• The difference between these models is their tightness, or how much pressure they apply on the limb. The Green Medium and the Blue Large are suitable for the low systolic blood pressure range (up to 130 mm Hg). They are mostly used for pediatric cases. The Red and the Orange are rated to work well when Systolic blood pressure is not greater than 160 mm Hg. They are used for normal adults with no history of high blood pressure. The Yellow and the Brown are for Systolic BP up to 190 mm Hg and we recommend using them when patients may spike high BP during surgery. All models are equally safe and effective.

  BTW, the XL model is used in the upper thigh in almost all adults. Its upper BP pressure is also 160 mm Hg and it is essentially a “one size fits all adults”.

General

There are many studies on use or no use of tourniquets in TKA. The frequently used end points are:

Blood loss

Pain

Mobility and strength

The studies all show higher intra-operative blood loss, but no significant overall difference in haemoglobin drop and need for transfusion

Less thigh pain when tourniquet is not used

Better mobility and quad strength when tourniquet is not used.

On the other hand, there is this study from J Arthroplasty that shows deeper cement penetration when tourniquet is used.

Please note that all of these studies were done with pneumatic tourniquets, not HemaClear.

I believe that if a study is done with HC vs. no tourniquet or a three-way study (no tourniquet/Pneumatic tourniquet/HemaClear) there will be advantages found for HemaClear.

As a policy, we do not recommend using HemaClear to surgeons who are not using tourniquets. We do remind them that patients in which they do use a tourniquet (e.g. haemophiliacs, anaemic, Jehovah Witnesses etc.) or in cases where they use a tourniquet “only” during cementation, it is better for the patient to use HemaClear.

Tourniquet Use Improves Cement Penetration and Reduces Radiolucent Line Progression at 5 Years After Total Knee Arthroplasty

General

• Superior Exsanguination: The rolling action of the occlusive silicone ring pushes 95% of blood out of the limb, as opposed to 67% with the Esmarch bandage, and 45% when a limb elevation method is used.
• Creates a Sterile Field: HemaClear® is a sterile, single use device that eliminates the need for contaminated reusable cuffs, thereby reducing the risk of infection.
• Increases Access to the Surgical Field: Being 1” wide, the narrow profile and small footprint of the HemaClear® facilitates a larger and more accessible surgical field.
• Simple and Cost-Effective: The easy application reduces preparation time and eliminates the need for tourniquet machines, contaminated reusable cuffs, and Esmarch Bandages.
• Reduces Post-Operative Complications: The HemaClear® reduces the risks of post-operative complications such as DVT, Infections, Excessive Blood Loss, Tourniquet Related Pain, Tourniquet Related Skin Lesions (“burns”), and has the potential to reduce Post TKA Cognitive Deficit.
• Used in Over 800,00 Around 1 Million Procedures Worldwide: HemaClear® is FDA listed and CE marked. More than 20 published studies demonstrate the safety, reliability and clinical superiority of HemaClear®
• No Skin Injury (vs. 20.7% for wide cuff)
• Diminished Tourniquet Pain (vs. 39.7% wide cuff)
• No Tourniquet-Induced Nerve Damage (vs. neuropraxia with a pneumatic wide-cuff tourniquet)

General, Regulation/Certification, FDA, CE

These are the HemaClear® Models currently available:

• HemaClear® Small Pink
• HemaClear® Medium Yellow, Red, Green zzHemaClear® Large Brown, Orange, Blue zzHemaClear® Extra-Large Black&White
• HemaClear® Model F
• HemaClear® Model A

Each HemaClear® Model is designed for a specific limb circumference range, and a maximal systolic blood pressure.

General

General, Sterility

General

Device composition, Sterility, Storage

• Temperature range: 7-28 degrees C (45-83 degrees F)
• Humidity: <60% RH.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® if the expiration date has passed.
• After 3 years, the sterility of the device may be compromised.
• For additional instructions regarding expired devices, please contact us

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• HemaClear® components (silicon ring, stockinet, and pulling straps) are non-sterile prior to assembly, after which the HemaClear® undergoes a process of sterilization.
• The product is shipped as a sterile unit.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® on patients with poor peripheral blood flow, edema, or Deep Vein Thrombosis (DVT ). See the Wells Score System for likelihood of DVT.
• Do not use HemaClear® if the limb is infected or with malignancy.
• Do not apply HemaClear® directly on skin that is fragile or has significant lesions.
• Use a sterile ace bandage to protect fragile skin before applying HemaClear®.
• Do not leave HemaClear® on a patient’s limb for more than 120 minutes.
• Do not place HemaClear® directly over the ulnar nerve (at the elbow) or the peroneal nerve (at the proximal tibia)..

Indications/Contraindications

An obese patient has a great deal of blood brought from the larger limbs into central circulation. This ‘auto-transfusion’ can amount to more than 1.5 pints of blood from a single large leg.

Pushing blood into central circulation very quickly within a few seconds, can cause a significant transient rise in blood pressure and increase the risk of tourniquet failure and bleeding.

Some users have suggested the following 3-step solution:

1. Apply the HemaClear® device up to knee level.
2. Pause for 30-90 seconds, in order to enable the anesthesiologist to measure the blood pressure and, if need be, to make an adjustment.
3. Once the blood pressure is under control, the surgeon can continue pulling the straps to bring the device up to the upper thigh.
   This procedure will avoid the risk of exceeding the pre-set value of systolic blood pressure of 160 mm Hg for HemaClear® Model Extra Large (B&W).

Indications/Contraindications

• Axial traction should be in place while applying HemaClear® if the fractured limb is unstable.
• If a limb has been fractured for 12-24 hours, there should be a full evaluation to rule out DVT prior to applying HemaClear®.
• Open fractures are a relative contraindication and a surgeon should use his best judgment to balance risk vs. benefits.

Source 1: Use of a New Exsanguination Tourniquet in Internal Fixation of Distal Radius Fractures, Norman D, et al., “Techniques in Hand & Upper Extremity Surgery” Dec 2009, Vol.13, No.4.
Source 2: Safety of using a novel device for creating a bloodless surgical field in pediatric limb fractures, Hous N, et al., Orthopedic Department B, Rambam Medical Center, Haifa, Israel. Presented at the 24th EFORT Conference in Nice France, 2008.

Indications/Contraindications

When amputation is performed on an ischemic limb due to peripheral vascular disease, diabetes, or other arterial occlusion diseases (e.g. Buerger’s disease), it is important to verify that the tissue at the amputation location is viable and has a good blood supply..

Indications/Contraindications

• It overcomes difficulties associated with the short tapered anatomy, providing a large surgical field with excellent visibility.
• The suitability of HemaClear® for children is defined by the limb circumference and not by age of the patient.
• Since a child’s thigh is usually wider than 24cm, HemaClear® Medium can be used for circumferences of 24cm-40cm.
• For small infants or narrow limbs with a circumference of 14cm-28cm the HemaClear® Small Pink is available.

Indications/Contraindications

• If too small a size is selected, it can be difficult to apply the device over the limb and may cause pain.
• If too large a device is selected, this may result in partial exsanguination and incomplete occlusion, causing blood to leak under the ring (‘tourniquet failure’).

Note: In case blood leakage does not stop, HemaClear® should be removed immediately.

It is important to work according to the Measurement Guidelines.

Indications/ Contraindications, Tourniquet failure, Tourniquet pain

Superficial Venous Thrombosis (SVT ) is a relative contraindication and surgeons should use their best judgment and verify that in addition to SVT there is no Deep Vein Thrombosis (DVT ) present.

Source

Indications/ Contraindications

• HemaClear® is routinely used in vascular access procedures such as brachiocephalic AV shunts.
• The HemaClear® is routinely used in emergency care cases where the patient suffered from a laceration to the limb (especially hand and feet), when a bloodless field would prove helpful for quick and precise evaluation and closure of the laceration. Using the HemaClear® in such cases can avoid the necessity of opening an OR (pneumatic tourniquets are located only in the OR).
• HemaClear® has been used in maxillofacial free flap graft procedures, as well as in various plastics procedures to limbs (reconstructions, etc.)

Indications/ Contraindications

• Blood-free surgery provides a clear surgical field, minimizes blood loss, gives the surgeon more control during the procedure, and shortens total OR time.
• HemaClear® provides a bloodless surgical field that provides excellent visibility and reduces risk of DVT and pulmonary embolism.
• HemaClear® is the first advancement in bloodless limb surgery technology since Henry Cushing introduced the Pneumatic Tourniquet in 1904.

Clinical

Limb tissues are far less susceptible to ischemia than are nerve cells (neurons) in the brain. Their metabolic needs are smaller and their ATP reserves, which come in the form of creatinine phosphate and oxygen attached to Myoglobin, are substantial.

Many studies done on humans, as well as animal experiments, show that no irreversible change can be detected, as long as the tourniquet time does not exceed 2 hours (list of publications available upon request). The 2 hour time limit for the HemaClear® device corresponds to the standard of care for all existing surgical and trauma tourniquets.

Clinical

Gradual release of pneumatic tourniquet pressure means that arterial blood enters the leg, while the veins are still blocked (venous
occlusion).

This has three negative effects:

1. Possible increased bleeding in the operation site due to increased venous pressure
2. A large volume of blood in the leg soaks all ischemia by-products from the extra-cellular space.
3. The tendency to lower the patient’s blood pressure.

Once the pneumatic tourniquet is finally completely deflated, the blood pool in the leg veins quickly re-enters the central circulation and the heart, actually worsening the load of cardiac-depressing chemicals on the patient’s heart.

HemaClear®, on the other hand, exsanguinates far more effectively than other methods, resulting in no blood left behind. Thus, the ischemia by-products stay in the tissue and do not accumulate in the blood.

• When the ring is cut and new blood enters the limb, ischemia by- products are gradually washed out with no sudden flooding of the central circulation and the heart.
• Anesthesiologists feel that the drop in blood pressure upon releasing the HemaClear® is less common than that which occurs when using a pneumatic tourniquet device..

Clinical, Tourniquet release, Ischemia

Clinical, Tourniquet release, Blood vessel damage, Bleeding

• There is an ongoing debate among surgeons whether hemostasis, wound closure, and packing should be done before or after tourniquet release. This debate is independent of the type of arterial blocking used.
• Generally, European surgeons’ first close the surgical incision, whereas in the US many surgeons prefer to remove the tourniquet, perform additional hemostasis, and then close the incision.
  The literature shows that closing and packing prior to release is associated with less overall blood loss. However, with this approach there are occasional cases of bleeding into the wound and hematoma formation, which sometimes may require re-operation. It is up to the surgeon to decide which method to use.
• Following surgeons’ experience in checking for “bleeders” we recommend pulling the HemaClear® ring away from the limb with two towel clamps or two Army-Navy retractors. Once the surgeon is ready, the ring is allowed to return to its original location, thus re- occluding blood flow from the surgical site. This maneuver should only be done towards the end of surgery to avoid prolonged blood stasis distal to the HemaClear®.

Note: On the forearm it is possible for the surgeon to use his fingers to pull the HemaClear® away from the skin to provide temporary blood flow.

Clinical, Tourniquet release, Blood vessel damage, Bleeding

Since HemaClear® pressure is factory calibrated and cannot be modified during surgery, it is the responsibility of the anesthesiologist to monitor blood pressure closely in order to avoid a rise in blood pressure.

Although patients suffering from hypertension have a significant tendency for their blood pressure to shoot up, a rise in blood pressure can be seen in all patients.

For patients who suffer from hypertension use the same 2 stage application approach applied with obese patients:

• Pull the HemaClear® device up to knee level; pause for 30-60 seconds for morbidly obese patients, in order to allow the anesthesiologist to measure the blood pressure and, if needed, to adjust accordingly.
• Once the blood pressure is under control, the surgeon can continue pulling the device to the upper thigh.

This prevents exceeding HemaClear® pre-set pressure value.

Clinical, Hypertension

HemaClear® has been used successfully to reanimate patients with very low blood pressure (shock) and even during cardiac arrest when used simultaneously on both legs (shifting blood from the limbs into central circulation increases the blood volume available and raises blood pressure)..

Clinical, Hypertension

It is perhaps better to first inject the anesthetics and then apply the HemaClear® device from the tourniquet and OR time management point of view.

Clinical, Local anesthesia

For further details on the use of HemaClear® for IVRA, please contact us at info@hemaclear.com..

Clinical, Local anesthesia

Intended occlusion location – groin or axilla:

• Clean the limb and apply sterile liquid to the entire limb (up to the groin/axilla).
• Sterile drapes should be placed on the proximal axilla/groin. The HemaClear® may be applied over the edge of the drape to create an overlapping section, to provide a recommended continuity of the sterile field.

HemaClear® has its own built-in sterile stockinet, which is applied to the limb as part of the application process. There is no need for an additional sterile stockinet, unless preferred by the surgeon.

HemaClear® can be applied over an impervious stockinet if there already is one on the foot.
If a foot holder is being used, it is imperative not to try and apply the HemaClear® over the foot holder. In that case, release the foot, cover it with a sterile cover, apply the HemaClear®, and only then return the foot to the holder.

Many HemaClear® users report that the entire motion from fingers or toes to the occlusion site, takes less than 12 seconds, shortening prep time by ~50% when compared to using a pneumatic tourniquet and Esmarch.

Device application, Preparation time

• Thigh – as proximal to the groin as possible. For procedures distal to the knee, HemaClear® may be placed at mid-thigh.
• Ankle – up to 15cm (6”) proximal to the lateral malleolus.
• Upper Arm – as close as possible to the axilla
• Forearm – up to 10cm (4”) proximal to the wrist.

For additional information, please refer to the HemaClear® User Guide..

Device application

Device application, Tourniquet time

Any watch may be used but a dedicated stop watch is preferred. Alternately, the HemaClear@ Pressure Calculator App has a dedicated tourniquet timer which is recommended.

Device application, Tourniquet time

Proper training for the correct use of HemaClear® should prevent the rolling back of the ring.

• This is done by wrapping the straps around the limb immediately distal to the ring of the device with a loose knot, making it virtually impossible for the device to roll back, even on a tapered limb.
• Clear visual instructions for proper application of the HemaClear® are available on the HemaClear® YouTube Channel.

For additional information and questions regarding HemaClear® please contact us..

Device application

• Place one handle facing the dorsum of the foot (top) and one handle facing the sole (bottom). Thus, the bottom handle assists in getting the ring over the heel.
• Pull the leg upward with one hand while pulling the bottom strap downward and over the heel. It might require some effort.

Device application

The recommended HemaClear® Model for foot and ankle procedures is the Model A.

If the limb circumference at the intended occlusion location is larger than 32cm, or if the patient’s foot is large (shoe size US14/EU47 or higher), it is recommended to use the HemaClear® Medium Orange in the same position (10-15 cm above the ankle).

Device application, Foot & Ankle

• When rolling over the heel, The person applying the HemaClear® should hold the upper straps steady 45 degrees to the heel, while at the same time leveraging the lower straps over the heel, similar to how a stocking or long socks are applied.
• The assisting person should make sure that the limb is elevated and the foot is stabilized by firmly holding the ankle in one hand and the foot in the other. This allows the person applying the device the best leverage to easily roll the HemaClear® over the heel.

Device application, Foot & Ankle

• Model F: The application cup allows the Surgeon to apply the HemaClear® without an assistant (no need to hold the fingers together).
• Model A: Since the silicone ring used is relatively stiff, it is difficult to stretch the device over the toes without the application cup. The application cup also protects the toes from getting caught or injured during the application process.

The application cups should NOT be removed prior to applying the device.

Device application, Foot & Ankle

• When using a metal “U shaped” holder, it is possible to cover the holder with sterile drapes so that it can be placed safely within the sterile field.
• The solution most surgeons prefer (especially for investigative arthroscopic procedures) is to use the HemaClear® in a non-sterile fashion, applying it after disinfection of the skin, but placing the ring proximal to the holder. Although this method reduces the available tourniquet time by ~5 minutes, surgeons report that having an absolutely bloodless field during these procedures is a huge benefit.

When the hamstring ligament is being harvested, the HemaClear® prevents hematomas near the groin that are bothersome during postoperative recovery.

Device application, Arthroscopy

• The exact pressure depends on: A) The HemaClear® Model used; B) The limb circumference at the occlusion location; C) The distance of this site from the fingers or toes.
• To find the exact pressure use the HemaClear® Pressure App (available free via Google Play) or alternatively, reference the Pressure Tables in the User Guide.
• While pressure is constant, advantages of the HemaClear® narrow cuff are clear:
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

Pressure

HemaClear® NARROW CUFF: In over 800,000 procedures performed with the HemaClear® worldwide, there have been no reports of nerve or muscle damage caused to patient’s limbs.

• HemaClear® does not cause any adverse reactions to the skin.
• No additional padding (webril and similar) is required when using the HemaClear®.
• With HemaClear® there is no pinching, folding, or burning of the skin.
• There are no adverse reactions resulting from the pressure of HemaClear® combined with the chemical reaction of antiseptic solutions applied to the skin.

Pneumatic Tourniquet WIDE CUFF: It has been well documented that nerve damage occurs in ~1 in 4,200 patients when using the Pneumatic Tourniquet and/or Esmarch Bandage.

• Skin injury – 20.7% (vs. no injury with HemaClear®)
• Tourniquet pain – 39.7% (vs. diminished pain with HemaClear®)
• Neuropraxia (vs. HemaClear® – no tourniquet-induced nerve damage)

Conclusion: HemaClear® is SAFE

Pressure, Clinical safety

• Prevents inadvertent over-pressurizing of the tourniquet.
• Ensures that pressure will remain constant once HemaClear® is applied and will not vary mid-procedure.

Pressure, Safety

• Pediatric Models: 130/160/190 mm Hg
• Medium and Large Models (Medium Yellow – 190 mm Hg and Brown – 190 mm Hg)
• Extra Large Black&White Model: 160 mm Hg
• Model F and Model A: 160 mm Hg

HemaClear® exerts sufficient force on the patient’s limb to provide safe and effective arterial blood flow occlusion, so long as the patient’s systolic blood pressure does not exceed the rated product pressure.

Hence, there is no need to regulate the pressure during the surgery.

Note: The practice of increasing pump pressure when blood escapes under the pneumatic tourniquet cuff without adequate exsanguination is risky due to clot formation in the blood vessels distal to the tourniquet. This can have SERIOUS consequences.

Pressure

• If a procedure goes over 120 minutes, it is recommended to release the tourniquet and resume the blood supply to the limb for a minimum of 20 minutes (references available).
• HemaClear® is no different in this respect. If surgery lasts over 120 minutes, the device should be removed by safely cutting the silicone ring.
• After a proper duration of limb reperfusion, a second HemaClear®
  can be applied.

HemaClear® can be placed safely over the surgical incision as it is a sterile device. While doing so, the surgical site should be protected by covering it with a sterile pad.

Pressure, Tourniquet time

• The device can be removed after 90-120 minutes.
• A new HemaClear® can be applied once reperfusion has occurred.
• There are significant issues surrounding the practice of temporary tourniquet release for reperfusion.
• A serious problem occurs when deflating and inflating a pneumatic tourniquet without adequate exsanguination prior to re-inflation.
• A significant amount of blood is trapped in the vessels distal to the tourniquet.
• This leads to intravascular clotting and to pulmonary and cerebral embolization.

Source: Cerebral Microembolism Diagnosed by Transcranial Doppler during Total Knee Arthroplasty, Sulek CA, et. al.

Clinical reperfusion, Tourniquet release

• One side of the cutting card has a triangular wedge shape.
• When it is time for the HemaClear® to be removed, the wedge side of the cutting card should be inserted under the HemaClear®, distally to the patient, between the stockinet and the HemaClear® ring.
• It is possible to use the left over application strap to pull the ring proximally to the patient in order to ease the insertion of the card.
• Once the protective card is firmly placed under the HemaClear® ring, it is safe to cut and remove the HemaClear® with a scalpel in small gentle motions.

Note: It is also possible to slide a surgical tool such as an Army-Navy retractor under to HemaClear® to protect the skin from being cut.

• Dr. Mark Dodson has developed a stainless steel protective accessory named the “Dodson Extremity Skin Saver,” designed to help protect the patient’s skin when removing a disposable tourniquet. It is available at:
  www.Innomed.net/general_orthopedic.htm#DodsonSkinSaverGen
• Please refer to the User Guide and the application videos on the HemaClear® YouTube channels for precise instructions.

For additional instructions regarding this matter, please contact us.

Removing HemaClear®

• Superior exsanguinations and occlusion
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

In order to stop arterial blood flow, it is sufficient to occlude the artery over a short (few mm) segment, which is efficiently achieved by HemaClear®.

Compressing a much larger volume of tissue in order to block the flow in an artery is definitely not necessary and may actually be detrimental.

While the skin pressure needed to occlude blood flow with a wide cuff is similar to that used by a narrow one, the fact that a greater area is exposed to external tissue compression is worrisome.

Furthermore, the wide cuff elongates the nerves, which may cause telescoping and damage.

According to information published in JBJS, nerve related injury

with a wide cuff is 1:4200, while none has been seen with the narrow HemaClear® thus far.

Source: Surgical Tourniquets in Orthopedics, Gavriely N, Journal of Bone & Joint Surgery, MD, DSc, Vol. 92-A, Number 5, May 2010.

Narrow vs. wide cuff

• The surgeon places the HemaClear® on the patient’s fingers or toes and pulls the handles proximally. The HemaClear® rolls up the patient’s limb and the stockinet unrolls.
• While rolling up the limb, the ring exerts pressure, which is greater than the patient’s systolic blood pressure that shifts blood away from the limb, performing the exsanguinating (blood removal) function quickly and effectively.
• When the 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 performing the occlusion function.
• During the pulling motion over the limb, a stockinet unrolls and covers the limb up to the occlusion location, providing an instant sterile drape over the surgical field. The entire motion from fingers or toes to the occlusion site, takes less than 12 seconds significantly shortening prep time when compared to using a pneumatic tourniquet and Esmarch.

General

• Superior Exsanguination: The rolling action of the occlusive silicone ring pushes 95% of blood out of the limb, as opposed to 67% with the Esmarch bandage, and 45% when a limb elevation method is used.
• Creates a Sterile Field: HemaClear® is a sterile, single use device that eliminates the need for contaminated reusable cuffs, thereby reducing the risk of infection.
• Increases Access to the Surgical Field: Being 1” wide, the narrow profile and small footprint of the HemaClear® facilitates a larger and more accessible surgical field.
• Simple and Cost-Effective: The easy application reduces preparation time and eliminates the need for tourniquet machines, contaminated reusable cuffs, and Esmarch Bandages.
• Reduces Post-Operative Complications: The HemaClear® reduces the risks of post-operative complications such as DVT, Infections, Excessive Blood Loss, Tourniquet Related Pain, Tourniquet Related Skin Lesions (“burns”), and has the potential to reduce Post TKA Cognitive Deficit.
• Used in Over 800,00 Around 1 Million Procedures Worldwide: HemaClear® is FDA listed and CE marked. More than 20 published studies demonstrate the safety, reliability and clinical superiority of HemaClear®
• No Skin Injury (vs. 20.7% for wide cuff)
• Diminished Tourniquet Pain (vs. 39.7% wide cuff)
• No Tourniquet-Induced Nerve Damage (vs. neuropraxia with a pneumatic wide-cuff tourniquet)

General, Regulation/Certification, FDA, CE

These are the HemaClear® Models currently available:

• HemaClear® Small Pink
• HemaClear® Medium Yellow, Red, Green zzHemaClear® Large Brown, Orange, Blue zzHemaClear® Extra-Large Black&White
• HemaClear® Model F
• HemaClear® Model A

Each HemaClear® Model is designed for a specific limb circumference range, and a maximal systolic blood pressure.

General

General, Sterility

General

Device composition, Sterility, Storage

• Temperature range: 7-28 degrees C (45-83 degrees F)
• Humidity: <60% RH.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® if the expiration date has passed.
• After 3 years, the sterility of the device may be compromised.
• For additional instructions regarding expired devices, please contact us

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• HemaClear® components (silicon ring, stockinet, and pulling straps) are non-sterile prior to assembly, after which the HemaClear® undergoes a process of sterilization.
• The product is shipped as a sterile unit.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® on patients with poor peripheral blood flow, edema, or Deep Vein Thrombosis (DVT ). See the Wells Score System for likelihood of DVT.
• Do not use HemaClear® if the limb is infected or with malignancy.
• Do not apply HemaClear® directly on skin that is fragile or has significant lesions.
• Use a sterile ace bandage to protect fragile skin before applying HemaClear®.
• Do not leave HemaClear® on a patient’s limb for more than 120 minutes.
• Do not place HemaClear® directly over the ulnar nerve (at the elbow) or the peroneal nerve (at the proximal tibia)..

Indications/Contraindications

An obese patient has a great deal of blood brought from the larger limbs into central circulation. This ‘auto-transfusion’ can amount to more than 1.5 pints of blood from a single large leg.

Pushing blood into central circulation very quickly within a few seconds, can cause a significant transient rise in blood pressure and increase the risk of tourniquet failure and bleeding.

Some users have suggested the following 3-step solution:

1. Apply the HemaClear® device up to knee level.
2. Pause for 30-90 seconds, in order to enable the anesthesiologist to measure the blood pressure and, if need be, to make an adjustment.
3. Once the blood pressure is under control, the surgeon can continue pulling the straps to bring the device up to the upper thigh.
   This procedure will avoid the risk of exceeding the pre-set value of systolic blood pressure of 160 mm Hg for HemaClear® Model Extra Large (B&W).

Indications/Contraindications

• Axial traction should be in place while applying HemaClear® if the fractured limb is unstable.
• If a limb has been fractured for 12-24 hours, there should be a full evaluation to rule out DVT prior to applying HemaClear®.
• Open fractures are a relative contraindication and a surgeon should use his best judgment to balance risk vs. benefits.

Source 1: Use of a New Exsanguination Tourniquet in Internal Fixation of Distal Radius Fractures, Norman D, et al., “Techniques in Hand & Upper Extremity Surgery” Dec 2009, Vol.13, No.4.
Source 2: Safety of using a novel device for creating a bloodless surgical field in pediatric limb fractures, Hous N, et al., Orthopedic Department B, Rambam Medical Center, Haifa, Israel. Presented at the 24th EFORT Conference in Nice France, 2008.

Indications/Contraindications

When amputation is performed on an ischemic limb due to peripheral vascular disease, diabetes, or other arterial occlusion diseases (e.g. Buerger’s disease), it is important to verify that the tissue at the amputation location is viable and has a good blood supply..

Indications/Contraindications

• It overcomes difficulties associated with the short tapered anatomy, providing a large surgical field with excellent visibility.
• The suitability of HemaClear® for children is defined by the limb circumference and not by age of the patient.
• Since a child’s thigh is usually wider than 24cm, HemaClear® Medium can be used for circumferences of 24cm-40cm.
• For small infants or narrow limbs with a circumference of 14cm-28cm the HemaClear® Small Pink is available.

Indications/Contraindications

• If too small a size is selected, it can be difficult to apply the device over the limb and may cause pain.
• If too large a device is selected, this may result in partial exsanguination and incomplete occlusion, causing blood to leak under the ring (‘tourniquet failure’).

Note: In case blood leakage does not stop, HemaClear® should be removed immediately.

It is important to work according to the Measurement Guidelines.

Indications/ Contraindications, Tourniquet failure, Tourniquet pain

Superficial Venous Thrombosis (SVT ) is a relative contraindication and surgeons should use their best judgment and verify that in addition to SVT there is no Deep Vein Thrombosis (DVT ) present.

Source

Indications/ Contraindications

• HemaClear® is routinely used in vascular access procedures such as brachiocephalic AV shunts.
• The HemaClear® is routinely used in emergency care cases where the patient suffered from a laceration to the limb (especially hand and feet), when a bloodless field would prove helpful for quick and precise evaluation and closure of the laceration. Using the HemaClear® in such cases can avoid the necessity of opening an OR (pneumatic tourniquets are located only in the OR).
• HemaClear® has been used in maxillofacial free flap graft procedures, as well as in various plastics procedures to limbs (reconstructions, etc.)

Indications/ Contraindications

• Blood-free surgery provides a clear surgical field, minimizes blood loss, gives the surgeon more control during the procedure, and shortens total OR time.
• HemaClear® provides a bloodless surgical field that provides excellent visibility and reduces risk of DVT and pulmonary embolism.
• HemaClear® is the first advancement in bloodless limb surgery technology since Henry Cushing introduced the Pneumatic Tourniquet in 1904.

Clinical

Limb tissues are far less susceptible to ischemia than are nerve cells (neurons) in the brain. Their metabolic needs are smaller and their ATP reserves, which come in the form of creatinine phosphate and oxygen attached to Myoglobin, are substantial.

Many studies done on humans, as well as animal experiments, show that no irreversible change can be detected, as long as the tourniquet time does not exceed 2 hours (list of publications available upon request). The 2 hour time limit for the HemaClear® device corresponds to the standard of care for all existing surgical and trauma tourniquets.

Clinical

Gradual release of pneumatic tourniquet pressure means that arterial blood enters the leg, while the veins are still blocked (venous
occlusion).

This has three negative effects:

1. Possible increased bleeding in the operation site due to increased venous pressure
2. A large volume of blood in the leg soaks all ischemia by-products from the extra-cellular space.
3. The tendency to lower the patient’s blood pressure.

Once the pneumatic tourniquet is finally completely deflated, the blood pool in the leg veins quickly re-enters the central circulation and the heart, actually worsening the load of cardiac-depressing chemicals on the patient’s heart.

HemaClear®, on the other hand, exsanguinates far more effectively than other methods, resulting in no blood left behind. Thus, the ischemia by-products stay in the tissue and do not accumulate in the blood.

• When the ring is cut and new blood enters the limb, ischemia by- products are gradually washed out with no sudden flooding of the central circulation and the heart.
• Anesthesiologists feel that the drop in blood pressure upon releasing the HemaClear® is less common than that which occurs when using a pneumatic tourniquet device..

Clinical, Tourniquet release, Ischemia

Clinical, Tourniquet release, Blood vessel damage, Bleeding

• There is an ongoing debate among surgeons whether hemostasis, wound closure, and packing should be done before or after tourniquet release. This debate is independent of the type of arterial blocking used.
• Generally, European surgeons’ first close the surgical incision, whereas in the US many surgeons prefer to remove the tourniquet, perform additional hemostasis, and then close the incision.
  The literature shows that closing and packing prior to release is associated with less overall blood loss. However, with this approach there are occasional cases of bleeding into the wound and hematoma formation, which sometimes may require re-operation. It is up to the surgeon to decide which method to use.
• Following surgeons’ experience in checking for “bleeders” we recommend pulling the HemaClear® ring away from the limb with two towel clamps or two Army-Navy retractors. Once the surgeon is ready, the ring is allowed to return to its original location, thus re- occluding blood flow from the surgical site. This maneuver should only be done towards the end of surgery to avoid prolonged blood stasis distal to the HemaClear®.

Note: On the forearm it is possible for the surgeon to use his fingers to pull the HemaClear® away from the skin to provide temporary blood flow.

Clinical, Tourniquet release, Blood vessel damage, Bleeding

Since HemaClear® pressure is factory calibrated and cannot be modified during surgery, it is the responsibility of the anesthesiologist to monitor blood pressure closely in order to avoid a rise in blood pressure.

Although patients suffering from hypertension have a significant tendency for their blood pressure to shoot up, a rise in blood pressure can be seen in all patients.

For patients who suffer from hypertension use the same 2 stage application approach applied with obese patients:

• Pull the HemaClear® device up to knee level; pause for 30-60 seconds for morbidly obese patients, in order to allow the anesthesiologist to measure the blood pressure and, if needed, to adjust accordingly.
• Once the blood pressure is under control, the surgeon can continue pulling the device to the upper thigh.

This prevents exceeding HemaClear® pre-set pressure value.

Clinical, Hypertension

HemaClear® has been used successfully to reanimate patients with very low blood pressure (shock) and even during cardiac arrest when used simultaneously on both legs (shifting blood from the limbs into central circulation increases the blood volume available and raises blood pressure)..

Clinical, Hypertension

It is perhaps better to first inject the anesthetics and then apply the HemaClear® device from the tourniquet and OR time management point of view.

Clinical, Local anesthesia

For further details on the use of HemaClear® for IVRA, please contact us at info@hemaclear.com..

Clinical, Local anesthesia

Intended occlusion location – groin or axilla:

• Clean the limb and apply sterile liquid to the entire limb (up to the groin/axilla).
• Sterile drapes should be placed on the proximal axilla/groin. The HemaClear® may be applied over the edge of the drape to create an overlapping section, to provide a recommended continuity of the sterile field.

HemaClear® has its own built-in sterile stockinet, which is applied to the limb as part of the application process. There is no need for an additional sterile stockinet, unless preferred by the surgeon.

HemaClear® can be applied over an impervious stockinet if there already is one on the foot.
If a foot holder is being used, it is imperative not to try and apply the HemaClear® over the foot holder. In that case, release the foot, cover it with a sterile cover, apply the HemaClear®, and only then return the foot to the holder.

Many HemaClear® users report that the entire motion from fingers or toes to the occlusion site, takes less than 12 seconds, shortening prep time by ~50% when compared to using a pneumatic tourniquet and Esmarch.

Device application, Preparation time

• Thigh – as proximal to the groin as possible. For procedures distal to the knee, HemaClear® may be placed at mid-thigh.
• Ankle – up to 15cm (6”) proximal to the lateral malleolus.
• Upper Arm – as close as possible to the axilla
• Forearm – up to 10cm (4”) proximal to the wrist.

For additional information, please refer to the HemaClear® User Guide..

Device application

Device application, Tourniquet time

Any watch may be used but a dedicated stop watch is preferred. Alternately, the HemaClear@ Pressure Calculator App has a dedicated tourniquet timer which is recommended.

Device application, Tourniquet time

Proper training for the correct use of HemaClear® should prevent the rolling back of the ring.

• This is done by wrapping the straps around the limb immediately distal to the ring of the device with a loose knot, making it virtually impossible for the device to roll back, even on a tapered limb.
• Clear visual instructions for proper application of the HemaClear® are available on the HemaClear® YouTube Channel.

For additional information and questions regarding HemaClear® please contact us..

Device application

• Place one handle facing the dorsum of the foot (top) and one handle facing the sole (bottom). Thus, the bottom handle assists in getting the ring over the heel.
• Pull the leg upward with one hand while pulling the bottom strap downward and over the heel. It might require some effort.

Device application

The recommended HemaClear® Model for foot and ankle procedures is the Model A.

If the limb circumference at the intended occlusion location is larger than 32cm, or if the patient’s foot is large (shoe size US14/EU47 or higher), it is recommended to use the HemaClear® Medium Orange in the same position (10-15 cm above the ankle).

Device application, Foot & Ankle

• When rolling over the heel, The person applying the HemaClear® should hold the upper straps steady 45 degrees to the heel, while at the same time leveraging the lower straps over the heel, similar to how a stocking or long socks are applied.
• The assisting person should make sure that the limb is elevated and the foot is stabilized by firmly holding the ankle in one hand and the foot in the other. This allows the person applying the device the best leverage to easily roll the HemaClear® over the heel.

Device application, Foot & Ankle

• Model F: The application cup allows the Surgeon to apply the HemaClear® without an assistant (no need to hold the fingers together).
• Model A: Since the silicone ring used is relatively stiff, it is difficult to stretch the device over the toes without the application cup. The application cup also protects the toes from getting caught or injured during the application process.

The application cups should NOT be removed prior to applying the device.

Device application, Foot & Ankle

• When using a metal “U shaped” holder, it is possible to cover the holder with sterile drapes so that it can be placed safely within the sterile field.
• The solution most surgeons prefer (especially for investigative arthroscopic procedures) is to use the HemaClear® in a non-sterile fashion, applying it after disinfection of the skin, but placing the ring proximal to the holder. Although this method reduces the available tourniquet time by ~5 minutes, surgeons report that having an absolutely bloodless field during these procedures is a huge benefit.

When the hamstring ligament is being harvested, the HemaClear® prevents hematomas near the groin that are bothersome during postoperative recovery.

Device application, Arthroscopy

• The exact pressure depends on: A) The HemaClear® Model used; B) The limb circumference at the occlusion location; C) The distance of this site from the fingers or toes.
• To find the exact pressure use the HemaClear® Pressure App (available free via Google Play) or alternatively, reference the Pressure Tables in the User Guide.
• While pressure is constant, advantages of the HemaClear® narrow cuff are clear:
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

Pressure

HemaClear® NARROW CUFF: In over 800,000 procedures performed with the HemaClear® worldwide, there have been no reports of nerve or muscle damage caused to patient’s limbs.

• HemaClear® does not cause any adverse reactions to the skin.
• No additional padding (webril and similar) is required when using the HemaClear®.
• With HemaClear® there is no pinching, folding, or burning of the skin.
• There are no adverse reactions resulting from the pressure of HemaClear® combined with the chemical reaction of antiseptic solutions applied to the skin.

Pneumatic Tourniquet WIDE CUFF: It has been well documented that nerve damage occurs in ~1 in 4,200 patients when using the Pneumatic Tourniquet and/or Esmarch Bandage.

• Skin injury – 20.7% (vs. no injury with HemaClear®)
• Tourniquet pain – 39.7% (vs. diminished pain with HemaClear®)
• Neuropraxia (vs. HemaClear® – no tourniquet-induced nerve damage)

Conclusion: HemaClear® is SAFE

Pressure, Clinical safety

• Prevents inadvertent over-pressurizing of the tourniquet.
• Ensures that pressure will remain constant once HemaClear® is applied and will not vary mid-procedure.

Pressure, Safety

• Pediatric Models: 130/160/190 mm Hg
• Medium and Large Models (Medium Yellow – 190 mm Hg and Brown – 190 mm Hg)
• Extra Large Black&White Model: 160 mm Hg
• Model F and Model A: 160 mm Hg

HemaClear® exerts sufficient force on the patient’s limb to provide safe and effective arterial blood flow occlusion, so long as the patient’s systolic blood pressure does not exceed the rated product pressure.

Hence, there is no need to regulate the pressure during the surgery.

Note: The practice of increasing pump pressure when blood escapes under the pneumatic tourniquet cuff without adequate exsanguination is risky due to clot formation in the blood vessels distal to the tourniquet. This can have SERIOUS consequences.

Pressure

• If a procedure goes over 120 minutes, it is recommended to release the tourniquet and resume the blood supply to the limb for a minimum of 20 minutes (references available).
• HemaClear® is no different in this respect. If surgery lasts over 120 minutes, the device should be removed by safely cutting the silicone ring.
• After a proper duration of limb reperfusion, a second HemaClear®
  can be applied.

HemaClear® can be placed safely over the surgical incision as it is a sterile device. While doing so, the surgical site should be protected by covering it with a sterile pad.

Pressure, Tourniquet time

• The device can be removed after 90-120 minutes.
• A new HemaClear® can be applied once reperfusion has occurred.
• There are significant issues surrounding the practice of temporary tourniquet release for reperfusion.
• A serious problem occurs when deflating and inflating a pneumatic tourniquet without adequate exsanguination prior to re-inflation.
• A significant amount of blood is trapped in the vessels distal to the tourniquet.
• This leads to intravascular clotting and to pulmonary and cerebral embolization.

Source: Cerebral Microembolism Diagnosed by Transcranial Doppler during Total Knee Arthroplasty, Sulek CA, et. al.

Clinical reperfusion, Tourniquet release

• One side of the cutting card has a triangular wedge shape.
• When it is time for the HemaClear® to be removed, the wedge side of the cutting card should be inserted under the HemaClear®, distally to the patient, between the stockinet and the HemaClear® ring.
• It is possible to use the left over application strap to pull the ring proximally to the patient in order to ease the insertion of the card.
• Once the protective card is firmly placed under the HemaClear® ring, it is safe to cut and remove the HemaClear® with a scalpel in small gentle motions.

Note: It is also possible to slide a surgical tool such as an Army-Navy retractor under to HemaClear® to protect the skin from being cut.

• Dr. Mark Dodson has developed a stainless steel protective accessory named the “Dodson Extremity Skin Saver,” designed to help protect the patient’s skin when removing a disposable tourniquet. It is available at:
  www.Innomed.net/general_orthopedic.htm#DodsonSkinSaverGen
• Please refer to the User Guide and the application videos on the HemaClear® YouTube channels for precise instructions.

For additional instructions regarding this matter, please contact us.

Removing HemaClear®

• Superior exsanguinations and occlusion
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

In order to stop arterial blood flow, it is sufficient to occlude the artery over a short (few mm) segment, which is efficiently achieved by HemaClear®.

Compressing a much larger volume of tissue in order to block the flow in an artery is definitely not necessary and may actually be detrimental.

While the skin pressure needed to occlude blood flow with a wide cuff is similar to that used by a narrow one, the fact that a greater area is exposed to external tissue compression is worrisome.

Furthermore, the wide cuff elongates the nerves, which may cause telescoping and damage.

According to information published in JBJS, nerve related injury

with a wide cuff is 1:4200, while none has been seen with the narrow HemaClear® thus far.

Source: Surgical Tourniquets in Orthopedics, Gavriely N, Journal of Bone & Joint Surgery, MD, DSc, Vol. 92-A, Number 5, May 2010.

Narrow vs. wide cuff

• The surgeon places the HemaClear® on the patient’s fingers or toes and pulls the handles proximally. The HemaClear® rolls up the patient’s limb and the stockinet unrolls.
• While rolling up the limb, the ring exerts pressure, which is greater than the patient’s systolic blood pressure that shifts blood away from the limb, performing the exsanguinating (blood removal) function quickly and effectively.
• When the 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 performing the occlusion function.
• During the pulling motion over the limb, a stockinet unrolls and covers the limb up to the occlusion location, providing an instant sterile drape over the surgical field. The entire motion from fingers or toes to the occlusion site, takes less than 12 seconds significantly shortening prep time when compared to using a pneumatic tourniquet and Esmarch.

General

• Superior Exsanguination: The rolling action of the occlusive silicone ring pushes 95% of blood out of the limb, as opposed to 67% with the Esmarch bandage, and 45% when a limb elevation method is used.
• Creates a Sterile Field: HemaClear® is a sterile, single use device that eliminates the need for contaminated reusable cuffs, thereby reducing the risk of infection.
• Increases Access to the Surgical Field: Being 1” wide, the narrow profile and small footprint of the HemaClear® facilitates a larger and more accessible surgical field.
• Simple and Cost-Effective: The easy application reduces preparation time and eliminates the need for tourniquet machines, contaminated reusable cuffs, and Esmarch Bandages.
• Reduces Post-Operative Complications: The HemaClear® reduces the risks of post-operative complications such as DVT, Infections, Excessive Blood Loss, Tourniquet Related Pain, Tourniquet Related Skin Lesions (“burns”), and has the potential to reduce Post TKA Cognitive Deficit.
• Used in Over 800,00 Around 1 Million Procedures Worldwide: HemaClear® is FDA listed and CE marked. More than 20 published studies demonstrate the safety, reliability and clinical superiority of HemaClear®
• No Skin Injury (vs. 20.7% for wide cuff)
• Diminished Tourniquet Pain (vs. 39.7% wide cuff)
• No Tourniquet-Induced Nerve Damage (vs. neuropraxia with a pneumatic wide-cuff tourniquet)

General, Regulation/Certification, FDA, CE

These are the HemaClear® Models currently available:

• HemaClear® Small Pink
• HemaClear® Medium Yellow, Red, Green zzHemaClear® Large Brown, Orange, Blue zzHemaClear® Extra-Large Black&White
• HemaClear® Model F
• HemaClear® Model A

Each HemaClear® Model is designed for a specific limb circumference range, and a maximal systolic blood pressure.

General

General, Sterility

General

Device composition, Sterility, Storage

• Temperature range: 7-28 degrees C (45-83 degrees F)
• Humidity: <60% RH.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® if the expiration date has passed.
• After 3 years, the sterility of the device may be compromised.
• For additional instructions regarding expired devices, please contact us

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• HemaClear® components (silicon ring, stockinet, and pulling straps) are non-sterile prior to assembly, after which the HemaClear® undergoes a process of sterilization.
• The product is shipped as a sterile unit.

Device composition, Sterility, Storage

Device composition, Sterility, Storage

• Do not use HemaClear® on patients with poor peripheral blood flow, edema, or Deep Vein Thrombosis (DVT ). See the Wells Score System for likelihood of DVT.
• Do not use HemaClear® if the limb is infected or with malignancy.
• Do not apply HemaClear® directly on skin that is fragile or has significant lesions.
• Use a sterile ace bandage to protect fragile skin before applying HemaClear®.
• Do not leave HemaClear® on a patient’s limb for more than 120 minutes.
• Do not place HemaClear® directly over the ulnar nerve (at the elbow) or the peroneal nerve (at the proximal tibia)..

Indications/Contraindications

An obese patient has a great deal of blood brought from the larger limbs into central circulation. This ‘auto-transfusion’ can amount to more than 1.5 pints of blood from a single large leg.

Pushing blood into central circulation very quickly within a few seconds, can cause a significant transient rise in blood pressure and increase the risk of tourniquet failure and bleeding.

Some users have suggested the following 3-step solution:

1. Apply the HemaClear® device up to knee level.
2. Pause for 30-90 seconds, in order to enable the anesthesiologist to measure the blood pressure and, if need be, to make an adjustment.
3. Once the blood pressure is under control, the surgeon can continue pulling the straps to bring the device up to the upper thigh.
   This procedure will avoid the risk of exceeding the pre-set value of systolic blood pressure of 160 mm Hg for HemaClear® Model Extra Large (B&W).

Indications/Contraindications

• Axial traction should be in place while applying HemaClear® if the fractured limb is unstable.
• If a limb has been fractured for 12-24 hours, there should be a full evaluation to rule out DVT prior to applying HemaClear®.
• Open fractures are a relative contraindication and a surgeon should use his best judgment to balance risk vs. benefits.

Source 1: Use of a New Exsanguination Tourniquet in Internal Fixation of Distal Radius Fractures, Norman D, et al., “Techniques in Hand & Upper Extremity Surgery” Dec 2009, Vol.13, No.4.
Source 2: Safety of using a novel device for creating a bloodless surgical field in pediatric limb fractures, Hous N, et al., Orthopedic Department B, Rambam Medical Center, Haifa, Israel. Presented at the 24th EFORT Conference in Nice France, 2008.

Indications/Contraindications

When amputation is performed on an ischemic limb due to peripheral vascular disease, diabetes, or other arterial occlusion diseases (e.g. Buerger’s disease), it is important to verify that the tissue at the amputation location is viable and has a good blood supply..

Indications/Contraindications

• It overcomes difficulties associated with the short tapered anatomy, providing a large surgical field with excellent visibility.
• The suitability of HemaClear® for children is defined by the limb circumference and not by age of the patient.
• Since a child’s thigh is usually wider than 24cm, HemaClear® Medium can be used for circumferences of 24cm-40cm.
• For small infants or narrow limbs with a circumference of 14cm-28cm the HemaClear® Small Pink is available.

Indications/Contraindications

• If too small a size is selected, it can be difficult to apply the device over the limb and may cause pain.
• If too large a device is selected, this may result in partial exsanguination and incomplete occlusion, causing blood to leak under the ring (‘tourniquet failure’).

Note: In case blood leakage does not stop, HemaClear® should be removed immediately.

It is important to work according to the Measurement Guidelines.

Indications/ Contraindications, Tourniquet failure, Tourniquet pain

Superficial Venous Thrombosis (SVT ) is a relative contraindication and surgeons should use their best judgment and verify that in addition to SVT there is no Deep Vein Thrombosis (DVT ) present.

Source

Indications/ Contraindications

• HemaClear® is routinely used in vascular access procedures such as brachiocephalic AV shunts.
• The HemaClear® is routinely used in emergency care cases where the patient suffered from a laceration to the limb (especially hand and feet), when a bloodless field would prove helpful for quick and precise evaluation and closure of the laceration. Using the HemaClear® in such cases can avoid the necessity of opening an OR (pneumatic tourniquets are located only in the OR).
• HemaClear® has been used in maxillofacial free flap graft procedures, as well as in various plastics procedures to limbs (reconstructions, etc.)

Indications/ Contraindications

• Blood-free surgery provides a clear surgical field, minimizes blood loss, gives the surgeon more control during the procedure, and shortens total OR time.
• HemaClear® provides a bloodless surgical field that provides excellent visibility and reduces risk of DVT and pulmonary embolism.
• HemaClear® is the first advancement in bloodless limb surgery technology since Henry Cushing introduced the Pneumatic Tourniquet in 1904.

Clinical

Limb tissues are far less susceptible to ischemia than are nerve cells (neurons) in the brain. Their metabolic needs are smaller and their ATP reserves, which come in the form of creatinine phosphate and oxygen attached to Myoglobin, are substantial.

Many studies done on humans, as well as animal experiments, show that no irreversible change can be detected, as long as the tourniquet time does not exceed 2 hours (list of publications available upon request). The 2 hour time limit for the HemaClear® device corresponds to the standard of care for all existing surgical and trauma tourniquets.

Clinical

Gradual release of pneumatic tourniquet pressure means that arterial blood enters the leg, while the veins are still blocked (venous
occlusion).

This has three negative effects:

1. Possible increased bleeding in the operation site due to increased venous pressure
2. A large volume of blood in the leg soaks all ischemia by-products from the extra-cellular space.
3. The tendency to lower the patient’s blood pressure.

Once the pneumatic tourniquet is finally completely deflated, the blood pool in the leg veins quickly re-enters the central circulation and the heart, actually worsening the load of cardiac-depressing chemicals on the patient’s heart.

HemaClear®, on the other hand, exsanguinates far more effectively than other methods, resulting in no blood left behind. Thus, the ischemia by-products stay in the tissue and do not accumulate in the blood.

• When the ring is cut and new blood enters the limb, ischemia by- products are gradually washed out with no sudden flooding of the central circulation and the heart.
• Anesthesiologists feel that the drop in blood pressure upon releasing the HemaClear® is less common than that which occurs when using a pneumatic tourniquet device..

Clinical, Tourniquet release, Ischemia

Clinical, Tourniquet release, Blood vessel damage, Bleeding

• There is an ongoing debate among surgeons whether hemostasis, wound closure, and packing should be done before or after tourniquet release. This debate is independent of the type of arterial blocking used.
• Generally, European surgeons’ first close the surgical incision, whereas in the US many surgeons prefer to remove the tourniquet, perform additional hemostasis, and then close the incision.
  The literature shows that closing and packing prior to release is associated with less overall blood loss. However, with this approach there are occasional cases of bleeding into the wound and hematoma formation, which sometimes may require re-operation. It is up to the surgeon to decide which method to use.
• Following surgeons’ experience in checking for “bleeders” we recommend pulling the HemaClear® ring away from the limb with two towel clamps or two Army-Navy retractors. Once the surgeon is ready, the ring is allowed to return to its original location, thus re- occluding blood flow from the surgical site. This maneuver should only be done towards the end of surgery to avoid prolonged blood stasis distal to the HemaClear®.

Note: On the forearm it is possible for the surgeon to use his fingers to pull the HemaClear® away from the skin to provide temporary blood flow.

Clinical, Tourniquet release, Blood vessel damage, Bleeding

Since HemaClear® pressure is factory calibrated and cannot be modified during surgery, it is the responsibility of the anesthesiologist to monitor blood pressure closely in order to avoid a rise in blood pressure.

Although patients suffering from hypertension have a significant tendency for their blood pressure to shoot up, a rise in blood pressure can be seen in all patients.

For patients who suffer from hypertension use the same 2 stage application approach applied with obese patients:

• Pull the HemaClear® device up to knee level; pause for 30-60 seconds for morbidly obese patients, in order to allow the anesthesiologist to measure the blood pressure and, if needed, to adjust accordingly.
• Once the blood pressure is under control, the surgeon can continue pulling the device to the upper thigh.

This prevents exceeding HemaClear® pre-set pressure value.

Clinical, Hypertension

HemaClear® has been used successfully to reanimate patients with very low blood pressure (shock) and even during cardiac arrest when used simultaneously on both legs (shifting blood from the limbs into central circulation increases the blood volume available and raises blood pressure)..

Clinical, Hypertension

It is perhaps better to first inject the anesthetics and then apply the HemaClear® device from the tourniquet and OR time management point of view.

Clinical, Local anesthesia

For further details on the use of HemaClear® for IVRA, please contact us at info@hemaclear.com..

Clinical, Local anesthesia

Intended occlusion location – groin or axilla:

• Clean the limb and apply sterile liquid to the entire limb (up to the groin/axilla).
• Sterile drapes should be placed on the proximal axilla/groin. The HemaClear® may be applied over the edge of the drape to create an overlapping section, to provide a recommended continuity of the sterile field.

HemaClear® has its own built-in sterile stockinet, which is applied to the limb as part of the application process. There is no need for an additional sterile stockinet, unless preferred by the surgeon.

HemaClear® can be applied over an impervious stockinet if there already is one on the foot.
If a foot holder is being used, it is imperative not to try and apply the HemaClear® over the foot holder. In that case, release the foot, cover it with a sterile cover, apply the HemaClear®, and only then return the foot to the holder.

Many HemaClear® users report that the entire motion from fingers or toes to the occlusion site, takes less than 12 seconds, shortening prep time by ~50% when compared to using a pneumatic tourniquet and Esmarch.

Device application, Preparation time

• Thigh – as proximal to the groin as possible. For procedures distal to the knee, HemaClear® may be placed at mid-thigh.
• Ankle – up to 15cm (6”) proximal to the lateral malleolus.
• Upper Arm – as close as possible to the axilla
• Forearm – up to 10cm (4”) proximal to the wrist.

For additional information, please refer to the HemaClear® User Guide..

Device application

Device application, Tourniquet time

Any watch may be used but a dedicated stop watch is preferred. Alternately, the HemaClear@ Pressure Calculator App has a dedicated tourniquet timer which is recommended.

Device application, Tourniquet time

Proper training for the correct use of HemaClear® should prevent the rolling back of the ring.

• This is done by wrapping the straps around the limb immediately distal to the ring of the device with a loose knot, making it virtually impossible for the device to roll back, even on a tapered limb.
• Clear visual instructions for proper application of the HemaClear® are available on the HemaClear® YouTube Channel.

For additional information and questions regarding HemaClear® please contact us..

Device application

• Place one handle facing the dorsum of the foot (top) and one handle facing the sole (bottom). Thus, the bottom handle assists in getting the ring over the heel.
• Pull the leg upward with one hand while pulling the bottom strap downward and over the heel. It might require some effort.

Device application

The recommended HemaClear® Model for foot and ankle procedures is the Model A.

If the limb circumference at the intended occlusion location is larger than 32cm, or if the patient’s foot is large (shoe size US14/EU47 or higher), it is recommended to use the HemaClear® Medium Orange in the same position (10-15 cm above the ankle).

Device application, Foot & Ankle

• When rolling over the heel, The person applying the HemaClear® should hold the upper straps steady 45 degrees to the heel, while at the same time leveraging the lower straps over the heel, similar to how a stocking or long socks are applied.
• The assisting person should make sure that the limb is elevated and the foot is stabilized by firmly holding the ankle in one hand and the foot in the other. This allows the person applying the device the best leverage to easily roll the HemaClear® over the heel.

Device application, Foot & Ankle

• Model F: The application cup allows the Surgeon to apply the HemaClear® without an assistant (no need to hold the fingers together).
• Model A: Since the silicone ring used is relatively stiff, it is difficult to stretch the device over the toes without the application cup. The application cup also protects the toes from getting caught or injured during the application process.

The application cups should NOT be removed prior to applying the device.

Device application, Foot & Ankle

• When using a metal “U shaped” holder, it is possible to cover the holder with sterile drapes so that it can be placed safely within the sterile field.
• The solution most surgeons prefer (especially for investigative arthroscopic procedures) is to use the HemaClear® in a non-sterile fashion, applying it after disinfection of the skin, but placing the ring proximal to the holder. Although this method reduces the available tourniquet time by ~5 minutes, surgeons report that having an absolutely bloodless field during these procedures is a huge benefit.

When the hamstring ligament is being harvested, the HemaClear® prevents hematomas near the groin that are bothersome during postoperative recovery.

Device application, Arthroscopy

• The exact pressure depends on: A) The HemaClear® Model used; B) The limb circumference at the occlusion location; C) The distance of this site from the fingers or toes.
• To find the exact pressure use the HemaClear® Pressure App (available free via Google Play) or alternatively, reference the Pressure Tables in the User Guide.
• While pressure is constant, advantages of the HemaClear® narrow cuff are clear:
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

Pressure

HemaClear® NARROW CUFF: In over 800,000 procedures performed with the HemaClear® worldwide, there have been no reports of nerve or muscle damage caused to patient’s limbs.

• HemaClear® does not cause any adverse reactions to the skin.
• No additional padding (webril and similar) is required when using the HemaClear®.
• With HemaClear® there is no pinching, folding, or burning of the skin.
• There are no adverse reactions resulting from the pressure of HemaClear® combined with the chemical reaction of antiseptic solutions applied to the skin.

Pneumatic Tourniquet WIDE CUFF: It has been well documented that nerve damage occurs in ~1 in 4,200 patients when using the Pneumatic Tourniquet and/or Esmarch Bandage.

• Skin injury – 20.7% (vs. no injury with HemaClear®)
• Tourniquet pain – 39.7% (vs. diminished pain with HemaClear®)
• Neuropraxia (vs. HemaClear® – no tourniquet-induced nerve damage)

Conclusion: HemaClear® is SAFE

Pressure, Clinical safety

• Prevents inadvertent over-pressurizing of the tourniquet.
• Ensures that pressure will remain constant once HemaClear® is applied and will not vary mid-procedure.

Pressure, Safety

• Pediatric Models: 130/160/190 mm Hg
• Medium and Large Models (Medium Yellow – 190 mm Hg and Brown – 190 mm Hg)
• Extra Large Black&White Model: 160 mm Hg
• Model F and Model A: 160 mm Hg

HemaClear® exerts sufficient force on the patient’s limb to provide safe and effective arterial blood flow occlusion, so long as the patient’s systolic blood pressure does not exceed the rated product pressure.

Hence, there is no need to regulate the pressure during the surgery.

Note: The practice of increasing pump pressure when blood escapes under the pneumatic tourniquet cuff without adequate exsanguination is risky due to clot formation in the blood vessels distal to the tourniquet. This can have SERIOUS consequences.

Pressure

• If a procedure goes over 120 minutes, it is recommended to release the tourniquet and resume the blood supply to the limb for a minimum of 20 minutes (references available).
• HemaClear® is no different in this respect. If surgery lasts over 120 minutes, the device should be removed by safely cutting the silicone ring.
• After a proper duration of limb reperfusion, a second HemaClear®
  can be applied.

HemaClear® can be placed safely over the surgical incision as it is a sterile device. While doing so, the surgical site should be protected by covering it with a sterile pad.

Pressure, Tourniquet time

• The device can be removed after 90-120 minutes.
• A new HemaClear® can be applied once reperfusion has occurred.
• There are significant issues surrounding the practice of temporary tourniquet release for reperfusion.
• A serious problem occurs when deflating and inflating a pneumatic tourniquet without adequate exsanguination prior to re-inflation.
• A significant amount of blood is trapped in the vessels distal to the tourniquet.
• This leads to intravascular clotting and to pulmonary and cerebral embolization.

Source: Cerebral Microembolism Diagnosed by Transcranial Doppler during Total Knee Arthroplasty, Sulek CA, et. al.

Clinical reperfusion, Tourniquet release

• One side of the cutting card has a triangular wedge shape.
• When it is time for the HemaClear® to be removed, the wedge side of the cutting card should be inserted under the HemaClear®, distally to the patient, between the stockinet and the HemaClear® ring.
• It is possible to use the left over application strap to pull the ring proximally to the patient in order to ease the insertion of the card.
• Once the protective card is firmly placed under the HemaClear® ring, it is safe to cut and remove the HemaClear® with a scalpel in small gentle motions.

Note: It is also possible to slide a surgical tool such as an Army-Navy retractor under to HemaClear® to protect the skin from being cut.

• Dr. Mark Dodson has developed a stainless steel protective accessory named the “Dodson Extremity Skin Saver,” designed to help protect the patient’s skin when removing a disposable tourniquet. It is available at:
  www.Innomed.net/general_orthopedic.htm#DodsonSkinSaverGen
• Please refer to the User Guide and the application videos on the HemaClear® YouTube channels for precise instructions.

For additional instructions regarding this matter, please contact us.

Removing HemaClear®

• Superior exsanguinations and occlusion
• No skin injury (vs. 20.7% for wide cuff )
• Diminished tourniquet pain (vs. 39.7% wide cuff )
• No tourniquet-induced nerve damage (vs. neuropraxia with a pneumatic tourniquet wide cuff )

In order to stop arterial blood flow, it is sufficient to occlude the artery over a short (few mm) segment, which is efficiently achieved by HemaClear®.

Compressing a much larger volume of tissue in order to block the flow in an artery is definitely not necessary and may actually be detrimental.

While the skin pressure needed to occlude blood flow with a wide cuff is similar to that used by a narrow one, the fact that a greater area is exposed to external tissue compression is worrisome.

Furthermore, the wide cuff elongates the nerves, which may cause telescoping and damage.

According to information published in JBJS, nerve related injury

with a wide cuff is 1:4200, while none has been seen with the narrow HemaClear® thus far.

Source: Surgical Tourniquets in Orthopedics, Gavriely N, Journal of Bone & Joint Surgery, MD, DSc, Vol. 92-A, Number 5, May 2010.

Narrow vs. wide cuff