Instructions for Use - Össur

1 Instructions for UseUNLOADER ONE 4EN | Instructions FOR USE 6DE | gebrauchsanweisung 9FR | NOTICE D UTILISATION 13ES | INSTRUCCIONES PARA EL USO 16IT | ISTRUZIONI PER L USO 20NO | BRUKSANVISNING 24DA | BRUGSANVISNING 27SV | BRUKSANVISNING 30EL | 33FI | K YTT OHJEET 37NL | GEBRUIKSAANWIJZING 40PT | INSTRU ES DE UTILIZA O 43PL | INSTRUKCJA U YTKOWANIA 46CS | N VOD K POU IT 50TR | KULLANIM TALIMATLARI 53JA | 56ZH | 59KO | 6241 2 3 5 4 6 e c f b g d h i j k l a h57 8 6 ENGLISHLIST OF PARTS (Figure 1)A.

2 Upper Dynamic Force System (DFS) strapB. Lower Dynamic Force System (DFS) strapC. Thigh strapD. Calf strapE. Polycentric hingeF. Thigh shellG. Calf shellH. Quick Fit BuckleI. Buckle Stability ShelfJ. Alligator clipK. Upper dosing dialL. Lower dosing dialUNLOADER ONE INDICATION FOR USE Unicompartmental Osteoarthritis May also be beneficial for unicompartmental knee conditions that require pain reduction in an affected compartment such as: Articular cartilage defect repair Meniscal cartilage repair Avascular necrosis Tibia plateau fracture Circumference limitation Thigh circumferences smaller than " ( cm) or larger than 29" ( cm). Calf circumferences smaller than 10" (25 cm) or larger than 24" ( cm).CAUTION For patients with peripheral vascular disease, neuropathy, and sensitive skin, close physician supervision is recommended. For patients with sensitive skin, it is recommended to use the Unloader One as tolerated.

3 If redness appears decrease the usage of the brace. Increase usage slowly as the skin tolerates the brace. The Unloader One is field adaptable to accommodate patient comfort issues. Modifications to flexion or extension stops and shell contour should only be made by the health care professional. The healthcare professional is responsible for advising patient on use of the Dynamic Force Control APPLICATION1. Open upper and lower Quick Fit Loosen the dosing ratchet to the 0 Place the brace on patient s leg. Align the center of hinge at mid patella and midline of A/P (Figure 1).4. Place button of lower Quick Fit Buckle into appropriate keyhole above Buckle Stability Shelf (Figure 2) and close carefully using the palm of the hand to snap the buckle closed. The button is color matched with an identical blue color in the keyhole for intuitive strap Bend knee to an 80 angle with foot flat on the Place button of upper Quick Fit Buckle into appropriate keyhole and close carefully using the palm of the hand.

4 The button is color matched with an identical yellow color in the keyhole for intuitive strap Turn upper dosing dial clockwise to tighten Dynamic Force Control System strap to prescribed position (Figure 3). Practitioner will need to determine optimum unloading based on patient s pain relief feedback. The strap tension should be set to provide optimal pain relief once the dosing dial is set to the setting of 5".To increase the DFS loading force on the calf, turn the lower dosing dial Fully extend leg in a sitting position and make sure that brace is still aligned correctly on leg (Figure 4).9. Ensure strap pad is positioned under strap crossing on nonratcheted DFS strap in the popliteal and not wrinkled. Quick Fit Buckles may have to be opened to relieve strap tension and allow positioning of strap pad on non-ratcheted DFS strap. Remove Upper DFS strap with dosing ratchet and feed strap through strap pad (Figure 5).

5 10. If patient requires more or less unloading, adjust the tension of upper DFS strap accordingly with Dynamic Force Control System and/or lower DFS strap by adjusting length at thigh Quick Fit If Dynamic Force Control System has been pulled to its maximum and patient requires more pain relief, DFS straps may require shortening at the lower Quick Fit Keyhole locks may be inserted into calf and thigh shells if desired to ensure straps cannot accidentally be disengaged from shells (Figure 6).note: Have patient wear brace for a few minutes to make sure straps are at comfortable BRACE1. Sit with the knee flexed to 90 Turn dosing dial counterclockwise to release tension on the upper DFS strap and adjust back to a setting of 0 (Figure 7).3. Open both upper and lower Quick Fit Remove Quick Fit Buckles from Remove brace from STRAP LENGTH ADJUSTMENT (OPTIONAL)1.

6 Remove alligator clip and trim strap to desired length. Alligator clips should be positioned near the Quick Fit buckles, away from popliteal region (Figure 5).2. Repeat for all OF MOTION ADJUSTMENT (ROM)The device comes with a 0 extension stop installed. Additional extension stops of 5 , 10 , 15 and 30 have been provided. A flexion stop of 90 is also : Optimal corrective forces are applied at full extension. If patient requires an extension stop change, make sure to readjust tension in DFSstraps if more unloading is CHANGE RANGE OF MOTION1. Peel condyle pad from hinge to expose Remove retaining Slide 0 stop out of Insert desired extension Secure with retaining screw. (do not over tighten)86. To add flexion stop: follow steps 1 and 2, insert desired flexion stop, then follow step MAINTENANCEU nloader One is designed for minimum maintenance and care.

7 Follow these easy maintenance steps to keep brace in good Liners may be wiped down in place with rubbing alcohol for a quick cleaning For more thorough cleaning: liners, straps and strap pads may be removed. To aid in strap application after cleaning, see Figure 8 for final configuration. do not machine wash do not place in dryer Hand-wash using mild non-detergent soap Rinse thoroughly and air dryHINGE For safety reasons, hinge should only be disassembled by a health care professional. Check regularly for foreign materials in hinge (i. e. dirt or grass). Clean dirt from hinge using tap water and/or compressed : If brace is used in salt water or chlorinated water, rinse well with fresh tap water and air dry brace. A regular service routine will ensure hinge, liners, straps and pads are in optimal working ACCESSORIES ssur offers accessories that meet specific needs of the Unloader accessories can be purchased through the brace provider or ssurCustomer Service Department.

8 Extra Set of Liners Replacement Straps Strap pads Anti Migration System (AMS) wrap9 DEUTSCHTEILELISTE (Abbildung 1)A. Oberer Dynamic Force System Strap (DFS)B. Unterer Dynamic Force System Strap (DFS)C. OberschenkelriemenD. WadenriemenE. Polyzentrisches GelenkF. OberschenkelschaleG. UnterschenkelschaleH. SchnellverschlussschnalleI. Buckle Stability ShelfJ. AlligatorklemmeK. Obere DosierscheibeL. Untere DosierscheibeUNLOADER ONE INDIKATIONEN Unikompartmentelle Osteoarthritis Kann auch bei unikompartmentellen Knieerkrankungen helfen, die eine Schmerzlinderung in einem betroffenen Kompartment erfordern, wie z. B. Behebung eines Gelenkknorpelschadens Behebung eines Miniskusknorpels Avaskul re Nekrose Tibiaplateaufraktur Umfangsbeschr nkung Oberschenkelumfang kleiner als 34,3 cm oder gr er als 73,5 cm. Wadenumfang kleiner als 25 cm oder gr er als 61,5 Bei Patienten mit peripherer Verschlusskrankheit, Neuropathie und empfindlicher Haut ist eine enge berwachung durch den Arzt zu empfehlen.

9 F r Patienten mit sensibler Haut: Es wird empfohlen, den Unloader One je nach Vertr glichkeit zu verwenden. Wenn R tungen entstehen,sollte die Orthese zun chst nur eingeschr nkt getragen werden. Wenn die Haut beginnt, sich an die Orthese zu gew hnen, kann sie langsam l nger getragen werden. Der Unloader One ist anpassungsf hig, um den Komfort des Patienten zu erh hen. nderungen am Flexions- oder Streckanschlag und an der Schalenkontur d rfen ausschlie lich durch Orthop dietechniker vorgenommen werden. Der Orthop dietechniker muss den Patienten in die Verwendung des Dynamic Force Control-Systems DER ORTHESE1. ffnen Sie die obere und untere Stellen Sie die Dosiersperre auf die 0 Legen Sie die Orthese auf das Bein des Patienten. Richten Sie die Gelenkmitte auf die Kniemitte und Mittellinie A-P aus (Abbildung 1).4. Setzen Sie den Knopf der unteren Schnellverschlussschnalle in das entsprechende Schl sselloch ber dem Buckly Stability Shelf (Abbildung 2) und schlie en Sie die Schnalle vorsichtig mit der Handfl che, sodass sie einrastet.

10 Der Knopf besitzt nun eine Farbmarkierung mit einer identischen blauen Farbentsprechung im Schl sselloch f r die intuitive Beugen Sie das Knie in einem 80 -Winkel und halten Sie den Fu dabei flach auf dem Setzen Sie den Knopf der oberen Schnellverschlussschnalle in das entsprechende Schl sselloch und schlie en Sie die Schnalle vorsichtig mit der Handfl che. Der Knopf besitzt nun eine Farbmarkierung mit einer identischen gelben Farbentsprechung im Schl sselloch f r die intuitive Drehen Sie die obere Dosierscheibe im Uhrzeigersinn, um den Dynamic Force Control System Strap in der vorgeschriebenen Position festzuziehen (Abbildung 3). Der Orthop dietechniker muss die optimale Entlastung anhand des Schmerzempfindens des Patienten ermitteln. Die Riemenspannung muss so eingestellt werden, dass eine optimale Schmerzlinderung erzielt wird, nachdem die Dosierscheibe auf 5 gestellt wurde.