Liability Waiver and Informed Consent Agreement
SoRay Hyperbarics LLC
(A California Limited Liability Company)
RECITALS
WHEREAS, SoRay Hyperbarics LLC, a California limited liability company, having its principal place of business at 1101 S. Winchester Blvd., Suite L-239, San Jose, CA 95128 (the "Company"), offers clients access to wellness-based hyperbaric oxygen therapy ("HBOT") services utilizing a soft-sided hyperbaric chamber operating at approximately 1.3 to 1.4 atmospheres absolute, subject to manufacturer tolerances ("Chamber");
WHEREAS, the Company requires each client to execute this Liability Waiver and Informed Consent Agreement (this "Agreement") as a condition precedent to participation in any HBOT session;
WHEREAS, the purpose of this Agreement is to ensure that each client fully understands, acknowledges, assumes, and accepts the risks associated with HBOT, affirms that he or she does not suffer from any listed contraindications, consents to treatment with full knowledge of potential risks, and releases the Company and its representatives from liability for ordinary negligence consistent with applicable California law;
WHEREAS, the Company expressly disclaims making any medical diagnosis, prognosis, prescription, or claim of cure, and represents that its services are limited to wellness purposes and not for medical treatment or substitution for licensed physician care;
NOW, THEREFORE, in consideration of the mutual covenants contained herein and as a condition of receiving HBOT services, the undersigned client (the "Client") hereby enters into this Agreement with the Company.
ARTICLE I – DEFINITIONS
Section 1.1 "Agreement" - This Liability Waiver and Informed Consent Agreement, including all Recitals and Exhibits attached hereto.
Section 1.2 "Chamber" - The soft-sided hyperbaric chamber operated by the Company with operating pressure typically between 1.3 to 1.4 ATA subject to manufacturer tolerances, and any associated equipment.
Section 1.3 "Client" - The undersigned individual seeking HBOT services from the Company who is 18 years of age or older. Company does not provide services to minors.
Section 1.4 "Company" - SoRay Hyperbarics LLC, a California limited liability company, including its owners, officers, directors, members, managers, employees, contractors, and representatives.
Section 1.5 "HBOT" - Hyperbaric oxygen therapy, defined as the breathing of oxygen-enriched air delivered via concentrator(s) within a pressurized Chamber for wellness and non-medical purposes only.
Section 1.6 "Contraindications" - The absolute medical conditions, relative medical conditions, and medication restrictions listed in Exhibit A hereto.
Section 1.7 "Services" - All activities provided by the Company relating to HBOT, including intake consultations, safety briefings, use of the Chamber, monitoring of sessions, emergency procedures, and any incidental services.
Section 1.8 "Session" - A discrete period of time, typically ninety (90) minutes, during which the Client is placed inside the Chamber and HBOT is administered in accordance with Company protocols.
ARTICLE II – ACKNOWLEDGMENT OF SPECIFIC RISKS
The Client acknowledges the following specific risks by initialing each category: Section 2.1 BAROTRAUMA RISKS _____ (Client Initials)
Ear barotrauma and inability to equalize ear pressure
Sinus squeeze and facial pressure complications
Potential for ear pain, hearing changes, or tympanic membrane rupture
Section 2.2 OXYGEN-RELATED RISKS _____ (Client Initials)
Oxygen toxicity from prolonged exposure
Visual disturbances and temporary vision changes
Respiratory complications in susceptible individuals
Section 2.3 PANIC AND CLAUSTROPHOBIA RISKS _____ (Client Initials)
Confinement anxiety and panic attacks
Psychological distress from enclosed space
Need for emergency decompression and exit
Section 2.4 FIRE AND SAFETY RISKS _____ (Client Initials)
Fire hazards from oxygen-enriched environment
Static electricity and flammable materials dangers
Risks from prohibited items entering the Chamber
Section 2.5 EQUIPMENT AND OPERATIONAL RISKS _____ (Client Initials)
Chamber malfunction, valve failure, or zipper problems
Compressor noise and mechanical complications
Entrapment or difficulty exiting the Chamber
Section 2.6 GENERAL PHYSICAL RISKS _____ (Client Initials)
Dizziness, nausea, fatigue, or disorientation
Complications from undisclosed medical conditions
Interaction with medications or supplements
ARTICLE III – ASSUMPTION OF RISK
Section 3.1 Voluntary Participation _____ (Client Initials) The Client affirms that participationin HBOT is entirely voluntary.
Section 3.2 Acknowledgment of All Risks _____ (Client Initials) The Client acknowledges and assumes all risks associated with HBOT, both known and unknown, including all risks described in Article II and Exhibit A.
Section 3.3 Assumption of Full Responsibility _____ (Client Initials) The Client assumes all risks of injury, illness, property damage, or death arising from participation in HBOT, except for risks arising from the Company's gross negligence, willful misconduct, fraud, or violation of law.
⚠ ARTICLE IV – RELEASE AND WAIVER OF LIABILITY ⚠
RELEASE OF LIABILITY FOR ORDINARY NEGLIGENCE — READ CAREFULLY
By initialing here _____, I RELEASE the Company from liability for ordinary negligence arising from my participation in HBOT, including use of the Chamber and related equipment.
THIS RELEASE DOES NOT APPLY TO:
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT
FRAUD OR INTENTIONAL MISREPRESENTATION
VIOLATIONS OF LAW OR STATUTORY DUTIES
LIABILITY THAT CANNOT BE WAIVED UNDER CALIFORNIA LAW
This provision is intended to be interpreted to the fullest extent permitted under California law. Client Signature for Release: _________________________________ Date: __________
Section 4.2 Scope of Release This release covers claims for personal injury, property damage, emotional distress, and economic losses arising from ordinary negligence in the provision of Services, except as specifically excluded above.
Section 4.3 Binding Effect This release is binding on Client's heirs, successors, and assigns, but only to the extent permitted by California law.
ARTICLE V – INFORMED CONSENT FOR HBOT
Section 5.1 Nature of Wellness Services _____ (Client Initials) Client understands that HBOT services are provided solely for wellness purposes and are not medical treatment. The FDA has not approved soft-sided hyperbaric chambers for medical treatment of any condition.
Section 5.2 No Medical Claims _____ (Client Initials) Company makes no medical claims regarding HBOT effectiveness and expressly disclaims any representation that HBOT will cure, treat, or diagnose any medical condition.
Section 5.3 Staff Limitations _____ (Client Initials) Client acknowledges that Company staff are not authorized to provide medical advice.
Section 5.4 Voluntary Informed Consent _____ (Client Initials) Client voluntarily consents to HBOT with full understanding of the risks, benefits, and limitations described in this Agreement.
ARTICLE VI – REPRESENTATIONS AND WARRANTIES OF CLIENT
Section 6.1 Truthful Health Disclosure _____ (Client Initials) Client represents that all medical and health information provided is true, complete, and accurate. Material misrepresentation voids the protection of this release.
Section 6.2 Medical Screening Compliance Client agrees to complete Company's Medical Screening Questionnaire before the first Session and to promptly update disclosures if health status changes.
Section 6.3 Physician Clearance Requirement If any Relative Contraindication or Medication Restriction in Exhibit A applies, Client must provide written physician clearance before any Session. Company may refuse service absent such clearance.
Section 6.4 Emergency Contact Requirement Client shall provide current emergency contact information including name, phone number, and relationship.
ARTICLE VII – CONTRAINDICATIONS AND PHYSICIAN CLEARANCE REQUIREMENTS
Section 7.1 Absolute Contraindications Client affirms they do not suffer from any Absolute Contraindications listed in Exhibit A. Presence of any Absolute Contraindication prohibits participation in HBOT.
Section 7.2 Relative Contraindications For any Relative Contraindication listed in Exhibit A, Client must obtain written physician clearance before participating in HBOT.
Section 7.3 Medication Restrictions Client affirms they are not taking any medications listed as restrictions in Exhibit A, or has obtained physician clearance for such medications.
Section 7.4 Ongoing Disclosure Duty Client agrees to immediately notify Company of any changes in health status or medications.
ARTICLE VIII – EMERGENCY PROCEDURES AND SAFETY PROTOCOLS
Section 8.1 Client Safety Obligations Client agrees to follow all safety instructions, use the communication system as directed, and immediately report any discomfort or concerns during Sessions.
Section 8.2 Emergency Treatment Consent _____ (Client Initials) Client authorizes Company personnel to summon EMS, provide basic first aid, and facilitate transport to a medical facility if necessary. Client is responsible for all related costs.
Section 8.3 Session Termination Authority Company may refuse or terminate a Session if Client provides inconsistent disclosures, fails to follow safety instructions, or if the Session presents a safety risk.
Section 8.4 Safety Protocol Compliance Company will operate the Chamber in accordance with manufacturer specifications and maintain daily pre-session checklists and equipment maintenance logs.
Section 8.5 Staff Qualifications Supervising staff will maintain current CPR and First Aid certification and complete HBOT safety training.
ARTICLE IX – LIMITATION OF LIABILITY AND DAMAGES
Section 9.1 Aggregate Liability Cap Except for liability arising from gross negligence, willful misconduct, fraud, or violations of law, the aggregate liability of Company for all claims shall not exceed the total fees paid by Client to Company in the 12 months preceding the event.
Section 9.2 Exclusion of Consequential Damages Company shall not be liable for indirect, special, consequential, or punitive damages, including lost wages, business interruption, or emotional distress damages beyond those directly caused by physical injury.
ARTICLE X – MISCELLANEOUS PROVISIONS
Section 10.1 Privacy and Information Use Client health and personal information will be used only for screening, safety, and emergency response purposes; retained for seven (7) years; not sold or shared with third parties; and protected by reasonable security measures.
Section 10.2 Governing Law This Agreement is governed by California law, with venue in Santa Clara County Superior Court.
Section 10.3 Severability If any provision is held invalid or unenforceable, the remaining provisions shall remain in full force and effect.
Section 10.4 Entire Agreement This Agreement supersedes all prior agreements and may be modified only by written instrument signed by both parties.
ARTICLE XI – EXECUTION
Section 11.1 Acknowledgment of Understanding Client acknowledges that they have carefully
read this Agreement, understand its terms, and voluntarily agree to be bound by all provisions.
CLIENT SIGNATURE
Client Name: ___________________________________
Signature: ____________________________________
Date: _______________________________________
Emergency Contact Information (Required):
Name: _________________ Relationship: _________ Phone: ________________ COMPANY SIGNATURE
SoRay Hyperbarics LLC
By: _________________________________________
Name: Sorena Linton
Title: Owner-Manager
Date: _______________________________________
EXHIBIT A – MEDICAL CONTRAINDICATIONS AND MEDICATION RESTRICTIONS
ABSOLUTE CONTRAINDICATIONS
(No HBOT permitted under any circumstances)
• Untreated pneumothorax (collapsed lung)
Severe COPD/emphysema with air trapping
Congenital spherocytosis (hereditary blood disorder)
Severe heart conditions or pacemaker malfunction
Recent thoracic surgery with unresolved complications
RELATIVE CONTRAINDICATIONS
(Require written physician clearance before HBOT)
Uncontrolled hypertension (blood pressure >160/100)
Diabetes mellitus with glucose >300 mg/dL or <100 mg/dL
Congestive heart failure with ejection fraction <35%
History of claustrophobia or severe confinement anxiety
Current upper respiratory infection, cold, or sinus congestion
Recent eye, retinal, or cataract surgery (within 3 months)
History of seizures or epilepsy
Active cancer treatment or untreated malignancy
Obstructive lung disease or severe asthma
Fever >100°F (37.8°C)
Pregnancy (any trimester)
Recent ear surgery or chronic ear problems
MEDICATION RESTRICTIONS
(Require physician clearance or discontinuation)
Bleomycin (cancer chemotherapy agent)
Disulfiram (Antabuse®) (alcohol deterrent)
Doxorubicin (Adriamycin®) (minimum 72 hours from last dose)
Mafenide Acetate (Sulfamylon®) (topical antibiotic)
OPERATIONAL RESTRICTIONS
(Chamber use policies)
No contact lenses worn inside the Chamber
No petroleum-based products on skin or hair
No electronic devices, batteries, or power banks
No lighters, matches, or smoking/vaping materials
No aerosol products or flammable substances
No jewelry that cannot be removed