the program is suitable for the person you are assigning it to.

When handing over measurement devices to a patient, ensure that they are capable of operating the devices and that the devices have been correctly configured by taking test measurements together with the patient.

Please note that the remote monitoring devices are intended for personal use only. Any measurements taken will automatically be transferred to the professionals and linked to the information of the individual to whom the device is assigned to.

Choosing not to set measurement limits may result in insufficient patient monitoring, which could delay the detection of critical health conditions.

A patient’s measurement limit requirements may change over time due to changes in their health condition, treatment goals, or updates to clinical guidelines. Regularly review and adjust limits as needed to ensure accurate monitoring.

For patient users 

If your condition has worsened or you suspect that you require a professional’s help, immediately contact your healthcare provider or local emergency service. 

If you do not feel comfortable using the devices, ask a health care professional for instructions on how to operate the devices. 

Please note that the remote monitoring devices are intended for personal use only. Any measurements taken will automatically be transferred to the professionals and linked to your personal record. 

Other notices for use 

Medixine Suite is best used on the following browsers: Google Chrome, Microsoft Edge and Apple Safari 

Any serious incidents that may have caused harm or potential harm for a patient’s health must be reported to the manufacturer (info@medixine.com) and your local competent authority. 

Supported monitoring devices: