Information about the device, its manufacturer, and information regarding safety and performance
1. Japet.W+ Device Information
1.a. Device Identification
Japet.W+
1.b. Manufacturer Identification
JAPET MEDICAL DEVICES
147 avenue Pierre Mauroy
59120 LOOS
France
2. Safety and performance information
2.a. Performance of the device
The clinical performance is the decompression of intervertebral discs. The device offers no essential performance.
2.b. Indications
The JAPET. W+ is indicated for adults with chronic and acute low back pain. The device is intended for ambulatory distraction of the lumbar spine.
The device can also be used by people in good health performing tasks involving high lumbar strain.
The device must be worn over a t-shirt. Its use is restricted to individuals trained by JAPET MEDICAL DEVICES®. The device can be used at home, in the workplace, and in commercial or hospital environments.
For use in the workplace, it is recommended to wear the JAPET W+ device before a painful episode.
2.c. Contraindications
The use of the device is contraindicated and is subject to approval by a physician in the following cases:
- Neurological root and spinal cord deficits,
- Treatment with implanted neurostimulation,
- Heart or circulatory disease and severe respiratory problems,
- Tumour or infectious process of the vertebrae,
- Symptomatic osteoporosis,
- Herniated disc surgery (< 3 months),
- Fracture of the dorsolumbar spine (< 3 months),
- Rib fracture (< 3 months),
- Skin injury, bruising and stretching injuries of the trunk,
- Pregnancy (> 4 months),
- Previous lumbar prosthesis surgery.
Contact your doctor if you experience pain or increased pain while wearing the device.
2.d. Possible adverse effects of the device
Improper positioning of the device or an incorrect size can cause:
- Haematoma
- Irritation
- Pain
- Discomfort
In the event of an unlisted adverse reaction related to the device, please contact JAPET MEDICAL DEVICES ®.
Contact information is available at the end of the user guide.
2.e. Warnings
- Do not use batteries and battery chargers other than those distributed by JAPET MEDICAL DEVICES®.
- To avoid the risk of electric shock, the battery charger should only be connected to a power supply network equipped with a protective earth.
- In case of damage to the protective case, please contact JAPET MEDICAL DEVICES®. Do not use the JAPET.W+ if it is damaged in any way.
- Take routine precautionary measures to avoid contact with blood or other materials at risk of biocontamination. Contaminated material must be treated in accordance with the hygiene requirements in force in the establishment.
- Do not expose this device to rain, dripping, or splashing. Do not immerse it.
- The device is powered internally by a battery that is recharged outside the device through the supplied charger.
- It is strictly forbidden for a third party, other than a technician authorised by the company JAPET MEDICAL DEVICES®, to open or modify the device.
- It is strictly forbidden to disassemble or modify the device (this act interrupts all warranties).
- The motors can heat up during normal use of the device, the maximum temperature that can be in contact with the skin is 41°C (105.8°F). If the temperature of the motors exceeds 41°C (105.8°F), stop wearing the device and contact JAPET MEDICAL DEVICES®.
- Keep the device away from lint, dust, and light that could damage the device.
- Avoid storing the device in an area where children, pets, or pests could enter. Unintentional handling could damage it. Keep out of reach of children.
2.f. Electromagnetic compatibility warnings
- WARNING: Use of this unit next to or stacked with other units should be avoided because it may cause malfunction. If such use is necessary, observe this unit and other units for normal operation.
- WARNING: Portable RF communications devices (including peripherals such as antenna cables and external antennas) should not be operated closer than 30 cm (12 inches) to any part of the device. Otherwise, the performance of this device may be impaired.
- WARNING: The use of accessories, transducers, and cables other than those specified or provided with this device may result in increased electromagnetic emissions or decreased immunity of this device and may result in improper operation.
2.g. Messages