Part No.: 2401-0900 Rev.: 1 Issue Date: 12/09

Instructions for use

Quattromed®

The Quattromed Brace

The Quattromed Brace has been designed to provide offloading and mild compression around the knee joint.

Quattromed’s ‘patella support’ provides compression around the front of the knee to help reduce swelling while avoiding pressure directly onto the patella. During walking, this changing pressure of the patella ring, assists with the circulation of the knee, promotes lymph drainage and encourages pain reduction and improved function.

Quattromed’s carefully selected Breath-O-Prene materials provide warmth and breathability. These materials incorporate the antibacterial benefits of SilverTec, the process in which silver nanocrystals are imbedded into the fabric. The antibacterial effects of SilverTec provides control against bacterial growth and odours for up to 30 washes.

Contraindications, Precautions and Warnings

The information below relates to the Contraindications, Precautions & Warnings in the application of the Quattromed Brace.

Contraindications:• There are no known contraindications in the use of the Quattromed Brace. If you experience any unusual symptoms, discontinue use and consult your medical practitioner.

Precautions and Warnings:• If in doubt always seek medical advice.• The Quattromed Brace should only be used for its intended purpose and in the manner described in this manual. No liability is accepted for improper use of the product.• It is not recommended that you wear your knee brace for more than 8 hours per day.• Quattromed is for single patient use only.• Please keep Quattromed out of the reach of children.• Should you experience any unusual changes (e.g. increased symptoms), please contact your healthcare specialist without delay.• Never connect your Quattromed Brace to an unapproved external power source.

Adverse Reactions:• Pain behind the knee has been reported when using the Quattromed brace. This pain is thought to have been associated with a significant increase in patient activity due to improved mobility with use of the brace. To reduce the likelihood of occurrence, we recommend a gradual increase in activity. If in doubt, always seek medical advice. • Excessive compression around the knee may lead to local redness or disturbance of the normal circulation of the lower limb.

Important:• There is a separate Quattromed Brace for use with the right or left leg. Under no circumstances should the left leg brace be used on the right leg or vice versa.• Correct size selection and fitting are strongly recommended to ensure the comfort of this device.

Size

Thigh

Mid Patella

Calf

XL

67 – 75

56 – 63

53 – 59

L

60 – 67

50 – 56

47 – 53

M

53 – 60

44 – 50

42 – 47

S

46 – 53

39 – 44

37 – 42

XS

39 – 46

33 – 39

31 – 37

Size Table

Technical Specifications

Product Type: 415/ 416Intended Use: Corrective knee brace for medial gonarthrosis.

AccessoriesUse only original neurotech accessories specified for use with Quattromed. Any others may not be compatible with your unit and could degrade the minimum safety levels.

Garment Materials:Outer Material: 90% Nylon, 10% SpandexInner Material: 85% Nylon, 15% SpandexFastenings: 100% Nylon Hook and LoopElectrode Studs: 95% Silicone, 5% CarbonKnee Joints: 100% Aircraft-Grade AluminiumPatella Buttress: 100% Silicone

This symbol indicates that the device meets the 92/42/EEC Dirctive for medical devices.

Designed by & Manufactured for: Customer Carelines:Bio-Medical Research Ltd., Republic Of Ireland: Freephone: 1800 511 511Parkmore Business Park West, N. Ireland/ UK: Lo-Call: 0845 600 1332 Galway, Ireland.

Environmental Specifications:Storage Range: Temperature: 0 - 55°C (32 - 131°F) Humidity: 10 - 90 % RH

Washing Instructions

Quattromed is suitable for hand-washing at 30 degrees Celsius. Do not machine wash.

Quattromed should not be tumble-dried. It should be hung when wet and then allowed to dry naturally, away from any direct heat sources. Failure to comply with this may result in damage to Quattromed.

Quattromed is unsuitable for ironing

Quattromed is unsuitable for dry-cleaning.

Do not use bleach when washing Quattromed.

Read manual before use.

Introduction

Thank you for selecting the Quattromed Brace from neurotech®. Quattromed is a revolutionary fusion of biomechanical capabilities in a single garment.

Please ensure that you read all of the instructions carefully before using this product.

Quattromed is designed by and manufactured for BMR Ltd., Parkmore Business Park West, Galway, Ireland. Copyright © 2009 by BMR Ltd., all rights reserved.

neurotech is a registered trademark of BMR Ltd. Quattromed is a registered trademark of BMR Ltd. in the EU. Registration is pending in the U.S.

If you have questions or require further information please contact:UK/Ireland:neurotech, Bio-Medical Research Ltd., Parkmore Business Park West, Galway, Ireland.Tel: +353 (0)91 774 377 Fax: +353 (0)91 774 303Email: info@neurotech.co.uk Web: www.neurotech.co.uk

Safety Information

ValidityThe information and technical data contained in this document relates to the Quattromed Brace provided with this User Manual. The information and technical data disclosed in this document are proprietary to Bio-Medical Research Ltd. (BMR Ltd.) and may only be used and disseminated for the purposes and to the extent specifically authorised in writing by the company.

DisclaimersAll equipment manufactured and sold by BMR Ltd. is rigorously checked and tested prior to shipment. However, the use of this equipment is outside of the control of the company. BMR Ltd. only accept responsibility for the safety, reliability and performance of the equipment when it is operated in accordance with the instructions herein and within the given specifications. Therefore, the user must bear full responsibility for any actions arising out of the use or misuse of this equipment. Any modifications, repairs or servicing must be undertaken by authorised BMR Ltd. personnel.

RestrictionsThe sale and/or operation of this equipment is subject to legislation in a number of localities. Compliance with this legislation rests with the importer, dealer, or user of the equipment as appropriate.

Indications For Use: Quattromed Brace, Type 415/416– Conservative treatment of complex ligamentous instability particularly in combination with unilateral osteoarthritis– Conservative treatment of advanced unilateral osteoarthritis– Post operative pressure relief and compartmental protection after fractures of the tibial head, cartilage surgery, meniscus refixation, correction osteotomy– Instability of the cruciate ligaments with pressure relief of the medial compartment

Bend knee 30° when measuring.

Bio-Medical Research Ltd.Parkmore Business ParkWest, Galway, Irland

embrace life.

Quattromed®

Pack Contents

Quattromed should always be applied while seated.

Single Buckle

Upper Wrap

Upper Strap

Corrective Strap

Sleeve

Knee Pad

Lower Wrap

Lower Strap

DoubleBuckles

RearStraps

Unclip the double buckle at the top of the brace...

Step 1: Unclip the buckles from the keyholes.

...unclip the single buckle at the bottom of the brace.

Do not adjust the rear straps.After step 4 the rear strap canbe adjusted for optimum comfort

Do not separate the two halves of this buckle.

Undo the upper and lower wraps, so the brace looks as shown. Thebrace is now ready to be applied.

Step 2: Open the brace and position the brace.

Pull the Quattromed sleeve onto your leg...

...keeping your leg as straight as possible, pull the sleeve until the knee pad is comfortably located just below the kneecap.

Pull-tabs mayalso be used.

Step 3: Close the lower wrap, attach the single buckle and tighten the strap.

Bring the lower wrap around your calf and fasten as shown.

Attach the single buckle by inserting it into the “keyhole”...

....and tighten the strap.

You may need to loosen the strap before attaching the buckle.

Step 4: Close the upper wrap, attach the double buckle and tighten the straps.

Bring the upper wrap around your thigh and fasten as shown.

You may need to loosen the strap before attaching the buckle.The corrective strap should be fastened as tight as is comfortable. Adjusting this strap will assist the offload function of the brace.

Attach the double buckle by inserting it into the “keyhole”...

...tighten the upper strap....

...and tighten the corrective strap.

Removing the Quattromed Brace

Step 1: Loosen the straps and unclip the buckles from the keyholes.

Loosen the upper straps and unclip the double buckle at the top of the brace...

...loosen the lower straps and unclip the single buckle at the bottom of the brace.

Step 2: Unwrap the brace and remove it from your leg.

Unfasten the upper wrap... ...unfasten the lower wrap... ...and carefully pull the sleeve down and off your leg. The pull-tabs may also be used.

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