Version 8 of 08 March 2024
Language: English

	Important. Read these instructions carefully before use.  Keep for future use.
	INNOVAHEALTH, L.S. Leonardo da Vinci St. 18, floor 5, module 1, 41092, Seville, Spain.
	ReHand is a class I medical device.

The following information is protected in accordance with the Intellectual Property Law

Instructions for use ReHand

Revision Level: version 8
Revision Date: 08 March 2024

MEDICAL PURPOSE: ReHand is a therapeutic exercise programme for the wrist-hand-finger segment conditions, either traumatic, orthopaedic or neurological pathology. These exercises are performed directly on a tablet device, through movements and exercises performed while touching the Tablet touchscreen. ReHand is based on the latest scientific evidence about home exercise and the sensorimotor system approach. The programme is continuously adapted to the patient depending on their condition and the evolution of their performance.

Before use, a trained healthcare professional should have confirmed that ReHand is right for you and your specific health situation.

ReHand offers structured therapy for patients with wrist-hand-finger segment conditions, either traumatic, orthopaedic or neurological pathology. The application has no measuring, diagnostic or therapeutic decision-making functions and therefore corresponds to a Class I medical device according to the Medical Device Regulation (Annex VIII, Chapter III, classification rules 6.3, Rule 11).

These instructions are intended to help and describe the intended use for the user -hereinafter user or patient- to start their treatment with ReHand. Likewise, the app presents explanatory videos at the beginning of each exercise and audio instructions, so we recommend that you use the app with the volume of your tablet device turned on and watch the videos before performing each exercise. In case your doubts are not resolved by this document, please contact us at [email protected].

WARNING: Read these instructions carefully before using ReHand. To prevent its misuse, it is necessary to obtain a prescription from a healthcare professional so the exercise program can be properly adapted to the patient’s condition.

ReHand programme can be carried out remotely at home or face-to-face in-room , with or without the direct supervision of a healthcare professional, but always under their indication and prescription.

1. The concept of ReHand

ReHand is a therapeutic exercise programme for wrist-hand-finger segment trauma, orthopaedic or neurological conditions. 

ReHand complements conventional therapies, e.g. pharmacotherapy, physiotherapy, occupational therapy or hand therapy. For example, ReHand can be used to reduce waiting time before the start of face-to-face (either in the clinic or at home as a complement to face-to-face therapy), or to continue the treatment after the end of face-to-face therapy.

WARNING: If the patients feel pain or excessive fatigue while performing the exercises or after the use of ReHand, stop the exercise and consult the healthcare professional.

The specific exercises of the programme for each patient are prescribed by their healthcare professional. These exercises are performed directly by touching and tapping the touch screen of a tablet device. This enables: the continuous adaptation of the exercises to the evolution of the patient’s abilities, the integration of a multisensory perspective in the exercise, and finally, to have an additional option for the visualisation of the patient’s exercise performance. The exercises contain video, audio and text instructions.

ReHand provides the patient with graphical data about their performance in their therapy and their adherence rate, including motivational messages for the patient in order to achieve optimal adherence levels. In addition, ReHand allows the patient to fill in the clinical questionnaires and scales that their healthcare professional has set up for them.

Progress reports can be downloaded both by the patient from the ReHand. The ReHand programme can be performed at home or in the clinic, with or without the direct supervision of a doctor, physiotherapist or therapist. Unless otherwise instructed by a healthcare professional, the ReHand exercises must be performed daily, at least three days a week. The daily execution time of the exercise programme is usually between 20-30 minutes (time per therapy unit). The duration of use depends on the type of condition and is therefore determined by the health care professional, but the duration of use is usually a maximum of 30 days.

Therapeutic exercise is the core of ReHand’s action, which also seeks to integrate the sensorimotor system approach through multisensory feedback to achieve an effect not only peripherally on the injured tissue, but also at the level of the central nervous system. Furthermore, the continuous adaptation of each of the exercises to the patient’s capabilities allows, on the one hand, to include a challenging and motivating component in the execution of the therapeutic exercise and, on the other hand, that the exercise is continuously adapted to the patient’s capabilities at each moment of his or her recovery. 

ReHand, by providing the patient with a therapeutic exercise programme, falls within the guidelines and updated scientific evidence for the treatment of these disorders, with a multitude of clinical trials demonstrating the positive effect of therapeutic exercise programmes on these disorders. Thus, ReHand’s exercises have been designed following this evidence, and have undergone previous clinical trials, demonstrating their effectiveness.

2. Intended Use

The indication for ReHand is wrist-hand-finger conditions in patients over 18 years old. The scope of such indication includes:

1. HAND, WRIST AND CARPAL FRACTURES
2. ELBOW PATHOLOGY
3. NERVE PATHOLOGY
4. SOFT TISSUE PATHOLOGY
5. DISLOCATIONS, CONTUSIONS ANS SPRAINS
6. RHEUMATIC PATHOLOGY
7. NEUROVEGETATIVE PATHOLOGY
8. PAIN
9. WOUNDS AND BURNS
10. NEUROLOGICAL PATHOLOGY

According to the results of the clinical trials conducted and the existing scientific evidence, its use would preliminarily lead to an early improvement in clinical variables such as functional ability, dexterity or strength. It has also shown improvements in other related variables, such as early return to work and fewer physiotherapy, rehabilitation or surgery consultations.

WARNING: The exercise programmes provided by the ReHand should only be performed in a safe and suitable environment.

3. Technical requirements for use and contraindications

3.1 Technical requirements of the app

In order to access the contents and resources of the Platform and all its new features, we recommend using updated browsers and operating systems.

ReHand must be used on a tablet device with an operating system equal to or higher than Android 7.0 and equal to or higher than iOS 14.0. 

ReHand must be used on a tablet device with a screen larger than 7” and a stable Internet connection in order not to limit the functionalities of the application.

In order to keep all functionalities and security systems of the ReHand in optimal condition, the user must update the application whenever it is offered. The application requires enough storage space to function correctly.

3.2 Contraindications

ReHand should not be used if any of the following contraindications exist, unless the prescriber´s clinical judgement recommends an exercise programme such as those included in ReHand app, either at-home autonomously or face-to-face supervised.

The use of ReHand is not recommended for the following diagnoses (contraindications according to ICD-10):

C41 Malignant neoplasm of bone and articular cartilage of other and unspecified sites;
C41.9 Malignant neoplasm of bone and articular cartilage, unspecified;
C71 Malignant neoplasm of brain;
C79.4 Secondary malignant neoplasm of other and unspecified parts of nervous system;
C79.5 Secondary malignant neoplasm of bone and bone marrow;
C79.9 Secondary malignant neoplasm of unspecified site;
D68 Other coagulation defects;
H54.0 Blindness, both eyes;
I01 Rheumatic fever with heart involvement;
I10 Essential (primary) hypertension;
I21 Acute myocardial infarction;
I22 Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
I24 Other acute ischemic heart diseases;
I26 Pulmonary embolism;
I80 Phlebitis and thrombophlebitis;
M00 Pyogenic arthritis;
M01 Direct infections of joint in infectious and parasitic diseases classified elsewhere;
M02 Postinfective and reactive arthropathies;
T84 Complications of internal orthopedic prosthetic devices, implants and grafts.

Acute inflammation or fever

Do not use ReHand if you have acute inflammation or fever, such as rheumatic fever, sepsis, bacterial infections or purulent arthritis.

Severe or acute disease of the cardiovascular system

Do not use ReHand if you have a serious or acute disease of the cardiovascular system such as acute myocardial infarction, acute ischaemic heart disease, high blood pressure with heart failure or hypertensive crisis.

Lung or respiratory tract disease

Do not use ReHand if you have a lung or respiratory tract disease such as pneumonia or pulmonary embolism.

Tumour diseases

Do not use ReHand if you have a tumour disease such as malignant neoplasm of bone, articular cartilage or internal organs.

Bleeding tendency, history of increased bleeding or use of anticoagulant medication

Do not use ReHand if you have a bleeding tendency, a history of increased bleeding or if you are using anticoagulant medication.

Psychiatric or cognitive disorders

Do not use ReHand if you have psychiatric or cognitive disorders or are undergoing treatment, such as psychosis.

Severe visual impairment

Do not use ReHand if you have severe visual impairment or blindness.

Complete lack of voluntary motor activity in the shoulder abductor and finger extensor muscles

Do not use ReHand if you have a complete lack of voluntary motor activity (against gravity) in the shoulder abductor and finger extensor muscles.

High levels of spasticity of the wrist, hand or fingers

Do not use ReHand if you have a high level of spasticity that prevents autonomous control of active wrist, hand or finger movements.

High baseline pain levels

Do not use ReHand if you have high levels of baseline pain.

Severe neuropathic pain not controlled with pharmacological treatment

Do not use ReHand if you have severe neuropathic pain that is not controlled with pharmacological treatment.

Other conditions not listed here may also be unsuitable for the exercise programmes included in the ReHand. Therefore, before use, prescribers should clarify whether the exercises used in the ReHand exercise programmes can be performed safely. If not, a contraindication exists.

If the disease has not stabilised with medical treatment, the prescriber should determine the best time to start the exercise programme.

3.3 Accessibility

ReHand is not barrier-free and is not suitable for visually impaired users.

4. Important safety instructions and serious incidents

4.1 Important safety instructions

WARNING: To avoid potential harm, both the prescriber and the patient must read and follow at all times the instructions provided by ReHand in this document.

WARNING: Before starting an exercise, the exercise instructions on video and in written form must be followed carefully at all times. They include essential information to perform the exercise correctly. If doubts still exist, the exercise should be stopped and consulted with the prescriber in charge.

WARNING: The therapist should guide the patient through the exercises in order to adapt the ReHand therapy to the range of motion, tolerance and speed according to the state of recovery.

WARNING: The patient must at all times answer honestly the scales and questionnaires received within the ReHand.

WARNING: Never share your ReHand account with others. Failure to do so could lead to problems.

4.2 Reporting serious incidents

Any serious incident involving ReHand (damage, injury, etc.) should be reported to us by writing directly to [email protected] and to the competent authority in the member state where you are established.

5. Initial setup

5.1 ReHand

At the beginning of the ReHand, the patient will be requested to enter an access code provided by the prescriber of the exercise programme. Once logged in, ReHand will ask the patient to add an email address and password to set up their account. In addition, your patient will be asked to enter their first name, last name and age, and to accept the terms and conditions of use, privacy policy and instructions for use. We encourage you to use “strong” passwords (passwords that use a combination of upper and lower case letters, numbers and symbols).

Once the initial account setup is complete, you will be able to use the ReHand.

6. Treatment System (ReHand)

6.1 Initial instructions

Initially, once registered in the application, the following “Program” page appears:

A pop-up appears with a warning of a new initial scale that can be found in the ‘Scales’ section.

TUTORIAL ICON

An information icon is also available on the top left of the “Program” menu. When you click on it, the initial instructions are shown. They will be displayed as you click on the “next arrow” button.

HAND SELECTION

At the top of the ‘Program’ page there is a button to select the hand you wish to view the programmed exercises for. If no exercise card appears on the screen, this means there is no exercise configured for that selected hand.

EXERCISE CARD

Each exercise is represented by a card where the type of exercise and hand to be treated is reflected in an image. The name of the exercise appears immediately below, followed by the finger/area.

DAILY REPETITIONS

To keep track of the repetitions made during the day, the crosses represent the number of daily repetitions to be made. As each repetition is performed, each cross changes to a blue tick.

LEVEL

Each blue circle represents the level of the exercise you are in. Therefore, as you perform exercises with a good score, the level of the exercise increases. On the other hand, if you perform  the exercises with a low score, the level decreases.

SPEED BAR

To level up in the exercises, it is necessary to achieve a score greater than 90 for each repetition as the speed bar increases.

Finally, we recommend activating the sound while using the application. If you have any doubts or problems, we recommend consulting the “FAQs (Frequently Asked Questions)” section by clicking on the “Account” button or to write to us at [email protected].

6.2. Exercises

Furthermore, before carrying out the exercise, the following instructions are given, complementing the text with audio messages for execution.

A. START OF ADJUSTMENT

When you click on an exercise card, you enter it and are given instructions on how to adjust the position. Before starting the adjustment, you will be given the opportunity to watch a video explaining the procedure.

B. EXPLANATORY VIDEO

The correct way to perform the adjustment and the exercise is described in the explanatory video.

C. POSITION ADJUSTMENT I

During the  first adjustment, a gif explaining how to adjust the position is displayed.

D. POSITION ADJUSTMENT II

In this first step, a position adjustment is performed. In this adjustment you have to place a certain hand-finger segment on the tablet screen and this position is recorded.

E. MOVEMENT ADJUSTMENT GIF

During  the second adjustment, a gif explaining how to make the movement adjustment is displayed.

F. MOVEMENT ADJUSTMENT

In this second step a movement adjustment is made. You must perform three times the movement of the exercise in a non-painful parameter. This non-pain range, optimal for the execution of the exercise, is recorded, and will be used later for the execution of the exercise.

G. EXERCISE EXECUTION

The exercise is carried out by moving or tapping on the screen, in the range configured by the movement adjustment. The exercise is timed and a performance score is reported based on how well the exercise was performed.

H. EXERCISE RESULT

At the end of the exercise, you will be  informed of the score obtained in the exercise.

6.3. Activity and Progress Display

Clicking on the “Progress” icon shows the page of the work carried out, where all the exercises performed are represented in a progress chart over time and each colour block corresponds to one of those exercises. Clicking on the blocks displays the name of each exercise, the hand related  to it, the number of repetitions performed, and a dashed line at the top, representing the number of daily repetitions expected throughout the treatment.

The percentage of adherence is calculated from the number of expected and performed repetitions, and shown next to the feedback messages of the application itself.

6.4 Scales

Clicking on the “Scales” button displays the screen with the scales and questionnaires available for completion. Initially you should select your dominant hand.

Once selected, you can answer the corresponding scale by clicking on the option that best represents your state.

6.5 Account

By clicking on the “Account” button, the screen with the “Settings”, “FAQs” and “Video tutorials” sections will be displayed. In addition, you will be able to access the legal documents and the instructions for use.

A. Settings

By clicking on the “Settings” button, the patient can perform actions such as changing the current password, changing the language or adjusting the size of the exercise circles.

B. FAQs

By clicking on the “FAQs” button, you will be shown a list of the most frequent situations that may cause questions during the use of the ReHand. By clicking on each of the headings, you will be able to view the content.

C. Explanatory videos

By clicking on the “Explanatory videos” button, buttons with access to the explanatory videos will be displayed.

7. Manufacturer’s data