Carefully read all information and precautions in this manual. Make sure you understand the use, the screens and the limitations of the moveUP App before using the service. If you have any questions please contact moveUP.
For security reasons, moveUP recommends that the user carefully reads and understands the manual of the devices used in conjunction with the moveUP App.
During the full use of the service, the necessary technical assistance and therapeutical assistance will be provided. In case of a defect or problem with the App, you will be able to contact the moveUP team via the message functionality of the App, by phone or by e-mail.
Intended use
For healthcare providers
For healthcare providers, moveUP provides efficient clinical management of pathologies and treatments. With the use of moveUP, valuable insights are given to the HCP/care team of the status of the patient and its evolution.
For patients
For patients, moveUP provides personalized information and instructions to help them managing their symptoms and progress in their rehabilitation. The intensity of follow-up is adapted based on patients’ needs and timepoint in the patient pathway:
- moveUP COMPANION = monitoring and information, no active follow-up
- moveUP companion offers targeted information and evolution reports to patients. Their care team takes the evolution reports into account in their further recovery when appropriate.
- moveUP COACH = active follow-up by the healthcare team
- moveUP coach offers targeted information and evolution reports to patients. Their care team is more actively involved and takes the evolution reports into account and can provide advice and exercise suggestions through the digital platform.
- moveUP THERAPY = active follow-up by the healthcare team, with data-driven validated care protocol
- moveUP therapy offers a data-driven validated care protocol with certain categories and levels of exercises and activities, specifically targeted to the individual patient. Their care team can manually adapt the data-driven validated protocol when needed. Patients can fully rehabilitate with moveUP without leaving their home environment.
Optional functionality that can be enabled: interoperability with Class IIa continues passive motion (CPM) medical device.
For knee and hip patients who are using a Class IIa CPM medical device, moveUP can interoperate with the Class IIa CPM software. moveUP acts as a facilitator to easily assign a designated CPM exercise protocol chosen by a physician to a patient and to display the performed CPM exercises in the medical dashboard.
Intended users
moveUP is intended to be used by patients and healthcare providers.
Patient
The main user of the mobile app and patient website is the patient. Patient users should be alert, mentally competent and capable of operating a tablet/smartphone and activity tracker.
Inclusion:
- Age:
- minimum: 18 years
- maximum: no limit
- Weight: NA
- Health & condition: capable of performing basic activities of daily living
- Language: understanding one of the available languages of the app (Dutch, French, German, English)
Exclusion:
- Patients who are mentally incompetent or having trouble expressing what they are feeling (for instance, mentally diseased people, people staying in elderly care centres, …) are excluded.
- Patients who are not capable of operating a tablet/smartphone and activity tracker.
- Patients who can’t understand one of the available languages of the app (Dutch, French, German, English)
Healthcare provider
The main user of the medical web interface is a healthcare practitioner (group) or clinical researcher (group), named the care team. The care team is able to operate a web interface via web browser on PC/tablet/smartphone. The healthcare practitioner needs to understand one of the available languages of the web interface (today only available in English).
Target population / indication for use
moveUP companion & coach is used by Musculoskeletal, oncologic, respiratory, gastro-intestinal, cardiovascular and neurologic patients, such as patients:
- who underwent or planning a gastric bypass or gastric sleeve operation
- who have or had a stroke, multiple myeloma, covid, familial hypercholesterolemia
- who have or had back or joint problems or operations
moveUP therapy is used by knee & hip arthroplasty patients.
moveUP app & devices
Supported devices moveUP app
The moveUP app runs on:
- iPhones/iPads (iOS 11.0 or newer)
- Android systems (Android 7.0.0 and newer).
- moveUP needs an internet connection when in use
- moveUP is compatible with the following browsers:
- Chrome
- Safari
- Firefox
- In specific cases the following tablets are provided and are supported:
- Lenovo Tab 3 – Android 6.0.1 or Higher
- Huawei MediaPad T3 – Android 7.0.0 or higher
For your data safety please enable 2-factor authentication(2FA) and use a safe network
Activity trackers
The following activity trackers are currently recommended to include the steps in the app:
- Garmin Vivofit 3 and Vivofit 4
- Nokia Withings Go
note: you can use any activity tracker of your choice, but the steps need to be included manually.
Warnings and precautions
moveUP is not an emergency tool. In case of emergency please contact your doctor or call 112.
moveUP is not intended to monitor/treat vital parameters of critical diseases.
moveUP companion is not a replacement for any treatment you need to follow but is used as an addition.
Patients need to be aware if questionnaires are not filled out on a frequent basis or not filled out trustworthy, the care team has more difficulty knowing their health situation & evolution.
The moveUP App offers personalized healthcare based on the patient’s profile and therefore can not be shared, borrowed or traded between users. The information and advice of the moveUP application do not apply to a patient other than the one whose profile is stored in the application. The patient may not grant access to the moveUP App to third parties. Any other person can, even accidentally, send wrong information or change the profile of the patient, with the result that the moveUP-guided advice no longer corresponds to the needs of the patient.
With software, there is always a residual risk for bugs. If you have the feeling something is wrong or you don’t get a response in the app, please reach out to us via support@moveup.care or call 0800 88 008.
Contra-indications and potential side effects
There are no contra-indications or known side effects.
Notification of serious incidents
A serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
- (a) the death of a patient, user or another person,
- (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health that resulted in any of the following:
- life-threatening illness or injury,
- permanent impairment of a body structure or a body function,
- hospitalisation or prolongation of patient hospitalisation,
- medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
- chronic disease,
- (c) a serious public health threat;
If you detect any of these cases please send an email to info@moveUP.care and;
- Netherlands: meldpunt@igj.nl
- Belgium: meddev@fagg.be
- France: dedim.ugsv@ansm.sante.fr
- Germany: zlg@zlg.nrw.de
Human body contact
No human body contact with the patient or user, due to the nature of the product (software).
Accessories/products used in combination
There are no accessories.
If the patient has no compatible tablet/smartphone or activity tracker, moveUP can lease these devices to the patient. The leased devices are CE-marked devices that meet the compatibility criteria outlined in the IFU for the app.
The leased devices are not medical devices by themselves and are not accessories of moveUP. The patient can choose any compatible tablet or any activity tracker. If the activity tracker is not compatible with moveUP the patient needs to include the steps manually on the device.
Device lifetime
2-years. Depending on the willingness of the user to update the app. We sent out a notification with the recommendation to update the app, to make sure the app will keep the performance & recently included features.
Claims
moveUP companion/coach/therapy
The intensity of follow-up is adapted based on the needs of the patient, via the moveUP Symptom & QoL monitoring tool.
- Enhancement— moveUP enhances the clinical management of the patient because early detection & management of complications are possible via the symptom & QoL monitoring tool
- Efficiency—More efficient clinical management, such as the number of consultations can be reduced
- Compliance—Enforces therapy compliance/adherence
- Information—The correct information is provided at the right time
moveUP therapy
- Rehabilitation from home—With the use of moveUP therapy knee & hip arthroplasty patients can fully rehabilitate via the in-app care team without leaving their home environment.
Company details
moveUP NV
Head office Brussel: Cantersteen 47, B-1000 Brussels, Belgium Office Ghent: Oktrooiplein 1, B-9000 Ghent, Belgium
Tel: 0800 88 008
Email: info@moveUP.care
Identification of the device:
Basic UDI-DI code:
| ++G166MOVEUPV1320WL |
| If you have any questions about the App, the tablet or the activity tracker, you can contact moveUP via the following channels – in order of priority: Via the message system of the App. Via email to support@moveup.care – Via phone during office hours: +32 800 88 008 If you need the eIFU in paper format please contact moveUP and we´ll supply you a copy in paper in 7 days. moveUP supplies the IFU in electronic format due to the topology of the product (software) and the availability of the eIFU at any moment that is needed for the user. |
