The Orthoflex line of products will provide lightweight, compact and convenient bracing solutions which adjust to the shape of the limb, joint or other body part, while at the same time allowing free blood circulation and ventilation and enabling medical inspection of the injured area. The Company’s devices will further allow for as much functionality as possible with rigidity and flexibility adjusted as needed.

• One splint supports the entire leg from heel to thigh and the upper limb.
• Adjustable flexibility – adjustable flexibility in cases where rigid splints are not desirable.
• Stabilizes the foot – straightens the leg and stabilizes the foot in a non-rotating plantigrade position.
• Stabilization for hip and femur-neck fractures – provides effective de-rotation stabilization for hip and femur-neck fractures.
• Protective aid – functions as a protective aid for mobile patients.
• Immobilize injuries above the knee – includes well-leg strap to immobilize injuries above the knee.
• Support injury to the 4 limbs – together with the contained well-leg strap it is single splint suitable for first aid support of all levels of injury to the 4 limbs.
• Non-circular braces – cover only three sides of the limb, allowing easy inspection.
• Rapid inflation, fast, easy and clean application – Orthoflex long braces can be applied in less than one minute and avoid the mess of casting.
• Accommodates swelling and the reduction of swelling – this can reduce the risk of compartmental syndrome, ischemia, and other complications associated with casting.
• Radiographic translucency – the braces do not disturb the quality of the radiographic image and need not be removed for x-ray examination.


• Deep absorption of jolting – Orthoflex unique brace provides effective absorption of jolting during movement and transport protecting the patient from further injuries and pain.
• Easily removable – the brace can be removed by the physician, nurse, or the patient at any time, thus allowing for easy change of dressings and further medical examinations as well as easy 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.

HOSPITALS

• EMERGENCY ROOMS
• OPERATING ROOMS
• ORTHOPEDIC AND OTHER DEPARTMENTS

EMERGENCY MEDICAL SERVICES

• AMBULANCES & HELICOPTERS
• MILITARY
• INDUSTRIAL AND ROAD TRAFFIC ACCIDENTS INJURIES
• SPORT INJURES
• RESCUE TEAMS

PRIVATE CLINICS AND HOME CARE

• DOCTORS CLINICS
• AMBULATORY CLINICS

• The need for single compact and effective braces for any limb in the Emergency Medical Services.
  Rather than using a cumbersome brace to support various parts of the limb, paramedics can use a flexible, inflatable brace that receiving the shape of the limb, which allows for maximal absorption of jolts during transportation, with easy and fast application and removal, and small volume capacity, responding to ambulances, helicopter and backpack storage limitations. The Long Brace can be applied over the patient’s shoe.
• 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 Long Brace using the special stabilizer attachment significantly reduces patients’ pain and discomfort, eases transport and nursing management up to the operation.

• General
  The Long Brace can be inflated to 760 mm Hg pressure. However this is never necessary: at 200-250 mm Hg the long 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 Long Brace support.To assess stiffness and the degree of inflation required, the Long Brace is tested during inflation by squeezing the tubes and assessing the ease of bending of the splint at its ankle location. The type and degree of inner padding required is also determined according to the condition being treated.

  The air pressure within the long 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 leg, knee, foot, ankle, or upper limb: the splint is inflated to full stiffness, the injured limb is placed gently in the splint (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 Long Brace: avoid sharp objects on the ground. The well leg strap is used as required (for the upper limb as a sling).In the ER (Emergency Room) the Long 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 Long Brace can be continued (minor leg or foot fractures, leg or foot wounds, fracture calcaneus’s not for operation, crush leg or 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 Long 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 long Brace plus outrigger is applied at the site of the fall by the ambulance paramedic, or on arriving at the ER (Emergency Room) by the trauma nurse or doctor, or failing these, on admission to the ward. The task of the Long 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 Long Brace is removed in the OR (Operating 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. However this does not correct the external rotation of the leg. Therefore Long Brace plus outrigger is applied, much reducing pain and facilitating transport.
• Elective Surgery: Leg and Knee
  Further to the use of the Long Brace post operatively, after the internal fixation of fractures, its application after elective Leg, Knee, or upper limb 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 (Operating Room) and nursing time, or as a permanent support and protection allowing immediate guarded function.

Weight (brace only): 420 Gr

Sizes:(in cm.)
Folded: 38×15×4
Inflated: Height:-70 , 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.
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 withstand 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. The Velcro surfaces on the sole and behind the heel possess a strong snap fit, to allow stability of the stabilizer.

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).