Harvest AdiPrep - Adipose Concentration System SL 164-1351

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Important Safety Information and Indications

This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have questions about Harvest products, ask your doctor. Only your doctor can determine if Harvest products are right for you.
Which patients or conditions will be most likely to respond to autologous, biologic-based products has not been characterized. Therefore, clinical success depends on several factors including diagnosis, the severity of condition being treated, patient age and co-morbidities. Consult with your doctor as there is limited information about the effectiveness of these treatments.

Important Safety Information And Indications

This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have questions about Harvest products, ask your doctor. Only your doctor can determine if Harvest products are right for you.
Patients or conditions that are most likely to respond to autologous, biologic-based products have not yet been characterized. Therefore, clinical success depends on several factors including diagnosis, the severity of condition being treated, patient age and comorbidities. Consult with your doctor as there is limited information about the effectiveness of these treatments.
These procedures require needle access (size, location and depth vary depending on the procedure). This may lead to apprehension, discomfort, pain, tenderness, bruising, bleeding, swelling, or infiltration at the access site. A vasovagal response, such as lightheadedness or fainting, nausea or vomiting, may occur. There is a small risk of infection at the access site.
The recommended technique for fat and bone marrow collection is considered to be minimally invasive because both the bone marrow and the fat graft are aspirated through a single needle into a syringe.
Clinical research shows that injections of these autografts are safe, with a minimal risk of adverse reactions or complications. Because the material is from your own body there is little concern of disease transmission, allergic reaction or tissue rejection.
There is always a small risk of infection at the injection site, but there is no evidence that the rate of infection is higher than that of any other routine shot or needle procedure you would receive at the doctor.
There may be redness and swelling at site of application at the site of application.
For Platelet-Rich-Plasma (APC) and concentrated bone marrow procedures, it is recommended that you discontinues NSAIDs like ibuprofen (Advil^®) and naproxen (Aleve^®) because these medicines can disrupt the healing process.
Before any medical procedure, tell your doctor about any prescription and nonprescription medicines you are taking or plan to take, including natural or herbal remedies.
Inform your doctor about all your medical conditions, including allergies.
Please consult your insurance company to verify coverage. Every payer has different guidelines for reimbursement, but generally platelet rich plasma procedures are not reimbursed. There is reimbursement for some of the expenses associated with concentrated bone marrow and concentrated adipose tissue procedures, but the physician or hospital must follow applicable coding and reimbursement guidelines from the payer. This means that some or all of the costs associated with the procedures using these autografts may need to be covered by the patient at the time of treatment.

Contraindications

The use of the SmartPrep system may be contraindicated if any of the following conditions occur:

There is clinical or laboratory evidence of blood infection.
The patient has taken aspirin or other medications that alter platelet function within 3 days prior to surgery.
The patient has a disorder associated with platelet dysfunction.

Warnings

Federal law (U.S.) restricts this device to sale by or on the order of a physician. The physician is solely responsible for the use of this device.
Safe and effective use of this device requires proper setup and operation by trained personnel.
This device should not be used in the presence of flammable agents.
Plasma, platelets and cell concentrate prepared with the SmartPrep system are not intended for transfusion.
For bone marrow aspirate concentrate (BMAC) processing, the safety and effectiveness of this device for in vivo indications for use has not been established.
Do Not Reuse/Not for Reuse: Terumo BCT products bearing the "Do Not Reuse" symbol are intended for single use only and are not intended to be reused or re‑sterilized in any manner. Terumo BCT cannot ensure the functionality or sterility of the product if it is reused or re‑sterilized. Reuse of a single‑use product could result in:
- Product performance issues due to a loss of product integrity, including but not limited to the following:
  - Fluid leaks
  - Parts that are warped or deformed
  - Plastics that are brittle and discolored
  - Filters that have reduced filtration capabilities
- Exposure to excessive ethylene oxide (EtO) residuals
- Viral infections such as hepatitis or human immunodeficiency virus (HIV)
- Bacterial infections
- Cross‑contamination
Any of these risks could result in serious injury or death. These risks are shared by product users, donors, patients and recipients of end products of the device
This system is intended for use by health care professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the SmartPrep system or shielding the area where it is located.
Follow your institution’s standard operating procedure (SOP) for wearing personal protective equipment when using the SmartPrep system.

Cautions

Each operator should be thoroughly familiar with the operating instructions for the SmartPrep system before using the device.
Health professionals responsible for blood collection must be trained in the practice of venipuncture and be aware of the inherent risks. Aseptic technique, proper skin preparation and continued protection of the venipuncture site are essential.
Bone marrow aspirate should be collected by or under the supervision of a qualified physician trained in this procedure.
All blood, bone marrow and adipose tissue components should be handled as infectious. To minimize the potential for exposure to bloodborne pathogens, observe universal precautions when handling blood and blood components.
Use aseptic technique throughout all procedures to ensure patient safety or product quality.
Heparin‐induced thrombocytopenia may occur in approximately 5% of patients receiving heparin therapy. This condition may cause hypercoagulability and may interfere with process results.
Separated blood, bone marrow and adipose tissue products should be used within four (4) hours of collection.

Indications

Harvest^® Bone Marrow Aspirate Concentrate (BMAC^®) Cellular System Indications For Use

The Harvest BMAC system is intended to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet-poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

Harvest^® Platelet Concentrate System Indications For Use

The Harvest platelet concentrate system is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (APC) from a small sample of blood at the patient’s point of care. The APC can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

Harvest^® SmartJet^®Liquid Applicator Indications For Use

The SmartJet applicator is designed to facilitate pre-mixing of allograft, autograft or synthetic bone graft materials for application to an orthopedic surgical site with IV fluids, autologous blood, plasma, APC or other specific blood component(s) as deemed necessary by the clinical use requirements.

The SmartJet applicator is intended for the application of fluids, as deemed necessary by the surgeon’s determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

Harvest^® Graft Delivery System Indications For Use

The graft delivery system is intended for the aspiration of bone marrow, autologous blood, plasma or other bodily fluids. The system is indicated for the delivery of autograft, allograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), IV fluids, blood, plasma, APC, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Harvest^® AdiPrep^® Adipose Concentration System Indications For Use

The Harvest AdiPrep system is used in medical procedures involving the harvest and transfer of autologous adipose tissue. The Harvest AdiPrep system concentrates adipose tissue that is harvested with a legally marketed lipoplasty system. The Harvest AdiPrep system is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired:

Neurosurgery
Gastrointestinal surgery
Urological surgery
Plastic and reconstructive surgery
General surgery
Orthopedic surgery
Gynecological surgery
Thoracic surgery
Laparoscopic surgery
Arthroscopic surgery