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HemaClear® an All-in-One Exsanguination Device

HemaClear History

HemaClear® Main Advantages

SUPERB EXSANGUINATION (95% vs. 45-67% – unprecedented)

  • Bloodless, dry surgical field – avoids risks of incomplete exsanguination
  • Improved anatomical visibility
  • Reduced incidence of post-op DVT
  • Reduced incidence of pulmonary embolism
  • Reduces blood loss, resulting in decreased need for blood transfusion

STERILITY

  • Reduced risk of Surgical Site Infection (SSI)
  • Single-use

NARROW CUFF

  • Increased visibility
  • Increased accessibility
  • Less likelihood of side effects due to pressure on tissue

EFFICIENCY

  • Reduced patient preparation time – 15 seconds vs. 12 minutes
  • Reduced OR clutter – replaces the need for 6 different products
  • Quick & easy to apply
HemaClear Product Line

HemaClear® is a Sterile Surgical Tourniquet.
It is an innovative all-in-one device that combines three important functions:
1| Superior exsanguination
2| A large sterile surgical field
3| Blocking of arterial blood re-entry

Solutions Prior to the Arrival of HemaClear®

Until the appearance of HemaClear® 2 methods were used to achieve exsanguination of the limb:

  • Exsanguination achieved with the Esmarch Bandage + Blood Occlusion via a Regular Tourniquet
  • Exsanguination achieved with the Esmarch Bandage + Blood Occlusion via a Pneumatic Tourniquet

Deficiencies of Existing Solutions

MAXIMAL EXSANGUINATION IS NEEDED TO PREVENT PULMONARY & CEREBRAL EMBOLIZATION. Partial exsanguination is inherent in the traditional Esmarch/PneumaticTourniquet method.

RISKS OF INCOMPLETE EXSANGUINATION (<67%):

  • Pulmonary Emboli (PE)*: Blood left behind results in clots and intravascular clotting and often occurs during surgery where a tourniquet is used. When the tourniquet is deflated, blood clots migrate to the heart and lungs, leading to risk of brain infarcts, e.g. post TKA Cognitive Dysfunction. Near perfect exsanguination by HemaClear® largely prevents embolization.
    Cerebral Emboli & Infarction: Small emboli block small arteries, reducing or preventing blood flow to brain regions, followed by small infarctions, resulting mostly in cognitive dysfunction.
    (*Thromboembolism Coincident with Tourniquet Deflation During Total Knee Arthroplasty. Lancet. 1993 Apr 24;341(8852):1057-8)
  • Post operative side effects: Risk of post-op DVT, skin injury – tourniquet burn (20.7%), tourniquet pain (39.7%), and nerve damage.

STERILITY ISSUES: Increased risk of Surgical Site Infection (SSI). Non-Sterile Pneumatic Tourniquets are Contaminated – A Potential Cause of SSI. Sterile HemaClear® is 100% safe.

REDUCED ACCESSIBILITY – WIDE CUFF: Reduced access, especially in obese limb or pediatric cases and limited anatomical visibility during surgery

SIDE EFFECTS DUE TO PRESSURE ON TISSUES: Traditional wide cuffs produce increased uniform pressure inside the limb vs. the HemaClear® narrow cuff where axial and radial pressure gradients result in less force on inner tissue.

INEFFICIENCIES: Increased preparation and setup time = less procedures, high cost derivative, and OR clutter.

  • Time wasted: Traditional methods require 12 minutes of patient setup time vs. 15 seconds with HemaClear® application
  • Inefficiency and aggregate cost of multiple products used during a procedure that employs the pneumatic tourniquet vs. the single-use sterile HemaClear® device.
  • OR clutter and shelf space incurred by the pneumatic tourniquet method is eliminated by HemaClear®.

THE NEED:

BLOODLESS SURGERY

~70% of all Limb Surgeries are Bloodless. On average, for every 1 million population, there are 4,000-10.000 bloodless procedures.

Relevant Bloodless Applications:
• Knee Arthroplasty & Arthroscopy
• Foot & Ankle Surgery & Podiatry (treats foot diseases and disorders)
• Upper Extremity & Hand
• Pediatric Orthopedics
• Vascular Surgery
• Trauma

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Testimonial

“I’m very, very impressed with HemaClear® including its predicable exsanguination and zero complications. Our staff saw the advantages within one or two uses. It is predictable and very simple, and they like it.”

Mr. Rhidian Morgan-Jones FRCS (Tr&Orth) Consultant Orthopedic & Trauma Surgeon, Cardiff & Vale NHS Trust, Wales

HemaClear® and PACU (Post Anesthesia Care Unit) Nursing Care

HemaClear® All-In-One Device

HemaClear® is a sterile exsanguination tourniquet that is used during limb surgery to provide a bloodless surgical field. It replaces the pneumatic tourniquet and the Esmarch bandage that have been in routine use for over 100 years.

The HemaClear® is placed on the limb above (proximal to) the surgical incision. For example:

  • In TKA it is placed high on the thigh, almost by the groin.
  • In elbow surgery it is placed on the upper arm.
  • In operations of the foot it is placed about 4” above the ankle
  • During hand surgery it is placed about 4” above the wrist.

It is left in place for no more than 2 hours, just like with the pneumatic tourniquet.

When the HemaClear® is used, intra-operative blood loss is nil. It does not, of course, prevent post-operative bleeding, so your care and observation of the surgical site and dressing continue to be important.

When pneumatic tourniquets are used, you often see skin abrasions or even blisters in the area of the tourniquet placement.  This is called “tourniquet burn”. When the HemaClear® is used, you’ll never see this. You may see an indentation, similar to the marks left by socks on your ankles, but these will go away within 30-60 minutes from the removal of the HemaClear®.

Tourniquet pain is also much reduced when HemaClear® is used compared to the pneumatic system. This may be significant when early mobilization of the post TKA patient is contemplated. Tourniquet Nerve damage is also part of the past history when HemaClear® is used. In more than 1,000,000 cases, there have been no reported cases of HemaClear®-related nerve dysfunction.

All together the HemaClear® has a much better safety track record than the pneumatic system. There are no special or new instructions for the PICU (Pediatric Intensive Care Unit) care of patients where HemaClear® has been used.

Check Item Pneumatic Tourniquet HemaClear®
Skin lesions on thigh/upper arm Abrasions and blisters Transient indentation and/or redness
Thigh or upper arm pain Deep muscle pain (like "Charlie Horse") None or slight
Sensory and/or motor deficit Occasional None
SpO2 depression Common None
Blood pressure May be reduced for several hours Transient reduction right after HemaClear® removal
Cognition Reduced after TKA in up to 40% of patients, even if only epidural used Reduction not reported
Resumption of normal blood flow to fingers and toes Always check color and capillary filling Always check color and capillary filling

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