Medical Disclaimer

Last Updated: [INSERT TODAY'S DATE]

CRITICAL: READ THIS BEFORE USING BAZU

This Medical Disclaimer applies to all users of the Bazu mobile application and services (the "Service") provided by Bazu Technologies, LLC ("Bazu," "we," "us," or "our").

BY USING BAZU, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD, AND AGREE TO THIS MEDICAL DISCLAIMER.

1. NOT A MEDICAL DEVICE

1.1 General Wellness Tool

BAZU IS A GENERAL WELLNESS APPLICATION, NOT A MEDICAL DEVICE.

Bazu is designed to help you:

  • Track your meals and nutrition
  • Log your glucose readings manually
  • Monitor your diabetes-related activities
  • Stay motivated through gamification and rewards

Bazu is NOT:

  • A medical device as defined by the FDA or any regulatory authority
  • A diagnostic tool
  • A treatment recommendation system
  • A clinical decision support tool
  • A substitute for medical devices, equipment, or professional healthcare

1.2 FDA Status

Bazu has not been evaluated, cleared, or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Bazu is not intended to be used as a medical device and does not require FDA clearance under current regulations.

1.3 No Device Integration

Bazu does NOT:

  • Connect to continuous glucose monitors (CGMs)
  • Read data from insulin pumps
  • Interface with any medical devices
  • Receive data from health monitoring equipment
  • Control or influence any medical devices

All data in Bazu is manually entered by you, the user.

2. NOT MEDICAL ADVICE

2.1 Information Only

BAZU DOES NOT PROVIDE MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT.

The Service provides:

  • Tools to help you track your health information
  • General educational information about nutrition and diabetes management
  • Motivational features to encourage healthy habits

The Service does NOT provide:

  • Medical opinions or recommendations
  • Diagnosis of any medical condition
  • Treatment plans or protocols
  • Medical advice tailored to your specific health situation
  • Clinical guidance on medication or insulin dosing

2.2 Not a Substitute for Professional Care

BAZU IS NOT A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT.

You should:

  • ALWAYS consult with your physician or qualified healthcare provider before making any medical decisions
  • NEVER disregard professional medical advice or delay seeking it because of information from Bazu
  • NEVER rely solely on Bazu for managing your diabetes or any medical condition
  • ALWAYS seek immediate medical attention in case of emergency

2.3 Healthcare Provider Relationship

Use of Bazu does NOT create a doctor-patient, therapist-patient, or any healthcare provider-patient relationship between you and Bazu Technologies, LLC, its employees, or contractors.

3. USER RESPONSIBILITY FOR DATA ACCURACY

3.1 Manual Data Entry

YOU ARE SOLELY RESPONSIBLE FOR THE ACCURACY OF ALL DATA YOU ENTER INTO BAZU.

Bazu relies entirely on information that you manually input, including:

  • Glucose readings
  • Insulin doses and timing
  • Meal information and nutritional data
  • Weight, height, and other health metrics
  • Health goals and preferences

3.2 No Validation

Bazu does NOT:

  • Verify the accuracy of your data entries
  • Validate glucose readings against medical standards
  • Check if your insulin doses are appropriate
  • Confirm that your nutritional data is correct
  • Assess whether your health data is medically reasonable

3.3 Your Obligations

You are responsible for:

  • Entering accurate and complete information
  • Double-checking all data you enter
  • Verifying nutritional information from reliable sources
  • Using your own judgment and medical guidance when interpreting your data
  • Consulting healthcare professionals about your health data

BAZU ASSUMES NO RESPONSIBILITY FOR ERRORS IN USER-ENTERED DATA.

4. NO INSULIN DOSING CALCULATIONS

4.1 No Dose Recommendations

BAZU DOES NOT CALCULATE, RECOMMEND, OR SUGGEST INSULIN DOSES.

Bazu allows you to record insulin doses that you have already taken, but:

  • We do NOT calculate what dose you should take
  • We do NOT provide dosing algorithms or formulas
  • We do NOT analyze your glucose data to suggest insulin adjustments
  • We do NOT provide insulin-to-carb ratios or correction factors

4.2 Consult Healthcare Team

ALL INSULIN DOSING DECISIONS MUST BE MADE IN CONSULTATION WITH YOUR HEALTHCARE TEAM.

Never adjust your insulin doses based on:

  • Patterns you see in Bazu
  • Trends displayed in the app
  • Achievements or rewards
  • Any information provided by Bazu

4.3 Medical Emergency

If you experience symptoms of hypoglycemia, hyperglycemia, or any medical emergency:

  • SEEK IMMEDIATE MEDICAL ATTENTION
  • Do NOT rely on Bazu
  • Follow your healthcare provider's emergency protocols
  • Call 911 or your local emergency number if needed

5. NUTRITIONAL INFORMATION DISCLAIMER

5.1 Nutritional Information Sources and Accuracy

Nutritional information in Bazu comes from multiple sources with varying levels of accuracy:

Source Priority (Most to Least Accurate):

  • Verified Food Databases: Edamam Food Database, internal verified database
    • Most accurate and reliable
    • Based on USDA data and verified sources
    • Used when exact food matches are found
  • AI Estimates: OpenAI analysis
    • Used when database matches not available
    • Based on pattern recognition and general nutritional knowledge
    • Subject to error and should be verified
  • User Manual Entry: Information you provide
    • Accuracy depends entirely on your data entry
    • We cannot verify user-entered data

Important Disclaimers:

  • All nutritional information is for informational purposes only
  • Information is subject to variation and error
  • Cooking methods, brands, and preparation affect nutrition
  • Portion sizes significantly impact nutritional values
  • Always verify critical nutritional information with reliable sources

Glycemic Index (GI) Values:

  • GI values from Sydney University Glycemic Index Database when available
  • AI-estimated GI values when database data unavailable
  • GI values are estimates and vary based on individual response, preparation, and other factors
  • Never use GI estimates alone for medical decisions

5.2 No Nutritional Advice

Bazu does NOT:

  • Provide personalized nutritional advice
  • Create meal plans tailored to your medical needs
  • Recommend specific foods for diabetes management
  • Advise on carbohydrate counting or meal timing

5.3 Consult Nutrition Professionals

For personalized nutritional guidance:

  • Consult with a registered dietitian (RD) or certified diabetes educator (CDE)
  • Work with your healthcare team to develop a meal plan
  • Do not rely solely on Bazu's nutritional information

5.4 AI-Powered Nutritional Analysis

Bazu uses artificial intelligence (AI) to analyze meals you enter through text descriptions or photos:

What AI Does:

  • Analyzes meal photos to identify food items visually
  • Processes text descriptions of meals (e.g., "grilled chicken with rice")
  • Estimates portion sizes from descriptions or visual analysis
  • Provides nutritional estimates when database data is unavailable
  • Estimates glycemic index values

AI Limitations:

  • AI estimates may not be 100% accurate
  • AI cannot account for cooking methods, ingredients, or preparation details
  • Text descriptions may be incomplete or ambiguous
  • Visual appearance in photos can be deceiving
  • AI estimates should be verified with reliable sources or your healthcare team

How Meal Entry Works:

  • Text Entry: You type what you ate (e.g., "1 cup pasta with tomato sauce") → AI processes text
  • Photo Entry: You take a picture of your meal → AI analyzes the image
  • Barcode Scan: You scan a barcode → Database lookup (Edamam)
  • Previous Meals: You select from meals you've logged before → Uses saved data

Data Sources for Nutritional Information:

  • Verified food databases (Edamam, internal database) - Most accurate
  • AI estimates (OpenAI from text or photos) - When database data unavailable
  • User manual entry - User is responsible for accuracy

Always prioritize verified database information over AI estimates when available.

6. GLUCOSE MONITORING DISCLAIMER

6.1 Not a Glucose Monitor

BAZU IS NOT A GLUCOSE MONITORING DEVICE.

Bazu:

  • Does NOT measure your blood glucose
  • Does NOT connect to glucose meters or CGMs
  • Only displays glucose readings that YOU manually enter
  • Cannot verify the accuracy of your glucose readings

6.2 Use Approved Devices

For glucose monitoring, you must use:

  • FDA-cleared blood glucose meters
  • FDA-cleared continuous glucose monitors (CGMs)
  • Other medical devices approved by regulatory authorities

Never rely on Bazu as your primary glucose monitoring tool.

6.3 Critical Glucose Readings

If you experience dangerously high or low glucose readings:

  • Take immediate action per your healthcare provider's instructions
  • Do NOT wait to see patterns in Bazu
  • Treat hypoglycemia immediately
  • Seek medical attention for severe hyperglycemia

6.4 Meal Entry and AI Analysis

Bazu allows you to log meals through multiple methods, with AI assistance for analysis:

Meal Entry Methods:

  • Text Description:
    • Type what you ate (e.g., "chicken breast with broccoli and brown rice")
    • AI processes your text to identify foods and estimate portions
    • AI cannot detect details you don't mention (oils, seasonings, exact portions)
  • Photo Capture:
    • Take a picture of your meal
    • AI analyzes the image to identify food items visually
    • AI estimates portion sizes from visual appearance
  • Barcode Scan:
    • Scan packaged food barcodes
    • Retrieves data from verified food database (Edamam)
  • Previous Meals:
    • Select from meals you've logged before
    • Uses previously entered/verified data

AI Analysis Limitations (Text & Photos):

For Text Descriptions:

  • AI may misinterpret ambiguous descriptions
  • AI cannot detect ingredients you don't mention
  • AI cannot know exact portion sizes without specific measurements
  • Cooking methods affect nutrition but may not be specified

For Photos:

  • AI may misidentify foods based on visual appearance
  • AI cannot detect ingredients not visible in photos (oils, seasonings, hidden ingredients)
  • AI cannot accurately determine portion sizes from photos alone
  • Lighting, angle, and photo quality affect AI accuracy
  • Similar-looking foods may be confused (e.g., white rice vs. cauliflower rice)

Your Responsibility:

  • Review and correct AI food identifications (whether from text or photos)
  • Manually adjust portion sizes if AI estimates seem inaccurate
  • Add hidden ingredients or details not captured by AI
  • Verify nutritional information before using it for health decisions

Never rely solely on AI analysis (text or photo) for:

  • Carbohydrate counting for insulin dosing
  • Calorie counting for weight management
  • Dietary restrictions or food allergies
  • Medical nutrition therapy

7. ACCURACY AND RELIABILITY

7.1 No Guarantees

WE MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS, OR TIMELINESS OF ANY INFORMATION PROVIDED BY BAZU.

This includes:

  • Nutritional data
  • Glycemic index values
  • Educational content
  • Calculations or analytics
  • Trends or patterns displayed

7.2 Potential Errors

Bazu may contain:

  • Inaccuracies in nutritional databases
  • Errors in calculations or data display
  • Bugs or technical issues
  • Outdated information

7.3 Use at Your Own Risk

YOU USE BAZU AT YOUR OWN RISK. You acknowledge that:

  • Errors in data could affect your health decisions
  • Technical issues may cause data loss
  • Information in Bazu should be verified with reliable sources

8. NO DIAGNOSIS OR DISEASE DETECTION

8.1 Not Diagnostic

BAZU DOES NOT DIAGNOSE ANY DISEASE OR MEDICAL CONDITION.

Bazu does NOT:

  • Diagnose diabetes or pre-diabetes
  • Detect diabetic complications
  • Identify patterns indicating disease progression
  • Alert you to medical problems
  • Screen for health conditions

8.2 Symptoms and Warning Signs

If you experience concerning symptoms:

  • Consult your healthcare provider immediately
  • Do not rely on Bazu to detect medical problems
  • Do not use Bazu to self-diagnose

8.3 Professional Diagnosis Required

Only qualified healthcare professionals can:

  • Diagnose medical conditions
  • Interpret medical test results
  • Assess your overall health status
  • Determine appropriate treatment

9. THIRD-PARTY CONTENT AND SERVICES

9.1 Nutritional Data Providers

Bazu uses third-party services to provide nutritional information:

OpenAI (AI Analysis):

  • Processes meal descriptions (text you type) to identify foods
  • Processes meal photos (images you capture) to identify foods visually
  • Estimates portion sizes and nutritional values from text or images
  • Provides glycemic index estimates
  • Does NOT receive your glucose readings, insulin doses, or other health data
  • Only receives the specific meal information you submit (text descriptions or photos)

Edamam (Food Database):

  • Provides verified nutritional information from food databases
  • Processes food names and barcode scans
  • Does NOT receive your glucose readings, insulin doses, or other health data
  • Only receives food search queries and barcode data

Important: These third-party providers do NOT have access to your complete health profile, glucose data, insulin doses, or medical information. They only receive the specific meal information (text or photos) you choose to submit for analysis.

9.2 External Information

Bazu may provide links to third-party websites or educational resources. This information:

  • Is NOT vetted or endorsed by Bazu
  • May be inaccurate, outdated, or misleading
  • Should be evaluated by your healthcare provider

9.3 No Responsibility

We are NOT responsible for:

  • Third-party medical advice
  • Information on external websites
  • Content accuracy from other sources
  • Actions of third-party service providers

10. EMERGENCY SITUATIONS

10.1 Do Not Use for Emergencies

BAZU IS NOT DESIGNED FOR EMERGENCY USE.

In case of medical emergency:

  • CALL 911 (or your local emergency number) IMMEDIATELY
  • Do NOT wait to log data in Bazu
  • Do NOT use Bazu to decide if you need emergency care
  • Follow your emergency action plan

10.2 Recognized Emergencies

Seek immediate medical attention for:

Hypoglycemia (Low Blood Sugar) Emergencies:

  • Blood sugar below 54 mg/dL (3.0 mmol/L)
  • Severe confusion or inability to think clearly
  • Loss of consciousness or seizures
  • Inability to swallow or drink safely
  • No improvement after treating low blood sugar

Hyperglycemia (High Blood Sugar) Emergencies:

  • Blood sugar persistently above 250 mg/dL (13.9 mmol/L) with ketones
  • Signs of diabetic ketoacidosis (DKA): fruity breath, rapid breathing, nausea, vomiting
  • Severe dehydration
  • Altered mental status

Other Medical Emergencies:

  • Chest pain or difficulty breathing
  • Severe abdominal pain
  • Signs of stroke (facial drooping, arm weakness, speech difficulties)
  • Severe allergic reactions
  • Any other medical emergency

EVERY SECOND COUNTS IN AN EMERGENCY. DO NOT DELAY SEEKING HELP.

DO NOT:

  • Open Bazu to log data during an emergency
  • Waste time documenting your emergency
  • Delay calling 911 to check your app
  • Use Bazu to decide if you need emergency care

11. INDIVIDUAL VARIATION

11.1 Personalized Medicine

Every person with diabetes is different. Factors affecting your health include:

  • Type of diabetes (Type 1, Type 2, gestational, etc.)
  • Duration of diabetes
  • Medications and insulin regimen
  • Other health conditions
  • Age, weight, activity level
  • Stress, illness, and other factors

11.2 Not One-Size-Fits-All

What works for one person may not work for you.

Do NOT:

  • Compare your data to other users
  • Assume patterns that work for others will work for you
  • Make medical decisions based on general trends

11.3 Personalized Care

Work with your healthcare team to develop a personalized diabetes management plan that considers your unique needs and circumstances.

12. LIMITATIONS OF LIABILITY

12.1 Health Outcomes

BAZU TECHNOLOGIES, LLC IS NOT LIABLE FOR ANY HEALTH OUTCOMES, MEDICAL COMPLICATIONS, INJURIES, OR DAMAGES ARISING FROM YOUR USE OF BAZU.

This includes but is not limited to:

  • Hypoglycemia or hyperglycemia events
  • Diabetic complications
  • Incorrect insulin dosing
  • Poor medical decisions
  • Reliance on inaccurate data
  • Failure to seek appropriate medical care
  • Any other health-related issues

12.2 Maximum Liability

As stated in our Terms of Service, our maximum liability to you is limited to the greater of:

  • $100 USD, or
  • The amount you paid us in the preceding 12 months

12.3 No Medical Malpractice

Because Bazu does not provide medical services or advice, claims of medical malpractice or negligence do not apply.

13. ASSUMPTION OF RISK

13.1 Your Acknowledgment

By using Bazu, you acknowledge and agree that:

  • You understand Bazu is not a medical device or medical service
  • You will NOT rely on Bazu for medical advice, diagnosis, or treatment
  • You will consult healthcare professionals for all medical decisions
  • You accept full responsibility for your health decisions
  • You assume all risks associated with using Bazu
  • You understand that errors in data entry or app functionality could affect your health
  • You agree that Bazu is a tool to complement, not replace, professional medical care

13.2 Informed Consent

You have read and understood this Medical Disclaimer and freely consent to use Bazu with full knowledge of its limitations and risks.

14. CHANGES TO THIS DISCLAIMER

We may update this Medical Disclaimer from time to time. When we do:

  • We will update the "Last Updated" date
  • We will notify you of material changes
  • Continued use constitutes acceptance of the updated disclaimer

We encourage you to review this disclaimer regularly.

15. INTERNATIONAL USERS

15.1 Regulatory Status

Bazu's regulatory status may vary by country. This disclaimer reflects:

  • U.S. FDA regulations and guidance
  • General wellness app classification
  • Non-medical device status

15.2 Local Regulations

If you use Bazu outside the United States:

  • Check your local regulations regarding health apps
  • Ensure Bazu's use complies with your country's laws
  • Understand that this disclaimer is based on U.S. law

16. QUESTIONS OR CONCERNS

If you have questions about this Medical Disclaimer or concerns about using Bazu:

For Medical Questions: Consult your healthcare provider

For App Questions: Email: support@withbazu.com

Website: https://withbazu.com

For Legal Questions: Email: legal@withbazu.com

FINAL ACKNOWLEDGMENT

BY CLICKING "I AGREE" OR BY USING BAZU, YOU ACKNOWLEDGE THAT:

  • ✓ You have read and fully understand this Medical Disclaimer
  • ✓ You understand Bazu is NOT a medical device
  • ✓ You understand Bazu does NOT provide medical advice
  • ✓ You will consult healthcare professionals for medical decisions
  • ✓ You accept full responsibility for your health decisions
  • ✓ You use Bazu entirely at your own risk
  • ✓ You will NOT hold Bazu Technologies, LLC liable for health outcomes

IF YOU DO NOT AGREE TO THESE TERMS, DO NOT USE BAZU.

© 2025 Bazu Technologies, LLC. All rights reserved.

APPENDIX: FDA GUIDANCE REFERENCE

For reference, Bazu's classification as a non-medical device is based on FDA guidance:

Primary Guidance:

  • "Policy for Device Software Functions and Mobile Medical Applications" (September 2022)
  • FDA Guidance Document

Bazu Classification:

Bazu falls under the category of "general wellness" software functions that:

  • ✓ Help users maintain or encourage a healthy lifestyle
  • ✓ Relate to general health, wellness, or chronic disease management
  • ✓ Do NOT connect to or control medical devices
  • ✓ Do NOT provide diagnostic capabilities
  • ✓ Do NOT calculate or recommend drug dosages
  • ✓ Rely on user-generated data entry

Key Distinction:

Bazu is NOT considered a "mobile medical application" under FDA regulations because it:

  • Does NOT interface with regulated medical devices (CGMs, insulin pumps)
  • Does NOT analyze medical device data
  • Does NOT provide treatment or diagnostic recommendations
  • Does NOT perform clinical decision support functions
  • Relies entirely on manual user data entry

Important Notes:

  • This guidance is subject to change
  • Regulatory classifications may evolve over time
  • Users should consult current FDA guidance if concerned about regulatory status

For More Information:

Visit: https://www.fda.gov/medical-devices/digital-health-center-excellence