User guidance

The manual and the product are marked with different symbols. The symbols and their function enable safe and efficient use of the product.

Warnings and saftey instructions

The warning and safety symbols should alert you to possible dangers. Read, understand and obey the warnings and safety instructions. Be aware of the limitations and risks associated with using this device. Warning signs differentiate between potential threats through the following visulization.

Warning

Warns of errors that result in injury. Warnings must be obeyed. Warnings are displayed in yellow and are also written as a warning.

Note

Serves the efficient use of the product. A non-compliance may result in damage or shorten the life of the product. Notes are displayed as blue and are also written as a note.

Symbols on the product

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Safety

Safety instructions

Follow the safety instructions to ensure the risk-free use of the Dividat SENSO. The safety instructions should alert you to possible dangers. Read, understand and follow instructions. Be aware of the limitations and risks associated with using this device.

Warnings

The Dividat SENSO is only for use in therapeutic (rehabilitation) centers, retirement institutions under the supervision oftrained professionals.

Make sure that the device is set up on a level surface with sufficient space for safe entry and exit.

Do not expose the device to direct sunlight, excessive dust, moisture, heat rays, sources of cold, vibrations or mechanical shocks.

Before each use check the device for cracks or damage to the glass plates which could result in injury.

Check the device for any visible damage before each use. Do not use the device if you have found damage.

Check all visible cables and adapters before each use. Do not use the device if you have found damage.

Pay attention to residual moisture, e.g. by prior cleaning or disinfection, remove them before use, otherwise there is an increased risk of slipping.

Regularly check the stability of the handrail. If the handrail is loose, check the attachment before use.

Never use the Senso in connection with any other devices, aids or products the use of which is expressly permitted.

Other electronic devices may interfere with the operation of the Dividat SENSO when operated in close proximity.

Changes to the device are not permitted.

Keep pets and unattended children away from the device.

Make sure that the device is electrically grounded by only connecting it to a grounded terminal that complies with the relevant national and local electrical codes.

Do not operate this device in an environment where short or microwave therapy is used.

Do not operate this device in an environment that is very humid or likely to come into contact with water spray or moisture.

Do not operate this device near heat sources such as heaters or infrared radiators.

Do not operate this device near mixtures of flammable substances, oxygen or nitrogen oxide.

If liquid has been detected or liquid has entered, immediately unplug the power cord and stop treatment. Report the incident to an authorized service person.

After switching on the SENSO always wait until the automatic self-test has been successfully completed.

Report repeated errors of the device to the manufacturer Dividat (contact information on the front).

Never exercise under the influence of alcohol, drugs, medications or narcotics.

Note the contraindications and risk factors before use.

Stop exercising immediately if you experience pain, nausea, dizziness or other symptoms. In this case, contact your doctor. Failure to stop training immediately may result in injury.

Before beginning your training, check with your doctor to determine if this type of training is right for you. This is especially true if you are physically or cognitively impaired.

Improper use may result in injury or property damage. This leads to the loss of liability and warranty claims against the manufacturer.

These safety instructions must be displayed clearly visible on the training device. All users must refer to the safety instructions. The manufacturer assumes no liability for any injuries or property damage

Notes

Also note the instructions on the SENSO.

The SENSO may only be used with clean shoes that are not worn on the street or in everyday life or "indoor shoes". The shoes should have a bright sole.

Security checks before use

To ensure safety for the user, check the device before each use. The review includes at least:

Examine the device for cracks or damage in the glass plates before each use

Checking all available visual and haptic signals for functionality

Check all cables and connections for damage

Check that all parts are undamaged and in the correct starting position

Annual security checks

Before any inspection or maintenance, unplug the power cord from the socket.

The nameplate is present and readable.

The cable connection sockets are not damaged and not loose.

Attached warning and operating instructions are available and readable.

An electrical safety test according to applicable regulations, if required.

Checking power supply

The power supply is maintenance-free and therefore requires no maintenance. Please be sure to protect it from dust, dirt and moisture! To clean, disconnect the power adapter from the power supply and rub gently with a dry cloth (do not use cleaning agents!). The connected cables must be inspected for proper installation, damage to the insulation and contact, corrosion and contamination and functionality.

Recurring electrical tests and their deadlines shall be carried out after e.g. BetrSichV / DGUV V3 or country-specific regulations. Deviating test intervals may also result in legislation applicable to specific applications (e.g. the Medical Device Operator Ordinance) or under private law regulations (e.g. the contractual conditions of the property insurance carrier) or other country-specific regulations

Checking glasses

The glasses are to be examined regularly for damage e.g. glass breakage, splintering, surface wear (satinato surface) or something similar. The slip resistance of the glasses must be guaranteed Maintenance also includes inspection of the glass support points, the motor adapter boards, the vibration motors and the engine retaining tabs. In addition, a check of the splices is carried out for damage and firm hold. With raised glass precautions must be taken to protect against ESD damage to the electronic components! The connected cables must be inspected for proper installation, damage to the insulation and contact, corrosion and contamination, and functionality. The glasses are to be cleaned with a glass cleaner.

Repairs

Warning

Repairs may only be made by the manufacturer or by a service technician certified by the manufacturer. The safety checks must be carried out after each repair.

Intended Use

Product description

The Dividat Senso is a training system designed to enhance physical and cognitive functioning and interplay, and to improve posture control and pace dynamics. The Dividat SENSO is specifically used for the training of gross motor movements, the balance and the step movements with specific pressure. Stimuli and feedback can be done through visual, auditory and tactile channels. Target groups are healthcare providers (hospitals, rehabilitation clinics, physiotherapies, ergo therapies, etc.) and social-medical institutions (e.g. retirement and nursing homes). The use of the Dividat Senso is only provided under the supervision of trained staff.

Indicators/Contraindications

The Dividat SENSO was developed specifically for geriatric and neurological prevention and therapy. Typically, the Dividat SENSO is used to address both motor and cognitive issues that affect walking ability, optimal planning, and targeted movement, and thus, targeted interaction with the human environment. This includes, among other things, the training of psychomotor information processing speed, weight transfer, cognitive flexibility and attention. As with any other therapy, the doctor in charge is responsible for the medical diagnosis, indication and selection of appropriate therapy.

Indicators

Danger of falling of physical or cognitive cause in elderly people
Geriatric and neurological gait disorders (e.g. after stroke)
Impairment of balance and posture control
Parkinson’s disease
Multiple sclerosis
Slight cognitive impairment
Chronic diseases
Orthopedic events, such as amputation, joint surgery or joint replacement
Vestibular diseases

Contraindications

The Dividat SENSO is a passive device because it does not move on its own. From the vibration motors in the bottom plate light vibrations are given off, which, however, cause no noticeable movements or inclinations in the training system. The floor plates only register movements and steps of the user. Accordingly, the same contraindications as those of conventional therapy apply to the same problem.

The Dividat SENSO is used with or without the consultation of a healthcare professional. Contact a healthcare professional if you are not sure if you have contraindications..

The following persons are not allowed to use the SENSO:

People with acute psychosis or neurotic disorders
People at risk of bone fracture due to advanced osteoporosis

Before starting the training, consult a healthcare professional to make sure the activity on the Dividat Senso is suitable. This is especially true for people with a pacemaker, arthritis, joint problems, cardiovascular problems, recently suffered but healed fractures, acute infections, osteoporosis, neurological diseases.

Parts

Overview of the components of the Dividat Senso

The SENSO consists of the components below:

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Base plate with pre-assembled electronics
Handrail left and handrail right
Cross strut handrail
Glass adapter plates (4 pcs.)
Glass center plate (1 piece)
Screw cross strut (2 pcs.)
Sleeve for screw cross strut (2 pcs.)
Clamp connector, handrail top (4 pcs.)
Clamp connector, handrail, bottom (4 pcs.)
Screw for clamping binding (4 pcs.)
Medical power supply

Accessories

Local computing device (game computer) Training with the Dividat Senso requires a GAME COMPUTER and a screen.

Properties of the system

Size: LxBxH 113cm x 113cm x 102.5cm
Product cycle: 10 years
Max. user weight: 180 kg
Satin finish (high slip resistance)
Power supply via tested power supply (low current)
Connection to the browser-based software via WLAN

Measuring ranges

KForce measuring range of 1 - 50 kg per sensor
Resolution of the force measurement: 0.5 kg
Accuracy of force measurement: <1%

Operating elements

The Dividat Senso contains the following operating elements
Elements that can be illuminated with RGB LEDs:

serve the visual support of the training
are individually adjustable in color and brightness
can flash in different frequencies, can be permanently on or off

Sensor plates:

consisting of 4 adapter plates and 1 center plate
Glass composite of safety glass and float glass

Vibration motors:

serve the haptic support of the training
Activation via the software application
can be switched on or off permanently in different pulse lengths

Force measurement sensors:

Each sensor plate has 4 sensors

Admission EU: medical device 1a according to Directive 93/42/EWG

Computer equipment

Local computer (GAME COMPUTER)

The GAME COMPUTER is connected to the SENSO
Connected to SERVER via the Internet

Management Computer (MCOMPUTER)

Does not need to be connected to SENSO
Connected to SERVER via the Internet

Server (SERVER)

The SERVER is operated by a Swiss provider and the server location is in Switzerland. Thus, all data are stored until they are explicitly deleted in Switzerland.
The Dividat data backend (DIVIDATA) is running on the SERVER.

Software und function

SENSO Firmware (FIRMWARE)

Runs on the SENSO hardware
Initial cleanup of sensor values
Transmission of sensor values to COMPUTER
Handling the LED / Motor Control Commands from COMPUTER

Dividat data backend (DIVIDATA)

Runs on the SERVER
Has a database for data, people, access accounts, …
Encrypted connections
Authentication via login / password
Fine authorization system

Dividat Manager (MANAGER)

Runs on the MCOMPUTER (single-page web application)
Connects with DIVIDATA

Dividat Play (PLAY)

Dividat Play runs on the GAME COMPUTER (single-page web application)
Connects to the FIRMWARE
Converts raw sensor data into power and center of gravity
Connects with DIVIDATA

Construction and installation

The installation of the hardware should only be carried out by persons who are familiar with the installation of electrical equipment.
For assembly, you must always be at least two. If you mount the device alone, you may get injured.
Be careful not to touch any electronics during the entire installation. Never plug the power cord of the Dividat Senso into a power outlet before the unit is fully installed. Make sure that nothing is trapped underneath the device.

Prepare suitable tools. You need:

Suction cup for glass plates
Screwdriver Torx TX 45
Screwdriver Torx TX 50

Delivery

When delivering your Dividat Senso, be aware of any transport damage. Report it to the forwarding agent immediately and have the damage acknowledged, preferably by the driver. Externally unrecognizable damage (hidden defects) must be reported to Dividat within seven days of receipt (contact details at the beginning of the document).
If the transport damage does not only affect the packaging but also damage to the device or parts of the device, or if you are not sure whether the device has suffered any damage, contact Dividat immediately. If the frame, handrail or sensor plates are damaged, you may be sent a replacement. If the bottom plate or the electronics have been damaged, the device must be replaced, as safe use can no longer be guaranteed.
If damages are not shown, only partially or not on time, it is assumed that the goods were delivered completely and undamaged, a claim for damages for transport damages does not apply.
Check the device for completeness of the parts before installation.

Warning

Check all the bottom plates and other pre-assembled parts. Make sure all parts are tight, no screws missing or loosely attached.

Attaching the handrail

Mount the handrail before inserting the glasses. For the assembly you need a Torx 45 and a Torx 50 screwdriver. To attach the handrail, place the bottom plate of the Dividat Senso on an elevated position. Make sure the sides are accessible with the screwdriver.

First, attach the clamp connectors to the designated locations on the bottom plate. Tighten the screws so that the clamp connectors are still slightly loosely attached. Once all clamp connectors have been fitted, you can place the left and right handrails in the clamp connectors. Tighten the screws with the Torx50. Then fasten the cross brace and use the screws provided.

Insert the glasses

When the handrail has been fastened and the Senso is placed on the ground, you can insert the glass plates. Check the glass plates for visible damage, especially at the edges. The glass plates must not be used if cracks are visible.

First insert 3 adapter plates in sequence. Make sure that the feet, which are attached to the glass plates, are resting correctly on the sensors. Then insert the middle plate in the middle of the bottom plate. Important: Make sure that the motor attached to the glass plate is inserted in the right place. Finally, insert the last adapter plate.

Connection to the power grid

Plug the power cord into the socket and connect it to a grounded wall outlet.

The device must not be placed in such a position that someone falls over the power cord or the power cord can be unplugged unattended during treatment.
Do not use the device if it is not properly grounded. Make sure that the device is electrically grounded by connecting it to a grounded electrical outlet that complies with applicable national and local electrical codes regarding the medical environment.

Start Dividat Senso

Before using the device, always check the device for any visible damage or danger to the user, such as: strongly heated or severely cooled surfaces, residual liquids from disinfection and cleaning.

Maintenance and troubleshooting

Warning

Do not open the Dividat Senso while it is in operation. For inspection or troubleshooting requiring access to its interior the device must always be powered off.

Cleaning the Dividat SENSO

General Cleaning The Dividat Senso should generally be cleaned regularly. Use a dry or slightly damp cloth. Do not use strong cleaning agents, soaps or solvents for cleaning. With stronger impurities, some cleaning alcohol can be used.

Hygiene measures before the start of training

Disinfection of the user’s hands
Disinfecting the handrail
Disinfection of the floor plates (when using without shoes)

Hygiene measures after the end of the training

Dry wipe the Dividat Senso when in contact with liquid
Disinfection of the floor plates (when using without shoes)
Disinfection of the handrail after each use

Troubleshooting

Technical maintenance The technical maintenance will be done by the manufacturer or by a technician certified by the manufacturer. The technical maintenance as well as the safety checks must be carried out at least once a year and after each repair in accordance with DIN EN 60601-1 and the sub-standards.

End of life The Dividat Senso is an active electronic medical device, it is not suitable for household waste.

Replacing parts

Replacing a sensor plate The replacement of a sensor plate may be necessary if a plate has been damaged, it has received an ugly appearance through long or frequent use or the surface has become irreparably dirty.

Always use suitable gloves to replace sensor plates, especially if the sensor plate is damaged, there is an increased risk of injury. Even if the sensor plates are made of safety glass, injuries can not be excluded!

Replacing the handrail The replacement of the handrail may be necessary if the handrail has been damaged and can no longer guarantee the safety, the handrail is to be retrofitted, a previously unplanned design alternative of the handrail is desired or the handrail by the long or frequent use has become an ugly appearance.

To replace the handrail you should always be two. Make sure that the device is secured against slipping or falling. Use only a suitable load lifter to lift the device.