MANU technical data sheet

MANU^® is an innovative dynamic and soft brace, specifically designed for the conservative treatment of the Carpal Tunnel Syndrome (CTS).

Several tests have confirmed its remarkable efficiency in reducing or eliminating the symptoms and in improving hand functionally in CTS. Moreover its structure and components have been carefully designed to guarantee maximum tolerability. Wear MANU^® in the evening, before going to bed, as described below, and take it off when standing up. MANU^® must be used only during the night rest.

Rational basis for the creation of MANU^® results from the observation that a moderate grip of the distal extremities of metacarpal bones, from the second to the fifth, and a concomitant extension of the thirth and fourth fingers, alleviate paresthesias and pain in Carpal Tunnel Syndrome (Manente et al. - Muscle & nerve, 1999).

Efficiency and tolerability of MANU^® have been proved by two randomized controlled studies (Manente et al. - Muscle & Nerve, 2001; De Angelis et al. - Acta Neurologica Scandinavica, 2009) respectively of the duration of one and three months.

MANU^® increases the available space inside the carpal tunnel (Manente et al. - Journal of Hand Surgery, 2002).

MANU^® is a registered European trademark. MANU^® has a Europena patent, a US patent and an Italian patent. All rights are reserved to AGF Orthopaedic Devices srl - Italy.

All MANU^® components have a soft, non-­irritant, transpiring, Lycra^®-­type coating (polyamide 80%, elastomer 20%); the inner lining and padding are made of moltoprene.

Class 1 medical device (in compliance with the law degree 24.2.97 no. 46, implementing Directive 93/42/EEC). CE trademark.

AGF Orthopaedic Devices s.r.l. Registered office: Via Michelangelo 41, San Nicolò a Tordino (Teramo) - Italy. Tel. +39.0861.233308 - Fax +39.0861.234528 - Email: info@agfmanu.com

MANU^® is used for assuaging the symptoms and to improve hand functionality in carpal tunnel syndrome. MANU^® must be worn during the night time, repose for 1 - 3 months (cycle repeatable to the need).

No absolute contraindications have been determined. However, due to its potential limited efficacy and/or tolerability, MANU^® is not recommended in the following cases:

Severe wrist and/or hand arthrosis or arthritis, especially if deforming;

Polyneuropathy;

Previous repeated infiltration of intracarpal steroids;

Severe osteoporosis of the hand bones;

Severe tendosynovitis of the fingers, especially in case of stenosis (Note: should they be specifically treated with an appropriate therapy, the use of MANU^® is not contraindicated);

Individual hypersensitivity to MANU^® external components.

In case of persistent CTS after surgery, the efficacy of MANU^® shall be evaluated on a case-by-case basis, by taking the causes of surgery failure into consideration.

1) MANU^® must be used only if the carpal tunnel syndrome has been diagnosed by a physician.

2) MANU^® efficiency and tolerability have been tested in a controlled study for three months continuous use. A longer and continuous use shall be in compliance with the physician's indications.

3) The user shall be fully aware that some hand functions are impaired or impossible when wearing MANU^®. Therefore, the user must wear MANU^® only during the night rest and take all the necessary measures to prevent any potential harmful consequences caused by limited hand functionality. For safety reasons, MANU^® shall not be used during the day. Different therapeutic measures shall be taken in case of prevailing or strong symptoms during the day.

4) Should MANU^® cause continuous and persistent pain and/or paraesthesia, which cannot be solved by adjusting its position or reducing its grip, discontinue its use.

MANU^® is a soft brace; trials have confirmed that it usually is very tolerated and has no undesired effects.

The temporary occurrence or exacerbation of the symptoms, while taking MANU^® off in the morning, have seldom been reported. This issue is generally solved spontaneously or by repeatedly moving the hand and is prevented by taking MANU^® off gradually.

Store MANU^® in a dry place, inside its case, away from heat sources; avoid improper use. Discontinue use in case of clear signs of deterioration.

Clean its surface with a cloth and warm water.

Available sizes are S, M, L, XL both for the right hand and for the left hand. You can choose your right measure by measuring the width of your hand, that must be opened with fingers side-by-side, at 1 cm from the base of the fingers (forefinger­little finger).

S = 5.5 - 6.5 cm

M = 6.5 - 7.5 cm

L = 7.5 - 8.5 cm

XL = 8.5 - 9.5 cm

NOTE: In case your measure is on the limit or near the limit between two sizes, choose the smaller one.

A) Place MANU^® triangular cushion between the 2nd (forefinger) and 5th (little finger) fingers, which must be in front of the cushion (towards the palm of the hand) and the 3rd (middle finger) and the 4th (ring finger) fingers, which must be on the back of the hand (see figures 1 and 2).

B) Fasten the Velcro palm strap, so as placed on the palm, near the finger base (metacarpal ends, see fig. 1).

The Velcro strap grip must be adjusted by the user in a way which benefits the symptoms without causing any hand pain.

NOTE: In case of unsatisfactory efficacy, increase the grip; in case of persistent hand pain, reduce the grip.

C) Finally, fasten and adjust the dorsal anti-removal strap on the hand dorsal support and the wrist strap around the wrist (see figures 1 and 2). (NOTE: The wrist wrap must not be too tight).