Healthcare Lumenis Agreement

HEALTHCARE LUMENIS AGREEMENT

Parties and Facility Information

Provider / Facility Name:

Clinician Performing Procedure:

Patient Information

Insurance Information

Medical History

Procedure and Device Information

Procedure / Treatment Description:

Device Manufacturer:

Intended Date of Treatment:

Risks, Benefits, and Alternatives

I acknowledge that the clinician has explained the nature and purpose of the procedure and that the procedure will utilize a Lumenis-branded energy-based medical device. I understand the anticipated benefits, possible risks, and potential complications, which may include but are not limited to: temporary or permanent changes in skin pigmentation, scarring, burns, infection, delayed healing, persistent pain or discomfort, allergic reaction to topical agents, and for procedures near the eye, vision changes or ocular injury. I acknowledge that not all risks can be anticipated.

Alternatives to the proposed treatment, including no treatment and alternative modalities, were explained. I have had the opportunity to ask questions regarding risks, benefits, and alternatives, and my questions have been answered to my satisfaction.

Acknowledgements and Authorizations

Voluntary Consent: I voluntarily consent to the performance of the procedure described above using the Lumenis device under the supervision of the clinician identified in this form. I understand that the device manufacturer is not the treating clinician and that the manufacturer does not practice medicine or provide clinical care.

Accuracy of Information: I certify that the medical history and all information provided on this form are complete and accurate to the best of my knowledge. I understand that failure to provide accurate information may increase the risk of complications.

Photographs and Records: I authorize the taking and use of clinical photographs and/or video for the purposes of treatment documentation, quality assurance, education, and record keeping. I understand that identifying information will be protected in accordance with applicable privacy laws.

HIPAA Authorization: I acknowledge receipt of the provider's privacy practices and hereby authorize the use and disclosure of my protected health information as necessary for treatment, payment, and healthcare operations, including communication with the device manufacturer for device-related safety reporting when required. This authorization expires:

Pregnancy and Reproductive Status: If applicable, I confirm that I am not pregnant and have informed the clinician if I could be pregnant. I understand that procedures using energy-based devices may present risk to an embryo or fetus.

Right to Withdraw: I understand that I may withdraw consent at any time prior to the procedure. If I withdraw consent during the procedure, I understand the clinician will determine whether it is safe to stop treatment immediately.

Device Malfunction and Manufacturer Interaction: I understand that in the unlikely event of a device malfunction the clinician will take appropriate steps. I authorize the clinician or facility to communicate device performance and safety information to the device manufacturer when necessary. I release the treating clinician and facility from liability for equipment malfunction except where caused by clinician gross negligence or willful misconduct.

Pre- and Post-Procedure Instructions

I acknowledge that I have received and understand the pre-procedure and post-procedure instructions, including wound care, activity restrictions, and medication guidance. I agree to follow the clinician's instructions and to attend any recommended follow-up appointments.

Certifications and Patient Statements

By signing below I certify that I have read and understand this Healthcare Lumenis Agreement, that the information I have provided is accurate, and that I give informed consent for the procedure described herein. I have had the opportunity to ask questions and understand those questions have been answered.

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