1. Parties
These Terms of Use ("Terms") constitute a legally binding agreement
between you ("User") and Focus Vision Pty Ltd (ABN 17 668 265 281),
Dr David Gunn, and Dr Brendan Cronin (collectively "Focus Vision",
"we", "us", or "our"), the developers of the Focus Vision Refractive
Outcomes Analyzer ("the Software").
2. Nature and Purpose of the Software
The Software is a browser-based analytical tool designed to assist
ophthalmic surgeons and healthcare professionals in reviewing
postoperative refractive outcomes data and performing lens constant
optimisation calculations. It is provided:
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As an
educational and informational resource only;
- Free of charge, without warranty of any kind;
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As a tool to assist professional judgement —
not to replace it.
The Software is not a medical device under the Australian
Therapeutic Goods Act 1989, the US Food, Drug, and Cosmetic Act, the
EU Medical Device Regulation (2017/745), or any equivalent
legislation in any jurisdiction. It has not been submitted to,
reviewed by, or approved by the Therapeutic Goods Administration
(TGA), the US Food and Drug Administration (FDA), the European
Medicines Agency (EMA), or any other regulatory body.
3. No Regulatory Approval or Independent Verification
The Software and its outputs, including but not limited to
prediction error analyses, visual acuity summaries, and lens
constant optimisation recommendations,
have not been independently verified, clinically validated, or
certified by any third party. The calculations performed by the Software are based on published
formulas and statistical methods that may contain errors, may be
incorrectly implemented, or may be inapplicable in specific clinical
situations.
You acknowledge that:
-
The Software may contain programming errors, algorithmic errors,
or inaccuracies;
-
Formula implementations may deviate from original published
specifications;
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Results may be affected by data entry errors, data quality, or
incomplete datasets;
-
Lens constant optimisation values produced by the Software are
estimates only and must be validated
prospectively before clinical adoption;
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The published benchmarks and other reference values incorporated
in the Software (including those drawn from the peer-reviewed
literature and registry reports) are subject to revision and may
not reflect current best practice.
4. User Responsibilities and Clinical Judgement
By accepting these Terms, you confirm that you are a qualified
healthcare professional with appropriate training to independently
assess, interpret, and apply the outputs of this Software. You agree
that:
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All clinical decisions remain
solely your professional responsibility;
-
Any optimised lens constants or analytical outputs must be
reviewed critically and validated against your own clinical
experience before use;
-
You will not apply any Software output to patient care without
independent verification;
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You will comply with all applicable laws, professional standards,
and institutional policies in your jurisdiction when using or
applying any outputs;
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You are responsible for ensuring that your use of the Software
complies with all applicable data protection and patient privacy
legislation, including but not limited to the Australian Privacy
Act 1988, GDPR, and HIPAA.
5. Limitation of Liability and Indemnification
To the maximum extent permitted by applicable law:
5.1 Exclusion of liability. Focus Vision Pty Ltd,
Dr David Gunn, Dr Brendan Cronin, and their respective employees,
contractors, agents, affiliates, and successors ("the Indemnified
Parties") shall not be liable — whether in contract, tort (including
negligence), breach of statutory duty, or otherwise — for any loss,
damage, injury, claim, or expense of any kind whatsoever arising out
of or in connection with your use of, or reliance upon, the Software
or its outputs, including without limitation:
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Any direct, indirect, consequential, special, punitive, or
exemplary loss or damage;
-
Any patient harm, adverse clinical outcome, or medico-legal
liability;
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Any loss of revenue, profit, data, goodwill, or business
opportunity;
-
Any error, omission, or inaccuracy in the Software's calculations
or outputs;
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Any failure of the Software to produce correct, complete, or
clinically appropriate results.
5.2 User indemnification. You agree to indemnify,
defend, and hold harmless the Indemnified Parties from and against
any and all claims, damages, losses, liabilities, costs, and
expenses (including reasonable legal fees) arising out of or
relating to: (a) your use of the Software; (b) your breach of these
Terms; (c) any clinical decision made in reliance upon the
Software's outputs; or (d) your violation of any applicable law or
third-party right.
5.3 Assumption of risk. You expressly assume all
risks associated with your use of the Software and its outputs. If
you do not accept this assumption of risk, you must not use the
Software.
6. No Warranty
The Software is provided on an "as is" and "as available" basis, without warranty of any kind, express or implied,
including but not limited to warranties of merchantability, fitness
for a particular purpose, accuracy, completeness, non-infringement,
or uninterrupted availability. No advice or information obtained
from Focus Vision or through the Software shall create any warranty
not expressly stated in these Terms.
7. Data Privacy and Security
The Software processes all data locally within your web browser. No
patient data is transmitted to Focus Vision or any third-party
server. Notwithstanding this, you remain solely responsible for
ensuring that any patient data you enter into the Software is
handled in accordance with all applicable privacy laws and your
institution's data governance policies. We strongly recommend
de-identifying all data before use.
8. Intellectual Property
The Software, including its design, code, analytical methodology,
and all associated documentation, is the intellectual property of
Focus Vision. You are granted a non-exclusive, non-transferable,
revocable licence to use the Software for professional and research
purposes only. You may not reproduce, redistribute, modify,
reverse-engineer, or commercialise the Software or any component
thereof without prior written consent from Focus Vision.
9. Governing Law
These Terms are governed by the laws of Queensland, Australia. Any
dispute arising under these Terms shall be subject to the exclusive
jurisdiction of the courts of Queensland, Australia, without regard
to conflict of law principles.
10. Amendments
Focus Vision reserves the right to amend these Terms at any time.
Continued use of the Software following notification of any
amendment constitutes acceptance of the revised Terms.
11. Severability
If any provision of these Terms is found to be invalid or
unenforceable, the remaining provisions shall continue in full force
and effect.
12. Entire Agreement
These Terms constitute the entire agreement between you and Focus
Vision with respect to your use of the Software and supersede all
prior representations, understandings, or agreements relating to the
same subject matter.
