HemaClear® Frequently Asked Questions

Tourniquet time is measured from the time HemaClear® is applied until the ring is cut.
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.

As with any other type of tourniquet, HemaClear® can remain on the limb for up to 120 minutes.

The recommended locations for applying HemaClear® to or on a limb are:
– 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.

Applying HemaClear® is easier and faster than using a pneumatic tourniquet and no equipment is needed other than the sterile HemaClear® device.
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.

Using HemaClear® for IVRA has been documented in literature, and is commonly used by surgeons.
For further details on the use of HemaClear® for IVRA, please contact us at info@hemaclear.com.

It is possible to carry out short procedures such as carpal tunnel release and trigger finger with only local anesthesia infiltration of the skin.
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.

Nothing needs to be done since there are no contraindications for using HemaClear® with hypotensive patients.
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).

It is possible to carry out short procedures such as carpal tunnel release and trigger finger with only local anesthesia infiltration of the skin.
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.

Nothing needs to be done since there are no contraindications for using HemaClear® with hypotensive patients.
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).

The situation must be handled very carefully.
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.

Experienced users report that benefits provided by HemaClear® make this a non-issue.
– 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.

In order to prevent such concerns, some surgeons perform homeostasis and suture the surgical incision after relieving the tourniquet pressure. Thus they ensure that no blood vessels have been harmed.

HemaClear®’s superb exsanguination (95%) reduces incidences of post-op DVT and pulmonary embolism. It also greatly reduces chances of ischemia by-products (e.g. potassium, acidity, and CO2) being released from the limb.
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.
Note: We are not aware of any publication that supports the practice of gradual tourniquet release.
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.

HemaClear® provides unprecedented exsanguination, eliminating almost entirely the chance of ischemia following up to 120 minutes in use.
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.

Yes.
– 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.

Yes.
– 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.

HemaClear® can be used with varicose veins. In fact it is used by vascular surgeons during stripping or laser treatment of varicose veins.
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: http://www.prweb.com/releases/2012/3/prweb9340666.htm

If the wrong HemaClear® Model (size) is used, the following may occur:
– 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.

Yes. HemaClear® is reported by many users to be extremely useful for pediatric limb surgery.
– 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.

Yes, unless there is limb malignancy (see 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.

The use of HemaClear® on fractured limbs has been documented to be effective and safe in two published paper (below).
– 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.

Yes. HemaClear® can be used on morbidly obese patients if the limb circumference does not exceed 85cm.
Extra care must be taken with obese patients by monitoring their blood pressure.
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).

No. Please read the following Contraindications before using HemaClear®:
– 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).

Yes. The inside of the silicone ring is sterile as is the entire HemaClear® device.

– 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.

HemaClear® is sterilized with Ethylene Oxide (EtO).

– 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 info@HemaClear.com.

3 years.

The HemaClear® should be stored in a clean environment suitable for sterile medical products under the following conditions:
– Temperature range: 7-28oC (45-83 oF)
– Humidity: <60% RH

Yes.

At present, around 2.5 million units have been used in orthopedic procedures globally.

– HemaClear® comes in 4 primary Models/sizes intended for proximal limb placement (axilla and upper thigh) suitable for children and adults with limb circumferences ranging from 14cm – 85cm with maximum systolic blood pressure under 190 mm Hg.
Additionally, there are 2 HemaClear® Models designed specifically for extremity placement (Model F for Forearm and Model A for Ankle).
These are the HemaClear® Models currently available:
– HemaClear® Small Pink
– HemaClear® Medium Yellow, Red, Green
– HemaClear® Large Brown, Orange, Blue
– HemaClear® 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.

– 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 800,000 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 tourniquet 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.

No. HemaClear® is a sterile single-use device that is removed by cutting when the procedure ends. Therefore, it cannot be re-used or re-sterilized.

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

• 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)

• 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”.

0.5% lidocaine = 0.5 gram in 100 cc = 500 mg. so 20 cc of 0.5% lidocaine = 100 mg = safe dose used often in emergency medicine for cardiac premature beats. This is how much you need for forearm Bier Block. For upper arm Bier Block with pneumatic cuff (no tight stockinet) you need 50-60 cc of 0.5% lidocaine which is 250-300 mg. This is overdose and not safe. May cause seizures and even cardiac arrest. As such, it is customary to wait at least 30-40 minutes after lidocaine injection for upper arm tourniquets before releasing the tourniquet to allow for it to be absorbed into the tissues.

We assume that at least 30 cc of lidocaine is needed for upper arm HemaClear placement (less is needed because the veins are compressed by the HemaClear stockinet). This is 150 mg which is the upper level of safety. If more than this is injected, the 30-40 minutes delay is also needed with HemaClear.

Now what does “slow” pressure release means?

When tourniquet pressure is released slowly, first the tourniquet pressure reaches the systolic level and blood starts to flow INTO the arm. Venous outflow remains zero until the venous pressure increases above the tourniquet pressure. At this point there is a lot of blood in the limb and when the tourniquet pressure is further released a gush of venous blood is exiting the limb into central circulation, not only with lidocaine, but also with Lactate, CO2, H2, K+ etc. Not very good for the heart.

• HemaClear® is a Sterile Exsanguinating Occlusion device for surgical limb procedures – providing up to 95% exsanguination (blood removal) compared to ~67% with current techniques.
• HemaClear® consists of an elastic silicone ring wrapped in a stockinet and 2 pulling straps with handles.
• HemaClear® can be used without a power supply or a compressed air source.