• Non-circular – covers only three sides of the limb. Allows easy inspection.
• Accommodates swelling and the reduction of swelling. This reduces the risk of compartment syndrome, ischemia, and other complications associated with casting.
• Rapid Inflation – fast, easy and clean application. Can be applied in less than one minute and avoids work intensive mess.
• Radiographic Translucency – The braces do not disturb the quality of the radiographic image and need not be removed for x-ray examination.

• Absorption of Jolting Forces – jolting forces are absorbed during movement and transport, protecting the patient from further injuries and pain.
• Easily Removable – the brace can be removed, at any time, by the physician, nurse, or the patient as indicated, thus allowing for easy change of dressings and further medical examinations, as well as facilitating bathing and showering.
• Lightweight and Compact – requires minimal storage space: prior to their inflation, the braces are a folded small package. This allows the braces fit in any limited storage space (even in a backpack).
• Increased Staff Compliance – the ease and simplicity of use significantly increases staff compliance.
• Easily Washable and Sterilizable – all braces can be hand laundered using standard antiseptic soap such as chlohexidine and gas sterilized.
• Protects and supports the foot and ankle with inflated padding.
• Functions as a protective boot for patients able to walk.
• Prevents pressure ulcers and leg complications in paralyzed or unconscious patients.
• Aids in prevention and treatment of diabetic foot ulcers.
• Effective for night-time padding of plantar Fasciitis (heel spurs) cases.

HOSPITALS

• EMERGENCY ROOMS
• OPERATING ROOMS
• INTENSIVE CARE UNITS
• ORTHOPEDIC AND OTHER DEPARTMENTS

EMERGENCY MEDICAL SERVICES

• AMBULANCES & HELICOPTERS
• MILITARY
• INDUSTRY AND ROAD TRAFFIC ACCIDENT INJURY
• SPORT INJURES
• RESCUE TEAMS

PRIVATE CLINICS AND HOME CARE

• DOCTORS CLINICS
• AMBULATORY CLINICS
• RETIREMENT HOME
• PRIVATE HOME

• The Need for Convenient and Easily Applied Pre and Post Operative Bracing.
  The brace is easily applied and removed, thus allowing physicians to effectively treat wounds and fractures before and after operations, when rigid fixation is not required. The brace will provide patients with a more convenient bracing solution during the healing process.
• Innovative, Immediate De-Rotating Bracing in Fractures of the Neck of the Femur.
  The Foot and Ankle Brace using the special stabilizer attachment significantly reduces patients’ pain and discomfort, eases transport and nursing management up to the operation.
• The Need for Compact and Effective FOOT AND ANKLE INJURY Braces for Emergency Medical Services.Rather than using a cumbersome brace to support various parts of the limbs, paramedics can use a flexible, inflatable brace, which allows for maximal absorption of jolts during transportation, with easy and fast application and removal. The brace, being of small volume, responds to ambulances, helicopters and backpack storage limitations. The Foot and Ankle Brace can be applied over the patient’s shoe, receiving the shape of the limb.
• Maintaining and protecting Foot Positioning in ICU Patients.
  Intensive Care Medicine is required to meet special and specific medical needs associated with patients in critical or unstable conditions. Intensive care unit (ICU) patients are exposed to several complications, including pressure ulcers and heel cord contracture. The Foot and Ankle Brace, a simple-to-use, user-friendly brace, will ensure consistent staff compliance and efficiently prevents these complications.
• Convenient night stretch brace for plantar fasciitis (heels spur).
  The Foot and Ankle Brace is perfectly suited for night stretching of the heel cord and plantar fascia owing to its flexibility at the ankle and its adjustable ankle angle straps.

• General
  The Foot and Ankle Brace can be inflated to 760 mm Hg pressure. However this is never necessary: at 200-250 mm Hg the Foot and Ankle Brace is stiff enough for passive support of the ankle at 90 degrees plantigrade, even without applying the plantigrade straps. When it is necessary to limit active plantar flexion the plantigrade straps must be used.The treating physician, surgeon, or paramedic decides whether more or less stiffness is indicated for the particular condition requiring Foot and Ankle Brace support.

  To assess stiffness and the degree of inflation required, the Foot and Ankle Brace is tested during inflation by squeezing the tubes and assessing the ease of bending of the splint at its ankle location. The inner padding required is determined according to the condition being treated.

  The air pressure within the Foot and Ankle Brace is well maintained over time and should not require any replenishment during the use in a single patient. However, the pressure can be increased to the required stiffness at any time by using the hand pump, or decreased by pressing on the sides of the valve. The valve should always be pressed in so as not to protrude from the side of the splint, to avoid inadvertent escape of air.

  Many methods are available for the initial inflation and all are legitimate; the most convenient should be used.

• Emergency and Accident
  First aid in the field, at the site of an accident causing an injury to the foot or ankle: the splint is inflated to full stiffness, the injured foot and ankle is placed gently in the splint (shoes and socks and trousers are not removed) and no padding is required. The straps are tightened firmly, including the plantigrade straps. An open wound must first be dressed. If suitable sterile dressings are not available, the “nappy” padding is the next best alternative. If the casualty is conscious, degree of comfort feed back from him is useful to achieve the optimal tightness of the straps. Ideally evacuation is by any means avoiding weight bearing on the injured limb. However if necessary the casualty may walk on the Foot and Ankle Brace Avoid sharp objects on the ground.In the ER the Foot and Ankle Brace is not removed but retained for transport within the hospital to X-ray, ward, OR, (Operating Room) etc. If the injury is such as not requiring surgery nor rigid fixation for maintaining the reduction of a displaced fracture, definitive support in the Foot and Ankle Brace can be continued (minor foot fractures, foot wounds, fracture calcaneus’s not for operation, crush foot, etc) after removing the footwear and clothing and adding suitable padding.

  If the injury requires surgery such as internal fixation of a fracture, “nappy” padded Foot and Ankle Brace is indicated as the post-operative temporary support which ensures plantigrade positioning, easy change of dressings, early movement option, and patient comfort, avoiding post operative plaster of Paris. Once swelling has receded and the stitches are out, the treating surgeon applies a plaster of Paris if rigid fixation or non-removable protection is needed.

• Fracture of the neck of the femur
  In pertrochanteric, subtrochanteric, and Garden type III and IV sub-capital fractures the leg lies in an external rotation deformity.The well padded Foot and Ankle Brace plus outrigger is applied at the site of the fall by the ambulance paramedic, or – on arriving at the Emergency Room – by the trauma nurse or doctor, or failing these – on admission to the ward. The task of the Foot and Ankle Brace with the outrigger is to correct the rotation deformity and prevent pressure on the heel and lateral malleolus: pain is much reduced, transport to and within the hospital and nursing is facilitated. The Foot and Ankle Brace is removed in the ER (Emergency Room) and its continued post-operative use is optional.
• Fracture of the shaft of the femur
  The famous classical Thomas splint which allows for traction in cases of femoral fractures is hardly used anymore because of its bulky size, difficulty of application, and the efficacy of modern casualty evacuation, which has made long term first aid splinting for fracture of the femur a rarity. Ordinary long leg splints cannot control a femur shaft fracture and therefore the usual treatment given is strapping the injured to the intact leg (the well leg strap). However this does not correct the external rotation of the leg. Therefore Foot and Ankle Brace plus outrigger is applied, much reducing pain and facilitating transport.
• Intensive Care
  Many patients lying unconscious in intensive care departments (general or neurosurgical) require Foot and Ankle splinting to preserve a plantigrade position of the ankles in order to prevent heel cord contracture and, at the same time, prevent pressure sores on the heel and other pressure points on the Foot and Ankle. These splints must be removed frequently (at least daily) for washing and for foot and ankle inspection. Therefore splint application in this situation must be convenient, rapid, achievable with one pair of hands by a single attendant, as well as efficient in achieving the above requirements. Then excellent staff compliance can be expected. The Orthoflex Foot and Ankle Brace is ideal for this purpose.
  Extreme care must be exercised in Foot and Ankle care in the intensive care situation.
  Application of the padded Orthoflex Foot and Ankle Brace must be meticulous, ensuring that no pressure points exist on the limb within the splint. Plantigrade straps are usually not required and great care with strap tightening ensures that excessive pressure is avoided.
  For spastic feet in the neurosurgical intensive care the well padded Orthoflex Foot and Ankle Brace is inflated only to that elasticity which allows the splint to conform to the equines position of the ankle. No attempt should be made to force the spastic foot into a plantigrade position since this may result in creating a pressure sore.
  When constant intermittent pressure sleeves are in use the Foot and Ankle Brace fits conveniently over them.
• Elective Foot and Ankle Surgery
  FFurther to the use of the Foot and Ankle Brace post operatively, after the internal fixation of fractures, its application after elective Foot and Ankle Brace operations is convenient and indicated. This may be as a temporary splint until swelling has receded and a definitive plaster is applied, saving much OR and nursing time, or as a permanent support and protection for forefoot procedures such as hallux valgus and Weil osteotomies allowing immediate guarded walking.
• Plantar Fasciitis and Heel Spurs
  • During an attack of heel pain the Foot and Ankle Brace is worn immediately as a house slipper on rising in the morning to alleviate the sharp “first steps” pain so characteristic of PF (Plantar Fasciitis) and then again in the evening on coming home or at any time the patient is at home.
  • During the night the Foot and Ankle Brace is worn as a night planter fascia stretcher: the plantigrade/dorsiflexion straps are tightened as much as sleep comfort allows.

Weight (brace only): 350 Gr

Sizes:(in cm.)
Folded: 36×15×4
Inflated: Height:-37, Breadth:-16 ,Length:-30 ,Breadth sole:-15

1. Material: Woven Nylon covered by polyurethane
2. Air pressure is according to the stiffness required by the treating physician. Commonly used pressures are 200-230 mm. Hg ( 0.25-0.3 Bar)
3. Loss of air pressure rate is 0-1% per 24 hours.
4. Maximum pressure recommended—250 MmHg (0.33 Bar).
5. Pressure leak is pre-tested at 350 MmHg (0.5 Bar).
6. Temperature range : -15C – +50C .
7. Suited to body surface contact according to international standards.
8. Laundering: use of soaps and antiseptic soap solutions such as chlohexidine scrub. ——-check washing machine at 40 degrees C
9. Imaging transparency for radiographs, computer tomograms and magnetic resonance imaging.
10. The cushion: designed to fully protect the heel and foot borders from pressure: at 60 grams per square cm pressure the spongy material looses 10% of its thickness.
11. Strap buckles withstand up to 15 kg of stretch
12. The strap-splint sutures withstands more than 20 kg tension without any material tear.
13. The cloth on the outside of the inner padding is cleaving the Velcro strips inside the brace. It can be removed easily, if necessary.
14. All Velcro strips of the inside the brace, designed to snap onto the pillow, are sewed with double stitch.
15. The pump is attached to the brace can build pressure of approximately 200 millimeters of mercury inside the brace, in approximately 60 seconds at blowing.
16. The stabilizer Attached to the brace, (found in the pocket at the lower part of the brace), enables stabilize the leg at required situations.
17. The Velcro surfaces on the sole and behind the heel possesses a strong Snap Fitness, to allow the stability in a non-rotating plantigrade position of the brace.

Visual check for all braces: This test involves the integrity of sewing the tracks, the integrity and the integrity of the connectors and how they have been installed, and the final stitches of brace fabric, the integrity of the inner padding, etc.
Testing samples from the serial production, every fifth brace. The test includes inspection pressure at 0.5 bar working pressure, check the air leakage through a whole week with daily snapshots of the pressure (fixed at room temperature), and check the durability of the connectors, the straps and sewing stitch by force of 15 kg.
Integrity test samples from the serial production – two braces from a series of production. Check the durability of the pressure at a temperature of 55°C and at -35°C as a function of time; continue to test the influence of extreme temperatures on the brace fabric and accessories related to it.

Long term storage temperature range for the closed plastic bag packaging: -15C to +65C. Storage temperatures for a short time, up to 24 hours, in a closed plastic bag packaging: -35°C to +75°C.

Do not open the packaging with a sharp tool.
Do not inflate the brace using a compressed air system without an air pressure control device.
Allows soap and water cleaning.
Allows disinfectant with usual disinfection materials such as Chlorehexidine
Do not wash in a washing machine.
Do not disinfect with alcohol stronger than 70%.
Do not wash with thinner.
Maximum recommended inflation pressure is 300mm Hg.
Shelf life 5 years (when stored as instructed above).