General Information
The MANU® is an innovative, dynamic handbrace designed to treat the symptoms of Carpal Tunnel Syndrome (CTS). Clinical trials have shown that it is very effective in reducing, and in some cases even eliminating, the tingling and the pain associated with CTS. The structure and the components were carefully designed to guarantee maximum comfort.
The MANU® should only be worn at night and is to be removed in the morning before the start of daytime activities.

Composition
All the external components of the MANU® are lined with a soft material called Lycra (80% polyamide, 20% elastomer) which does not irritate the skin and allows it to breathe.

Device Category
Medical Device Class 1 (D.I., 24.2.97 n.46, directive 93/42/CEE).  















Use
The MANU® is worn to alleviate the night-time symptoms of Carpal Tunnel Syndrome.

Risks
THe MANU® should be used only after the diagnosis of Carpal Tunnel Syndrome has been confirmed by a physician. The efficacy and tolerability of the MANU® worn every night for one month have been demonstrated in a controlled study.  A more prolonged use requires medical control and periodic electroneurographical exams to evaluate the functioning of the medium nerve. It has to be kept in mind that while the MANU® is being worn, it will limit the movement of the hand. For safety reasons therefore, the device should only be worn at night during sleep and not during the day when usual activities will require complete use of the hand. In cases of CTS symptoms which are intense during the day, additional therapeutic care will be necessary. In instances in which the use of the MANU® causes persistent tingling and/or pain which are not alleviated by correting the positioning of the device or loosening it, the use of the MANU® should be suspended.

When not to Use the MANU®
The are not absolute contraindications to the use of the MANU®; however, persons with severe forms of arthritis or osteoporosis affecting the wrist or the hand, or active inflammation of joints in the wrist or hand, should not wear this device. Known cases of sensitivity of the skin to the outside components of the device would also proclude its use.

Side Effects
The MANU® is a soft, comfortable handbrace which is generally very well tolerated and practically devoid of side effects. There have been rare reports of the temporary reappearance of the CTS symptoms when the MANU® is being put on or taken off. These symptoms resolve quickly and spontaneously if the device is put on and removed slowly and gently.
N.B. Any side effets not described in this insert must be reported to the manufacturer.

Care of the MANU®
The device should be stored in its own packaging in a cool, dry location, far from any source of heat. It can be cleaned with a soft cloth and warm water. It should no longer be used if it shows signs of deteriorating.

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How the MANU®  Should Be Worn

With the palm of the hand facing downwards, position the cushion of the MANU® between the forefinger and the little finger so that these two fingers are beneath the cushion while the two middle fingers remain on top of it (see fig.1).

Then fasten the velcro strap across the palm of the hand below the fingers as shown in fig.2. The strap must be tight enough to expert the maximum benefit on the CTS symptoms without causing pain to the hand.

N.B. If the device does not seem to be working porperly, tighten it a little more. If pain persists, loosen the pressure of the device.

Lastly, position the strap on the back of the hand as shown in fig.1 and close the velcro wrist strap around.

N.B. The wrist strap should not be tight.

Available Sizes ( Left and Right Hand)
Width of the palm of the hand at the base of the middle finger (teste metacarpaali)