Gloreha Professional 2

Transcription

1 User Manual Gloreha Professional 2 &Gloreha Active Package (December 2017 Review F)

2 2 Summary 1. Description of Gloreha Professional Description of Gloreha and GAP The Essential Accessories for Operation The Optional Accessories Legend of Symbols Used Information on Gloreha use Instructions Clinical Benefits Application Contraindications Possible Undesired Effects Safety Precautions and Warnings Switch On and Off Gloreha Switch On Gloreha Switch Off Gloreha Add a New Patient Choose the Sizes of Gloreha Brace and Gloreha Glove Choose the Size of Gloreha Sensor Glove Add a New Patient Prepare the Patient for Therapy A. Prepare the Patient for Passive Mobilisation B. Prepare the Patient for Interactive Games C. Prepare the Patient for Active-Assisted Mobilisation D. Prepare the Patient for Bilateral Therapy Program the Therapy... 47

3 3 7A. Program Passive Mobilisation A.1. Select the Passive Exercises A.2. Define the Settings for Each Exercise A.2.1. Set the Joint Range of Motion A.2.2. Set the Effects A Background Effect A Audio Effect A D Preview Effect A Start & End Effect A Step by Step Effect A Movie Effect A.2.3. See a Preview of the Effects A.2.4. Set the 3D Hand Viewpoint A.2.5. Run a Patient Test A.2.6. Set the Custom exercise B. Program the Interactive Games B.1. Calibrate the Sensor Glove B.2. Select the Interactive Games B.3. Define the Settings for Each Active Game B.3.1. Set the effects B Audio Effect B Start & End Effect B Movie effect C. Program Active-Assisted Mobilisation C.1. Calibrate the Sensor Glove C.2. Select Active-Assisted Exercises C.3. Define the Settings for Each Active-Assisted Exercise C.3.1. Set the Joint Range of Motion C.3.2. Set the Effects C Audio Effect

4 4 7C Start & End Effect C Step by Step Effect C Movie Effect D. Program Bilateral Therapy D.1. Calibrate the Sensor Glove D.2. Select Bilateral Exercises D.3. Define the Settings for Each Bilateral Exercise D.3.1. Set the Joint Range of Motion D.3.2. Set the Effects D Audio Effect D Start & End Effect C Movie effect Perform the Therapy A. Perform Passive Mobilisation A.1. Vary the Settings of the Exercise in Progress A.2. Activate the Emergency Button A.3. End Therapy B. Play the Interactive Games B.1. Vary the Settings of the Game in Progress B.2. End Therapy C. Perform Active-Assisted Mobilisation C.1. Vary the Settings of the Exercise in Progress C.2. Activate the Emergency Button C.3. End Therapy D. Perform Bilateral Therapy D.1. Vary the Settings of the Exercise in Progress D.2. Activate the Emergency Button D.3. End Therapy

5 5 9. Other Software Functionalities Display and Edit the Patient's Data Delete a Patient Edit the List of Diseases Add a New Therapist Change Exercise Order Export a Patient Export a Patient on a USB Pen Export a Patient on Cloud Import a Patient Import a Patient from a USB Pen Import a Patient from Cloud Assess the Progress of a Patient and Create a pdf/xls Report Use the "Patient" Profile How to Apply Optional Accessories Gloreha Splint Gloreha SAS (Static Arm Support) Gloreha DAS (Dynamic Arm Support) Install Gloreha DAS Use Gloreha DAS: adjust the force Use Gloreha DAS: position the patient's arm Reposition Gloreha DAS after use Clean Gloreha DAS Gloreha Loop Personalise Gloreha Glove Problems and Errors Installation and Transport Cleaning and Care Cleaning and Care of the Chassis

6 Cleaning and Care of the Gloreha Brace and Gloreha Glove Cleaning and Care of the Gloreha Sensor Glove Cleaning and Care of the Gloreha Thimble Spare Parts and Maintenance Warranty Technical Specifications Contacts and Technical Support Appendix Sheet to Measure Hand Size Order Form for Gloreha Accessories Accidents and Problems Notification Form

7 7 1. Description of Gloreha Professional 2 Gloreha Professional 2 (herein abbreviated to: Gloreha) is a neuromotor rehabilitation support device: electrically powered, it mobilises the metacarpophalangeal, proximal interphalangeal and distal interphalangeal finger joints. Gloreha is a product by Idrogenet Srl, pursuant to Directive 1993/42/EEC on Medical Devices (and subsequent amendments). Gloreha is the result of years of research and design, involving doctors, physiotherapists, engineers and university lecturers. Gloreha, thanks to its modular composition, is a highly flexible device which adapts to the patient's characteristics. The weight and dimensions of the accessories assembled on the patient's hand and forearm are negligible: these are braces and gloves specifically designed for Gloreha application, to maximise the patient's comfort and optimise flexion and extension generated by the device. During therapy, the patient's arm can move or can be freely moved in space. Gloreha enables a multitude of exercises, programmable by the therapist, to offer personalised therapy based on the patient's clinical requirements. On mobilisation, visual and sound effects are associated to stimulate the patient's neurocognitive recovery and neuronal plasticity. Gloreha enables passive mobilisation exercises to be carried out accompanied by simultaneous, three-dimensional representation on screen, functional tasks with real objects and treatments according to the Action-Observation Therapy scheme. In association with the additional, optional Gloreha Active Package module (herein abbreviated to GAP), Gloreha also enables bilateral therapies, Active-Assisted exercises and interactive games. Gloreha is a continuously evolving rehabilitation system. Our company would be happy to hear your ideas, suggestions, advice and collaboration proposals, to ensure the device is always being improved.

8 DESCRIPTION OF GLOREHA AND GAP handle regulation compartment cable bundle wheels power supply connection cable emergency button USB communication connection cable main switch

9 9 electronic board for Gloreha connection cable sensors for movement recognition

10 THE ESSENTIAL ACCESSORIES FOR OPERATION Gloreha Brace Gloreha Glove Gloreha Thimble

11 THE OPTIONAL ACCESSORIES Gloreha Splint Gloreha Loop Gloreha DAS (Dynamic Arm Support) Gloreha SAS (Static Arm Support) IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

12 LEGEND OF SYMBOLS USED Symbol Description MANUFACTURER Alongside, the name and address are provided of the manufacturer (Idrogenet Srl). BATCH NUMBER Alongside, the batch code is given. ATTENTION! Refer to the USER MANUAL. The product must be collected separately from other waste. Part applied type B. Continuous current. CLASS II device. Hand wash at 30. Do not treat with chlorine. Do not iron. Do not tumble dry. Washable with tetrachloroethylene, monofluoride trichloromethane and hydrocarbons. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

13 13 2. Information on Gloreha use 2.1. INSTRUCTIONS Gloreha is an upper limb neuromotor rehabilitation support device. In particular, Gloreha can passively mobilise the metacarpophalangeal, proximal interphalangeal and distal interphalangeal finger joints, associating a series of visual and acoustic stimuli with motor therapy, simultaneous or not. The patient, within certain limits, can actively accompany the motor exercises, also thanks to involvement generated by the software. If used in association with the GAP, the device enables bilateral, Active-Assisted or completely active exercises. For bilateral exercises, the patient can guide finger movements of the affected hand through voluntary movements of the finger on the healthy hand. Active-Assisted exercises instead allow the patient to start movements of the finger joints and complement them with a support, dynamic and measured as necessary, by the device motors. The completely active exercises, lastly, do not involve the motors on the device: in interactive games, the patient is free to move his or her fingers in a completely voluntary manner; the system, in this case, does not support the movements, but recognises and uses them to give the patient adequate feedback on screen. Gloreha is a tool made available to therapists: it assists them in their normal activities, capable of intensifying rehabilitative treatment on the patient. Gloreha can only be used by trained operators. Use of Gloreha is indicated for patients with paresis or plegia of the hand following lesions to the central nervous system (e.g. stroke, head injury) or peripheral nervous system or myelin lesions. It is also indicated in the post-operative period and in post-acute treatment of the following operations or illnesses: Reduction and synthesis of intra-articular fractures, diaphysis and metaphysis of the phalanges and the metacarpus; Stiffness due to immobilisation after stabilisation of fractures and reduced dislocation; Capsulotomy, arthrolysis and tenolysis due to post-traumatic stiffness of the metacarpophalangeal and interphalangeal joints; Tenolysis of the flexor and extensor tendons; Synovectomy of the flexor and extensor tendons; Arthrotomy; Endoprosthesis of the metacarpophalangeal and interphalangeal joints; Replantation of hands or fingers; Aponeurectomy for Dupuytren's contracture; Burns.

14 CLINICAL BENEFITS Use of Gloreha can have the following benefits: Maintenance and improvement of joint range; Prevention of adhesion, contracture, damage caused by immobilisation; Reduced pain, of the oedema and hypertonia; Proprioceptive stimulation; Improved metabolism of the joints and lymphatic and blood circulation; Maintenance of functional afference and perception of one's body; Increase coordination, dexterity and functional independence; Increased grasping and pinching strength; Improved visual-spacial and attentive capacity APPLICATION The intensity and duration of the treatment vary greatly from patient to patient: only a doctor can assess the appropriateness of Gloreha use on the individual patient, correctly defining the type of use and the timespan the treatment shall be performed. Gloreha is typically used on a temporary basis (continuous duration on the same patient under 60 minutes). Sometimes, more than one treatment session per day may be indicated. If the patient has paresis or plegia of the hand following lesions of a neurological nature, it is advised to use Gloreha from the first phase after the acute event. If the patient underwent an operation of an orthopaedic nature, it is advised to use Gloreha immediately after concluding the operation and continuing treatment without interruption for a few weeks. In any case, use of Gloreha and the use methods are conditioned by the doctor's precise instructions. Over time, the doctor must check the conditions persist to use Gloreha and, if necessary, update the instructions, until they are consistent with the patient's clinical evolution. It is important to respect the tissue strength by adjusting, as a result, the joint range of motion planned during treatment and pay attention to arising pain during the exercise.

15 CONTRAINDICATIONS Gloreha must not be used in presence of: Active and uncontrolled inflammations; Arthritis; Unstable fractures; Haemorrhages; Untreated and unprotected skin infections and lesions; Uncooperative or aggressive behaviours; Severe spasticity. Before applying Gloreha on the patient the operator must ensure non-existence of the above conditions. In the event of hypertonia, the doctor must assess with particular caution if the conditions for applicability of a continuous passive mobilisation treatment are met like those permitted by Gloreha. Even more restrictive are the requirements for use of Gloreha combined with GAP: bilateral and Active-Assisted exercises should be excluded in the presence of medium-high hypertonia and any patient who is not sufficiently collaborative and aware; the active exercises are not applicable if the patient has hypertonia and/or does not have a broad, active ROM both in flexion and extension. The above list is not exhaustive, since the doctor is responsible for assessing the applicability of Gloreha case by case, in accordance with the expected effectiveness on the specific patient POSSIBLE UNDESIRED EFFECTS During Gloreha use, the following signs and/or symptoms can occur, such as: Skin rash; Irritation; Strong sense of heat; Excess perspiration; Swelling; Haemorrhage; Increased pain; Hyperthermia; Unusual reactions. In each of these cases, you must immediately interrupt treatment.

16 16 3. Safety Precautions and Warnings Before use, carefully and fully read this user manual. Non-compliance with these instructions may cause harm to people or damage to property. If you do not have medical or paramedical training, do not access Gloreha using the "therapist" profile. If you have never used Gloreha, before treating a patient, test Gloreha on a healthy person. Only and exclusively use Gloreha on medical prescription. Do not use Gloreha on patients who present contraindications or on patients whose behaviour during therapy is unpredictable. Only use the device in premises suitable to carry out motor rehabilitation exercises, with electrical installations compliant with the requirements established by national standards in force. Position the device in a suitable place and ensure nobody can trip up when in use. Only connect Gloreha to a power socket with protective contact, installed in compliance with regulations. Only use the original power supply unit supplied by Idrogenet. Visually inspect the device is intact before using it. Do not use the device if damaged or if there are exposed electrical wires. Position the patient correctly from an ergonomic point of view. Ensure the patient does not come in contact with any part of the device, with the exception of the original accessories. The Gloreha Thimbles are in silicone: in the event of particular sensitivity or allergy, Gloreha cannot be used. The Gloreha Glove, Gloreha Brace and Gloreha Sensor Glove are flammable. Only use original accessories and spare parts, supplied by the manufacturer Idrogenet, to ensure the operator can work Gloreha as per its intended use and to avoid an increase in emission values or reduce Gloreha immunity. Supervise the patient while the therapy is in progress. While the therapy is in progress, avoid third party interference, that does not meet the safety provisions. If irritation or circulatory difficulties arises, suspend Gloreha use. Disconnect the power supply unit by removing the plug and not by grabbing it by the cable. Never place a head or any other object in the adjustment chamber. Place Gloreha back in a safe place. Do not expose any part of Gloreha to contact with water or other liquids. Do not rest any liquid containers with liquid inside on Gloreha or near Gloreha. Do not use Gloreha near water or heat sources. Do not use Gloreha near or on other electrical appliances. Regularly check all the parts, to check for any damage. If faulty, not working or malfunctioning, contact technical support. The repair and maintenance works must only be carried out by authorised people; on the contrary, any warranty and liability of Idrogenet Srl is void. Do not make changes to Gloreha, its components, wiring, software files, etc. Changes made by staff unauthorised by Idrogenet Srl can compromise the safety and functionality of Gloreha. Idrogenet Srl cannot be held in any way liable for harm to people or damage to objects if the use instructions and safety provisions in this manual are not followed.

17 4. Switch On and Off Gloreha 4.1. SWITCH ON GLOREHA To use Gloreha, you are required to use the 24V power supply unit supplied by Idrogenet. To use Gloreha you are requested to use a PC on which GSWP2 Software is correctly installed. The PC must meet the following minimum requirements: Operating system: Windows 7-64bit or higher RAM: 8GB Processor: i5, frequency 2Ghz RAM video card: 2GB Free space: 500 Mb Screen resolution: 1600x900 Dimensions on the monitor: 20 inch To switch on Gloreha, carry out the following actions as follows: 1. Connect Gloreha and the PC using the USB type B male/type A male communication cable. This cable can be inserted in any USB port on the PC. 2. If you want to use GAP, connect the electronic board for Gloreha Sinfonia (ELE0033) to the Gloreha control PC, using a USB type B male / type A male communication cable. This cable can be inserted in any USB port on the PC. To encourage use of GSG sensor gloves, and in particular passage from the right hand to the left hand, you can use a switch that enables immediate selection of the side you want to treat. 3. Switch on the PC. 4. Connect the Gloreha power supply cable to the device and put the electricity plug in the electricity socket. 5. Turn the Gloreha main switch clockwise, bringing it from position 0 to position I. When the device is on, the green led on the switch turns on.

18 18 6. Choose your profile, type the access password and press the button [V]. Therapist Profile: it is the most commonly used profile. It enables management of patient data, programming of exercises and management of therapy sessions. All the instructions that follow refer to the Therapist Profile. Patient Profile: it is the profile that is used when the therapist intends getting others (for example a nurse) to routinely start a therapy already set for a certain patient. See par. 10. Technician Profile: it is the profile used by technicians authorised by Idrogenet to conduct device maintenance.

19 SWITCH OFF GLOREHA To switch off Gloreha, carry out the following actions in sequence: 1. Press the [Esc] button, on the home page. 2. Press [Stop system] if you want to switch off the PC or [Exit program] if you want to keep the PC on. 3. Turn the Gloreha main switch anti-clockwise, bringing it from position I to position 0. When the device is off, the switch led is off. 4. Disconnect the electricity plug on the Gloreha power supply unit from the electricity socket.

20 20 5. Add a New Patient If the patient willing to undergo therapy has never had a Gloreha treatment, you firstly need to choose the most suitable glove and enter the patient's data. Instead, if the patient has been already treated with Gloreha, you can pass to par. 6. There are 4 therapy methods which can be carried out with Gloreha: Passive Mobilisation Gloreha mobilises the finger joints, even without any active mobilisation by the patient. Interactive Games The patient trains the voluntary movements of the hand through interactive games which do not require any motor support by the device. Active-Assisted Mobilisation The device recognises the patient's active movements and supports them only when necessary. Bilateral Therapy The patient moves his or her healthy hand, the device executes the same movement on the hand to rehabilitate. There are 2 types of gloves: Gloreha Brace+Glove It can only be used after inserting the mobilisation cables in the specific through-holes. It is applied in the event of passive or bilateral mobilisation. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

21 21 Gloreha Sensor Glove Size It can be used with or without the cables for mobilisation, according to the therapy methods you want to execute. It is used "free", without the mobilisation cables, for Interactive Games or Bilateral Therapy; instead, it is used with the mobilisation cables inserted in the specific through-holes for Active-Assisted Mobilisation. Based on the therapy method chosen, it is therefore necessary to use a type of glove and set a specific configuration, as outlined in the following table: Passive mobilisation Hand with Motor Deficit Healthy Hand Gloreha Brace+Glove with mobilisation cables - Interactive games Gloreha Sensor Glove Size without cables - Active-Assisted mobilisation Gloreha Sensor Glove Size with mobilisation cables - Bilateral therapy Gloreha Brace+Glove with mobilisation cables Gloreha Sensor Glove Size without cables IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

22 CHOOSE THE SIZES OF GLOREHA BRACE AND GLOREHA GLOVE Firstly, select the size of the most suitable Gloreha Brace and the Gloreha Glove. Each size is obviously available both for the right and left hand. Gloreha Brace Sizes XXS XS-S M-L XL Gloreha Glove Sizes Thimble I (thumb) Thimble II (index finger) Thimble III (middle finger) Thimble IV (ring finger) Thimble V (little finger) XXS XS S M L XL The table specifies which Gloreha Thimbles are contained in each Gloreha Glove. If the Gloreha Thimbles contained in each Gloreha Glove identified as suitable for the patient are too tight or too wide given the particular configuration of the patient's fingers, you can "personalise" the Gloreha Glove with the most suitable Gloreha Thimbles for the patient (see par. 12). Use a photocopy of the card in the appendix to make a quick choice.

23 23 Keep a specific Gloreha Brace and a specific Gloreha Glove for each patient. After the end of a whole cycle of treatment, follow the cleaning instructions (see par. 15.2), before using the same brace and glove on another patient. If you want to avoid any direct contacts with patient s skin, before wearing the Gloreha Brace and the Gloreha Glove, you can use a disposable underglove (i.e. Class I medical device. E.g. vinyl), suitable for such purpose. The size of the Gloreha Glove should be chosen so that when worn on the patient's hand and connected to the Gloreha Brace, it is not too tight. The size of the Gloreha Glove should be chosen so that when worn on the patient's hand and connected to the Gloreha Brace, the strip of "male" velcro on the Gloreha Glove is completely overlapping the strip of "female" velcro on the Gloreha Brace glove.

24 CHOOSE THE SIZE OF GLOREHA SENSOR GLOVE To identify the size of the Gloreha Sensor Glove most suitable for the patient in question, you need to consider hand length, in particular finger length, and the size (circumference) of these two. Each size is obviously available both for the right and left hand. Gloreha Sensor Glove Sizes XS S M L XL Use a photocopy of the card in the appendix, to make a quick choice. Before wearing the Gloreha Sensor Glove, disinfect the patient's hand and forearm. If you want to avoid any direct contacts with patient s skin, before wearing the Gloreha Sensor Glove, you can use a disposable underglove (i.e. Class I medical device. E.g. vinyl), suitable for such purpose. The Gloreha Sensor Glove size should be chosen so that when worn on the patient's hand, it is not tight on the patient's hand and at the same time is not too loose.

25 ADD A NEW PATIENT On the home page, select the button [Add new patient]. Enter the new patient's data: Surname; Name; Gender; Date of Birth; Hand to Rehabilitate; Brace (Tutor) Size; Glove Size (glove for index, middle, ring or little finger); Glove Size Thumb. Other than the compulsory data listed above, you can specify: Gloreha Sensor Glove Size; Gloreha DAS support level; Pathology (to edit the list of pathologies, see par. 9.3); Pathology detail (to edit the list of pathology item details, see par. 9.3); Date of Acute Event; Internal Code; Notes. The Password and First Session Date fields are generated automatically by the software, once the new patient is added. Once the new patient's data is entered, press [Save] to confirm and return to the home page.

26 26 Press [Back] to delete entering the new patient and return to the home page.

27 27 6. Prepare the Patient for Therapy Based on the therapy method you want to perform, you need to use a specific type of glove, as outlined in the table below: Hand with Motor deficit Healthy Hand Passive Mobilisation see par. 6A Gloreha Brace+Glove with mobilisation cables - Interactive games see par. 6B Gloreha Sensor Glove without cables - Active-Assisted Mobilisation see par. 6C Gloreha Sensor Glove Size with mobilisation cables - Bilateral Therapy see par. 6D Gloreha Brace+Glove with mobilisation cables Gloreha Sensor Glove Size without cables A specific sub-paragraph (A, B, C, D) illustrates the preparation procedure for each therapy (respectively: Passive, Active, Active-Assisted, Bilateral). Each procedure is composed of steps in green (compulsory) and others in grey (optional). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

28 28 Before wearing a glove, check the patient's hand and forearm have no contraindications (see par. 2.4).

29 29 6A. Prepare the Patient for Passive Mobilisation 1. LOWER THE REGULATORS Move the blue curtain covering the adjustment chamber and turn all the levers anti-clockwise (orange arrow), starting with I. Push all the cylinders (yellow arrow) down. 2. CONNECT THE CABLES TO THE GLOREHA GLOVE. Hold the patient's Gloreha Glove in your hand. Insert the cables in the through-holes, coupling the spherical head in the specific compartment at the end of the glove. Pay attention to associate each cable to the correct finger (on the finger cuff of each cable, the number is indicated of the corresponding finger (I: thumb, II: index; III: middle; IV: ring; V: little). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

30 30 3. PLACE GLOREHA SPLINT If the conditions of the patient's wrist require (in the event of highly accentuated flexor tendency of the wrist and following the doctor's instruction) you can use the Gloreha Splint accessory to keep the hand in the horizontal neutral position (par explains how to use the Gloreha Splint accessory properly). 4. WEARING THE GLOREHA BRACE Sit the patient down on a chair or a wheelchair, near Gloreha. If the patient is bed bound, move Gloreha to his/her bedside. The patient should wear the Gloreha Brace accessory on his/her forearm.

31 31 5. WEAR THE GLOREHA GLOVE The patient must wear the Gloreha Glove. Extend each patient's finger as much as possible. Fasten the Gloreha Glove to the Gloreha Brace with the velcro. Do not stretch the Gloreha Glove while coupling to the Gloreha Brace. The Gloreha Glove should be attached to the Gloreha Brace so the strip of "male" velcro on the Gloreha Glove is completely overlapped by the strip of "female" velcro on the Gloreha Brace. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

32 32 6. FASTENING THE FINGER CUFFS Insert the finger cuff in the specific bases. To facilitate positioning on the patient's hand, it may be appropriate or necessary to shorten the cables, using the specific regulators. To release the regulators, turn the levers anti-clockwise. 7. ADJUSTING THE START POSITION Before starting therapy, shorten or lengthen the cables using the specific regulators, to bring the patient's hand to the desired departure position. Adjust the departure position of the little finger by adequately raising the cylinder of the little finger (V). Once the desired position is reached, block adjustment by turning the lever of the cable for the little finger (V) clockwise. Repeat the previous operation for all the other fingers, in the following order: ring (IV), middle (III), index (II), thumb (I). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

33 33 You are advised to bring the patient's finger to a completely extended position, unless there is joint stiffness or medical instructions that suggest otherwise. You are advised to use both hands during this operation: with one hand, the therapist can use the regulators, the other can be used to check the effect of this action on the patient's finger. Shortening the cables too much may cause the patient's finger to go into hyperextension, damage and pain. Regulation of the cables should be gradually carried out and looking at the same time at the effects on the patient's hand. Excessive lengtheningg of the cables can cause the Gloreha treatment to have little effect, determining, during operation of the device, a unsatisfactory extension level. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

34 8. WEAR THE GLOREHA LOOP 34 If finger joints on the hand to treat have a high level of stiffness/spasticity, it may be useful to apply the Gloreha Loop accessories for mobilisation purposes (the par explains how to use it correctly). 9. POSITIONING THE ARM ON GLOREHA DAS If adequate, support the patient's forearm on an arm support. It is possible to choose between two types of support: Gloreha SAS (Static Arm Support) or Gloreha DAS (Dynamic Arm Support). Par and 11.3 explain how to use the Gloreha SAS and Gloreha DAS accessories properly. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

35 35 6B. Prepare the Patient for Interactive Games If the patient presents hypertonia and/or has a very limited active ROM, interactive games cannot be performed. In this case, assess the feasibility of passive mobilisation (par. 6A). 1. CONNECT THE GLOREHA SENSOR GLOVE TO THE ELECTRICAL BOARD Before placing the glove on the patient's hand, you need to connect the glove selected to the electronic board for Gloreha Sinfonia (ELE0033), using one of the two sockets (right and left), under the table beside the bases of Gloreha DAS. Ensure the socket is correctly connected before starting therapy. In case of use of a switch for selection on the side to treat (right hand or left hand), ensure the selector indicates the desired hand. 2. WEAR THE GLOREHA SENSOR GLOVE Hold the Gloreha Sensor Glove selected for the patient in your hand. Let the patient sit down on a chair or a wheelchair, in front of the PC. Ensure the sensors are not tight, loosening them to the maximum using the specific cable locks. Place the Gloreha Sensor Glove on the patient's hand, - Starting from the ends of the glove insert the fingers in the 5 thimbles. - Spread the glove over the back of the hand, beyond the wrist.

36 36 Using the two velcro covered strips, fasten the glove to the wrist, taking care to delicately tighten the glove so the elastic belt is positioned behind the wrist bone.

37 37 3. ADJUST AND TIGHTEN THE SENSORS Before starting therapy, you need to adjust the position of the sensors, ensure they are tight and firmly on each finger. This is possible thanks to the pre-assembled elastics (tightening devices): Pull the tightener on each finger, paying attention to the corresponding diagram in the following image. Fasten the position with the specific cable lock when the sensor is sufficiently tight and not bumpy.

38 38 4. POSITION THE ARM ON GLOREHA DAS If adequate, support the patient's forearm on an arm support. It is possible to choose between two types of support: Gloreha SAS (Static Arm Support) or Gloreha DAS (Dynamic Arm Support). Par and 11.3 explain how to correctly use these accessories.

39 39 6C. Prepare the Patient for Active-Assisted Mobilisation If the patient presents hypertonia and/or has a very limited active ROM and/or is not sufficiently collaborative or aware, Active-Assisted mobilisation cannot be performed. In this case, assess the feasibility of Passive Mobilisation (par. 6A). 1. CONNECT THE GLOREHA SENSOR GLOVE TO THE ELECTRICAL BOARD Before placing the glove on the patient's hand, you need to connect the glove selected to the electronic board for Gloreha Sinfonia (ELE0033), using one of the two sockets (right and left), under the table beside the basess of Gloreha DAS. Before starting therapy, ensure the socket is connected properly. In case of use of a switch for selection on the side to treat (right hand or left hand), ensure the selector indicates the desired hand. 2. LOWER THE REGULATORS Move the blue curtain covering the adjustment chamber and turn all the levers anti-clockwise (orange arrow), starting with I. Push all the cylinders (yellow arrow) down. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

40 40 3. CONNECT THE CABLES TO THE GLOREHA GLOVE Hold the patient's Gloreha Sensor Glove in your hand. Ensure the sensors are not tight, loosening them to the maximum using the specific cable locks. Insert the cables in the through-holes, coupling the spherical head in the specific compartment at the end of the glove. Pay attention to associate each cable to the correct finger (on the finger cuff of each cable, the number indicates of the corresponding finger (I: thumb, II: index; III: middle; IV: ring; V: little). 4. POSITIONING GLOREHA SPLINT If the conditions of the patient's wrist require (in the event of highly accentuated flexor tendency of the wrist and following the doctor's instruction) you can use the Gloreha Splint accessory to keep the hand in the horizontal neutral position (par explains how to use the Gloreha Splint accessory properly).

41 41 5. WEAR THE GLOREHA SENSOR GLOVE Let the patient sit down on a chair or a wheelchair, near Gloreha. Starting from the ends of the glove, insert the fingers in the 5 thimbles. Spread the glove over the back of the hand and beyond the wrist. Use the two velcro covered strips, fasten the glove to the wrist, taking care to delicately tighten the glove as to the elastic belt is positioned behind the wrist bone.

42 42 6. FASTEN THE FINGER CUFFS Insert the finger cuff in the specific bases. To facilitate positioning on the patient's hand, it may be appropriate or necessary to shorten the cables, using the specific regulators. To release the regulators, turn the levers anti-clockwise. 7. ADJUST THE STARTING POSITION Before starting therapy, shorten or lengthen the cables using the specific regulators, to bring the patient's hand to the desired starting position. Adjust the departure position of the little finger by raising the cylinder of the little finger properly (V). Once the desired position is reached, block adjustment by turning the lever of the cable for the little finger (V) clockwise. Repeat the previous operation for all the other fingers, in the following order: ring (IV), middle (III), index (II), thumb (I).

43 43 You are advised to bring the patient's finger to a completely extended position, unless there is joint stiffness or medical instructions that suggest otherwise. You are advised to use both hands during this operation: with one hand, the therapist can use the regulators, the other can be used to check the effect of this action on the patient's finger. Shortening the cables too much may cause the patient's finger to go into hyperextension, causing possible damage and pain. Regulation of the cables should be gradually carried out, while looking at the same time at the effects on the patient's hand. Excessive lengtheningg of the cables may cause the Gloreha treatment to have little effect, determining, during operation of the device, an unsatisfactory extension level. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

44 44 8. ADJUST AND TIGHTEN THE SENSORS Before starting therapy, you need to adjust the position of the sensors, ensure they are tight and firmly on each finger. This is possible thanks to the pre-assembled elastics (tightening devices): Pull the tightener on each finger, paying attention to the corresponding diagram in the following image. Fasten the position with the specific cable lock when the sensor is sufficiently tight and not bumpy.

45 45 9. PLACE THE ARM ON GLOREHA DAS If adequate, support the patient's forearm on an arm support. It is possible to choose between two types of support: Gloreha SAS (Static Arm Support) or Gloreha DAS (Dynamic Arm Support). Par and 11.3 explain how to correctly use these accessories.

46 46 6D. Prepare the Patient for Bilateral Therapy If the patient presents hypertonia of the hand with a motor deficit and/or is not sufficiently collaborative or aware, Bilateral Therapy cannot be performed. In this case, assess the feasibility of Passive Mobilisation (par. 6A). If both the patient's hands have considerable motor deficit, Bilateral Therapy cannot be performed. In this case, assess the feasibility of Passive Mobilisation on both hands, one hand at a time (par. 6A). In Bilateral Therapy, both patient's hands will be involved in the exercises: On the healthy hand (or less compromised) the Gloreha Sensor Glove as for interactive games is worn (see par. 6B); On the hand with motor deficit the Gloreha Brace+Glove are worn for Passive Mobilisation (see par. 6A).

47 47 7. Program the Therapy Firstly, you need to select the patient to treat. After selecting the patient to treat, press the button [V]. By pressing on Id (entry order) or Surname and Name, or Date of birth, or Hand, you can vary the order of patients in the list on the home page. The aim is to facilitate the search for the patient to treat. Once the patient is selected, you need to choose one of the therapy methods available:

48 48 Based on the patient's clinical conditions and the treatment purposes, you can opt for: Passive Mobilisation Gloreha mobilises the finger joints, even without any active mobilisation by the patient. If you want to program and/or implement passive mobilisation, click on the corresponding icon and pass to paragraph 7A. Interactive Games The patient trains the voluntary movements of the hand through interactive games which do not require any motor support by the device. If you want to program and/or implement interactive Calibration icon and pass to paragraph 7B. games, click on the Active-Assisted Mobilisation The device recognises the patient's active movements and supports them only when necessary. If you want to program and/or implement Active-Assisted Mobilisation, click on the Calibration icon and pass to paragraph 7C. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

49 49 Bilateral Therapy The patient moves his or her healthy hand, the device executes the same movement on the hand to rehabilitate. If you want to program and/or implement Bilateral Therapy, click on the Calibration icon and pass to paragraph 7D. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

50 50 7A. Program Passive Mobilisation 7A.1. SELECT THE PASSIVE EXERCISES The patient's personal data are summarised in the data sheet positioned in the column on the left, by clicking on "Patient". The summarised data of the therapy, as well as the connection status between the PC and Gloreha, are displayed in the data sheet positioned in the column on the left, by clicking on "Therapy". In this screen and the subsequent ones, the column on the left can be hidden by double clicking on the vertical bar that separates it from the rest of the page. Similarly, by double clicking, you can make it re-appear. The central part of the screen displays the exercises involved in the therapy. The exercises are displayed on multiple pages, easily accessible using the forward/back arrows located on the bottom. You can change the order and distribution of the exercises in the various pages, using the general settings (see par. 9.5). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

51 51 Each therapy is composed of one or more exercises, up to a maximum of 12. Single Finger Sequence Involves individual flexion and extension of the finger, in order, from thumb (I) to little finger (V). Fist Involves the following movements: Flexion of the index, middle, ring and little fingers (II, III, IV, V); Flexion of the thumb (I); Extension of the thumb (I); Extension of the index, middle, ring and little fingers (II, III, IV, V). Pinch Involves - according to the parameters selected - one of the following pinches: Thumb-index (I-II); Thumb-middle (I-III); Thumb-ring (I-IV); Thumb-little (I-V). Counting Involve functional movements for counting with fingers, from 1 to 5. Pinches Sequence Involves sequential pinching: Thumb-index (I-II); Thumb-middle (I-III); Thumb-ring (I-IV); Thumb-little (I-V). Handle Involves the following movements: Flexion and extension of the thumb (I); Flexion and extension of the index, middle, ring and little fingers (II, III, IV, V). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

52 52 Wave Involves flexion from the little finger (V) to the thumb (I) and extension from the thumb (I) to the little finger (V) to create a harmonic "wave"" effect. Single Finger Random Involves flexion and extension of each finger separately in a random sequence. Random Numbers Involves movements associated with the numbers from zero to five, in random order. Picking Objects Involves functional movements of grasping an object with two fingers (the thumb and one of the other 4 fingers). Grasping Objects Involves functional exercises of grasping an object with the whole hand. Custom Exercise Enables choosing which finger to move and in which sequence The software displays the last therapy programmed for the patient being treated. This allows the therapist to speed up preparation of the therapy: in fact, if you do not intend changing anything since the last session programmed, the therapist can directly start the therapy (see par. 8A). If you are treating a patient who has never been treated with Gloreha before, or you think the therapy should be changed, follow the instructions below carefully. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

53 53 The Therapy screen displays the exercises in the order they are performed. If there is a green [V] beside an exercise, it is included in the therapy. If there is a red [X] beside an exercise, it is excluded from the therapy. To include or exclude an exercise, press the red [X] or green [V] placed beside the exercise icon. By pressing the icon of an exercise, you go to the parameters setting screen of the exercise selected. Once the exercises accompanying the therapy have been selected, press [Save] to confirm the changes made. Press [Back] to delete the changes made and return to the home page.

54 54 7A.2. DEFINE THE SETTINGS FOR EACH EXERCISE A E I H B C F D G The settings screen of the parameters of each exercise enables the therapist to set: The joint range of motion of the individual fingers (A; see par. 7A.2.1.); The effects associated with the exercise (E; see par. 7A.2.2.); The duration of the exercise (B); The speed of finger movement (F); A delay in start of movement between two simultaneous movements (G); Pause in flexion (C); Pause in extension (D). At any time, changes made can be checked: By displaying a graphical simulation preview of the effects (H; see par. 7A.2.3);

55 55 By testing on the patient (I; see par. 7A.2.5). The Custom Exercise, enabling a personalised sequence of movements, includes further specific commands, illustrated in par. 7A Once the operating parameters are changed, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the therapy summary screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

56 56 7A.2.1. SET THE JOINT RANGE OF MOTION Move the cursor up to increase the flexion level generated on the hand by the rehabilitation glove. Move the cursor down to decrease the flexion level generated on the hand by the rehabilitation glove. The numbers on the cursors indicate an increasing value from 0 to 100, not directly referencing to the angular values. High levels of flexion could generate something similar to what shown in the picture below. This case must be avoided: during motion, the cable must not create a bend between the finger cuff and the inlet of the fabric opening. If you note a similar situation during mobilisation, decrease the flexion level of the cable: this does not cause less flexion of the patient's finger, but only better efficiency of the device. Situation to avoid!

57 57 If the cursor changes from green to yellow, the ideal joint range level is being surpassed for the patient's size. The shape of the patient's hand or the assembly method of the accessories can make it ideal to position the cursor in the "yellow range". The therapist' 's attention and caution is recommended! The Pinch Exercise consists of mobilising the thumb and another finger (index, middle, ring or little). The regulation of joint ranges takes place as follows: Choose which finger to mobilise with the thumb by clicking on one of the four buttons representing the 4 possible pinches. With reference to the two fingers selected, move the cursors up to increase the joint range of motion. With reference to the two fingers selected, move the cursors down to decrease the joint range of motion. The Sequence of Pinches consists of performing the following pinch exercisess in sequence: Thumb-index (I-II); Thumb-middle (I-III); Thumb-ring (I-IV); Thumb-little (I-V). The regulation of joint ranges takes place as follows: Choose the type of pinch by clicking buttons. on one of the four With reference to the two fingers selected, move the cursors up to increase the joint range of motion. With reference to the two fingers selected, move the cursors down to decrease the joint range of motion. Save and move to subsequent pinch regulation, repeating the actions described above. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

58 58 7A.2.2. SET THE EFFECTS Gloreha therapy includes mobilisation of fingers which can be associated with audio and visual effects that focus on multi-sensory involvement and stimulation of the patient. These effects were developed consistently with the most advanced rehabilitative methods (Action Observation Therapy, Motor Imagery, etc.) and the most recent neurophysiological research on neuronal plasticity. Background Effect It sets the background in which the 3D hand moves, associating the varied colours to different movements or displaying an evocative landscape or inserting three- dimensional objects. Audio Effect It combines the finger movements with chords or musical scales. It also enables to select a song as a musical background for the motor exercise. 3D Preview Effect It enables to set the duration of the 3D preview of the motor exercise. In fact, before the rehabilitative glove starts to mobilise the patient's fingers according to the specific exercise, the patient can view a three-dimensional hand do the same exercise on screen for one or more minutes. The 3D hand reproduces male and female traits, according to the patient's gender entered on the personal details. Start & End Effect It enables to set two messages for the patient: one for the start of the exercise and one for the end. This customisable message can be read and/or listened to by the patient. By doing so, you can pre-announce to the patient that the exercise is about to start and/or warn the patient the exercise has ended. You can also use this effect to give the patient a certain instruction. Step by Step Effect It enables to set a series of messages for the patient during therapy. For each fraction of the exercise (step), you can enter a customisable message which can be read and/or listened to by the patient. By doing so, the patient can be guided, step by step, to perform the therapy, helping him or her to recognise which finger is involved in the movement and the type of motor exercise in progress. Movie effect It enables to set the video preview of the motor exercise. In fact, before the rehabilitative glove starts to mobilise the patient's fingers according to the specific exercise, the patient can watch a video of a real hand do the same exercise on screen for one or more minutes. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

59 59 7A BACKGROUND EFFECT To set the Background effect, click on the [Background] icon on the main page of the exercise parameters adjustment. Click on the icon that represents the desired Background effect. If a [V] appears besidee a Background effect, the effect is selected. If a [X] appears besidee a Background effect, the effect is not selected. When you do not want to associate any Background effect to the exercise, select the first icon on the top left. The effects which can be set are: Shading: Background colours change during flexion and extension of the fingers: colours are more intense when fingers are extended, while more faded when the fingers are flexed. Colours: Background colours changes according to the finger that is moving. Mountain: A mountain landscape background is displayed. City: An urban landscape background is displayed. Sea: A marine landscape background is displayed. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

60 60 Dice: Beside the 3D image of the hand, a dice is displayed. number Gloreha is reproducing on the patient's hand. It indicates the same Pen holder: Beside the 3D image of the hand, a pen holder is displayed with a number of objects equal to the number Gloreha is reproducing on the patient's hand. Kitchen: The grasping action of a teaspoon is displayed in virtual reality. Office: The grasping action of a pen is displayed in virtual reality. Bathroom: The grasping action of a toothbrush is displayed in virtual reality. Bottle: The grasping action of a bottle is displayed in virtual reality. Ball: The grasping action of a ball is displayed in virtual reality. Not all the Background effects are available for all the exercises. The following table summarises the Background effects associated with each exercise: IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

61 61 Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

62 62 Once you set the desired Background effects, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

63 63 7A AUDIO EFFECT To set the Audio effect, click on the [Audio] icon on the main page of the exercise parameters adjustment. Click on the icon that represents the desired Audio effect. If a [V] appears besidee a Background effect, the effect is selected. If a [X] appears besidee a Background effect, the effect is not selected. When you do not want to associate any Audio effect to the exercise, select the first icon on the top left. The effects that can be set are: Chord: The movements of the fingers are associated with musical notes. Notes: A descending musical scale accompanies flexion of the musical scale accompanies extension of the finger. fingers, an ascending Music: It enables to add background music to the exercise, by selecting a song (mp3 file) saved on the PC. Once the Music effect is selected: Press [Folder] to try and select the mp3 file you want to associate with the exercise, that is saved on the PC. Press [Play] to listen to the selected tune. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

64 64 Press [Pause] to temporarily stop playing the selected tune. Pressing [Play] again: the tune will return from the point it was stopped. Press [Stop] to stop playing the selected tune. By pressing [Play] again, the tune will return from the beginning. Not all the Audio effects are available for all the exercises. The following Audio effects associated with each exercise: table summarises the Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom Once you have set the desired Audio effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

65 65 7A D PREVIEW EFFECT To set the 3D Preview effect, click on the [3D Preview] icon on the main page of the exercise parameters adjustment. Choose the duration of the 3D Preview with the buttons [+] and [-]. Before the motor exercise starts, the virtual simulation of the specific exercise will be reproduced for a number of minutes equal to that set. If you do not want to associate minutes. any 3D Preview effects to the exercise, set the duration to zero You can let the patient listen to and/or read a message on 3D Preview implementation. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings. If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

66 66 The 3D Preview effect is available for all exercises, with the exception of two Grasp to pinch and Grasp to fist functional exercises, as summarised in the table below: Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom Once you have set the desired 3D Preview effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

67 67 7A START & END EFFECT To set the Start & End effect, click on the [Start & End] icon on the main page of the exercise parameters adjustment. You can let the patient listen to end of each motor exercise. and/or read a message before starting and immediately after the Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings. If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Start & End effect, place an [X] beside Text and Voice. The Start & End effect is available for all exercises, as summarised in the following table: Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

68 68 Once you have set the desired Start & End effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

69 69 7A STEP BY STEP EFFECT To set the Step by Step effect, click on the [Step by step] icon on the main page of the exercise parameters adjustment. You can let the patient listen to and/or read a message before each step. A step is intended as each simultaneous motor action. for example, for the Handle exercise, the first step is to flex the thumb, the second step is to extend the thumb, the third is to flex the index finger, middle finger, ring finger and little finger, the fourth step is to extend the index, middle, ring and little fingers. Press [Step] to display the description, the text of the message and the settings of each step. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Step by Step effect, place an [X] beside Text and Voice. Press [All steps] to apply the Text and Voice settings of the message on all steps. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

70 70 Press [Only selected steps] to apply the Text and Voice settings of the message to selected steps only. To select a step, press the number under the corresponding icon until this is blue. To de-select a step, press the number under the corresponding icon until this is grey. The Step by Step effect is available for all exercises, with the exception of Custom, where a specific programming method is planned of the messages (par ). Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom Once you have set the Step by step desired effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

71 71 7A MOVIE EFFECT To set the Movie effect, click on the [Film] icon on the main page of the exercise parameters adjustment. Choose the number of repetitions with the buttons [+] and [-]. Before the motor exercise starts, the film associated with the specific exercise will be reproduced for a number of times equal to that set. The relevant field for duration (minutes) is automatically updated on the basis of the number of repetitions set. If you do not want to associate repetitions. any Movie effects to the exercise, set the duration equal to zero You can let the patient listen to and/or read a message on film reproduction. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings. If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

72 72 The Movie effect is available for all exercises, with the exception of the Custom exercise, as summarised in the following table: Single Finger Sequence Handle Fist Pinch Wave Counting Picking Objects Grasping Objects Random Numbers Single Finger Random Pinches Sequence Custom Once you have set the desired Movie effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

73 73 7A.2.3. SEE A PREVIEW OF THE EFFECTS Press the button [3D Hand] to display a preview of the effects which were set. Press the button [Viewpoint] to display the commands that allow the perspective to be changed of the 3D display of the hand (par. 7A.2.4). Press [STOP] to interrupt the preview of the set effects. Press [PLAY] to re-start the preview of the set effects. Press the [START] button to bring the 3D hand back to the starting position. The [Start] button can only be pressed after the [Stop] button. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

74 74 The graphic simulation does not precisely show the real exercise of the patient's hand: the joint range of motion may not exactly correspond to the real joint range of motion.

75 75 7A.2.4. SET THE 3D HAND VIEWPOINT Each exercise proposes the 3D hand with a particular default viewpoint. However, it is possible to change the viewpoint to: Make the image more attractive for the patient; Make the image more coherent with the real position of the patient's hand; Make the therapy more variable. While 3D animation is in progress, press the button [Viewpoint] to display the commands that allow the perspective to be changed of the 3D display of the hand Press on Camera, Wrist or Rotation to view the desired cursors. Move each cursor upwards or downwards until you reach the preferred display. For example you can turn the hand in various ways, expanding or collapsing it, vary the wrist position, etc. Once you have reached the prospective of 3D visualisation of the desired hand, press [Save] to confirm. Automatically, the Camera, Wrist and Rotation cursors disappear from the screen, and the new settings will be maintained each time the specific patient will carry out the specific exercise. Once the 3D display perspective has been selected on the desired hand, press [Viewpoint] for the Camera, Wrist and Rotation cursors to be removed from the screen. The new settings will be only maintained up to the end of the exercise in progress, but they will not be saved.

76 76 If you want to restoree the default settings, press [Default]. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

77 77 7A.2.5. RUN A PATIENT TEST Press the [TEST] button to test an exercise just programmed on the patient. The test consists of a complete cycle. Press the [STOP] button to interrupt the test. Press the [START] button to bring the patient's 3D hand back to the starting position. The [Start] button can only be pressed having pressed the [Stop] button. The [Test], [Stop] and [Start] button can only be pressed when they are blue. If grey, the buttons are temporarily disabled.

78 78 7A.2.6. SET THE CUSTOM EXERCISE Press the [Set movements] button to access the list of exercisee steps. Remember, a step is intended as each simultaneous motor action: for example, for the Handle exercise, the first step is to flex the thumb, the second step is to extend the thumb, the third is to flex the index finger, middle finger, ring finger and little finger, the fourth step is to extend the index, middle, ring and little fingers. The Custom exercise enables open programming of the order and composition of the various steps. Press the [Add movement in line] to start creating the first step of the exercise. Since the hand always starts from the maximum extension position established by the therapist for the specific patient (see par. 6A), the first step will always be flexion of a finger or multiple fingers. Click on the finger you intend to flex and, by using the single cursor, adjust its joint range of motion (to understand how the cursor of the joint range works, see par. 7A.2.1). You can insert a message associated with motion and establish if this message will be read and/or displayedd by the software, similar to what happens to the other exercises using the Step by Step Effect (see par. 7A.2.2.5). Lastly, you can display by one or more tenths of a second the start of motion by pressing the delay [+]. If the delay remains equal to 0 tenths of a second, the programmed movement will start without delay based on the other simultaneous movements, i.e. including the same step. Press [Save] to save the first movement and return to the list of exercise steps. Press [Back] to delete insertion of the first movement and return to the list of exercise steps. Once the first movement is inserted, this will be represented in the list of steps with a rectangle as that outlined below: Direction of movement: Flexion (arrow down) or Extension (arrow up) Finger in motion (highlighted) Full description of movement IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

79 79 Once the first movement is inserted, this coincides with the first step. However this step could include further movements, if you want to move multiple fingers at the same time. There are two fundamental rules to consider during the programming of the Custom exercise: The movements included in a step must have the same direction: it is not possible to flex a finger and simultaneously extend another finger. If a finger is flexed, before the end of the exercise, this finger must be extended: it is not possible to end an exercise leaving a finger flexed. The software automatically proceeds to ensure the rules are respected and signals with specific messages any errors to correct. The error messages are very useful because they give a precise indication, also in terms of the correct action to apply. At any time, however, it is possible to press [Ok] to ask the software to check the correctness and completion of the steps entered and display any error message. If multiple errors are present, the software displays a single error message. Once the error signalled is resolved, you are advised to press [Ok] again to check there are no other errors. To add new movements, click on the last/next movement the movement you want to create and press: The [Add movement movement selected; in line] button to enter a movement inside the same step of the The [Add movement before] button to enter a movement before the movement selected; The [Add movement after] button to enter a movement after the movement selected. In this case, the screen you reach shows the same elements: a) Choice of motion direction (flexion or extension): clicking on the arrow to obtain the desired direction (arrow down for flexion, arrow up for extension). b) Choice of finger to move: click on desired finger. c) Joint range of finger to flex (cursor not enabled in the case of extension): move the cursor upwards to increase the flexion level generated on the hand by the rehabilitative glove or downwards to decrease it. d) Setting a message before the step; write the message in the specific field. e) Choice of message reproduction method (text and/or voice): if a [V] appears beside Text, the message will be displayed on screen, while if an [X] appears, the messagee will not be displayed on screen; if a [V] appears beside "Voice, the message will be pronounced by the software, while if an [X] appears, the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

80 80 f) Setting a possible delay (if you want the finger to start moving after a certain number of tenths of a second from the start of the first movement of the same step): adjust the number of seconds. If you do not want to set any delay, leave 0 as the delay indication. g) Press [Save] to save the movement set and return to the list of exercise steps. h) Press [Back] to delete insertion of the movement and return to the list of exercise steps. To modify an already entered movement, click the movement you want to change and press: The button [V] to access the settings screen again for movement. All the parameters can be modified. To vary the order of already entered steps, click on the movement of the step you want to move and press: The [Move down] button to move the selected step to the next position to the current one; The [Move up] button to move the selected step to the previous position to the current one. To delete movements already entered: Press the [X] button to delete all the movements; Select the movement you want to delete and press the [Bin] button to only eliminate the selected movement. When there are numerous steps, their display can be compacted, pressing the [-] button beside the number that indicates the step. Pressing the [+] button, vice versa, you can display the detailed movements composing the step. Once the desired Custom exercise is composed, press [Back] to return to the parameters setting screen of the exercise. You are advised to display the 3D preview of the exercise (see par. 7A.2.3) to further check the Custom exercisee was set as desired. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

81 81 7B. Program the Interactive Games 7B.1. CALIBRATE THE SENSOR GLOVE The Interactive Games to be selected if the patient has recovered partial active joint range of motion of the finger. Calibration is necessary to identify and register this patient's voluntary motor capacity. This is an important step for the preparation of treatment. During therapy the patient will train their fingers in flexion and extension within the ROM calibrated in this phase. According to the patients motor capacity, the size of their hand and the fit of the Gloreha Sensor Glove, the results of calibration may vary. For these reasons, it is good practice to calibrate starting before each treatment session. Select [Active]. Press the [PLAY] button to start calibration and ask the patient to flex and extend their 5 fingers. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

82 82 If you want the patient to work within a broader ROM than their current capacity, during calibration the therapist can manually intervene on the glove, helping the patient to flex and/or extend the finger more. Press the [STOP] button to pause or stop calibration. Once calibration is complete, press [Save] to confirm the changes made. If you want to exclude a finger from the calculation of the fingers positioning or analyse functioning of each sensor, you can access the technical calibration screen: Select [Technical screen]. The screen displays a graphic representation of the signal of each sensor/finger: during flexion, a cursor moves to the left to definee the maximum level of flexion; during extension, the same cursor moves to the right to define the maximum level of extension. The blue strip created as such represents the range of each sensor/finger. When you want to exclude one or more fingers from the treatment, press the specific button. When the movements to the left/right of the vertical bar are not consistent with the flexion/extension movements of the finger, check the glove has been worn correctly and the sensors have been adjusted correctly. If the anomaly persists, consult chapter 13. When assessing the important. quality of calibration, the broadness of the blue strip is not Press [Back] to return to the summary page of the therapy methods available. Press the corresponding icon for interactive games. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

83 83 7B.2. SELECT THE INTERACTIVE GAMES The patient's personal data are summarised in the data sheet in the column on the left, by clicking on "Patient". The summarised data of the therapy, as well as the connection status between the PC and Gloreha Sensor Glove, are displayed in the data sheet in the column on the left, by clicking on "Therapy". In this screen and the subsequent ones, the column on the left can be hidden by double clicking on the vertical bar that separates it from the rest of the page. Similarly, by double clicking, you can make it re-appear. The central part of the screen displays the individual games involved in the therapy. You can change the order of the games by changing the general settings (see par. 9.5) ). Each therapy is composed of one or more games, up to a maximum of 3. Spaceship Through flexion and extension of the fingers, the patient moves a space shuttle to the left and to the right. In particular, by flexing the fingers, the patient moves the shuttle to the right; by extending the fingers, the shuttle moves to the left. Aim of the game: avoid the meteorites freely falling in space. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

84 84 Shopping Cart Through flexion and extension of the fingers, the patientt moves the shopping cart to the left and to the right, while coloured fruit "rains down", in various sizes (bananas, apples, strawberries, melons...). In particular, by flexing the fingers, the patient moves the trolley to the right; by extending the fingers, the trolley moves to the left. Purpose of the game: collect as much fruit in the cart as possible. The bigger the fruit, the higher the score. Walls Through flexion and extension of the fingers, the patient moves a small bar to the left of right, useful to strike a bouncing ball. In particular, by flexing the fingers, the patient moves the bar to the right; by extending the fingers, the bar moves to the left. Purpose of the game: destroy all the bricks composing the wall on the upper part of the screen. The software displays the last therapy programmed for the patient being treated. This allows the therapist to speed up preparation of the therapy: in fact, if you do not intend to change anything since the last session programmed, the therapist can directly start the therapy (see par. 8B). If you are treating a patient who has never been treated with Gloreha before, or you think the therapy should be changed, follow the instructions below carefully. The Therapy screen displays the games in the order they are performed. If there is a green [V] beside a game, it is included in the therapy. If there is a red [X] beside a game, it is excluded from the therapy. To include or exclude a game, press the red [X] or green [V] placed beside the game icon. By pressing the icon of a game, you go to the parameters setting screen of the game selected. Once the games accompanying the therapy have been selected, press [Save] to confirm the changes made. Press [Back] to deletee the changes made and return to the home page. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

85 85 7B.3. DEFINE THE SETTINGS FOR EACH ACTIVE GAME D B C A E The settings screen of the parameters of each game enables to set: The duration of the game (A); The level of difficulty of the game (B); Possible narrowing of the range considered by the glove as significant (C); The effects associated with the exercise (D; see par. 7B.3.1). The level of difficulty changes the speed and/or the number of stimuli to which the patient is subjected. For the "Walls" game, you can vary the length of the bar on which the ball bounces by using the specific button: obviously, the wider the bar, the easier the exercise. For the "Walls" game, there is also a "Scenario" parameter to vary the shape of the bricks to destroy. For the "Spaceship" and "Shopping Cart" games, there is also a "Focus" parameter (E) to identify an area of the screen where the patient would have to work more. For the "Spaceship" game, in the selected area there will be less falling meteorites; on the contrary, in the game "Shopping Cart", the selected area will have more falling fruit.

86 86 If you want to restoree the default settings, press [Default]. Press [Back] to return to the therapy summary screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

87 87 7B.3.1. SET THE EFFECTS Gloreha therapy includes mobilisation of fingers which can be associated with audio and visual effects that focus on multi-sensory involvement and stimulation of the patient. These effects were developed consistently with the most advanced rehabilitative methods (Action Observation Therapy, Motor Imagery, etc.) and the most recent neurophysiological research on neuronal plasticity. Audio Effect It enables association of the finger movements with reproduction of musical scales. It also enables setting a song as a musical background for the motor exercise. Start & End Effect It enables to set two messages for the patient: one for the starting of the game and one for the end. This customisable message can be read and/or listened to by the patient. By doing so, you can pre-announce to the patient that the game is about to start and/or warn the patient the game has ended. You can also use this effect to give the patient a certain instruction. Movie effect It enables to set the video preview of the motor exercise and/or tutorial video of the game. In fact, it is possible to ensure that before the game starts, the patient sees on the screen for one or more minutes a video of a real hand that completes the same exercise, or a real tutorial video of the game. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

88 88 7B AUDIO EFFECT To set the Audio effect, click on the [Audio] icon on the main page of the exercise parameters adjustment. Click on the icon that represents the desired Audio effect. If a [V] appears besidee a Background effect, the effect is selected. If a [X] appears besidee a Background effect, the effect is not selected. When you do not want to associate any Audio effect to the exercise, select the first icon on the top left. The effects that can be set are: Notes: A descending musical scale accompanies flexion of the musical scale accompanies extension of the fingers. It is musical instrument the scale will be played with. fingers, an ascending possible to select the Music: It enables to add background music to the exercise, by selecting a song (mp3 filed) saved on the PC. Once the Musical effect is selected: Press [Folder] to try and select the mp3 file saved on the PC you want to associate with the exercise. Press [Play] to listen to the selected tune. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

89 89 Press [Pause] to temporarily stop playing the selected tune. Pressing [Play] again: the tune will return from the point it was stopped. Press [Stop] to stop playing the selected tune. By pressing [Play] again, the tune will return from the beginning. Notes + Music: It enables combined Notes effect and Music effect. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

90 90 7B START & END EFFECT To set the Start & End effect, click on the [Start & End] icon on the main page of the exercise parameters adjustment. You can let the patient listen to end of each game. and/or read a message before starting and immediately after the Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings. If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Start & End effect, place an [X] beside Text and Voice. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

91 91 7B MOVIE EFFECT To set the Movie effect, click on the [Film] icon on the main page of the game parameters adjustment. Choose the number of repetitions with the buttons [+] and [-]. Before the motor exercise starts, the film associated with the specific game will be reproduced for a number of times equal to that set. The relevant field for duration (minutes) is automatically updated on the basis of the number of repetitions set. If you do not want to associate any Movie effects to the exercise, set the duration to zero repetitions. It is also possible to upload a mp4 film different from the default one. Press [Folder] to try and select the mp4 file saved on the PC you want to associate with the game. You can let the patient listen to and/or read a message on film reproduction. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

92 92 Once you have set the desired Movie effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the game. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

93 93 7C. Program Active-Assisted Mobilisation 7C.1. CALIBRATE THE SENSOR GLOVE Active assisted mobilisation is selected if the patient recovers partial active joint range of motion of the fingers. Calibration is an important step for the preparation of treatment. During therapy the patient will train their fingers in flexion and extension within the ROM calibrated in this phase. The results of calibration are based on the size of the patient's hand, the fit of the Gloreha Sensor Glove and the starting position, using the specificc regulators. For these reasons, it is good practice to calibrate before each treatment session starts. Select [Passive]. Press the [PLAY] button to start calibration. The glove will flex and extend the fingers: first the index finger, the middle finger, the ring finger and the little finger, then the thumb. The patient can actively participate to flexion and extension of the fingers. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

94 94 If the level of flexion is not met, press the [ROM] button to display the regulators of the flexion level of each finger and change them as explained in par. 7C.3.1. Then press the [PLAY] button again to re-start calibration with the new mobilisation parameters. Press the [STOP] button to pause or stop calibration. Once calibration is complete, press [Save] to confirm the changes. If you want to exclude a finger from the calculation of the fingers positioning or analyse the functioning of each sensor, you can access the technical calibration screen: Select [Technical screen]. This page displays a graphic representation of the signal of each sensor/finger: during flexion, a cursor moves to the left to definee the maximum level of flexion; during extension, the same cursor moves to the right to define the maximum level of extension. The blue strip created as such represents the range of each sensor/finger. When you want to exclude one or more fingers from the treatment, press the specific button. When the movements to the left/right of the vertical bar are not consistent with the flexion/extension movements of the finger, check the glove has been worn correctly and the sensors have been adjusted correctly. If the anomaly persists, consult chapter 13. When assessing the important. quality of calibration, the broadness of the blue strip is not Press [Back] to return to the summary page of the therapy methods available. Press the corresponding icon for Active-Assisted Mobilisation. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

95 95 7C.2. SELECT ACTIVE-ASSISTED EXERCISES The patient's personal data can be seen on the left, by clicking on "Patient". The summarised data of the therapy, as well as the connection status between the PC and Gloreha Sensor Glove and between the PC and the device, are displayed in the dataa sheet on the left, by clicking on "Therapy". In this screen and the subsequent ones, the column on the left can be hidden by double clicking on the vertical bar that separates it from the rest of the page. Similarly, by double clicking, you can make it re-appear. The central part of the screen displays the individual Active-Assisted exercises involved in the therapy. You can change the order of the exercises by using the general settings (see par. 9.5). Each therapy is composed of one or more exercises, up to 5. Assisted Grasping Object The patient must: Flex his or her fingers to grasp a real object; Hold the object in their hand for a few seconds; Extend their fingers to release the object; Keep the fingers extended for a few seconds. If the patient is not capable of completing the flexion movement autonomously, once the timer has expired, the device will intervene to flex the fingers. Similarly, IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

96 96 if the patient is not capable of completing the extension movement autonomously, once the timer has expired, the device will intervene to extend the fingers. Grasping Freee Object The patient must interact with a real object, training with the grasping exercise (and, possibly, reaching). In this case, the difference with the guided exercise is thatt the patient must not subtract the timing suggested by the software. In this exercise, there is no timer or pre-orderedd action which, if not implemented by the patient, is performed by the device. The glove is limited to detecting the active movements and assisting them by activating the motors. Dice in the Box The patient must interact with some die, moving them from the table into a box, and vice versa. In this exercise, there is no timer or pre-ordered action which, if not implemented by the patient, is performed by the device. The glove is limited to detecting the active movements and amplifying them by activating the motors. Build a Tower The patient must interact with some die, building a tower. In this exercise, there is no timer or pre-ordered action which, if not implemented by the patient, is performed by the device. The glove is limited to detecting the active movements and amplifying them by activating the motors. Build a Pyramid The patient must interact with some die, building a pyramid. In this exercise, there is no timer or pre-ordered action which, if not implemented by the patient, is performed by the device. The glove is limited to detecting the active movements and amplifying them by activating the motors. The software displays the last therapy programmed for the patient being treated. This allows the therapist to speed up preparation of the therapy: in fact, if you do not intend to change anything since the last session programmed, the therapist can directly start the therapy (see par. 8C). If you are treating a patient who has never been treated with Gloreha before, or you think the therapy should be changed, follow the instructions below carefully. The Therapy screen displays the exercises in the order they are performed. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

97 97 If there is a green [V] beside an exercise, it is included in the therapy. If there is a red [X] beside an exercise, it is excluded from the therapy. To include or exclude an exercise, press the red [X] or green [V] placed beside the exercise icon. By pressing the icon of an exercise, you go to the parameters setting screen of the exercise selected. Once the exercises have been selected, press [Save] to confirm the changes made. Press [Back] to delete the changes made and return to the home page.

98 98 7C.3. DEFINE THE SETTINGS FOR EACH ACTIVE-ASSISTED EXERCISE C B D E A F G The settings screen of the parameters enables to set: the joint range of motion of the individual fingers (A: see par. 7C.3.1); the effects associated with the exercise (B: see par. 7C.3.2); the duration of the exercise (C); the speed of finger movement (D); pause in flexion (E); pause in extension (F). Clicking on the "Advanced" label, you can also set: facilitating flexion or extension (I): if equal to 0 (as in the figure), the motors of the device loyally follow the patient's active motion, without any amplifier effect; vice versa, extension or flexion can be facilitated by rotating the specific virtual knob.

99 99 For the "Assisted Grasping Object" exercise, you can also set: Timer (G): it is the available time the patient has to complete the pre-ordered movement, before the motors of the device intervene on the patient's behalf. Flexion and extension movements are split into intermediate thresholds. The software enables to set the number of seconds available to complete each task. If time is over without reaching the objective, the device intervenes and passively completes the task. In the contrary, if the patient manages to complete the task in the time, the device is limited to following the patient's motion and the count starts again. H M N O P Flexion Thresholds (%) (H): flexion and extension movements are split into thresholds that represent the intermediate tasks to reach within the time established by the timer. Ten thresholds are available for each movement. To add/remove thresholds, click on the desired threshold. When defining the thresholds, besides patient's residual motor capacity you should consider the impedance caused by the cables during the extension phase. Single Assisted Threshold (M): when this option is enabled, you can see a green [V]; when it is disabled, a red [X] is visible. If enabled, once the timer is over, the device executes movement only up to the next threshold, after which the system will stand by for the patient's active motion. If disabled, once the timer is over, the device completes the motion. As a default setting, this option is disabled. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

100 100 Show Thresholds Percentage % (N): when this option is enabled, you can see a green [V]; when it is disabled, a red [X] is visible. If enabled, the screen displays the selected thresholds (e.g. 10% 20% 40% etc.): the path is therefore made available that the patient must take, sub-divided into intermediate steps. If the option is disabled (as it is by default), no percentage is displayed on screen. Show Threshold Separator (O): when this option is enabled, you can see a green [V]; when it is disabled, a red [X] is visible. If enabled, the screen displays the separator bars of the thresholds selected: the path is therefore made available that the patient must take, subdivided into intermediate steps. If the option is disabled (as it is by default), no intermediate bar is displayed on screen. Object Size (%) (P): the guided exercise of grasping the object allows patients to grasp real objects. To make the exercise more precise, you can enter an indication on the size of the object; the software will automatically re-calibrate the parameters of the exercise taking into consideration the stroke of the sensors will not be the maximum, registered during the calibration phase. The greater the dimensions of the object, the higher the decrease percentage of the sensor stroke, according to the diagram below: Note that this parameter has no impact on the ROM adjustment carried out by the motion cables: as for the passive functional exercises, if appropriate, work on the specific regulators of the motor strokes, based on the dimensions of the object the patient will interact with (see paragraph 7C.3.1).

101 101 For Grasping Free Object, Dice in the Box, Build a Column and Build a Pyramid exercises, you can also set: Q R Start Cycle % and End Cycle % (Q and R): during therapy, a bar on the left gradually changes colour when the patient flexes the fingers. Each time the patient flexes his or her fingers to entirely colour the bar and then re-extend the fingers (the bar is white again), the software counts a complete cycle has been done. You can therefore understand the importance of choosing the right ROM for the beginning of the cycle (bottom of the bar) and the end of the cycle (top of the bar). The default software proposes a limited pause. The patient should not completely flex his or her fingers to grasp an object.

102 V 102 T S Show Start-End Cycle Percentages (S): when this option is enabled, you can see a green [V]; when it is disabled, a red [X] is visible. If enabled, the screen displays the % thresholds set as the task to reach in extension (cycle start) and flexion (cycle end). If the option is disabled (as it is by default), no percentage is displayed on screen. Chase Accuracy (T): when performing these exercises, the glove detects the active motions and assists them by activating the motors. The range from 0 to 20 is the reactivity of the motors after the patient's movement: o 0 means that the motors are activated after a minimum active movement; o 20 means the motors are activated when the patient autonomously completes approximately 20% of the ROM registered during the calibration phase. Chase Mode (V): by default, the calculation algorithm of the signal of the sensors is based on an average of the fingers. You can also tune assistance considering the signals of the individual fingers. If you want to restoree the default settings, press [Default]. Press [Back] to return to the therapy summary screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

103 103 7C.3.1. SET THE JOINT RANGE OF MOTION Move the cursor up to increase the flexion level generated on the hand by the rehabilitation glove. Move the cursor down to decrease the flexion level generated on the hand by the rehabilitation glove. During the choice of joint range of motion, you should take into consideration that the level of flexion needed to interact with real objects is generally lower than the "free hand" exercises. The numbers on the cursors indicate an increasing value from 0 to 100, not directly equal to angular values. High levels of flexion could generate something similar to what shown in the picture below. This case must be avoided: during motion, the cable must not create a bend between the finger cuff and the inlet of the fabric opening. If you note a similar situation during mobilisation, decrease the flexion level of the cable: this does not cause less flexion of the patient's finger, but only better efficiency of the device. Situation to avoid!

104 104 If the green cursor turns into yellow, the ideal joint range level for the patient's size has been exceeded. Yellow range might be acceptable in case of a particular hand shape or when accessories are added to the glove. The therapist's attention and caution is always recommended!

105 105 7C.3.2. SET THE EFFECTS Gloreha therapy includes mobilisation of fingers which can be associated with audio and visual effects that focus on multi-sensory involvement and stimulation of the patient. These effects were developed with the most advanced rehabilitative methods (Action Observation Therapy, Motor Imagery, etc.) and the most recent neurophysiologic research on neural plasticity. Audio Effect It enables to associate the finger movements with musical scales. It also enables to select a song as background for the motor exercise. Start & End Effect It enables to set two messages for the patient: at the beginning and at the end of the exercise. This customisable message can be read and/ /or listened to by the patient. By doing so, you can pre-announce to the patient that the exercise is about to start and/or warn the patient the exercise has ended. You can also use this effect to give the patient a certain instruction. Step by Step Effect It enables to set a series of messages for the patient during therapy. For each fraction of the exercise (step), you can enter a customisable message which can be read and/or listened to by the patient. By doing so, the patient can be guided, step by step, to perform the therapy, helping him or her for example to recognise the finger involved in the movement and the type of motor exercise in progress. Movie Effect It enables to set the video preview and/or tutorial video of the motor exercise. In fact, it is possible to ensure that before the exercise starts, the patient sees on the screen for one or more minutes a video of a real hand that completes the same exercise, or a real tutorial video. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

106 106 7C AUDIO EFFECT To set the Audio effect, click on the [Audio] icon on the main page of the exercise parameters adjustment. Click on the icon that represents the desired Audio effect. If a [V] appears besidee a Background effect, the effect is selected. If a [X] appears besidee a Background effect, the effect is not selected. When you do not want to associate any Audio effect to the exercise, select the first icon on the top left. The effects that can be set are: Notes: A descending musical scale accompanies flexion of the musical scale accompanies extension of the fingers. It is musical instrument the scale will be played with. fingers, an ascending possible to select the Music: It enables to add background music to the exercise, by selecting a song (mp3 filed) saved on the PC. Once the Musical effect is selected: Press [Folder] to try and select the mp3 file saved on the PC you want to associate with the exercise. Press [Play] to listen to the selected tune. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

107 107 Press [Pause] to temporarily stop playing the selected tune. Pressing [Play] again: the tune will return from the point it was stopped. Press [Stop] to stop playing the selected tune. By pressing [Play] again, the tune will return from the beginning. Notes + Music: It enables combined Notes effect and Music effect. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

108 108 7C START & END EFFECT To set the Start & End effect, click on the [Start & End] icon on the main page of the exercise parameters adjustment. You can let the patient listen to end of each game. and/or read a message before starting and immediately after the Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; by pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Start & End effect, place an [X] beside Text and Voice. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

109 109 7C STEP BY STEP EFFECT To set the Step by Step effect, click on the [Step by step] icon on the main page of the exercise parameters adjustment. You can let the patient listen to and/or read a message before each step. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; by pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Step by Step effect, place an [X] beside Text and Voice. Once you have set the Step by step desired effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

110 110 7C MOVIE EFFECT To set the Movie effect, click on the [Film] icon on the main page of the exercise parameters adjustment. Choose the number of repetitions with the buttons [+] and [-]. Before the motor exercise starts, the movie will be reproduced for a number of times equal to that set. The relevant field for duration (minutes) is automatically updated on the basis of the number of repetitions set. If you do not want to associate any Movie effects to the exercise, set the duration to zero repetitions. It is also possible to upload a mp4 movies different from the default one. Press [Folder] to try and select the mp4 file saved on the PC you want to associate with the exercise. You can let the patient listen to and/or read a message on film reproduction. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings. If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; by pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

111 111 Once you have set the desired Movie effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

112 112 7D. Program Bilateral Therapy 7D.1. CALIBRATE THE SENSOR GLOVE Bilateral Therapy is selected if the patient has a healthy hand, or a hand that is just slightly compromised, and you want the patient to guide motion of the hand to rehabilitate using voluntary movements of the healthy hand. Before starting the treatment, calibration of the sensor glove is an important step to do. If the calibration is done properly, the movements replicated by the device on the hand with motor deficit will be as accurate as possible to those of the healthy hand. According to patient's motor capacity, hand size and the fitting of the Gloreha Sensor Glove, the results of calibration may vary. For these reasons, it is good practice to calibrate before each treatment session starts. Select [Active]. Press the [PLAY] button to start calibration and ask the patient to flex and extend the fingers. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

113 113 If you want the patient to work within a broader ROM compared to his/her current capacity, the therapist can manually intervene on the glove during calibration, helping the patient to flex and/or extend the finger more. Press the [STOP] button to pause or stop calibration. Once calibration is complete, press [Save] to confirm the changes made. If you want to exclude a finger from the calculation of the fingers positioning or analyse functioning of each sensor, you can access the technical calibration screen: Select [Technical screen]. The screen displays a graphic representation of the signal of each sensor/finger: during flexion, a cursor moves to the left to definee the maximum level of flexion; during extension, the same cursor moves to the right to define the maximum level of extension. The blue strip created as such represents the range of each sensor/finger. When you want to exclude one or more fingers from the treatment, press the specific button. When the movements to the left/right of the vertical bar are not consistent with the flexion/extension movements of the finger, check the glove has been worn correctly. Check also the sensors have been adjusted correctly. If the anomaly persists, consult chapter 13. When assessing the important. quality of calibration, the broadness of the blue strip is not Press [Back] to return to the summary page of the therapy methods available. Press the corresponding icon for Bilateral Therapy. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

114 114 7D.2. SELECT BILATERAL EXERCISES Patient's personal data are summarised in the data sheet on the left, by clicking on "Patient". The summarised data of the therapy, as well as the connection status between the PC and Gloreha Sensor Glove and between the PC and the device, are displayed in the dataa sheet on the left, by clicking on "Therapy". In this screen and the subsequent ones, the column on the left can be hidden by double clicking on the vertical bar that separates it from the rest of the page. Similarly, by double clicking, you can make it re-appear. The central part of the screen displays the individual bilateral exercises included in the therapy. You can change the order of the exercises by using the general settings (see par. 9.5). Each therapy is composed of one or more exercises, up to 3. Flexion and extension of the fingers on the hand with motor deficit is passively generated by the device on the basis of voluntary movements of the healthy hand. However, it is always worth asking the patient to concentratee and then strive to move both hands. The screen displays a three- with both dimensional simulation of both hands in motion. Fist The patient can flex and extend all the fingers simultaneously hands. Grasping The patient is asked to grasp and release one or more real objects with both hands. Reaching The patient is asked to grasp one or more real objects, move them in the space and then release them with both hands. The software displays the last therapy programmed for the patient being treated. This allows the therapist to speed up preparation of the therapy: in fact, if you do not intend to change anything since the last session programmed, the therapist can directly start the therapy (see par. 8D). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

115 115 If you are treating a patient who has never been treated with Gloreha before, or you think the therapy should be changed, follow the instructions below carefully. The Therapy screen displays the exercises in the order they are performed. If there is a green [V] beside an exercise, it is included in the therapy. If there is a red [X] beside an exercise, it is excluded from the therapy. To include or exclude an exercise, press the red [X] or green [V] placed beside the exercise icon. By pressing the icon of an exercise, you go to the parameters setting screen of the exercise selected. Once the exercises accompanying the therapy have been selected, press [Save] to confirm the changes made. Press [Back] to delete the changes made and return to the home page.

116 116 7D.3. DEFINE THE SETTINGS FOR EACH BILATERAL EXERCISE B C D E A F G H The settings screen of the parameters enables to set: The joint range of motion of the individual fingers (A: see par. 7D.3.1); The effects associated with the exercise (B: see par. 7D.3.2); The duration of the exercise (C); The speed of finger movement (D); Help Flexion or Extension (E): if equal to 0 (as in the figure), the motors of the device move to accurately replicate patient's healthy hand motion, without any amplifier effect; on the contrary, extension or flexion can be amplified by rotating the specific virtual knob. Chase Accuracy (F): the software enables to set the range from 0 to 20, that is the reactivity of the motors after patient's movement: o 0 means that the motors are activated after a minimum active movement; o 20 means the motors are activated when the patient autonomously completes approximately 20% of the ROM registered during the calibration phase. Start Cycle % and End Cycle % (G and H): during therapy, a bar on the left gradually changes colour when the patient flexes the fingers. Each time the patient flexes his or her

117 117 fingers to entirely colour the bar and then re-extend the fingers (the bar is white again), the software counts a complete cycle has been done. You can therefore understand the importance of choosing the right ROM for the beginning of the cycle (bottom of the bar) and the end of the cycle (top of the bar). The default software proposes a limited pause. The patient should not completely flex his or her fingers to grasp an object. If you want to restoree the default settings, press [Default]. Press [Back] to return to the therapy summary screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

118 118 7D.3.1. SET THE JOINT RANGE OF MOTION Move the cursor up to increase the flexion level generated on the hand by the rehabilitation glove. Move the cursor down to decrease the flexion level generated on the hand by the rehabilitation glove. The numbers on the cursors indicate an increasing value from 0 to 100, not directly equal to angular values. High levels of flexion could generate something similar to what shown in the picture below. This case must be avoided: during motion, the cable must not create a bend between the finger cuff and the inlet of the fabric opening. If you note a similar situation during mobilisation, decrease the flexion level of the cable: this does not cause less flexion of the patient's finger, but only better efficiency of the device. Situation to avoid!

119 119 If the cursor changes from green to yellow, the ideal joint range level is being surpassed for the patient's size. The shape of the patient's hand or the assembly method of the accessories can make it ideal to position the cursor in the "yellow range". The therapist's attention and caution is recommended!

120 120 7D.3.2. SET THE EFFECTS Gloreha therapy includes mobilisation of fingers which can be associated with audio and visual effects that focus on multi-sensory involvement and stimulation of the patient. These effects were developed consistently with the most advanced rehabilitative methods (Action Observation Therapy, Motor Imagery, etc.) and the most recent neurophysiological research on neuronal plasticity. Audio Effect It enables association of the finger movements with reproduction of musical scales. It also enables setting a song as a musical background for the motor exercise. Start & End Effect It enables to set two messages for the patient: one for the start of the exercise and one for the end. This customisable message can be read and/or listened to by the patient. By doing so, you can pre-announce to the patient that the exercise is about to start and/or warn the patient the exercise has ended. You can also use this effect to give the patient a certain instruction. Movie effect It enables to set the video preview and/or tutorial video of the motor exercise. In fact, it is possible to ensure that before the exercise starts, the patient sees on the screen for one or more minutes a video of a real hand that completes the same exercise, or a real tutorial video. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

121 121 7D AUDIO EFFECT To set the Audio effect, click on the [Audio] icon on the main page of the exercise parameters adjustment. Click on the icon that represents the desired Audio effect. If a [V] appears besidee a Background effect, the effect is selected. If a [X] appears besidee a Background effect, the effect is not selected. When you do not want to associate any Audio effect to the exercise, select the first icon on the top left. The effects that can be set are: Notes: A descending musical scale accompanies flexion of the musical scale accompanies extension of the fingers. It is musical instrument the scale will be played with. fingers, an ascending possible to select the Music: It enables to add background music to the exercise, by selecting a song (mp3 filed) saved on the PC. Once the Musical effect is selected: Press [Folder] to try and select the mp3 file saved on the PC you want to associate with the exercise. Press [Play] to listen to the selected tune. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

122 122 Press [Pause] to temporarily stop playing the selected tune. Pressing [Play] again: the tune will return from the point it was stopped. Press [Stop] to stop playing the selected tune. By pressing [Play] again, the tune will return from the beginning. Notes + Music: It enables combined Notes effect and Music effect. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

123 123 7D START & END EFFECT To set the Start & End effect, click on the [Start & End] icon on the main page of the exercise parameters adjustment. You can let the patient listen to end of each game. and/or read a message before starting and immediately after the Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any Start & End effect, place an [X] beside Text and Voice. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

124 124 7C MOVIE EFFECT To set the Movie effect, click on the [Film] icon on the main page of the exercise parameters adjustment. Choose the number of repetitions with the buttons [+] and [-]. Before the motor exercise starts, the film will be reproduced associated with a number of times equal to that set. The relevant field for duration (minutes) is automatically updated on the basis of the number of repetitions set. If you do not want to associate any Movie effects to the exercise, set the duration to zero repetitions. It is also possible to upload a mp4 film different from the default one. Press [Folder] to try and select the mp4 file saved on the PC you want to associate with the exercise. You can let the patient listen to and/or read a message on film reproduction. Enter the message text in the specific field. The message will be read and/or displayed automatically, according to the following settings: If a [V] appears beside "Text", the message will be displayed on the screen. If an [X] appears beside "Text", the message will not screen. be displayed on the If a [V] appears beside "Voice", the message will be pronounced by the software. If you want to have a preview of what the patient will listen to, by pressing [Play] you can listen to the message; pressing [Stop] the message will stop playing. If an [X] appears beside "Voice", the message will not be pronounced by the software. If you do not want to associate any message, place an [X] beside Text and Voice. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

125 125 Once you have set the desired Movie effect, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the parameters setting screen of the exercise. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

126 Perform the Therapy 8A. Perform Passive Mobilisation Before starting the therapy, place the PC in a stable and suitable position to be displayed to the patient, but at the same time ensuring there will be no contact between the PC and the patient. Press the [PLAY] button to start therapy. After a few seconds, the screen will display the first effect set for the first exercise. By pressing the [Play] button after the [Stop] or [Skip] button: if the fingers are partially or completely flexed, Gloreha will bring the patient's hand to the starting position; then therapy will re-start. Press the [STOP] button to pause therapy. Press the [SKIP] button to go to the next exercise. The [Skip] button can only be pressed after the [Stop] button. The [Skip] button can be pressed multiple times to skip exercises (note that on each pressing of the button, in the column on the left the therapy scroll bar is updated, indicating the exercise was reached). Press the [START] button to bring the patient's 3D hand back to the starting position. The [Start] button can only be pressed after the [Stop] button. Press the button [Viewpoint] to display the commands that allow the change the perspective of the 3D hand animation (see par. 7A.2.4). Press the [Back] button to leave the therapy session. If the fingers are partially or completely flexed, Gloreha will bring the patient's hand to the starting position. The [Back] button can only be pressed after the [Stop] button. In the column on the left, the therapy scroll bar displays the advancement status of the exercise and the time passed can be displayed. While therapy is in progress, never touch the flexible cables.

127 127 If in doubt on the correctness of the setting, immediately stop the therapy. Movement must always be performed without feeling pain and irritation. If during use of Gloreha, signs and/or symptoms appear such as skin rash, irritation, strong sense of heat, excessive perspiration, swelling, haemorrhage, increased pain, hyperthermia and/or unusual reactions, immediately stop the treatment. The [Play], [Stop], [Skip] [Start] buttons can only be pressed when they are blue. If grey, the buttons are temporarily disabled.

128 128 8A.1. VARY THE SETTINGS OF THE EXERCISE IN PROGRESSS During therapy, press the [Settings] button to display the settings screen of the exercise in progress. Now you can edit all the parameters available. The joint range of motion of the individual fingers (see par. 7A.2.1); The effects associated with the exercise (see par. 7A.2.2); The duration of the exercise; The speed of finger movement; A delay at the beginning of a movement between two simultaneous movements; Pause in flexion; Pause in extension; Press [Save] to save the changes made. Press the [-] and [+] buttons to display the therapy progress screen. By repeatedly pressing the [-] button, it will be only displayed the therapy progress screen. By repeatedly pressing the [+] button, it will be only displayed the therapy progress screen. Intermediate display is also possible with both the screens overlapped: it is a useful function, especially to instantly check the changes made. Press [Back] to return to the therapy progress screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

129 129 8A.2. ACTIVATE THE EMERGENCY BUTTON If you need to urgently stop Gloreha, press the emergency button. By doing so, the electrical power supply stops the parts in motion of the device. The screen will display the message "The emergency stop button was pressed" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol is displayed. To re-enable the system, releasee the emergency stop button, turning it clockwise. The screen will display the message "The emergency stop button was released" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol will disappear. The emergency button does not cut power to the electronic board to enable the operator to understand the situation. The electronic board can communicate to the software the emergency stop button was pressed and there are no risks that any motor can start, causing undesired events. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

130 130 8A.3. END THERAPY When the therapy has ended, the software automatically returns to the summary screen of the therapy. You can therefore let the patient free, by following these steps: Remove the patient's arm from Gloreha DAS (if used) and position the patient's hand on a surface; Open the two Velcro straps fastening the Gloreha Brace to the patient's forearm; Remove the Gloreha Loop accessories (if used); Remove the Gloreha Splint accessory (if used); Free the patient's fingers from the distal ends of the Gloreha Glove. To disconnect the Gloreha Glove from the cables; Release the cable length regulators turning the levers anti-clockwise; Release the finger cuffs from the specific bases. Release the spherical head from the relevant compartment at the end of the Gloreha Glove; Remove the cables from the Gloreha Glove through-holes. Disconnect the Gloreha Glove from the Gloreha Brace, covering the velcro strip with the specific protection.

131 131 8B. Play the Interactive Games Before starting the therapy, place the PC in a stable and suitable position to be displayed to the patient, but at the same time ensuring there will be no contact between the PC and the patient. Press the [PLAY] button to start therapy. After a few seconds on the screen, the first game will be displayed. Press the [STOP] button to pause therapy. Press the [SKIP] button to go to the next game. The [Skip] button can only be pressed having pressed the [Stop] button. The [Skip] button can be pressed many times to skip multiple games. Press the [Back] button to leave the therapy session. The [Back] button can only be pressed having pressed the [Stop] button. If in doubt on the correctness of the setting, immediately stop the therapy. Movement must always be performed without feeling pain and irritation. If during use of Gloreha, signs and/or symptoms appear such as skin rash, irritation, strong sense of heat, excessive perspiration, swelling, haemorrhage, increased pain, hyperthermia and/or unusual reactions, immediately stop the treatment. The [Play], [Stop] and [Skip] buttons can only be pressed when they are blue. If grey, the buttons are temporarily disabled.

132 132 8B.1. VARY THE SETTINGS OF THE GAME IN PROGRESS During therapy, press the [Stop] button and then [Settings] to display the settings screen of the game in progress. Now you can edit all the parameters available: The duration of the game; The level of difficulty of the game; Possible narrowing of the range considered as significant by the glove; The effects associated with the exercise (see par. 7B.3.1); Any other specific parameters for the game in progress (see par. 7B.3). Press [Save] to save the changes made. Press [Back] to return to the therapy progress screen.

133 133 8B.2. END THERAPY When therapy has ended, the software automatically returns to the summary screen of the therapy. You can therefore let the patient free, by following these steps: Remove the patient's arm from Gloreha DAS (if used) and position the patient's hand on a surface; Open the two Velcro straps by fastening the Gloreha Sensor Glove to the patient's forearm; Free the patient's fingers from the distal ends of the Gloreha Glove; Disconnect the Gloreha Sensor Glove from the electronic board for Gloreha Sinfonia and place the glove back in its specific container.

134 134 8C. Perform Active-Assisted Mobilisation Before starting the therapy, place the PC in a stable and suitable position to be displayed to the patient, but at the same time ensuring there will be no contact between the PC and the patient. Press the [PLAY] button to start therapy. After a few seconds, the screen will display the first effect set for the first exercise. Press the [STOP] button to pause therapy. Pressing the [Stop] button, if the fingers are partially or completely flexed, Gloreha will bring the patient's hand to the start position. Press the [SKIP] button to go to the next exercise. The [Skip] button can only be pressed having pressed the [Stop] button. The [Skip] button can be pressed many times to skip multiple exercises. Press the [Back] button to leave the therapy session. The [Back] button can only be pressed having pressed the [Stop] button. In the column on the left, the therapy scroll bar displays the advancement status of the exercise and the time passed can be displayed. While therapy is in progress, never touch the flexible cables. If in doubt on the correctness of the setting, immediately pause the therapy. Movement must always be performed without feeling pain and irritation. If during use of Gloreha, signs and/or symptoms appear such as skin rash, irritation, strong sense of heat, excessive perspiration, swelling, haemorrhage, increased pain, hyperthermia and/or unusual reactions, immediately stop the treatment. The [Play], [Stop] and [Skip] buttons can only be pressed when they are blue. If grey, the buttons are temporarily disabled.

135 135 8C.1. VARY THE SETTINGS OF THE EXERCISE IN PROGRESS During therapy, press the [Stop] button and then [Settings] to display the settings screen of the exercise in progress. Now you can edit all the parameters available. the joint range of motion of the individual fingers (see par. 7C.3.1); the effects associated with the exercise (see par. 7C.3.2); the duration of the exercise; the speed of finger movement; pause in flexion; pause in extension; the other settings typical of each exercise (see par. 7C.3). Press [Save] to save the changes made. Press [Back] to return to the therapy progress screen.

136 136 8C.2. ACTIVATE THE EMERGENCY BUTTON If you need to urgently stop Gloreha, press the emergency button. By doing so, the electrical power supply stops the parts in motion of the device. The screen will display the message "The emergency stop button was pressed" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol is displayed. To re-enabled the system, release the emergency stop button, turning it clockwise. The screen will display the message "The emergency stop button was released" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol will disappear. The emergency button does not cut power to the electronic board to enable the operator to understand the situation. The electronic board can in fact communicate to the software the emergency stop button was pressed and there are no risks that any motor can start, generating undesired events. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

137 137 8C.3. END THERAPY When therapy has ended, the software automatically returns to the summary screen of the therapy. You can therefore free the patient, following these steps: Remove the patient's arm from Gloreha DAS (if used) and position the patient's hand on a surface; Open the two Velcro straps fastening the Gloreha Sensor Glove to the patient's forearm; Remove the Gloreha Splint accessory (if used); Free the patient's fingers from the distal ends of the Gloreha Glove. To disconnect the Gloreha Sensor Glove from the cables: Release the cable length regulators turning the levers anti-clockwise Release the finger cuffs from the specific bases. Release the spherical head from the relevant compartment at the end of the glove; Remove the cables from the glove through-holes. Disconnect the Gloreha Sensor Glove from the electronic board for Gloreha Sinfonia and place the glove back in its specific container.

138 138 8D. Perform Bilateral Therapy Before starting the therapy, place the PC in a stable and suitable position to be displayed to the patient, but at the same time ensuring there will be no contact between the PC and the patient. Press the [PLAY] button to start therapy. Press the [STOP] button to pause therapy. Pressing the [Stop] button, if the fingers are partially or completely flexed, Gloreha will bring the patient's hand to the start position. Press the [SKIP] button to go to the next exercise. The [Skip] button can only be pressed having pressed the [Stop] button. The [Skip] button can be pressed many times to skip multiple exercises. Press the [Back] button to leave the therapy session. The [Back] button can only be pressed having pressed the [Stop] button. While therapy is in progress, never touch the flexible cables. If in doubt on the correctness of the setting, immediately pause the therapy. Movement must always be performed without feeling pain and irritation. If during use of Gloreha, signs and/or symptoms appear such as skin rash, irritation, strong sense of heat, excessive perspiration, swelling, haemorrhage, increased pain, hyperthermia and/or unusual reactions, immediately stop the treatment. The [Play], [Stop] and [Skip] buttons can only be pressed when they are blue. If grey, the buttons are temporarily disabled.

139 139 8D.1. VARY THE SETTINGS OF THE EXERCISE IN PROGRESS During therapy, press the [Stop] button and then [Settings] to display the settings screen of the exercise in progress. Now you can edit all the parameters available: The joint range of motion of the individual fingers (see par. 7D.3.1); The audio and video effects associated with the exercise (see par. 7D.3.2); The duration of the exercise; The speed of finger movement; Help; Precision; % cycle start; % cycle end. Press [Save] to save the changes made. Press [Back] to return to the therapy progress screen.

140 140 8D.2. ACTIVATE THE EMERGENCY BUTTON If you need to urgently stop Gloreha, press the emergency button. By doing so, the electrical power supply stops the parts in motion of the device. The screen will display the message "The emergency stop button was pressed" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol is displayed. To re-enabled the system, release the emergency stop button, turning it clockwise. The screen will display the message "The emergency stop button was released" and in the column on the left, in the PC-Gloreha Connection image the emergency button symbol will disappear. The emergency button does not cut power to the electronic board to enable the operator to understand the situation. The electronic board can in fact communicate to the software the emergency stop button was pressed and there are no risks that any motor can start, generating undesired events. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

141 141 8D.3. END THERAPY When therapy has ended, the software automatically returns to the summary screen of the therapy. You can then let the patient free. During Bilateral Therapy, both hands are wearing a glove. Free the "compressed" hand from the Gloreha Glove, following these steps: Remove the patient's compromised arm from Gloreha DAS (if used) and position the patient's hand on a surface; Open the two Velcro straps fastening the Gloreha Brace to the patient's forearm; Remove the Gloreha Loop accessories (if used); Remove the Gloreha Splint accessory (if used); Free the patient's fingers from the distal ends of the Gloreha Glove. To disconnect the Gloreha Glove from the cables: Release the cable length regulators turning the levers anti-clockwise; Release the finger cuffs from the specific bases. Release the spherical head from the relevant compartment at the end of the glove; Remove the cables from the glove through-holes; Disconnect the Gloreha Glove from the Gloreha Brace, covering the Velcro strip with the specific protection. Free the healthy hand from the Gloreha Sensor Glove following these passages: You can therefore free the patient, following the passages below in order: Remove the patient's arm from Gloreha DAS (if used) and position the patient's hand on a surface; Open the two Velcro straps by fastening the Gloreha Sensor Glove to the patient's forearm; Free the patient's fingers from the distal ends of the Gloreha Glove; Disconnect the Gloreha Sensor Glove from the electronic board for Gloreha Sinfonia and place the glove back in its specific container.

142 Other Software Functionalities 9.1. DISPLAY AND EDIT THE PATIENT'S DATA On the home page, after selecting a patient, press the [Patient data] button to display the patient's data. This screen allows you to edit all the patient's personal data.

143 143 Once the patient's data have been changed, press [Save] to confirm and return to the home page. Press the [Back] button to return to the home page.

144 DELETE A PATIENT On the home page, after selecting a patient, press the [Bin] button to delete the patient. Once a patient is deleted, you can no longer recover the data.

145 EDIT THE LIST OF DISEASES On the home page, press the [Settings] button and on the next screen press the [DISEASES] button The detail items of each disease are displayed on the right column once the disease is selected in the column on the left. This screen allows you to: Add a new disease and new detail items (type the new word to enter and press on the button [+]); Select what diseases and what detail items to "activate" (the diseases and detail items are selected when there is a tick [V] beside them). The software does not allow diseases and detail items to be deleted: unless you want to view a certain disease (or detail item), add an [X] beside that disease (or detail item). Press the [Save] button to confirm the changes made and return to the previous screen. Press the [Back] button to return to the previous screen, cancelling the changes made.

146 ADD A NEW THERAPIST On the home page, press the [Settings] button and on the next screen press the [PASSWORD] BUTTON. On the "List of Therapists" screen, press the [Add new Therapist] button. Enter the new patient's data: Surname Name Password (twice) Once the new therapist's data is entered, press the [Save] button to confirm and return to the list of therapists. Press the [Back] button to delete insertion of the new therapist and return to the list of therapists.

147 CHANGE EXERCISE ORDER On the home page, press the [Settings] button and on the next screen press the [EXERCISES] BUTTON. Choose among the four labels on top of the therapy method you want to change the exercises order. The screen displays three coloured lines, each composed of 9 boxes. Line 1 corresponds to the first screen of the exercises accessed by selecting a patient; line 2 corresponds to the second screen; line 3 to the third screen. There are various ways to modify the display order (and therefore execution) of the exercises. The simplest is pressing the icon for an exercise, by keeping the mouse pressed, dragging it to the desired destination: if the destination box is already occupied by another exercise, the positions of the two exercises will be inverted. If you work on a touch screen without the mouse, you need to follow the procedure described below: Press the icon of the [Size] button. exercise whose position you want to change and then press the IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

148 148 If you want to move the selected exercise in a certain position dragging forward by a position all the subsequent exercises: press on the destinationn box of the exercise selected and then press the [Paste] button. If you want to insert the selected exercise in a box without changing the position of the next exercises: press on the destination box of the exercise selected and then press the [Invert] button. If the destination box is already occupied by another exercise, the positions of the two exercises will be inverted. Once you have reached the desired order of exercises, press [Save] to confirm. If you want to restoree the default settings, press [Default]. Press [Back] to return to the previous screen. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

149 EXPORT A PATIENT This functionality of the software enables to export all the data of a patient on another PC on which the GSWP2IT software was already correctly installed. There are two exporting methods: On USB pen (par ); On Cloud (par 9.6.2). This functionality allows you to continue the therapy on a specific patient with another Gloreha device (e.g. installed in another facility, in another gym or at patient's home), without any loss of data and without selecting everything again EXPORT A PATIENT ON A USB PEN On the home page, after selecting a patient, press the [Patient data] button to display the patient's data. Press the [Export on USB] button. Select the destination USB and confirm by pressing [Ok]. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

150 150 On USB pen, a folder will be created with the patient's identification, contained an encrypted file. The name of the file contains the patient's identification and the date and time it was saved, according to the following format: PatientIdenfication_yyyyMMddHHmmss.txt. This file can be easily imported on any PC where the GSWP2IT software (par ) EXPORT A PATIENT ON CLOUD This functionality is only active if the PC is connected to the Internet. On the home page, after selecting a patient, press the [Patient data] button to display the patient's data. Press the [Export on Cloud] button. On Cloud (Dropbox: IdrogenetGlorehaCloud folder) a folder will be created with the patient's identification, contained an encrypted file. The name of the file contains the patient's identification and the date and time it was saved, according to the following format: PatientIdenfication_yyyyMMddHHmmss.txt. This file can be easily imported on any PC where the GSWP2IT software was correctly installed and whose database already contains the specific patient (par ). IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

151 IMPORT A PATIENT This functionality of the software enables to import all patient's data: From the USB pen (par ); On Cloud (par 9.7.2). This functionality enables: Follow-up of the therapy of a specific patient, set/started on another PC/Gloreha, Monitoring of the therapy performed by the specific patient with another PC/Gloreha IMPORT A PATIENT FROM A USB PEN On the home page, after inserting the USB pen in one of the PC USB ports, press the [Import from USB] button. Select the path containing the file relating to the specific patient and confirm pressing [Ok]. If the patient you are importing already exists on the database, during importation confirmation you are asked to replace that patient. In case of substitution, all the patient's data on the database will be replaced with those on the USB pen, regardless of the first data are more or less recent than the second ones. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

152 IMPORT A PATIENT FROM CLOUD This functionality is only active if the PC is connected to the Internet. This functionality is only possible if the patient is already on the database. A new patient cannot be imported from Cloud. If the specific patient is not on the database, import him or her from the USB pen (par ). On the home page, after selecting a patient, press the [Patient data] button to display the patient's data. Press the [Import on Cloud] button. The most recent version of the file related to the patient will be searched on Cloud. If the patient's data on the database are more recent than those on Cloud, during importation a confirmation is requested for replacement. In case of substitution, all the patient's data on the database will be replaced with those on Cloud, regardless of the first are more or less recent than the second. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

153 ASSESS THE PROGRESS OF A PATIENT AND CREATE A PDF/XLS REPORT Firstly, you need to select the patient whose data you want to analyse. After selecting the patient to treat, press the button [V]. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

154 154 To assess a patient's progress and export the pdf/xls file with the data related to the treatment sessions with Gloreha on the selected patient, click on the [Assessment] icon. Choose the therapy method you want to analyse by clicking on one of the two labels placed up high: Gloreha or Gloreha Active Package. If you choose Gloreha, the selected data will be those related to the treatment sessions made with Gloreha on the selected patient: all the passive mobilisation sessions carried out on that patient and all the parameters which were set. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

155 155 The software automatically starts creating Pdf and Excel files related to the specific patient selected. The percentage of loading appears in transparency on the two icons. Once the loading is completed, the files are downloadable by clicking on the respective icon. If you choose the Gloreha Active Package, you can select the lapse of time you want to analyse as well as the type of graph you want to see: to see the options, drag the grey flap indicated in the below image:

156 156 After selecting the lapse of time and the type of graph, you can choose the exercises you want to analyse among those automatically shown by the software: Clicking on the [+] key, the exercises belonging to this category are displayed.

157 157 Clicking [+] on the desired exercise again, the graph will be displayed relating to the performance indexes of the patient for the selected exercise. The performance indexes change according to the particular features of each exercise. Within each exercise, you can select or de-select each index. If there is a green [V] beside an index, the graph will be exported if downloaded. If there is a red [X] beside an index, the exercise will not be downloaded. By clicking [+] beside the [DETAIL] label, all the values of the parameters set will be displayed for each exercise and for each session carried out with the patient selected. The software enables to export the data of each patient in PDF or XLS format based on the analysis requirements. Click on one of the two keys placed on the right of the screen in the commands section: Press the [Update] button to update the data. Press the [Download PDF] button to export the graphs and the data in PDF format. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

158 158 Press the [Download XLS] button to export the graphs and the data in PDF format. The same button [Download XLS] is also present on the home page. By pressing it, you can export the database containing the personal data for all the patients and the data related to the treatment sessions carried out with Gloreha. The database is exported to a file with txt extension, inside a folder selected by the user. IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

159 Use the "Patient" Profile As explained in par. 4.1, if the therapist decides to ask a third party (for example a nurse) to do the already set routine start-up of the therapy for a patient, the appointed person must access the software by using the "Patient" profile. The password used must be communicated to the person appointed by the therapist. The therapist can display the patient's password on the [Patient's folder] page. The password is automatically generated by the software the moment a patient is added. By accessing the "Patient" profile, the summary screen is directly displayed of the therapy already programmed. It is therefore possible to: Perform the therapy (par. 8); Change the therapy (par. 7.2 and 7.3). The entire user manual must be read and understood by the appointed people to access with the "Patient" profile, with the exception of par. 5, 7.1 and 9, which refer to the activities and functionalities not within their competence. Before using the device, the people appointed to access with the "Patient" profile must be well trained by the therapist.

160 How to Apply Optional Accessories GLOREHA SPLINT When putting on the glove, if the conditions of the patient's wrist require (in the event of highly accentuated flexor tendency of the wrist and following the doctor's instruction) you can use the Gloreha Splint accessory to keep the hand in the horizontal neutral position. Before wearing the Gloreha Brace (or the Gloreha Sensor Glove), you need to place Gloreha Splint under the patient's forearm: this allows to support the hand and use Gloreha Splint properly. Tighten the strips of Velcro on the Gloreha Brace (or Gloreha Sensor Glove) to firmly place the Gloreha Splint.

161 GLOREHA SAS (STATIC ARM SUPPORT) Gloreha SAS is useful in the following situations: Patient's incapacity to move the arm; Patient's incapacity to maintain an ergonomic position during therapy; Need to keep arm tilted during therapy; Aid and support for that patient who, even if capable of autonomously lifting the arm, may need to rest after some cycles. Support the patient's forearm on the Gloreha SAS armrest. The support is height adjustable and its inclination can adapt to various needs. Armrest Inclination regulator Height regulator Never place the patient's skin in direct contact with the armrest. When using the armrest, the patient's forearm should be rested so the patient's fingers are free to move.

162 GLOREHA DAS (DYNAMIC ARM SUPPORT) Gloreha DAS (Dynamic Arm Support) is a compensation system of the weight of the upper limb. It allows the arm to freely move in the space and supports the patient during functional exercises. Integrated with Gloreha, it makes the exercises more motivating, efficient and involving. Gloreha DAS can support an arm with a weight between 900 and 4800 grams. The level of compensation of the weight is adjustable in 12 levels with a difference of approximately 350 grams between one level and the next. Upper Arm Loop

163 163 Gloreha DAS is delivered in a box with the following dimensions: Length: 49 cm Width: 29 cm Height: 17 cm Weights: Gloreha DAS including the DAS Table Clamp and DAS Brace: 2,730 grams DAS Table Clamp: 930 grams Complete Gloreha DAS set: 3,400 grams Do not apply Gloreha DAS on patients who can make sudden and uncontrolled movements of the upper limb during therapy.

164 INSTALL GLOREHA DAS Follow the procedures described below to install Gloreha DAS. Firstly, fasten the DAS Table Clamp to a solid and horizontal surface (surface of a table); by rotating the knob, you can tighten or loosen the socket. Before proceeding with connection of the Gloreha DAS Links, ensure the DAS Table Clamp is firmly fastened on the surface. Parking handle Pin Table Knob The DAS Table Clamp must be positioned at approximately 50 cm from the patient's shoulder, as in the following pictures: LEFT RIGHT SHOULDER

165 165 Couple the DAS Links to the pin of the DAS Table Clamp. Insert the pin of the DAS Table Clamp in the hole of the DAS Links by pushing the latter in the direction indicated by the green arrow. Pay attention to the DAS Links direction before positioning it. The DAS Links must be coupled as indicated in the following picture: LEFT RIGHT CENTRAL PART OF DAS LINKS OUTWARDS

166 166 Check the tip of the pin exits to the hole of the DAS Links. Otherwise the bearings could break. See the picture below: Tip of pin Place the DAS Base on opposite end of the DAS Links. Insert the pin of the DAS Base in the hole of the DAS Links in the direction represented by the green arrow.

167 167 Check the tip of the pin exits the hole of the DAS Links. Otherwise the bearings could break. See the picture below: Tip of pin Slide the upper arm inside the slot of the DAS Brace hook in the direction represented by the green arrow. Washers Slot Hook Upper Arm

168 168 Pull the clip inwards in the direction indicated by the green arrow and slide the hook of the DAS Brace between the two washers of the upper arm. Push the clip inwards Check the clip is fastened beyond the bolt head. The bolt head must be visible after fastening the clip, as in the image below. Check the clip is fastened beyond the bolt head

169 USE GLOREHA DAS: ADJUST THE FORCE The level of support supplied by Gloreha DAS can be easily regulated. Choose among 12 force levels. The table below allows you to see the force applied by Gloreha DAS for each level: Level Strength (grams) , , , , , , , , , , ,800 Adjustment interval Adjust the compensation level following the passages outlined here: Pull the upper arm upwards in the direction of the yellow arrow (see the image on the following page). Move the loop upwards or downwards as indicated by the green arrow (see the image on the following page) and fasten at the desired level. The force increases when the loop is fastened at lower levels. Conversely, the force decreases when the loop is fastened to the levels placed higher up. Place the loop in the lowest position to enable support of approximately 4.5 kg; place the loop in the highest position to support approximately 1kg. The force level must be set in order to avoid the Gloreha DAS elements banging off the surface of the table during therapy.

170 170 During force adjustment, the patient's arm cannot be positioned on the device. Pull the upper arm upwards Adjust the position of the loop Release the upper arm. Gloreha DAS is now ready to be used.

171 USE GLOREHA DAS: POSITION THE PATIENT'S ARM Position the patient's arm in the DAS Brace. Pay attention to the following instructions: The forearm must be positioned over the DAS Brace. The arm, just over the elbow, must support the upper support of the arm. The elbow must be left free. The bundle of Gloreha cables can be stabilised on the upper arm of Gloreha DAS using the Velcro strap. Velcro strap Arm upper support

172 172 Run a test to check the force level set supports the patient's arm. If the force set is inadequate for the weight of the arm: Take the patient's arm out; Adjust again (par. 3.1); Re-position the patient's arm; Repeat the procedure until the right force level let the patient's arm swing smoothly. You can set the force levels to relieve the weight of the patient's arm. The choice of the right level depends on the patient's condition and the purpose of treatment. Gloreha DAS can be used for different purposes: move the arm on a flat surface, interact with objects, move the arm in empty space and perform more ample movements, etc. Check the bundle of cables connected to the Gloreha Glove does not get stuck in the Gloreha DAS structure. Gloreha DAS can only be used to lift or compensate the weight of the arm. Before use, check if Gloreha DAS is fastened firmly to a solid and horizontal surface.

173 REPOSITION GLOREHA DAS AFTER USE Once therapy has ended, if Gloreha DAS is not used, but remains assembled and fastened to the table, it should be coupled to the parking handle to keep it in a stable and safe position. Insert the Gloreha DAS eyelet in the parking handle and take the patient's arm out. Gloreha DAS will remain in this position until the eyelet is released again from the parking handle. Eyelet Handle When Gloreha DAS is installed on the table, but it is not used, the eyelet must always be coupled to the parking handle.

174 CLEAN GLOREHA DAS The various parts of the Gloreha DAS can be cleaned with a wet cloth. Do not use chemical substances or solvents to clean the Gloreha DAS.

175 GLOREHA LOOP If finger joints on the hand to treat have a significant level of stiffness/spasticity, it may be useful to use the Gloreha Loop accessories for mobilisation purposes. rung clear tape Before fastening the starting position of the finger, choose on which fingers you want to apply the Gloreha Look accessory. Position Gloreha Loop on the back of the phalanges, equally distant from the metacarpophalangeal and proximal interphalangeal joints, widening the Gloreha Loop to allow them to "hug" the small cable on the back of the finger. Pull the clear tape; Wind up the transparent tape around the finger;

176 176 Couple the clear tape on the rung of the Gloreha Loop by using the holes at the end of the clear tape. The hole on which the tape is coupled must be chosen based on the size of the finger. By doing so, the accessory stays firmly on the back of the finger. Do not tighten excessively; Repeat the previous operations for the other fingers. Fasten Gloreha Loop so as to keep the small cable aligned with the finger. Gloreha Loop cannot be applied if the Gloreha Sensor Glove is used: if applied, it would compromise sensor functioning. On the other hand, in the presence of significant spasticity of the finger, the exercises permitted by the Gloreha Sensor Glove are not advised.

177 Personalise Gloreha Glove If the Gloreha Thimbles contained in each Gloreha Glove are too tight or too wide for the particular configuration of a patient's finger, you can "personalise" the Gloreha Glove with Gloreha Thimbles. Once a new combination of the Gloreha Thimbles has been found, you must: Replace the Gloreha Thimbles from the Gloreha Glove which does not correspond to the patient's characteristics (to remove a thimble: turn the hood over, pull the thimble and remove the stick from the hole); Replace them with the selected Gloreha Thimbles (to insert a thimble: turn the hood and insert the stick in the hole). Use original Gloreha Thimble accessories only. Personalisation of the thimbles is not possible for Gloreha Sensor Gloves. The procedure described in this chapter is valid only for Gloreha Gloves without sensors.

178 Problems and Errors Description of the problem/error What to do A) The joint range of motion is less than desired. B) Mobilisation of the fingers is partial and/or incorrect because patient's wrist if flexed. C) During mobilisation, the cable is not aligned with the finger, but falls sideways. 1. Increase the joint range of motion via software (par. 7A.2.1, 7C.3.1, 7D.3.1). 2. Check the Gloreha Glove was fastened correctly to the Gloreha Brace (par. 6A). 3. Vary the size of the gloves/braces (par. 5.1, 5.2). In the event of passive mobilisation, it is also possible to modify the size of the thimbles (par. 12). 4. Apply Gloreha Loop (par. 10.4). 1. Set the patient free from Gloreha (par. 8B.2, 8B.3, 8C.3, 8D.3). 2. Fit the glove/brace again, but only after placing the Gloreha Splint accessory properly (par. 11.1). 1. Ensure the glove is aligned with the finger and, if necessary, adjust its positioning. 2. Check the size of the glove is correct. 3. Apply Gloreha Loop (par. 11.4). D) Correct operation of the Gloreha stops leaving the patient's hand in a different position to the start position, with a finger/fingers partially or completely flexed. 1. Press the emergency button. 2. Release the emergency button, turning it clockwise. 3. Press the [Back] button. 4. If the hand is not brought to the start position, release the patient from Gloreha (par. 8A.3, 8B.2, 8C.3, 8D.3). 5. Start a new therapy working the Gloreha "empty", without any patient connected to the device. E) The following message appears on the monitor: Check the PC-Gloreha connection and on the left the image of the PC-Gloreha connection displays the broken cable. 1. Check the Usb communication cable between the PC and the device is correctly inserted both in the PC and in the device. If accidentally disconnected, re-connect it: 2. If the problem was not solved: connect the Usb communication cable to another Usb port of the PC. 3. If the problem is still not solved: switch off Gloreha. Wait

179 179 at least 30 seconds before switching on again. 4. If the problem is still not resolved: exit the Gloreha software and start up again. 5. If the problem persists: contact technical support. F) Once the main switch is activated on Gloreha, the led on the switch will not switch on after waiting 10 seconds. 1. Check if Gloreha is not powered: in this case, the problem is limited to the led and you can continue to power on the device. If Gloreha is not powered, implement the actions indicated below until the problem is solved. 2. Check the plug is correctly inserted in the wall socket. 3. Check the power supply cable is inserted correctly in the power supply unit. 4. Check the connector is correctly inserted in the device socket. 5. If the problem was not solved following the aforementioned actions: contact technical support. G) The PC blocks and does not respond to the commands, despite the input systems (mouse, keypad, touch screen, trackpad) working properly. H) The device is not working properly and none of the previous anomalies occurred. I) From the calibration technical page, it appears the left/right movements of the cursor (sensors signal) are not consistent with flexion/extension movements of the fingers. 1. If the patient's hand is in a different position than the starting position (with a finger/multiple fingers partially or totally flexed), switch off Gloreha and wait at least 30 seconds before switching on Gloreha again. 2. Force shutdown/re-start of the Gloreha/PC software. 1. If the patient's hand is in a different position than the start position (with a finger/multiplee fingers partially or totally flexed), switch off Gloreha and wait at least 30 seconds before switching on Gloreha again. Release the patient from Gloreha. The Gloreha Brace/Gloreha Sensor Glove is kept on the patient's forearm through Velcro straps which can be quickly opened. Then remove the straps and Gloreha Loops and set the patient's finger free by removing the thimbles at the end of the glove. 2. Switch off Gloreha. 3. Contact technical support. 1. Make sure the plug of the glove is inserted in the socket. The glove must be placed properly and the sensors must be tense in the most appropriate way (parr. 6B, 6C, 6D). 2. If you are using a switch to select the side to be treated, make sure the selector indicates the desired hand (right or left). 3. Press [Back] to return to the summary page of the mode IDROGENET Srl - Via Repubblica 25/A, Lumezzane (BS), Italy - tel/fax info@gloreha.com

180 180 selection of the therapies available, and click again on the icon Sensor calibration to try to make a new calibration. 4. If the inconsistency affects only one finger or two fingers, exclude them from detection by pressing the appropriate button (par. 7B.1, 7C.1, 7D.1). Despite the flaw found, it can still effectively execute the treatment. 5. If the inconsistency affects more than two fingers, contact technical support.

181 Installation and Transport Gloreha must be delivered to the rehabilitation facility which will use it by authorised staff from Idrogenet, who will install it and train staff intending to use the device within their professional competence. Gloreha has two wheels to facilitate its transport inside the rehabilitation facility. Before starting transport, check the power supply cable and the Usb pen are not connected to Gloreha. Move Gloreha carefully and cautiously, tilting it as necessary to operate the wheel (approx. 45 ). Once you have reached the desired position, stabilise Gloreha by putting it back to the vertical position.

182 Cleaning and Care Periodically clean Gloreha. Protect Gloreha from intense ultra-violet radiation (sunlight) and open flames. Keep Gloreha in a safe and comfortable place. The symbol of the barred bin on the Gloreha and GAP plate indicates the device must be separately collected from other waste at the end of its useful life. The differentiated collection of Gloreha and GAP is organised and managed by the manufacturer Idrogenet. The user who wants to dispose of the device should therefore contact the manufacturer and follow the system implemented by the manufacturer to enable separate collection of the equipment at the end of its useful life. Adequate differentiated collection for subsequent start-up of the decommissioned device for recycling, treatment and disposal compatible, from an environmental point of view contributes to avoiding possible negative effects on the environment and on health and promotes re-use and/or recycling of materials composing the device. Illegal disposal of the product by the holder will lead to administrative sanctions as outlined by law CLEANING AND CARE OF THE CHASSIS Before cleaning the chassis, disconnect the electricity plug from the electricity socket. Clean the outer walls of the chassis with a damp cloth and weak detergent. Use disinfectant for common use and delicate detergent for domestic use. Dry with a soft cloth. Do not open the device and do not try to clean it inside. No liquid must penetrate the device. When cleaning the device, pay attention to the most delicate parts (sheaths and cables): do not bend the sheaths into too tight angles, do not damage or wear the black surface of the cables, do not damage the rounded heads of the cables. Tampering with or damaging these parts requires extraordinary maintenance intervention.

183 CLEANING AND CARE OF THE GLOREHA BRACE AND GLOREHA GLOVE Never use accessories in poor conditions. Only use original accessories, intact and dry. After use, place the Gloreha Brace or Gloreha Glove in the same box with the patient's name on it. Attach the Gloreha Glove and Gloreha Brace and close the Gloreha Brace Velcro straps (the free Velcro could damage other fabric parts). Before washing the Gloreha Brace, close the Velcro straps. Before washing the Gloreha Glove, remove the Gloreha Thimbles. To remove a thimble: turn back the hood, pull the thimble, remove the stick from hole. You can wash the Gloreha Brace and Gloreha Glove, machine washable up to 90 C (no spin cycle). Put them into wash bags or bra balls (typically used to protect underclothing and the most delicate items). Tetrachloroethylene, monofluoride trichloromethane and hydrocarbons can be added to wash. Do not treat with chlorine. Do not iron it. Do not dry in a tumble dryer. After washing the Gloreha Glove, put the Gloreha Thimbles back on. To put a thimble back: overturn the hood and insert the stick in the hole.

184 CLEANING AND CARE OF THE GLOREHA SENSOR GLOVE Never use products in poor conditions. Only use original products, intact and dry. After use, loosen the cord locks to the maximum on the sensors and place the Gloreha Sensor Glove in the relevant original box. Be careful while handling the Gloreha Sensor Glove to avoid damaging its inner electronic parts. sensor holding pockets protective cover protective bridge The protective cover can be removed and washed. It is machine washable up to 90 C (no spin cycle). Do not treat it with chlorine. Do not iron it. Do not dry it in a tumble dryer. The protective cover can be washed with tetrachloroethylene, monofluoride trichloromethane and hydrocarbons. To wash the Gloreha Sensor Glove, lightly wipe the surface of the product in contact with the patient's skin with a sponge soaked in detergent (sensor holding pockets, protective bridge, protective cover). Do not use aggressive detergents nor acids. If you are in need of further support to clean the Gloreha Sensor Glove, please contact the manufacturer Idrogenet CLEANING AND CARE OF THE GLOREHA THIMBLE To clean the Gloreha Thimble, lightly rub a sponge soaked in detergent on the internal surface of the thimble. Do not use aggressive detergents nor acids.

185 Spare Parts and Maintenance The intervention of a specialist authorised by Idrogenet Srl is required every 12 months to run a periodic control of all the Gloreha and GAP parts. If more than 12 months have passed since the last maintenance intervention by staff authorised by Idrogenet Srl, do not use Gloreha and GAP and request extraordinary maintenance intervention! Use spare products and original accessories only. Do not use Gloreha and GAP if parts are damaged or worn. To solve the problem, contact specialist staff authorised by Idrogenet. The intervention of authorised specialist staff is not necessary only if Gloreha accessories need replacing: in such cases, the operator can order the original spare parts. To order the accessories, contact the manufacturer Idrogenet or a distributor, specifying the code of the item and the quantity desired. You can find the order form in the appendix. Never open the device: access to any internal part, with the exception of the adjustment compartment for cable tightening, is permitted only to staff authorised by Idrogenet. Do not tamper in any way with the Gloreha Sensor Glove: maintenance and repairs can only be carried out by specialist staff authorised by Idrogenet. When using the device, the repeated washing or other events damage, weaken the closure seals in Velcro or compromise in any way the efficiency and intactness of the Gloreha Braces or Gloreha Gloves, replace them immediately. Check the packaging of the accessories is intact and the accessories themselves before using them. The useful life of a Gloreha Glove is determined by the life of its parts, which can be replaced with adequate maintenance. Carrying out periodic routine maintenance, the useful life of the Gloreha depends on the duration of the actuators (at least 200,000 cycles for each actuator). The actuators can be replaced, thereby prolonging the life of the Gloreha.

186 Warranty The Gloreha device is covered by a 12-month warranty starting from the date on the transport document related to manufacturing defects on electrical, electronic and mechanical parts. Parts and accessories subject to normal wear due to use are not covered by warranty. To obtain the warranty service, the purchasers must contact Customer Service, giving clear indication of the faults found. If the device must be returned for repair, the device, within 15 days of communication by Customer Service, must be delivered carriage free to Idrogenet Srl. The device must be packaged in the original package and delivered to: Idrogenet Srl, Via Repubblica 25/A, Lumezzane (BS). The device returned for the warranty service must have the following information attached: name and telephone number of the person to contact; faults found. Idrogenet will check the device and communicate to the purchaser the repair or replacement which will be carried out under warranty. Idrogenet reserves the right at exclusive choice and expense, to improve or replace parts or sub-parts and to update them according to the most recent manufacturing standards. If the device is received incomplete, a quote will be provided for the missing parts. Only after a confirmation by the purchaser, these parts will be replaced; the expenses will be charged to the purchaser. Idrogenet, in normal conditions, will repair or replace the device and will send it back carriage forward within 30 days of the receipt date. The transport expenses will be charged to the addressee. Idrogenet is in no way responsible for any loss of data and information saved on the PC. This warranty expires in case of damage or defects due to: incorrect or improper use; noncompliance with this use manual; use of the device with non-original accessories; attempts to repair the device by staff unauthorised by Idrogenet; changes made to the device or tampering with folders with the software files; lightening, fires and other causes outside Idrogenet control. Idrogenet cannot be held liable for indirect, accidental or specific damages or resulting from Gloreha defects or loss of profit or other costs generated by the purchaser. No declaration of any representative of Idrogenet will extend to Idrogenet liability as established or limited here.

187 Technical Specifications Model Classification according to standard... Electrical connection... Absorbed power... Level of protection against liquid infiltration.. Protection class from electric shock... Part applied Gloreha Professional 2 (& Gloreha Active Package) medical device class IIa 24 V max 6.5 A common protection II type B Dimensions. Weight. 25 kg 530 x 440 x 1050 mm Working conditions: Ambient temperature. Atmospheric humidity Atmospheric pressure Transport and storage conditions: Ambient temperature. Atmospheric humidity Atmospheric pressure Polarity of power supply connection. Medical power supply unit.. Noise. from +10 C to +40 C from 30% to 75%, relative 90% without condensate from 700 hpa to 1060 hpa from -20 C to +60 C from 20% to 75% from 700 hpa to 1060 hpa pin 1 and pin 2: positive polarity pin 3 and pin 4: negative polarity output power 150 W output voltage 24.0 VDC output current 6.25 A 60 db Chassis auto-extinguishing level.. V0 Appliance for continuous operation Appliance not suitable for use in the presence of flammable anaesthetic mix

188 188 Gloreha was designed to work in the electromagnetic ambient specified below. The client or user of Gloreha must ensure it is used in this ambient. Emission test Conformity Electromagnet ambient - guide RF Emissions (CISPR 11) RF Emissions (CISPR 11) Harmonic emissions (IEC ) Emission of voltage fluctuations/flickering (IEC ) Group 2 Class B Class B Compliant Gloreha must emit electromagnetic energy to perform its planned function. The electronic equipment placed nearby may be influenced. Gloreha is suitable for use in non-residential buildings and structures directly connected to the public power mains with low voltage that powers buildings intended for domestic use. Table 2 (CEI EN : parag ) Guide and declaration of the manufacturer - electromagnetic immunity Gloreha was designed to work in the electromagnetic ambient specified below. The client or user of Gloreha should ensure it is used in this ambient. Test level of IEC IMMUNITY test Conformity level Electromagnet ambient - guide Electrostatic discharge (ESD) IEC in contact ± 6 kv in air ± 8 kv in contact ± 6 kv in air ± 8 kv The floors must be made of wood, concrete or ceramic tiles. If the floors are covered in synthetic material, relative humidity should be at least equal to 30%. Transistors/sequen ce of rapid electrical impulses IEC Overvoltages IEC Voltage dips, short power cuts and variations in voltage on the input lines of the power supply IEC ± 2 kv for the power supply lines ± 1 kv for the input/output lines ± 1 kv between the phases ± 2 kv between the phase and the earth <5 % UT (>95% dip in UT) for 0.5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s ± 1 kv for power supply lines ± 1 kv for input/output lines ± 1 kv between the phases ± 2 kv between the phase and the earth <5 % UT (>95% dip in UT) for 0.5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s The quality of the mains voltage should be that typical of a commercial or hospital environment. The quality of the mains voltage should be that typical of a commercial or hospital environment. The quality of the mains voltage should be that of a typical commercial or hospital environment. If the Gloreha user requires continuous operation during power cuts, you are recommended to power Gloreha with a UPS unit or battery.

189 189 Magnetic field at the mains frequency (50/60 Hz) 3 A/m 3 A/m IEC NOTE UT is the mains voltage in a.c. before application of the test level. The magnetic fields at mains frequency should have levels characteristic with a typical premises in a commercial or hospital environment. Table 4 (CEI EN : par ) Guide and declaration of the manufacturer - electromagnetic immunity Gloreha was designed to work in the electromagnetic ambient specified below. The client or user of Gloreha should ensure it is used in this ambient. IMMUNITY test Test level of IEC Conformity level Electromagnetic ambient - guide Portable and mobile RF communication devices should not be used near any part of Gloreha, including cables, except when they comply with the recommended separation distances, calculated with the equation applicable to the transmitter frequency. Recommended separation distance d =1.2 P RF conducted IEC V eff from 150 khz to 80 MHz 3 V eff. d =1.2 Pfrom 80 MHz to 800 MHz d =2.3 P from 800 MHz to 2.5 GHz RF radiated IEC V/m from 80 MHz to 2.5 GHz 3 V/m where P is the maximum rated output power of the transmitter, in watt (W), according to the manufacturer of the transmitter, and d is the recommended separation distance, in metres (m). The field intensities of the fixed RF transmitters, determined by an electromagnetic survey on site a, should be lower than the level of conformity for each frequency interval. b Interference can occur near the equipment marked with this symbol: NOTE 1 To 80 MHz and 800 MHz the separation distance is applied for the higher frequency interval. NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is influenced by absorption and reflection of the structures, objects and people. a. The field intensities for fixed transmitters, such as the base stations for mobile/cordless phones and terrestrial radio-based devices, equipment for amateur radio, radio transmitters in AM and FM and TV transmitters cannot be theoretically precisely planned. To assess an electromagnetic ambient caused by fixed RF transmitters an electromagnetic survey should be considered onsite. If the field intensity measured onsite where Gloreha is used exceeds the conformity level applicable as above, Gloreha use should be placed under observation. If irregular performance is noted, additional measures may be necessary, such as different orientation or position of Gloreha. b. The field intensity of the frequency intervals from 150 khz to 80 MHz should be less than [V1] V/m.

190 190 Table 6 (CEI EN : parag ) Separation distances recommended between the portable and mobile radio-communication devices and Gloreha Gloreha is planned to work in an electromagnetic environment where RF radiated disturbances are under control. The client or Gloreha user can contribute to preventing electromagnetic interferences by ensuring a minimum distance between the RF mobile and portable communication devices (transmitters) and Gloreha, as recommended below, in relation to the maximum output power of the radio-communication devices. Separation distance of transmitter frequency Maximum rated output power of the transmitter W from 150 khz to 80 MHz d =1.2 P m from 80 MHz to 800 MHz d =1.2 P from 800 MHz to 2.5 GHz d =2.3 P For the transmitters specified for a maximum output power not outlined above, the recommended separation distance d, in metres (m), can be calculated using the equation applicable to transmitter frequency, where P is the maximum rated output power in watt (W) according to the manufacturer of the transmitter. NOTE 1 To 80 MHz and 800 MHz the separation distance is applied for the higher frequency interval. NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is influenced by absorption and reflection of the structures, objects and people. Portable or mobile radio frequency-operated communication devices can interfere with Gloreha. Use converters and cables supplied by Idrogenet or ordered from Idrogenet as spare parts only. The serial number identifier of the device is legible on the plate on the bottom rear of Gloreha. Batch number Product code Serial number Year of batch

191 Contacts and Technical Support Any technical problems? Do you need help? Any doubts or need to send us notifications? For any information regarding the Gloreha device and for customer service, do not hesitate to contact us. IDROGENET S.r.l. Via Repubblica 25/A, Lumezzane (BS) Italy Tel: Fax:

192 Appendix SHEET TO MEASURE HAND SIZE This sheet can be photocopied and used by the therapist to facilitate identification of the size of the Gloreha Brace, Gloreha Glove and Gloreha Sensor Glove accessories. The palm of the patient's hand should be positioned over this sheet, keeping the left side of the index finger along the vertical line, as indicated in the figure. According to where the right side of the little finger "falls", you can identify the approximate size of the hand: XS, S, M, L or XL. This sheet allows you to define the approximate size of the patient. The correctness of the size of the accessories should however be checked by the therapist.

193 ORDER FORM FOR GLOREHA ACCESSORIES This sheet can be photocopied and used to order the Gloreha accessories, sending it via to or via fax to Hospital:..... Delivery address:.... Telephone: Fax: Name and surname of contact person: Notes:. Size Hand Code Notes No. XXS Right GBGXXSR XXS Left GBGXXSL XS Right GBGZXSR GLOREHA BRACE+GLOVE (1 brace + 1 glove + 5 thimbles, ready for use) XS Left GBGZXSL S Right GBGZZSR pack containing: 1 Gloreha Brace, 1 Gloreha Glove, 5 Gloreha Thimbles S Left GBGZZSL M Right GBGZZMR M Left GBGZZML L Right GBGZZLR L Left GBGZZLL XL Right GBGZXLR XL Left GBGZXLL GLOREHA BRACE+GLOVE SET (10 Gloreha Braces+Gloves, ready for use) SET - GBG0SET Pack containing: 10 Gloreha Braces, 10 Gloreha Gloves, 50 Gloreha Thimbles (sizes from XS to XL)

194 194 XXS Right GBRXXSR XXS Left GBRXXSL XS-S Right GBRXSSR GLOREHA BRACE XS-S Left GBRXSSL M-L Right GBRZMLR pack containing: 1 Gloreha Brace M-L Left GBRZMLL XL Right GBRZXLR XL Left GBRZXLL XXS Right GGLXXSR XXS Left GGLXXSL XS Right GGLZXSR XS Left GGLZXSL GLOREHA GLOVE (glove without thimbles) S Right GGLZZSR S Left GGLZZSL pack containing: 1 Gloreha Glove M Right GGLZZMR (without Thimbles) M Left GGLZZML L Right GGLZZLR L Left GGLZZLL XL Right GGLZXLR XL Left GGLZXLL GTH GTHZ000 GLOREHA THIMBLE 00 - GTHZZ GTHZZZ0 pack containing: 1 piece 1 - GTHZZZ1 2 - GTHZZZ2 3 - GTHZZZ3 4 - GTHZZZ4

195 195 GLOREHA THIMBLE SET SET - GTH7SET GLOREHA LOOP SET (in silicone) SET - GLO5SET pack containing: 14 pieces (2 per size from 000 to 4) pack containing: 5 pieces, one size (accessories useful for finger with spasticity) GLOREHA SPLINT (for wrist) S - GSPZZZS L - GSPZZZL pack containing: 1 piece size S pack containing: 1 piece size L Date: Signature:..