medi protect.ROM cool

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Wichtige Hinweise

Das Medizinprodukt

ist nur zum mehrfachen Gebrauch an einem Patienten bestimmt

. Wird es für die Behandlung von mehr als ei-

nem Patienten verwendet, erlischt die Produkthaftung des Herstellers. Sollten übermäßige Schmerzen oder ein unangenehmes Gefühl wäh-

rend des Tragens auftreten, kontaktieren Sie bitte umgehend Ihren Arzt oder ihr versorgendes Fachgeschäft. Tragen Sie das Produkt nur auf

intakter oder wundversorgter Haut, nicht direkt auf verletzter oder versehrter Haut und nur unter vorheriger medizinischer Anleitung.

Important notes

This medical device

is made only for multiple uses on a single patient

. If it is used for treating more than one patient, the

manufacturer’s product liability will become invalid. If undue pain or an unpleasant sensation develops while you are wearing the product,

please consult your doctor or orthotist immediately. Only wear the product on unbroken skin or over injured skin that has been medically

treated, not directly on injured or damaged skin, and only after previous consultation with a medical professional.

Remarques importantes

Le dispositif médical

est destiné à un usage multiple sur un patient

. S´il est utilisé pour le traitement de plusieurs patients, le

fabricant décline toute responsabilité. Si des douleurs extrêmes ou une sensation de gêne devaient se manifester durant l’utilisation, veuillez

consulter immédiatement votre médecin ou votre technicien-orthopédiste. Ne portez le produit que sur la peau intacte ou dont la plaie est

soignée, et non directement sur la peau blessée ou abîmée et seulement suivant une recommandation médicale préalable.

Advertencia importante

El producto médico

solo está destinado a su uso múltiple en un paciente

. En el caso de que se utilice para el tratamiento de más de un

paciente, desaparece la responsabilidad del fabricante sobre el producto. De producirse dolores excesivos o una sensación de incomodidad

durante el uso del producto, sírvase solicite ayuda de su medico o técnico ortopédico inmediato. Coloque el producto solo sobre la piel intacta

o curada, no lo haga directamente sobre la piel lesionada o dañada y hágalo siempre bajo prescripción médica.

Indicações importantes

O dispositivo médico

destina-se a utilização múltipla em apenas num paciente

. Se for utilizado para o tratamento de mais de um

paciente, prescreve a responsabilidade do fabricante. Se surgirem dores excessivas ou uma sensação desagradável durante a utilização,

por favor consulte imediatamente o seu médico ou técnico ortopédico. Use o produto apenas com a pela intacta ou com feridas tratadas e

cobertas, mas não diretamente sobre a pele lesionada ou daniﬁcada e apenas sob orientação médica prévia.

Avvertenze importanti

Dispositivo medico

riutilizzabile destinato a un singolo paziente

. L’utilizzo per il trattamento di più di un paziente farà decadere

la responsabilità da parte del produttore. Nel caso in cui, durante l’uso, sopravvengano dolori o sensazione di disagio, consultare

immediatamente il medico o il negozio specializzato di ﬁducia che l’ha fornita. Indossare il prodotto solo su pelle integra o medicata, non

direttamente su pelle lesa o danneggiata e solo secondo le istruzioni del medico curante.

Belangrijke aanwijzingen

Het medische product

is gemaakt voor herhaaldelijk gebruik door één patiënt

. Indien ze voor de behandeling van meer dan één

patiënt wordt gebruikt, aanvaardt de producent geen aansprakelijkheid. Mocht u tijdens het dragen veel pijn of een onaangenaam gevoel

hebben, vraag onmiddellijk uw arts of ortopedisch instrumentenmaker om raad. Breng het product enkel aan op een intacte huid of huid met

verzorgde wonden, niet rechtstreeks op een gekwetste of beschadigde huid en enkel met voorafgaande medische begeleiding.

Vigtige oplysninger

Det medicinske produkt

er kun beregnet til at blive brugt ﬂere gange på én patient

. Bruges den i behandlingen af mere end en patient,

bortfalder producentens produktansvar. Skulle der opstå store smerter eller en følelse af ubehag mens du har produktet på, skal du straks

tage produktet af og konsultere din læge eller bandagist. Påfør produktet kun på uskadt eller behandlet hud, ikke direkte på såret eller skadet

hud og kun efter forudgående medicinsk vejledning.

Viktiga råd

Den medicinska produkten

är endast avsedd att användas ﬂera gånger för en och samma patient

. Om den används av ﬂera patienter,

gäller inte tillverkarens garanti. Om starka smärtor eller obehagskänslor uppträder vid bärande av produkten, kontakta omgående din läkare

eller din återförsäljare. Använd produkten endast på intakt eller sårvårdad hud, inte direkt på skadad eller ärrad hud och endast under

medicinsk vägledning.

Důležité informace

Zdravotnický prostředek

je určen pro opakované použití u pouze jednoho pacienta . Budete-li ho používat při léčbě více než jednoho

pacienta, zaniká záruka za produkt poskytovaná výrobcem. Pokud by se během nošení vyskytly nepřiměřené bolesti nebo nepříjemný pocit,

sejměte, prosím okamžitě výrobek a vyhledejte svého lékaře nebo prodejnu, kde jste výrobek zakoupili. Výrobek noste pouze na neporušené

nebo ošetřené pokožce, nikoli přímo na poraněné nebo poškozené pokožce, a jen podle předchozího lékařského návodu.

Važna upozorenja

Medicinski proizvod

je namijenjen za višekratnu upotrebu isključivo na jednom pacijentu . Ako se isti koristi za liječenje više od jednog

pacijenta, jamstvo proizvođača prestaje vrijediti. Ako se za vrijeme nošenja proizvoda pojavi bol ili osjećaj nelagode, odmah potražite savjet

liječnika ili specijalizirane trgovine u kojoj ste kupili proizvod. Proizvod nosite samo na neozlijeđenoj koži ili na liječenim ozljedama, a ne

izravno na ozlijeđenoj koži te isključivo prema uputama liječnika.

Bажные замечания

Данное медицинское

изделие

предназначено для многоразового использования только одним пациентом . В случае

использования изделия более чем одним пациентом гарантии производителя утрачивают силу. Если при пользовании изделием у

Вас возникли боль или неприятные ощущения,пожалуйста, немедленно снимите его и проконсультируйтесь у Вашего врача.

Носите изделие исключительно на неповрежденной коже/после обработки ран. Не следует надевать его поверх поврежденной или

пораненной кожи. Используйте изделие только после получения указаний от медперсонала.

Önemli uyarı

Bu ürün tıbbi

cihaz

kategorisine girer ve yalnızca hastalar üzerinde birden fazla kez kullanılmalıdır . Aynı ortezin birden fazla hastada

kullanılması durumunda tıbbi ürünlere düzenleme getiren kanunun anladığı anlamda üreticinin üründen kaynaklanan sorumluluğu sona

erer. Taşıma sırasında aşırı ağrı ve rahatsızlık duygusu görülmesi durumunda, lütfen derhal doktor veya ortopedi teknisyenini arayınız. Ürünü

yalnızca sağlıklı cilt veya gerekli tıbbi müdahalesi ve bakımı yapılmış, üstü örtülü yaralar üzerinde kullanın; doğrudan açık yara üzerinde ve

önceden gerekli tıbbi talimatları almadan kullanmayın.

medi GmbH & Co. KG

Medicusstraße 1

95448 Bayreuth

Germany

T +49 921 912-0

F +49 921 912-780

ortho@medi.de

www.medi.de

medi Australia Pty Ltd

83 Fennell Street

North Parramatta NSW 2151

Australia

T +61-2 9890 8696

F +61-2 9890 8439

sales@mediaustralia.com.au

www.mediaustralia.com.au

medi Austria GmbH

Adamgasse 16/7

6020 Innsbruck

Austria

T +43 512 57 95 15

F +43 512 57 95 15 45

vertrieb@medi-austria.at

www.medi-austria.at

medi Belgium NV

Staatsbaan 77/0099

3945 Ham

Belgium

T: + 32-11 24 25 60

F: +32-11 24 25 64

info@medibelgium.be

www.medibelgium.be

medi Canada Inc / médi Canada Inc

597, Rue Duvernay, Verchères

QC Canada J0L 2R0

T: +1 450-583-3317 / +1 800 361 3153

F: +1 888-583-6827

service@medicanada.ca

www.medicanada.ca

MAXIS a.s.,

medi group company

Slezská 2127/13

120 00 Prague 2

Czech Republic

T: +420 571 633 510

F: +420 571 616 271

info@maxis-medica.com

www.maxis-medica.com

medi Danmark ApS

Vejlegardsvej 59

2665 Vallensbaek Strand

Denmark

T +45-70 25 56 10

kundeservice@sw.dk

www.medidanmark.dk

medi Bayreuth Espana SL

C/Canigo 2-6 bajos

Hospitalet de Llobregat

08901 Barcelona

Spain

T +34-932 60 04 00

F +34-932 60 23 14

medi@mediespana.com

www.mediespana.com

medi France

Z.I. Charles de Gaulle

25, rue Henri Farman

93297 Tremblay en France Cedex

France

T +33-1 48 61 76 10

F +33-1 49 63 33 05

infos@medi-france.com

www.medi-france.com

medi Hungary Kft.

Bokor u. 21.

1037 Budapest

Hungary

T +36 1 371-0090

F +36 1 371-0091

info@medi.hu

www.medi.hu

medi Japan K.K.

5-1 Nihonbashi Kabutocho Chuoku

103-0026 Tokyo

Japan

T: +81 3 6778 2590

F: +81 3 5847 7901

info@medi-japan.jp

www.medi-japan.co.jp

medi Nederland BV

Heusing 5

4817 ZB Breda

The Netherlands

T +31-76 57 22 555

F +31-76 57 22 565

info@medi.nl

www.medi.nl

E009629 / 11.2023

4051526 183810

medi Polska Sp. z.o.o.

ul.Łabędzka 22

44-121 Gliwice

Poland

T: +48-32 230 60 21

F: +48-32 202 87 56

info@medi-polska.pl

www.medi-polska.pl

medi Bayreuth Unipessoal, Lda

Rua do Centro Cultural, no. 43

1700-106 Lisbon

Portugal

T +351-21 843 71 60

F +351-21 847 08 33

medi.portugal@medibayreuth.pt

www.medi.pt

medi RUS LLC

Business Center NEO GEO

Butlerova Street 17

117342 Moscow

Russia

T +7-495 374 04 56

F +7-495 374 04 56

info@medirus.ru

www.medirus.ru

medi Sweden AB

Box 6034

192 06 Sollentuna

Sweden

T +46 8 96 97 98

F +46 8 626 68 70

info@medi.se

www.medi.se

medi Trading (Shanghai) Co. Ltd.

Room 1703, T1, CES WEST BUND CENTER,

No. 277, Long Lan Road

Xuhui District

200232 Shanghai

People‘s Republic of China

T: +86-21 50582319

F: +86-21 50582319

UK Responsible Person

medi UK Ltd.

Plough Lane

Hereford HR4 OEL

Great Britain

T +44-1432 37 35 00

F +44-1432 37 35 10

enquiries@mediuk.co.uk

www.mediuk.co.uk

medi. I feel better.

protect.ROM cool

Universalknieschiene zur Mobilisierung · Universal knee

brace for mobilisation

Gebrauchsanweisung. Instructions for use. Mode d’emploi. Instrucciones de

uso. Instruções de uso. Istruzioni per l’uso. Gebruiksaanwijzing. Brugsve-

jledning. Bruksanvisning. Návod k použití. Uputa za uporabu. Инструкция

по использованию. Kullanma kılavuzu. Instrukcja zakładania. Οδηγία

εφαρμογής. Uputstvo za upotrebu. 

使用说明. Instrucțiuni de

utilizare. שומיש תוארוה. Uzvilkšanas instrukcija.

E009629_AAL_protect.ROM.indd 1 14.11.23 08:33

Need help?

Do you have a question about the medi protect.ROM cool and is the answer not in the manual?

The medi protect.ROM cool is a knee orthosis designed for mobilization, offering early functional mobilization with restricted movement of the knee joint. It is indicated for various conditions, including ligament injuries (post-traumatic/post-operative), meniscal injuries (post-traumatic/post-operative), and tendon injuries (post-traumatic/post-operative). There are no known contraindications for its use.

Function Description:

The protect.ROM cool facilitates controlled movement of the knee, allowing for early functional rehabilitation while protecting the joint from excessive motion. Its design incorporates adjustable extension and flexion limits, which are crucial for guiding the knee through a prescribed range of motion during recovery. The orthosis helps to stabilize the knee, reduce pain, and prevent further injury, promoting healing and a return to normal activity. The immobilization provided by the device is a risk factor for deep vein thrombosis in the legs, especially after surgery or trauma.

Important Technical Specifications:

The orthosis features adjustable extension and flexion limits.

Extension limits: 0°, 10°, 20°, 30°
Flexion limits: 0°, 10°, 20°, 30°, 45°, 60°, 75°, 90°, 105°, 120° The medial (inner) and lateral (outer) degree adjustments must always be set to the same values to ensure proper alignment and function. The material composition includes aluminum, PU-foam, and cotton, providing a balance of rigidity, comfort, and breathability.

Usage Features:

The protect.ROM cool is designed for ease of application and adjustment.

Preparation: Open all straps and detach the joint splints from the padding.
Application: Wrap the thigh and calf paddings tightly around the leg and fasten them at the front.
Splint Attachment: First, attach the external (lateral) splint to the padding, ensuring the splint's joint is centered over the patella and aligned with the knee's midline. Then, attach the internal (medial) splint in the same manner, making sure both joints are at the same height.
Strap Fastening: First, fasten the upper calf strap, then the lower thigh strap. Subsequently, fasten the remaining straps from bottom to top.
Removal: To remove the orthosis, simply open the straps and paddings and pull the orthosis backward.
Adjustment of ROM: To adjust the range of motion, first turn the plastic opening until it reaches one of the pins. Then, by pressing the red button and simultaneously shifting, you can set the desired degree. Repeat this process for the second pin. The extension and flexion limits should only be changed according to the instructions of a doctor or orthotist.

Maintenance Features:

Proper maintenance ensures the longevity and effectiveness of the orthosis.

Strap Care: Hook and loop fasteners should be closed before washing to prevent damage and maintain their effectiveness.
Padding Wash: Soap residues, lotions, and ointments can cause skin irritation and material wear. The paddings should be hand-washed, preferably using medi clean washing agent.
Drying: Do not bleach. Allow to dry naturally. Do not iron. Do not dry clean.
Storage: Keep the brace in a dry place and do not expose it to direct sunlight.

Risks and Side Effects:

If the accessories are too tight, local compression phenomena or constriction of blood vessels or nerves may occur in individual cases. Therefore, consult your treating physician before use if you experience the following symptoms:

Skin diseases or injuries in the application area, especially signs of infection (excessive heat, swelling, or redness).
Sensory disturbances and circulatory disorders (e.g., in diabetes, varicose veins).
Lymph drainage disorders – as well as unclear swellings of soft tissues away from the application area. Wearing tightly fitting accessories can cause localized skin irritations/itching due to mechanical irritation of the skin (especially in combination with perspiration) or the composition of the accessory. The immobilization achieved by the device is a risk factor for deep vein thrombosis in the leg veins, especially after surgical interventions or trauma.

Intended Users and Patient Target Groups:

The intended users include healthcare professionals and patients, including individuals providing care after receiving information from healthcare professionals. The patient target group includes adults and children, treated by healthcare professionals according to available dimensions/sizes and required functions/indications, based on manufacturer information and under their own responsibility.

Liability and Disposal:

The manufacturer's liability becomes void if the product is not used as intended. Always refer to the corresponding safety information and instructions in this manual. The product can be disposed of with domestic waste. In case of complaints regarding the product, such as damaged fabric or fitting defects, contact your specialist medical retailer directly. Only serious incidents that could lead to a significant deterioration in health or death must be reported to the manufacturer and the competent authorities in the EU member state. Serious incidents are defined in Section 2, No. 65 of Regulation (EU) 2017/745 (MDR).