Eve – intended use

Not available in all markets

Name and address of the manufacturer

Wandercraft

23-23 bis avenue d'Italie

75013 Paris.
France

Product name

Eve is a medical device.

Basic UDI-DI: 3665965EVEV14X

Intended use

Eve – the Personal Exoskeleton by Wandercraft is intended to enable the user to perform walking functions and activities of daily living hands-free, using self-balancing technology. Eve is intended for use in home and community environments under the supervision of a specially trained companion, in accordance with the user eligibility assessment and training certification program.

Eve is intended for use by individuals with lower limb and trunk impairments who are able to tolerate a standing position and to operate the device with a controller.

Eve is not intended for sports or stair climbing.

Indications for use

Eve is to be used to support mobility and ambulation for adult individuals with the following medical indications, regardless of underlying cause:

• Paraplegia / Paraparesis
• Tetraplegia / Tetraparesis
• Hemiplegia / Hemiparesis

Performance (clinical benefit)

The clinical performance, safety, and clinical benefit claims presented in this section are limited to individuals with spinal cord injury (SCI).

Perfomance:

• Indoor walking performance with Eve is assessed by the mean walking speed achieved by users during the 10-Meter Walk Test (10MWT), against a literature-derived success threshold of ≥0.10 m/s.
• Overground walking performance with Eve is assessed by the mean distance covered by users during the Six-Minute Walk Test (6MWT), against a literature-derived success threshold of ≥40 m.
• Functional mobility with Eve is assessed by the mean time to complete the Timed Up and Go (TUG) test, against a literature-derived success threshold of ≤180 seconds.

Safety:

Based on the state-of-the-art review of similar devices, the following safety acceptability thresholds were defined for Eve:

• Acceptable rate of orthostatic hypotension: <6%;
• Acceptable rate of skin lesions: ≤20%;
• Acceptable rate of adverse events other than skin lesions and orthostatic hypotension (fractures, other musculoskeletal events, and pain-related events): ≤7,4%.

Benefits:

Following completion of the Eve training program, the following patient-reported benefits are expected to be achievable in a proportion of SCI users:

• patient satisfaction with the training program, with an agreement rate of at least 95.2%;
• perceived improvement in health-related outcomes, including:
• a reduction in leg spasticity in at least 37.5% of patients;
• improvement in sitting balance control in at least 44.4% of patients; and
• improvement in intestinal elimination in at least 40.0% of patients.

In addition, Eve is expected to allow verticalization for at least 20 minutes per session in SCI users.

A user manual is provided with the device.

Contraindications

Use of the Eve - Personal Exoskeleton is contraindicated in the following cases:

• Untreatable severe spasticity judged by the treating practitioner to be contraindicated.
• Bone health as determined by the treating practitioner to be insufficient for weight bearing and walking.
• Open or unhealed skin pressure sores, abrasions, or bruises at any exoskeleton contact point.
• Inability to operate Eve using the controller, due to functional and/or cognitive impairment.
• Uncontrolled hypertension or hypotension, judged by the treating practitioner to be contraindicated.
• Severe concurrent medical disease, illness, or condition judged by the treating practitioner to be contraindicated.
• Uncorrectable leg length discrepancy > 2cm even when using additional correction tools.
• Morphological contraindications to the use of the device.
• Improper fitting in the device.
• Uncontrolled autonomic dysreflexia.
• Use of a ventilator while operating the exoskeleton.
• Pregnancy.

The device is contraindicated in the following cases for the companion:

• Inability to communicate with the user due to cognitive or language disorders.
• Insufficient strength and performance capability, as evidenced by the ability to hold and stabilize Eve in case of imbalance/fall.

The contraindications above are not exhaustive. Final eligibility and written clearance for device use are at the prescribing practitioner’s sole discretion, based on an individualized risk– benefit assessment

Warnings

• Eve must not be operated in or near inappropriate environments or on unsuitable surfaces. Operation outside the intended environment may result in loss of balance and could cause serious injury.
• Eve's maximum walking speed is insufficient for safe street crossing. Eve must not be used to cross streets or enter roadways under any circumstances.
• Eve must not be used with revolving doors, or with any door that does not meet the minimum clearances specified above.
• User and companion must be trained in the use of Eve. Using the device without training can result in serious injury.
• The first use must occur within one month of training. If necessary, a refresher training session may be issued.
• User must be screened and approved by a licensed healthcare professional to ensure they meet the usage criteria and do not have any contraindication.
• The use of the exoskeleton is restricted to its intended user. Use by another person may cause injuries due to contraindications and individual morphological differences.
• Prior to using Eve for the first time, verify with a healthcare professional that the user’s bone development and joint range of motion meet the device indications. If any changes are observed, discontinue use and seek medical advice.
• User must wear closed-toe shoes similar in platform height and style to those worn during the screening when using the exoskeleton.
• No modification of Eve is allowed. Any modification may cause unsafe operation and voids use within indications.
• The use of Eve requires constant attention, and the companion must always provide proper and continuous supervision when the exoskeleton is in use.
• The companion must remain within arm’s reach of Eve at all times and never leave the user alone inside the exoskeleton. If this condition cannot be maintained, e.g., in an emergency, the user must immediately move into a safe position and switch to STANDING mode.
• Companion must keep both hands on the handle in the following situations, where there is a higher risk of imbalance or fall: Moving on irregular surfaces, i.e., transitions and thresholds including slopes up to 1.15° (2%) and irregularities up to 1.27 cm. For nearby obstacles that could come into contact with the device (e.g., objects, door frames, pets, etc.) When the device is in safety mode, as indicated by the controller.
• User must not manipulate loads over 3.9 kg while using the exoskeleton, which is approximately the weight of four bottles of water.
• Do not hang objects from the armrests or use them to carry any loads (e.g., grocery bags, purses, backpacks, etc.)
• User shall not make voluntary sudden movements that could unbalance the exoskeleton.
• Do not push, pull, or apply external force to the exoskeleton. Only the trained companion may assist the user.
• Using the device in conjunction with other equipment or devices should be avoided, as doing so may interfere with Eve’s functionality, compromise its performance, or result in unexpected behavior that could jeopardize user or companion safety.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic immunity of the device and result in improper operation.
• Do not expose the device to an equipment generating magnetic field at less than 15 cm.
• Do not use the device in the list of environments below: Military areas, Heavy industrial areas, Medical treatment areas with high-powered medical device equipment.
• Do not expose the device to a source of strong heat, open flames, or any other source of ignition, and do not smoke near or in the proximity of the device.
• The companion must perform an emergency extraction in case of fumes, burning smell, or fire of the Eve device.
• Do not charge the exoskeleton when the user is inside the exoskeleton.
• User must be able to demonstrate correct use of the controller during training certification.
• Companion must place the exoskeleton with sufficient sitting depth with the back of the device fully supported by the seat and about 4in (10 cm) of clearance, to ensure stability of the device on the seat.
• Make sure the wheelchair of user is close enough to the device for safe transfer of the user.
• Companion must supervise the transfer of the user and provide assistance if necessary.
• The user must be secured to the device immediately after transfer to prevent any injuries or falls.
• Before standing and once donning is complete, verify that the belt, the shoulder straps, and shoulder pads are securely attached. Next, verify the HALO and both protective armrests are fully lowered and locked. This helps maintain device stability and creates a safety buffer in case of an accidental fall, ensuring enough space between the user and the ground.
• Before standing and once donning is complete, check that the tibia interfaces are correctly locked.
• During sit-to-stand, the companion must keep at least one hand on the exoskeleton handle at all times. If needed, assist the movement by guiding it forward with a light push on the handle to support a safe and successful stand.
• Always ensure the belt and shoulder straps are properly adjusted, that shoulder pads are correctly positioned at the level of the humeral heads and securely tightened, and that the HALO is locked in the horizontal position.
• Never open the armrests, belt, shoulder straps and pads and/or HALO while standing, walking, or sitting. They provide a safety buffer in the event of a fall, helping to maintain enough distance between the user and the ground.
• Reaching for objects while inside the Eve must be performed only in FREE mode, which provides the stability required for sideways leaning and semi-squatting. If the user cannot rise from the semi-squat, the companion must press the PAUSE button to return the exoskeleton to the STANDING position.
• After removing the belt and the shoulder straps, secure the user to prevent the risk of fall.
• Use the EMPTY mode to move the exoskeleton only when no user is inside.
• Eve may be transported in EMPTY mode on flat surfaces only; on slopes, it must be transported in a seated position on a compatible seat.
• Avoid any obstacles or hazards that could affect the balance of the walk.
• In case of loss of balance, the companion must immediately correct the exoskeleton’s balance by grabbing the handle and to prevent the risk of fall.
• When necessary, such as in case of loss of balance or presence of obstacles or hazards, immediately use the PAUSE button to return the exoskeleton to a safe position.
• The companion must perform a controlled descent of the exoskeleton to the ground and an emergency extraction in case of loss of power or in case of failure.
• The companion must perform an emergency extraction in case of environmental or medical reasons.
• After a fall, discontinue use, safely remove the user, and contact Wandercraft support service: support-eve@wandercraft.health or +33 (0)1 84 60 84 41 Do not use the device again until it has been checked and confirmed compliant by Wandercraft.
• Check battery level before and during use. Stop using Eve and charging the device if there is any visual or auditory feedback.
• Do not transport the exoskeleton by airplane.
• Do not charge the exoskeleton when the user is inside Eve.
• Eve contains lithium batteries for which incorrect replacement (including reversed polarity or use of non-approved components) may lead to a hazardous situation such as excessive temperatures, fire, or explosion.
• Battery replacement must be performed only by Wandercraft’s support team. Replacement by untrained individuals may create hazardous situations.
• (Water exposure IP22): Eve is protected only against light dripping water (for example, a few rain drops falling from above, even at a slight angle). It is not waterproof. Do not immerse it in water. Do not spray it with water (no shower, hose, or water jets). Avoid splashes, spills, or large amounts of liquid
• Respect the storage conditions.
• Do not carry the device when it is on.
• Do not use the device in case of suspicion of failure and contact Wandercraft support service.
• Use only seats meeting the specifications.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it may result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers and cables other than provided by the manufacturer could result in increased electromagnetic emissions or decreased electromagnetic immunity of the device and result in improper operation.
• Portable RF communications equipment should be used no closer than 30 cm to any part of the power supply or battery charger, including cables. Otherwise, degradation of the performance of this equipment could result.

Cautions

• User’s condition must be regularly checked by a licensed healthcare professional to ensure that they do not have any contraindications.
• User must wear long pants and closed-toe shoes when using the exoskeleton to prevent bruises, irritation, and other injuries due to rubbing and accidental impacts.
• The companion must not obstruct the movements of the exoskeleton when handling it.
• Ensure all detachable parts are correctly secured in place before operating the device with a user inside.
• After use, conduct thorough skin inspection of the user to identify any possible abrasions. If present, the user must stop using the device until they have fully healed.
• While using Eve, the user should change position regularly to relieve pressure (e.g., shift weight/reposition at frequent intervals).
• Eve has not been evaluated for Magnetic Resonance (MR) safety in the Magnetic Resonance Environment and shall not be brought in proximity of an MR scanner. It has not been tested for heating, migration, or image artifacts. Scanning a patient who wears this device or bringing the device in such an environment may result in harm to the patient, medical staff, or other persons within the MR environment.
• Once donning is complete, check the contact points between the user and the device to ensure Eve will not exert harmful pressure and to avoid skin abrasions from occurring. Pay special attention to the following points: neck, clavicles, third and fourth ribs from the top of the chest, sacrum, ischium, trochanters, knees, thigh and feet.
• Ensure the user's lower limbs (thighs, legs, and feet), belt, and shoulder straps and pads are properly secured according to the procedure detailed above. Do not overtighten the straps or leave them too loose.
• When navigating with the exoskeleton, ensure its movements are not obstructed to prevent any risk of entrapment.
• Ensure the seat is positioned at a sufficient distance behind the device before and during sitting down movement, allowing the user to sit properly and the exoskeleton to be fully supported by the seat with adequate seat depth.
• The companion must supervise the sitting-down motion and provide assistance if necessary.
• In case of wrong or unsafe trigger of the sitting-down motion, cancel the movement.
• The companion must use the EMPTY mode to move the exoskeleton to prevent any injuries.
• The companion must use a safe posture when correcting a loss of balance to prevent any injuries. To reduce risks, the knees should be bent and the back kept straight when lifting the device.
• The batteries powering the device are based on Li-ion technology and the following instructions must be respected: Do not open the device (e.g., by unscrewing or disassembling). Do not expose the device to extreme temperatures (below -25°C or above 70°C). In case of visible damage, abnormal heating, unusual odor, or smoke, immediately stop using the device and contact Wandercraft: support-eve@wandercraft.health or +33 (0)1 84 60 84 41
• If the straps or foams are in poor condition and cannot be resolved with regular cleaning, contact Wandercraft support.
• Eve must be cleaned and maintained in accordance with the instructions described in this instruction for use. Improper cleaning or maintenance can damage the device.
• Use the device at nominal operating temperature.

Informations

• The user may feel discomfort or pain in certain areas of their body. It is important to monitor for any signs of discomfort and discontinue use of the device if needed. If the user feels dizzy or lightheaded (e.g., orthostatic hypotension episode), they should sit down immediately.
• The companion should always stand behind the exoskeleton when handling a loss of balance.
• Reaching for objects while inside the Eve must be performed only in FREE mode, which provides the stability required for sideways leaning and semi-squatting. If the user cannot rise from the semi-squat, the companion must press the PAUSE button to return the exoskeleton to the STANDING position.