HemaClear
Product Line
OHK has developed a unique product, HemaClear®, that performs 3 functions:
blood removal (exsanguination)
arterial flow occlusion
placement of sterile stockinet

HemaClear® may be used on the upper or lower extremities.

With current methods, exsanguination is achieved either by elevating the limb and/or by wrapping the limb with an Esmarch bandage. The arterial flow is occluded by inflating a pneumatic tourniquet. Some surgeons use the original Esmarch technique and tightly wrap the bandage to block the arterial flow.

The Esmarch bandage is then removed and a sterile stockinet is placed over the disinfected limb.

HemaClear® performs both exsanguination and occlusion, replacing the Esmarch bandage and the pneumatic tourniquet. Furthermore, the HemaClear® replaces the surgical stockinet, by providing a sterile field covering.

The HemaClear® is a sterile, single-use, latex-free product. The HemaClear® provides the 3 in 1 functionality without any concerns about cross-contamination or latex allergy reactions. The pressure applied by the HemaClear® is accurately factory calibrated to prevent concern of over pressurizing the limb.

How it works
HemaClear® consists of a silicone ring wrapped in a stockinet sleeve and pull straps.

The physician places the ring on the fingers (or toes) and then pulls the pull straps proximally. The silicone ring rolls up the limb and the stockinet sleeve unfolds onto the limb.

During the rolling up the limb, the ring exerts pressure and squeezes the blood away from the limb, thus performing the exsanguinating function quickly and effectively.

When the elastic ring reaches the occlusion site, the pulling motion is stopped. The ring exerts pressure on the limb at this position, blocking arterial blood flow into the limb and thus performing the tourniquet occlusion function.

During the motion over the limb, the stockinet sleeve unfolds onto the limb, covering it entirely up to the occlusion level and thus placing the HemaClear® sterile stockinet over the surgical field.

The entire motion on the limb: from fingers (toes) to the occlusion location, takes less than 12 seconds. In less than 12 seconds the HemaClear® exsanguinates, occludes and places a stockinet to fully prepare the surgical field for bloodless surgery.

 
Using HemaClear Traditional Tourniquet Application

The HemaClear® Advantage
The HemaClear® performs the 3 functions in a fast, simple and reliable method. HemaClear® outperforms the current methods in speed, reliability and consistency.
HemaClear® is a sterile, single-use product. HemaClear® ensures patient protection from cross contamination and eliminates time consuming and costly postoperative clean-up.
Being sterile, the HemaClear® may be placed near the surgical incision without concern, thereby minimizing the volume of ischemic limb tissue.
HemaClear® is a latex free product. It can be safely used in the operating room environment without concern for any latex-related allergies.
HemaClear® can be used in many extreme procedures in which a standard pneumatic cuff cannot be used such as surgery on obese patients, and surgery in areas that were not accessible before for bloodless surgery.

Exsanguination
The current methods, limb elevation or Esmarch bandage, are time-consuming (limb elevation: up to 5 minutes, Esmarch wrapping and unwrapping: 2-4 minutes).

The effectiveness of the Esmarch bandage is strongly dependent on the wrapping tension and technique used by the surgeon. The physician has no feedback or quantitative indicator on the pressure applied to the patient’s limb.

In addition, the effectiveness of both methods in removing blood from the limb is limited. Published reports show the limb elevation method removes less than half (45%) of the blood from the limb and the Esmarch bandage technique is 60%. Clinical results with the HemaClear® have consistently shown excellent exsanguination.

HemaClear® exsanguination advantages are:
FASTER: the application time is less than 12 seconds
CONSISTENT: the pressure is independent of the application technique
BETTER: Higher percentage of blood removal

Occlusion
The current method of arterial occlusion is based on pneumatic tourniquets. While tourniquets are the accepted gold standard, they are not a favorite among physicians. Tourniquets are prone to operational and reliability problems. There are numerous reports in the literature documenting patient injury as a result of malfunctioning tourniquets, particularly the application of excess pressure to the limb. Other problematic areas are:
Gas tube occlusion or release
Inadvertent cuff release
Non-calibrated pressure levels
Distal tourniquet "migration" towards the surgical incision when the limb (thigh) is tapered.

The pneumatic tourniquet cuff is placed on the patient’s limb, outside the sterile field. In many operations the cuffs are soiled with the patient’s blood or the disinfectant solution and create problems of cross-contamination and chemical irritation. Cleaning and/or sterilization of the cuffs is not always done. If done, it is a time consuming, bothersome and costly preoperative procedure. HemaClear® need not be cleaned or sterilized. It is both sterile and disposable.

Since the HemaClear® is a sterile product and it remains in the sterile field during the operation, the surgeon applies and removes the HemaClear® without the need for any non-sterile OR technical personnel. The pneumatic tourniquet is a non-sterile device. A non-sterile nurse or technician is required for the cuff placement and removal and also for the pressurizing and deflation of the cuff during the operation. By providing the surgeon with a sterile product, the HemaClear® gives the surgeon complete control over the course of the operation without the need for help from non-sterile, rotating OR staff.

The pneumatic tourniquet requires a compressed air source, gas tubing and electrical connections. These connections both clutter the operating room and are a source of potential reliability problems if an OR personnel trips on the tubing or cables.

HemaClear® occludes the blood flow with pressure applied from the silicone ring. No use is made of pressurized gas and there is no need to transport and regulate the gas.

HemaClear® is completely contained on the patient’s limb. There is no need for tube connections from the patient’s limb to a remote location or any electrical connections and no cluttering of the OR with tubes and cables. As such, it can easily be used in a small ambulatory clinic or Dr's office or in field hospitals.

HemaClear® occlusion advantages:
STERILE and DISPOSABLE: no cross-contamination
SAFE: No inadvertent or accidental pressure loss or over-pressure. The pressure at the occlusion location is constant and accurate. The HemaClear® applies pressure on a narrow tissue area thus minimizing the danger of tissue damage. There is no need for extra padding as the skin under the tourniquet is left with no more than a faint mark equivalent to that left by a sock on a calf.
FUSS FREE: No need for calibration, sterilization or servicing.
CLUTTER FREE: No need for power or gas supplies. Compact and self contained on the patient.
LATEX-FREE: no danger of latex sensitivity

 
With HemaClear – No Tourniquet Burn Traditional Application Burn Result

Sterile Field Stockinet

HemaClear® includes a single-ply stockinet, matching the standard stockinet in use today. The stockinet unfolds on the patient’s limb as the HemaClear® moves proximally to the occlusion location. The stockinet placement is part of the exsanguination process and no extra time is required for its placement. The stockinet is elastic, stays in place with a sufficiently tight fit to prevent inadvertent sliding during the procedure.

In summary, the HemaClear® provides a 3-in-1 functionality for quick, reliable, sterile and latex-free blood flow management.

Examples of cases where the HemaClear® was a must:
HemaClear® has recently been used successfully in a case of a 6 year old child suffering from congenital femoral deficiency Paley type 1B (short femur + severe hip dysplasia). According to Dr. Eidelman of Rambam Medical Center, Haifa, Israel, in view of the short and tapered thigh it was impossible to use a conventional pneumatic tourniquet and the HemaClear® offered an excellent solution.
In a case of a child with an arm fracture very close to the axilla it was impossible to use a pneumatic tourniquet due to its width. An HemaClear® was used and rolled up to the patient's axilla. Thanks to the HemaClear® it was possible to have a bloodless surgical field.
In a case of total knee replacement in an obese patient, the pneumatic tourniquet cuff was too short and the surgeons feared they may either have trouble closing it or it may reopen once inflated. An HemaClear®/XL was placed on the thigh and the surgeon reported excellent exsanguination.

For additional information please contact Regulatory@HemaClear.com.