Information on the device, its manufacturer and information on safety and performance

1.Informations about Japet.W⁺ device :

1.a. Device indentification :

Model :

Japet.W⁺

1.b. Manufacturer identification :

Manufacturer :

JAPET MEDICAL DEVICES

F3A – 12 avenue Pierre Mauroy

59120 LOOS

France

2. Safety and performance information

Clinical performance of the device

Decompression of the intervertebral discs.

Indications

The JAPET.W+ device is indicated for adult people with chronic and acute low back pain. The device is intended for ambulatory distraction of the lumbar spine.

It is recommended to use the device over a T-shirt.

The use of the device is intended for healthcare professionals and/or referents who have been trained by JAPET MEDICAL DEVICES® or by a third party authorised to carry out this training.

It is recommended to use the device in 30- 60 minute sessions (2-3 times a day).

For use in the workplace, it is recommended that the JAPET.W+ device be worn before a painful episode.

Contraindications

This device is contraindicated 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
Osteoporosis (< -2.5 ds)
History of arthrodesis surgery
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 an increase in pain when wearing the device.

Possible adverse effects of the device

Incorrect positioning of the device or incorrect sizing can cause :

Haematoma,
Irritation,
Pain.

In case of an adverse reaction not listed and related to the device, please contact JAPET MEDICAL DEVICES ®.

Avertissements


	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.
	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.
	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.
	Do not use other batteries than those distributed by JAPET MEDICAL DEVICES®.
	Do not use other battery chargers than the one distributed by JAPET MEDICAL DEVICES®.
	To avoid the risk of electric shock, the battery charger should only be connected to a mains supply with an earth terminal.
	If the protective case is damaged, please contact JAPET MEDICAL DEVICES®. Do not use the JAPET. W® device if it is damaged in any way.
	Take routine precautions to avoid contact with blood or other bio-contaminating materials. Contaminated material should be treated in accordance with the hygiene requirements of the establishment.
	Do not expose the device to rain, dripping or splashing liquids. Do not immerse it in water.
	The device is internally powered by a battery which is recharged externally with the supplied charger.
	It is strictly forbidden for a third party, other than a technician authorised by JAPET MEDICAL DEVICES®, to open or modify the device.
	It is strictly forbidden to dismantle or modify the device (this act interrupts all guarantees).
	The motors may become hot during normal use of the device, the maximum temperature that can be in contact with the skin is 41°C (105.8°F). If motors temperature 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 a place where children, pets or vermin could get in. Inadvertent handling could damage the device. Keep out of the reach of children

Messages

Messages	Likely causes	Solution
The LED above the On/Off button remains lit and the HMI no longer respond	When the battery was inserted, the actuators were unable to fully retract.	Remove the battery and insert it with the device lying flat.
	When switching from level 1 to level 0, the actuators were unable to move into the middle position.	Remove the battery, loosen the belt and reinsert the battery to restart the device.
	When the product was switched off (long press on the Off button), the actuators were unable to fully retract.	Switch off the device by removing the battery. When you switch off the device, make sure you have loosened the belt.
When the battery is inserted, there is 1 beep, all the HMI LEDs remain lit and the device no longer responds.	Left front actuator faulty	Remove and reinsert the battery
When the battery is inserted, there is 2 beeps, all the HMI LEDs remain lit and the device no longer responds.	Left back actuator faulty	Remove and reinsert the battery
When the battery is inserted, there is 3 beeps, all the HMI LEDs remain lit and the device no longer responds.	Right back actuator faulty	Remove and reinsert the battery
When the battery is inserted, there is 4 beeps, all the HMI LEDs remain lit and the device no longer responds.	Right front actuator faulty	Remove and reinsert the battery
When the device is switched on (long press on the On button), there are 3 beeps and the first LED flashes 3 times.	The battery is defective	Remove the battery and check the charge level. If it is empty, charge it. If not, try starting the device with another battery.

Note : If the problem persists, contact Japet Medical

Operating conditions

Temperature : +0°C to +40°C (+32°F to +104 °F)

Humidity in the air : 5% to 95%

Atmospheric pressure : 570hPa to 1060hPa

Storage and transport conditions

Temperature : -20°C to +40°C (-4°F to +104°F)

Humidity in the air : 5% to 95%

Atmospheric pressure : 570hPa to 1060hPa