HKAFO COMPLEX/2R DUAL

hip, knee, ankle and foot orthosisAFOKAFO

Product description
HKAFO orthosis (hip, thigh and calf part) is made of innovative fabric ActiveDistance II and ActiveDistance. The device is equipped with orthopaedic splints and dynamic carbon foot. Splints are made of high quality aluminium hot covered by special powder surface, making them neutral to patient’s sweat. The hip joint is equipped with a single-axis hinge with ROM adjustment in every 15° and the knee joint holds a double-axis polycentric hinge with ROM adjustment in every 20°. The ankle joint is non-hinged by default. For special orders, an orthopedic hinge 1R with ROM adjustment in every 15° can be added to the ankle joint. Each drop-lock can be adjusted to the required position and blocked against displacement. The thigh and calf parts provide height adjustment to fit the device to individual patient size. The carbon foot is resilient in the front and heel parts. A semi-rigid spiral splint and shin pelotte stabilize the orthosis on the calf. The carbon foot has 3 points of support: front middle tibia, tibial tuberosity, and proximal tibial and fibula epiphyses. This construction accumulates forces during limb loading and assists with foot dorsiflexion. The dynamic ankle-foot orthosis (AFO) allows medial-lateral control of the foot and ankle complex due to strong lateral fixation of the lower leg. The AFO construction is very light and easy to put into a shoe.

Design and fastening
HKAFO orthosis is equipped with three pairs of Velcro straps: 2 straps for pelvis, 2 for thigh and 2 for calf. The thigh and calf parts hold 2 pairs of pelottes made of plastic material where the splints are attached. Safe construction combined with soft, skin-friendly fabrics enhances comfort and makes COMPLEX unrivalled on the market.

Indications
Double-sided COMPLEX

• flaccid paraparesis
• myelocystocele, hydromyelomeningocele
• spinal muscular atrophy
• muscular dystrophy / myodystrophy with upper limbs mobility

One-sided COMPLEX

• severe knee joint instability or degeneration with foot paresis (sciatica, SM, poliomyelitis – Heine-Medin disease)
• tetraparesis – in upright position, while gait learning
• to immobilize in rehabilitation process after knee surgeries or diseases
• to prevent hip, knee or ankle muscle contractures
• to ensure correct hip position during walking or upright position

Modularity
The orthosis can be used as a modular device – with patient recovery, the hip splint can be stopped and the lower limb and ankle brace can be used independently. The COMPLEX orthosis is also an innovative solution for partial foot amputation when a non-standard insole is required; the construction directs forces to the upper tibia to offload the amputated foot.

Product variants / configurations

• A. AFO
• B. KAFO
• C. HKAFO
• D. HKAFO + TLSO

Materials & components
ActiveDistance II™: active 3-layered fabric made of non-elastic polyamide self-gripping layer, comfort foam and cotton terry; skin-friendly and Oeko-Tex Standard 100 certified; self-gripping allows precise fitting.
ActiveDistance™: technical off-loading lamination with 3-layer construction (EVA foam double-sided laminated with non-elastic polyamide); non-elastic, stabilizing and waterproof; provides wide range of adjustment and comfort.

Technological systems
DOMINO System: special markings to help patients fasten straps in the correct order and easily.

Splints
Splint 1RE
Single-axis orthopedic splints used in knee, upper limb and hip joint braces. ROM adjustment in every 15°. Hyperextension adjustment in secured range of -15° and -30°. Low weight, excellent lateral joint stabilization. Angle adjustment clock sets without tools; safety system prevents unauthorized change. Made of high-quality aluminium alloy and plastic with carbon fibre. Patented design.

Splint 2R
Double-axis polycentric splints with rack gear reflecting anatomical knee movement. ROM adjustment in every 20° using special pins. Oval covers prevent pin loss and unauthorized angle change. Standard length 390 mm; longer splints may include lateral knee stabilization. Made of high-quality aluminium alloy with durable cover; patented design.

Paddings
3D relief supports made of supporting foams or EVA foam combined with skin-friendly materials and adhesive-function materials. Anatomically shaped pads relieve rigid elements (splints, stays, drop locks) and protect skin contact points.

Sizes and limits
TABLE 1
Size | Waist circumference | How to measure
Single size | min 75 cm – max 125 cm (min 29" – max 50") | measurement at pelvis/lumbar area

TABLE 2
Size | (A) Thigh circumference 15 cm above the patella | (B) Calf circumference 15 cm below the patella | How to measure
Single size | min 40 cm – max 75 cm (min 15" – max 30") | min 30 cm – max 55 cm (min 11" – max 22")

TABLE 3
Size | (C) Distance between knee joint interstice and groin | (D) Distance between knee joint interstice and foot | How to measure
S | 27-37 cm (10"-15") | 34-45 cm (13"-18")
M | 33-43 cm (13"-17") | 40-51 cm (15"-20")
L | 36-46 cm (14"-19") | 42-54 cm (16"-22")
XL | 49-61 cm (19"-24") | 49-61 cm (19"-24")

TABLE 4
Size | Foot length | How to measure
S | 22-24 cm (8"-10")
M | 24-26 cm (9"-10")
L | 26-28 cm (10"-11")
XL | 28-30 cm (11"-12")

Limits
Maximum user weight up to 75 kg. Any combinations from Tables 3 and 4 are possible.

Setting up / instructions
Detailed setting up and adjustment instructions are available as the device manual and fitting documentation. Follow the manual for correct configuration of splints (1RE / 2R), ROM settings, and modular changes.

Technical specifications

• Brand: 4medic
• Code: COMPLEX/2R DUAL HKAFO
• Trade name: LOWER-EXTREMITY SUPPORT
• Model: COMPLEX/2R DUAL
• Device class: Class I medical device (Regulation (EU) 2017/745)
• Materials: ActiveDistance II™, ActiveDistance™ (EVA foam, non-elastic polyamide, comfort foam, cotton terry)
• Hip joint: single-axis hinge with ROM adjustment every 15°
• Knee joint: double-axis polycentric hinge with ROM adjustment every 20°
• Ankle joint: non-hinged by default; optional 1R hinge with ROM adjustment every 15°
• Carbon foot: dynamic AFO, resilient front and heel, 3 points of support (front middle tibia, tibial tuberosity, proximal tibial and fibula epiphyses)
• Fastening: three pairs of Velcro straps (2 pelvis, 2 thigh, 2 calf)
• Size system: single size options for waist/thigh/calf ranges; S/M/L/XL combinations available per tables
• Maximum user weight: 75 kg