VascuTherm 4
The VascuTherm 4 is a Multi-Modality Approach to the Prevention of Venous Thromboembolism (VTE), Post-Operative Pain, and Edema
VascuTherm 4 Thermal Compression Therapy

The VascuTherm 4 by ThermoTek delivers a totally unique and proprietary thermal compression therapy solution in one easily transportable device. Thermoelectric technology eliminates the need for ice, offers precise temperature control for preventing thermal tissue damage, and delivers exceptional reliability.

The VascuTherm 4 offers highly effective DVT prophylaxis through unique and programmable multiple treatment modalities – combining cooling/heating temperature management with vascular compression.

Clinical Benefits of DVT Prophylaxis Therapy

Deep Vein Thrombosis and Pulmonary Embolism (DVT/PE) are often underdiagnosed and serious, but preventable medical conditions. Deep vein thrombosis (DVT) is a medical condition that occurs when a blood clot forms in a deep vein. These clots usually develop in the lower leg, thigh, or pelvis, but they can also occur in the arm. It is important to know about DVT because it can happen to anybody and can cause serious illness, disability, and in some cases, death (CDC - Centers for Disease Control and Prevention, 2017). This type of post-surgical complication is very common and is an epidemic causing more deaths than HIV, breast cancer and automobile accidents combined (American Public Health Association, 2003). The positive aspect of this epidemic is that there are numerous preventative measures that can be taken to significantly reduce the risk of a DVT. Some of these preventive measures include mechanical IPC, pharmacological agents or a combined approach, which is considered a best practice.

Orthopedic surgery, including total joint replacement and complex arthroscopic procedures, are known to be the highest risk surgical procedures; causing over 600,000 patients to suffer from DVT complications each year. In fact, in the absence of preventative treatments, 40%-60% of patients will suffer from DVT*; and according to the US Surgeon General, resulting in over 100,000 deaths per year.

The VascuTherm provides the solution for DVT Prophylaxis Therapy.

Clinical Benefits of Cold Therapy

Soft tissue trauma from injury, overuse, or surgical intervention causes an inflammatory response. At the cellular level, trauma causes disruption at the cell wall and can damage the cell and surrounding cells. As a response, the cell attempts to repair itself using anaerobic metabolism, which cannot be sustained. Because of this, the damaged cell cannot regulate the concentration gradients and allows water to pass through. As water dilutes the cells, the body releases a number of chemicals to correct the issue and get rid of cellular debris. As this happens, vasodilation occurs, increasing blood flow and transporting of fluid to the inflamed area. This process accounts for the redness and swelling sometimes associated with inflammation.

 By utilizing cold therapy, the temperature of the tissue is lowered and the rates of the chemical reactions that actually cause the inflammation are slowed. Therefore, more cells survive, the damage slows, and healing is accelerated.  The cold also acts as an analgesic and reduces the pain from any inflammation and the associated swelling.

It should be mentioned that cold is effective only if used properly. Using a device that is too warm is not therapeutic, while using a device that is able to get too cold can cause damage to the tissue and nerves. The VascuTherm is one of the only ice-free devices available on the market, so temperature is precise and stable, therefore removing the worry of running out of ice or running another device at a low temperature that could potentially cause cold injury. The VascuTherm is regulated to operate between specific temperatures (43F-50F), therefore significantly reducing any risk of cold injury.

The VascuTherm provides the solution for safe and clinically effective continuous cold therapy!

Clinical Benefits of Compression Therapy

Compression also aids the effectiveness of the cold therapy by improving the contact of the cold therapy wrap with the skin. Compression also helps reduce the excess fluid that can be accumulated after soft tissue injury or trauma. The compression also addresses the musculoskeletal injury by reducing the blood flow and swelling, removing the edema and reducing post-operative blood drainage, which can be an ictus for infection or hematoma formation.

The combination of cold and compression therapy is very beneficial for patients recovering from orthopedic surgery and has many far reaching benefits. In multiple clinical controlled and randomized studies, the combination of cold and compression therapy has been shown to improve outcomes in numerous ways, including lower VAS pain scores, reduction of analgesics and narcotics, lower suctioned blood loss, improved range of motion 14 days post operatively, reduce hospital stays on an average of 1.5 days, and faster independent ambulation.

The VascuTherm provides the solution for effective compression and edema management.

Treatment Modalities

Precise Temperature Control

  • Cold:  43° F to 50°F
  • Heat: 105°F
     

Compression Therapy (3 settings)

  • Low: 15 mmHg
  • Medium: 30 mmHg
  • High: 50 mmHg
     

DVT Prophylaxis Therapy

  • Calf: cycles at 45 mmHg
  • Foot: cycles at 100 mmHg
     

Proprietary, Integrated Compression with DVT Prophylactic Therapy

Thermoelectric Cooling/Heating – No Ice Required!

Operating Fluid: 90% Distilled Water/10% Isopropyl Alcohol

Specifications

Weight:  9.5 lbs.
Dimensions:  9.81” W x 9.88” H x 8.75” D
Umbilical Hose Length: 5 feet
Hospital Grade Power Cord
Safety: IEC 60601-1; IEC 60601-1-2
FDA 510K

Indications

Pain:

Localized thermal therapy (hot or cold) for post traumatic and post-surgical and/or medical conditions.

Edema:

Reduction of edema associated with soft tissue injuries such as burns, post-operative edema and ligament sprains

DVT Prophylaxis:

Decrease the risk of deep venous thrombosis (DVT)

Lymphedema:

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.

Related Accessories
Therapy Wraps

ThermoTek manufacturers a variety of single-patient use therapy wraps exclusively for use with the VascuTherm therapy device. ThermoTek’s single patient use therapy wraps are latex-free and provide a precise, comfortable fit.

  • Name
  • Part #
  • Kit, Umbilical, Connector, Wrap Side (2 female, 1 male)
  • 0P9KWSUCKT
  • Kit, Umbilical, Connector, System Side (3 male)
  • 0P9KSSUCKT

Warning & Precautionary Statement on Single Patient Use Wraps:

INTENDED USE: Disposable therapy wraps are designed for single patient use only and may only be used on same patient for length of treatment.

WARNING: DO NOT REUSE OR REPROCESS TO USE ON MORE THAN ONE PATIENT. Per FDA, 21 CFR Part 820, this product has not been validated for reprocessing or reuse.

CAUTION: Fluid can diffuse from wrap and condense inside plastic bag. This may cause insert to get wet and form mold inside the package. ThermoTek will not warrant wraps for mold formation after 30 days from the date of purchase. To prevent wrap deterioration, ThermoTek makes the following recommendations:

Recommended Storage Protocol:

  • Store between 50-80ºF (ambient)
  • Rotate stock to use older inventory first (FIFO)
  • Do not store in a manner that blocks air vent holes in bag
  • Fluid may evaporate in the wrap within 30 days if stored at 80ºF or higher
  • Fluid may freeze in the wrap if stored at 32ºF or lower and damage the wrap.

PRECAUTIONS:

  • Carefully read user instructions and warnings prior to operation.
  • Therapy wraps are available in sterile and non-sterile; non-sterile therapy wraps should not be directly applied to an open wound. Do not use directly over breached skin. This product should not be used during the inflammatory phlebitis process or during episodes of pulmonary embolism, congestive heart failure, pulmonary edema, suspected deep vein thrombosis, acute inflammations of the veins (thrombophlebitis), decompensated cardiac insufficiency, arterial dysregulation, erysipelas, deep acute venal thrombosis (Phlebothrombosis), carcinoma and carcinoma metastasis in the affected extremity, decompensated hypertonia, acute inflammatory skin diseases, infection, venous or arterial occlusive disease or in any instances where increased venous and lymphatic return is undesirable. Use with caution on an extremity which is not sensitive to pain. Individuals with extremely low blood pressure should check with their doctor before using ThermoTek products.
  • A licensed healthcare practitioner must select the correct temperature setting. Patients vary in sensitivity to cold. A regular check of the temperature must be made once it has been established for the patient. Caution should be taken during prolonged use, for children, diabetics, incapacitated patients, and those with decreased skin sensitivity or poor circulation.
  • Due to individual differences in sensitivity and susceptibility to cold, patient’s skin should be frequently observed. Follow instructions of your physician for length, frequency and duration of treatment.
  • These products are to be fitted initially by a healthcare professional that is familiar with the purpose for which they are used. The healthcare professional is responsible for providing wearing instructions and precautions to other healthcare professionals, care providers involved in the patient’s care, and the patient. If unusual swelling, skin discoloration or discomfort occurs, use should be discontinued and a healthcare professional consulted.
  • A therapy wrap with therapy unit should be used in a medical facility or clinical environment with direct healthcare provider supervision. If the prescribing healthcare practitioner determines it is appropriate for a patient to use the therapy wrap at home, the healthcare practitioner must provide the patient with adequate and appropriate instructions for use of the device. Further, the healthcare practitioner must monitor the patient’s use of the device to assure appropriate use of the device and appropriate application of cold therapy.
  • Cold therapy should not be used by patients with Raynaud’s Disease, poor peripheral circulation, diabetes, decreased skin sensitivity or hypersensitivity to cold.
  • Do not attempt to sterilize a non-sterilized wrap or re-sterilize a sterilized wrap by any means.
  • Do not use wraps near open flame.
  • Do not smoke while therapy wraps are in use.
  • Disposable therapy wraps are designed for single patient use only and may be used on the same patient for the length of the treatment.
  • Do not wrap the therapy wrap so tightly as to restrict blood or fluid flow. Do not use pins to secure the therapy wrap or hoses.
  • Do not allow the therapy wrap or hoses to contact sharp objects.
  • Dressings used under the therapy wrap should be applied lightly.
  • Wraps should not be left open (off of the patient) and inflated to a “balloon” or “ball” state for extended periods of time.
  • Prolonged exposure to cold has a potential to cause injury to tissue. Please consult your medical practitioner for therapy setting, duration and frequency of treatment.

 

Braces

ThermoTek’s BraceTek line provides physicians and patients with the total patient solution approach to lower extremity and spine stability. (Pictured 13" Knee ROM Brace)

 

 

 

Accessories

ThermoTek manufacturers a variety of accessory items exclusively for use with the VascuTherm therapy device.

  • Name
  • Part #
  • Power Supply, External, Med, 250W
  • 0P9PTXT36V
  • TekDocTM Interface Kit - VascuTherm 4
  • 0P9KTDVAS4
  • Umbilical, Therapy, Standard, 5 ft. (VT4)
  • 0P9AVT4UMB
  • Air Filter Assembly, Nano/Vascu (w/Hook and Loop)
  • 0P9PTDVTFA
  • Air Filter, Nano/Vascu (no Hook and Loop)
  • 0P2CDMARFT
  • Cord, PW 10A/125 VAC, Hospital Grade, 12 ft.
  • 0P3WHG13PC
  • Manual, Operating, VascuTherm 3, AI
  • 0P1DVAS3AT
  • TekDocTM Interface Kit - VascuTherm 3
  • 0P9KTDVAS3
  • TekDocTM Interface Kit - VascuTherm 2 / NanoTherm
  • 0P9KTDVASC