Baird Medical

Important Safety Information

Safety Information

Last updated: September 7, 2026

This page summarizes indications, contraindications, warnings, and precautions for the Microwave Ablation System (BD-GT) and the Disposable Microwave Ablation Needle. It does not replace the Instructions for Use.

Devices covered

Microwave Ablation System (BD-GT), FDA 510(k) K232240, Class II.

Disposable Microwave Ablation Needle, FDA 510(k) K232241, Class II. Used with the Microwave Ablation System (BD-GT).

Manufactured by Betters (Suzhou) Medical Co., Ltd.

U.S. sales and support by Baird Medical LLC.

Indications for use

The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.

The Disposable Microwave Ablation Needle is used with the Microwave Ablation System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Ablation Needle is not intended for cardiac use.

Contraindications and treatment precautions

  • Contraindicated in patients with massive bleeding tendency.
  • Microwave therapy is not recommended for pregnant women.
  • Use caution in patients with severe coagulation dysfunction.
  • Patients with severe or acute cardiovascular or cerebrovascular disease, pulmonary dysfunction, or acute or active infectious lesions at any site should be treated only after the condition is stable or the infection is controlled.
  • In patients with diabetes, treatment should be managed under the guidance of a clinician familiar with the characteristics of microwave energy.

Warnings and precautions

The following is a summary of clinically relevant warnings and precautions. Installation, service, and maintenance requirements are addressed in the Instructions for Use.

Patient screening and preparation

  • Before microwave therapy, exercise caution regarding any conductor or conductive material in close proximity to the patient.
  • Metal jewelry, and clothing with metal objects such as buttons, clips, wires, or zippers, must be removed before microwave treatment can proceed.
  • Patients with metallic implants such as intramedullary pins, pacemakers, or cardiac electrodes must report them, and treatment proceeds under the plan of the primary surgeon. Hearing aids should be removed.
  • Do not use in patients with electronic implants such as cardiac pacemakers without first consulting a qualified professional, for example a cardiologist. Interference with the implant, or damage to the implant, may occur.
  • Warn patients with reduced thermal sensation at the treatment site, and maintain communication with the patient throughout treatment.

Procedural use

  • The ablation needle must be inserted into soft tissue before microwave output is started.
  • Do not activate the needle in a no-load state, or when it is not in contact with target tissue.
  • Keep the needle within the lesion area throughout energy delivery to avoid microwave leakage.
  • Position the needle so as to minimize microwave exposure of non-target tissue.
  • Keep sensitive organs, including the eyes and testes, outside the treatment field.
  • Use the lowest microwave output power that achieves the treatment objective.
  • Avoid repeated torsion or radial movement of the needle, which may cause the needle tip to separate.

Device handling

  • The ablation needle is sterile, single use, and ethylene-oxide sterilized. Check the sterilization indicator before use and use within the stated shelf life. Do not use if the packaging is damaged.
  • Do not reuse the ablation needle, and do not immerse it in liquid.
  • The ablation needle has a sharp tip. Handle it correctly to avoid injury.
  • Inspect instruments and cables for damage before each use, including the insulation. Visual inspection alone may not be sufficient to confirm that insulation is intact.
  • Use only the products, instruments, and accessories supplied by the manufacturer.
  • No modification of this device is permitted.
  • The device is intended for use only by healthcare professionals.

Use environment

  • Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen, or in close proximity to volatile solvents such as ether or alcohol. Explosion may occur.
  • Do not place instruments near or in contact with flammable materials such as gauze or surgical drapes. Instruments that are activated, or hot from use, may cause a fire.
  • When not in use, place instruments in a clean, dry, clearly visible area, not in contact with the patient. Inadvertent contact may result in burns.
  • Keep high-power equipment such as motors at least one meter from the system during normal use, to avoid electromagnetic interference.

Prescription use only

Rx only. Federal (USA) law restricts this device to sale by or on the order of a physician. These devices are intended for use only by healthcare professionals trained in image-guided ablation procedures.

Refer to the Instructions for Use

This page is a summary and is not a substitute for approved labeling. Prescribers should refer to the Microwave Ablation System Instructions Manual and the Disposable Microwave Ablation Needle Instructions Manual for the complete indications, contraindications, warnings, precautions, operating parameters, and other important product information.

To request the Instructions for Use or product documentation, please contact Baird Medical.

Product availability

Product availability, indications, and clearance status vary by market. The information on this page reflects United States clearance and labeling. Refer to current local labeling and regulatory status outside the United States.

Summarized from the Microwave Ablation System Instructions Manual and the Disposable Microwave Ablation Needle Instructions Manual.