> ⚠️ **Important Medical Disclaimer — Please Read Before Use**
>
> - **Not a diagnostic device.** Picterus® Jaundice Pro is a screening and monitoring aid. Results must not be used as the sole basis for any clinical decision.
> - **Cannot replace blood testing.** The app does not replace laboratory serum bilirubin measurement. Where a blood test is clinically indicated, it must be performed.
> - **All results must be reviewed by a qualified healthcare professional.** Clinical decisions must follow applicable national clinical guidelines.
> - **If you are concerned about jaundice, seek immediate medical attention.** Do not delay seeking care on the basis of an app result.
> - **For home monitoring (Jaundice@Home):** use only under direct guidance of your healthcare provider. Contact your provider or go to your nearest hospital immediately if you have any concern about your baby.
> - To the maximum extent permitted by applicable Indian law, Phoenix Medical Systems (P) Ltd. and Picterus AS are not liable for any clinical decisions made on the basis of app results.
>
> *This disclaimer is a mandatory requirement under India’s Medical Devices Rules, 2017 and CDSCO guidance for Class B SaMD.*
## 1. Introduction and Acceptance
These Terms and Conditions ("Terms") are issued by **Phoenix Medical Systems (P) Ltd.** ("Phoenix", "we", "us", "our"), the legal manufacturer responsible for Picterus® Jaundice Pro in India. Phoenix’s registered address is **DP-42, SIDCO Industrial Estate, Thirumudivakkam, Chennai – 600132, Tamil Nadu, India**.
By downloading, installing, accessing, or using the Picterus® Jaundice Pro application (the "App"), or by using the Picterus® Calibration Card, you ("User") agree to be bound by these Terms. If you do not agree, you must not use Picterus® Jaundice Pro.
Where the User is a healthcare professional accessing the App through an institution or organisation, the User also represents that they have the authority to bind themselves to these Terms and that their organisation has agreed to an appropriate agreement with Phoenix.
### Updates to These Terms
Phoenix may update these Terms from time to time. When we make material changes, we will notify you via an in-app notification and/or email before the changes take effect. Continued use of Picterus® Jaundice Pro after the notified date constitutes acceptance of the revised Terms. The version date and version number at the top of this page will be updated on each revision. We encourage you to review these Terms periodically.
## 2. About Picterus® Jaundice Pro
Picterus® Jaundice Pro is a medical device system consisting of two components that work together:
| Component | Description | Regulatory Classification |
| --- | --- | --- |
| **Picterus® Jaundice Pro App** | Mobile application available for iOS and Android smartphones. Estimates transcutaneous bilirubin levels in neonates using smartphone camera images combined with the Calibration Card. | Class B Software as a Medical Device (SaMD) — CDSCO. Licence No. *[INSERT CDSCO LICENCE NO.]* |
| **Picterus® Calibration Card** (Cat. No. 00763) | Physical paper-based accessory required for colour calibration of images. Must be present in the camera frame during every measurement. | Class A Medical Device — CDSCO |
### Intended Purpose
Picterus® Jaundice Pro is intended for two settings of use:
- **Clinical use by healthcare professionals (HCPs):** Screening and follow-up monitoring of neonatal jaundice in clinical settings (NICUs, postnatal wards, neonatal outpatient clinics), by authorised healthcare professionals registered through their institution.
- **Home monitoring by parents/caregivers (Jaundice@Home):** Remote monitoring of neonates at home, used by parents or caregivers only under the direction and supervision of a healthcare provider who has enrolled the family into the Jaundice@Home web platform.
### Technical Requirements
Use of the App requires a stable internet connection. Image processing and bilirubin estimation are performed on Picterus servers. Server-side processing means that an active network connection is required to generate results; the App will not produce results in offline mode.
**Validated patient population:** Picterus® Jaundice Pro has been clinically validated for use in neonates aged 24 hours to 14 days postnatal age, with gestational age greater than 35 weeks and birth weight of 2,000 g or above. Use outside these parameters has not been validated.
## 3. Medical Disclaimer
> **This section is critical. Please read it carefully.** It describes the limitations of Picterus® Jaundice Pro as a medical device and the responsibilities of all users.
### Screening and Monitoring Aid — Not a Diagnostic Device
Picterus® Jaundice Pro is a **screening and monitoring aid** for neonatal jaundice. It is designed to support clinical decision-making, not to replace it. The app provides an estimate of transcutaneous bilirubin — it does not provide a diagnosis of jaundice or any other condition.
### Results Must Not Be Used as the Sole Basis for Clinical Decisions
App results must not be used as the sole basis for any clinical decision, including but not limited to decisions about phototherapy, exchange transfusion, discharge, or hospital readmission. All results must be:
- reviewed by a qualified healthcare professional;
- interpreted in the context of the full clinical picture, the neonate’s history, and applicable national clinical guidelines (including but not limited to the Indian Academy of Pediatrics neonatal jaundice guidelines); and
- confirmed by laboratory serum bilirubin measurement where the clinical situation requires it.
### Cannot Replace Serum Bilirubin Testing
Picterus® Jaundice Pro is a non-invasive transcutaneous method. It **cannot replace blood-based serum bilirubin measurement**. Where a serum bilirubin test is clinically indicated, it must be performed without delay.
### Seek Immediate Medical Attention if Concerned
If at any time you are concerned about a baby’s jaundice — whether you are a healthcare professional or a parent/caregiver using Jaundice@Home — seek immediate medical attention. Do not delay going to a hospital or clinic on the basis of an app result.
### Limitation of Liability for Clinical Decisions
To the maximum extent permitted by applicable Indian law, Phoenix Medical Systems (P) Ltd. and Picterus AS are not liable for any clinical decision, outcome, harm, or loss arising from reliance on Picterus® Jaundice Pro results. Clinical decisions are the responsibility of the qualified healthcare professional providing care. See Section 11 for full details of our limitation of liability, including the liabilities that cannot be excluded under Indian law.
## 4. Eligibility and Authorised Use
### Healthcare Professional (HCP) Use
Access to the clinical features of Picterus® Jaundice Pro is restricted to authorised healthcare professionals registered through their institution. To use the App in a clinical setting, you must:
- be a qualified healthcare professional (doctor, nurse, midwife, or other qualified clinical staff) with a valid registration under applicable Indian law;
- be registered and verified through your institution’s account with Phoenix; and
- use the App only for neonatal jaundice screening and monitoring within the validated patient population and clinical settings described in the Instructions for Use (IFU).
### Home/Caregiver Use (Jaundice@Home)
Parents and caregivers may use the Jaundice@Home features of the App only:
- if a healthcare provider has specifically set up Jaundice@Home monitoring for their baby; and
- strictly in accordance with the instructions and monitoring plan provided by their healthcare provider.
### Age Requirement
You must be **18 years of age or older** to create an account or use Picterus® Jaundice Pro. The system is designed for use in relation to neonatal patients meeting the clinical criteria described in Section 2.
### Prohibited Uses
The following uses are expressly prohibited:
- **Jailbroken/Rooted devices:** Use on jailbroken (iOS) or rooted (Android) devices is prohibited. Such devices may compromise the security and accuracy of the App.
- **Outside validated conditions:** Use outside the validated patient population, clinical indications, or environmental conditions specified in the IFU.
- **Circumventing access controls:** Any attempt to bypass, circumvent, or exploit access controls, authentication mechanisms, or security features.
- **Sharing login credentials:** Sharing account login credentials with any other person. Each user must have their own individual account.
- **Unauthorised purposes:** Use for any purpose other than neonatal jaundice screening and monitoring as described in these Terms and the IFU.
- **Reverse engineering:** Reverse engineering, decompiling, modifying, or attempting to extract the algorithm or source code of the App.
## 5. Calibration Card (Cat. No. 00763)
The Picterus® Calibration Card is a **required component** of Picterus® Jaundice Pro. The App cannot generate bilirubin results without the Calibration Card being present and visible in the camera frame at the time of measurement.
### Usage
The Calibration Card is intended as a single-patient, multi-use accessory. It may be reprocessed (cleaned/disinfected) between uses in accordance with the instructions provided in the Instructions for Use (IFU). Always follow the IFU for reprocessing procedures.
### Storage and Handling
| Requirement | Details |
| --- | --- |
| Temperature | Store below 35°C. Do not expose to extreme heat. |
| Sunlight | Protect from prolonged direct sunlight, which can cause colour fading and affect accuracy. |
| Moisture | Keep dry. Protect from water, liquids, and excessive humidity. |
| Contaminants | Protect from oils, lotions, skin creams, and other substances that may contaminate the colour patches. |
| Physical Damage | Protect from scratches, bending, or other physical damage to the colour reference patches. |
| Shelf Life | 5 years from date of manufacture when stored as directed. Check expiry date printed on the card. |
### When to Replace the Calibration Card
**Do not use a Calibration Card that is:**
- expired (past the shelf-life date printed on the card);
- visibly damaged, scratched, or physically deformed;
- contaminated (with blood, skin preparations, oils, or other substances) and cannot be effectively reprocessed;
- discoloured or faded due to UV exposure or improper storage; or
- otherwise outside the condition described as acceptable in the IFU.
Use of a compromised Calibration Card will affect measurement accuracy and may produce unreliable results.
### Disposal and Replacement
The Calibration Card is a Class A medical device. Dispose of used or expired cards in accordance with local medical waste regulations and your institution’s waste management procedures.
Replacement Calibration Cards are available from Phoenix Medical Systems (P) Ltd. To order, contact us at [sales@pmsind.com](mailto:sales@pmsind.com) or call [+91 44 2478 1705](tel:+914424781705).
## 6. Account and Access
### HCP Registration
Healthcare professional registration requires institutional verification. HCPs are provisioned accounts through their institution’s organisation account with Phoenix. Individual self-registration outside an institutional framework is not available for clinical use features.
### Account Security
You are responsible for:
- maintaining the confidentiality of your account credentials (username and password);
- all activity that occurs under your account; and
- notifying Phoenix or your institution’s administrator immediately if you become aware of any unauthorised use of your account or any other security breach.
Phoenix and Picterus AS are not liable for any loss, harm, or damage arising from unauthorised use of your account where you failed to take reasonable steps to protect your credentials.
### Session Timeout
For patient safety and data security, the App will automatically log out inactive sessions after **14 days**. Users will be required to log in again after this period.
### Account Suspension and Termination
Phoenix may suspend or terminate access to your account, with or without prior notice, in the following circumstances:
- material breach of these Terms;
- regulatory requirement or direction from CDSCO or any competent authority;
- concern for patient safety; or
- closure of your institution’s organisation account.
Where possible, Phoenix will give reasonable advance notice of account suspension or termination unless immediate action is required for patient safety or regulatory compliance.
## 7. Organisation Accounts
Hospitals, clinics, and other healthcare institutions ("Organisations") access Picterus® Jaundice Pro through an organisation account, subject to a separate agreement with Phoenix. These Terms apply to all individual users provisioned under an organisation account.
### Administrator Responsibilities
Organisation administrators may manage HCP accounts within their organisation, including:
- adding and removing individual HCP users;
- assigning and modifying user roles and permissions; and
- accessing clinical data generated by users within their organisation.
### Organisation’s Obligations
The Organisation is responsible for:
- ensuring that all HCP users provisioned through its account have read and accepted these Terms before using the App;
- ensuring that only authorised and appropriately qualified healthcare professionals are given access;
- all administrative decisions made by its administrators within the organisation account; and
- compliance with applicable Indian laws governing use of medical devices in clinical settings.
**Phoenix and Picterus AS are not responsible** for administrative decisions made by an Organisation’s administrators, nor for the actions of individual HCP users provisioned by an Organisation.
## 8. Intellectual Property
### Ownership
**Picterus®** and the Picterus logo are registered trademarks of Picterus AS, Norway. The Picterus® Jaundice Pro application, underlying bilirubin estimation algorithm, software, user interfaces, and all associated content and documentation are the intellectual property of Picterus AS and are protected under applicable international copyright, patent, and trade secret laws.
Phoenix Medical Systems (P) Ltd. holds a licence from Picterus AS to manufacture, distribute, and support Picterus® Jaundice Pro in India.
### Licence Granted to Users
Subject to your compliance with these Terms, Phoenix grants you a **limited, non-exclusive, non-transferable, revocable licence** to install and use the Picterus® Jaundice Pro App solely for its intended medical device purpose as described in these Terms and the IFU. This licence does not include any right to:
- copy, reproduce, or distribute the App or any part of it;
- modify, adapt, translate, or create derivative works;
- reverse engineer, decompile, or disassemble the App or its algorithm;
- remove or alter any proprietary notices, labels, or marks; or
- sub-licence or transfer your rights to any third party.
Any use of the App beyond the scope of this licence requires the prior written consent of Phoenix Medical Systems (P) Ltd. and Picterus AS.
### Feedback
If you provide Phoenix or Picterus with suggestions, feedback, or ideas relating to the App, you grant Phoenix and Picterus AS a non-exclusive, perpetual, royalty-free licence to use, incorporate, and commercialise that feedback without any obligation to compensate you.
## 9. Privacy and Data Protection
Phoenix Medical Systems (P) Ltd. is the **Data Fiduciary** under the Digital Personal Data Protection Act, 2023 (DPDPA 2023) for personal data processed through Picterus® Jaundice Pro in India. Picterus AS, Norway acts as the Data Processor under a formal Data Processing Agreement.
By using Picterus® Jaundice Pro, you consent to the collection, processing, and use of your personal data (and, where applicable, neonatal patient data) as described in our **Privacy Notice**. Our Privacy Notice forms part of these Terms and should be read together with them.
> **Privacy Notice:** Please read our full Privacy Notice, available at [phoenixmedicalsystems.com/privacy-policy](/news-corner/privacy-policy). It describes in detail what data we collect, why, how long we keep it, and your rights under the DPDPA 2023.
The Privacy Notice describes, among other things:
- the categories of personal data collected from HCPs and neonatal patients;
- the purposes and legal bases for processing;
- data retention periods;
- data security measures including storage in India (Google Cloud, Mumbai); and
- your rights to access, correct, erase, and withdraw consent, and how to exercise them.
## 10. No Warranties
Picterus® Jaundice Pro is provided as a medical device for its stated intended purpose as described in these Terms and the IFU. To the maximum extent permitted by applicable Indian law, Phoenix and Picterus AS make no representations or warranties beyond those expressly stated herein or required by law, including:
- **No warranty of uninterrupted service.** We do not guarantee that the App or the server-side processing service will be available at all times, without interruption, or free from errors or bugs. Scheduled maintenance and unplanned outages may occur.
- **No warranty of fitness for any other purpose.** The App is warranted only for its stated intended purpose. No warranty is given for any use outside the intended purpose, outside the validated patient population, or outside the conditions described in the IFU.
- **No warranty regarding third-party services.** We are not responsible for failures, delays, or errors caused by third-party services including but not limited to mobile network operators, internet service providers, or cloud infrastructure providers.
- **No warranty for unsupported devices.** Accurate results require a supported smartphone model. Phoenix publishes a validated device list. No warranty is given for performance on devices not included on the validated device list.
Nothing in this section affects any rights you may have under mandatory Indian consumer protection law, including the Consumer Protection Act, 2019, or under the Medical Devices Rules, 2017, which cannot be excluded by agreement.
## 11. Limitation of Liability
### General Limitation
To the maximum extent permitted by applicable Indian law, neither Phoenix Medical Systems (P) Ltd. nor Picterus AS shall be liable for any **indirect, consequential, special, incidental, or punitive losses or damages** arising out of or in connection with the use of Picterus® Jaundice Pro, even if advised of the possibility of such damages.
### Specific Exclusions
Without limiting the generality of the above, neither Phoenix nor Picterus AS shall be liable for losses or harm arising from:
- reliance on App results as the sole basis for any clinical decision;
- failure to follow the Instructions for Use (IFU) or these Terms;
- use of the App outside the validated patient population (e.g., neonates under 35 weeks gestational age or under 2,000 g birth weight);
- use of the App on unsupported or jailbroken/rooted devices;
- use of a damaged, contaminated, expired, or otherwise compromised Calibration Card;
- connectivity failures, network outages, or failures of third-party infrastructure; or
- administrative decisions made by Organisation administrators.
### Cap on Direct Liability
Where liability cannot be excluded in law, Phoenix’s total aggregate liability to a user or organisation for direct losses arising from a particular event shall not exceed the total fees paid by that user or organisation to Phoenix for the service in the **12 months preceding the event** giving rise to the claim.
### Exceptions — Liability That Cannot Be Excluded
Nothing in these Terms limits or excludes liability for:
- death or personal injury caused by negligence on the part of Phoenix or Picterus AS;
- fraud or fraudulent misrepresentation; or
- any other liability that cannot be excluded or limited under Indian law, including under the Consumer Protection Act, 2019 or the Medical Devices Rules, 2017.
### Personal Liability of Officers and Employees
Officers, directors, employees, agents, and contractors of Phoenix Medical Systems (P) Ltd. and Picterus AS cannot be held personally liable under these Terms.
## 12. Service Availability and Changes
### Modifications and Updates
Phoenix and Picterus AS may modify, update, or change features of Picterus® Jaundice Pro (including the App, the server-side processing service, and the Jaundice@Home platform) from time to time. Material changes that affect the intended purpose or user workflow will be notified to users in advance through the App or by email.
### Suspension
Phoenix may temporarily suspend access to the App or the processing service for scheduled maintenance, unplanned emergency maintenance, or to address a safety or security issue. We will provide advance notice of scheduled maintenance where practicable. Emergency suspension may occur without prior notice where necessary for patient safety or system security.
### Discontinuation
If Phoenix decides to permanently discontinue the Picterus® Jaundice Pro service in India, we will:
- provide a minimum of **90 days’ prior written notice** to all active organisations and users;
- make a proportional refund of any prepaid subscription fees covering the discontinued period; and
- ensure that a data export facility is available for a period of at least **3 months** from the date of discontinuation notice, allowing organisations to download their clinical data.
### Force Majeure
Neither Phoenix nor Picterus AS shall be liable for any delay or failure in performance caused by events beyond their reasonable control, including but not limited to: natural disasters, pandemics, government or regulatory actions, actions of CDSCO, power failures, internet outages, acts of war, cyberattacks, or failures of third-party cloud infrastructure. In such circumstances, the affected party will notify the other as soon as reasonably practicable and will make best efforts to resume normal service.
## 13. Payments and Billing
Pricing for Picterus® Jaundice Pro (including the App licence and Calibration Cards) is set out in the order confirmation or subscription agreement provided by Phoenix to the relevant organisation at the time of purchase. Individual users accessing the App through an organisation account do not make separate payments to Phoenix.
All applicable Indian taxes, including Goods and Services Tax (GST), will be applied to invoices as required by law. Tax invoices will be issued in accordance with applicable GST rules.
For billing queries, disputed invoices, or payment-related matters, please contact **sales@pmsind.com** or write to Phoenix Medical Systems (P) Ltd., DP-42, SIDCO Industrial Estate, Thirumudivakkam, Chennai – 600132.
## 14. Consumer Rights
Where Picterus® Jaundice Pro is used by a parent or caregiver as a consumer in connection with the Jaundice@Home home-monitoring service, the provisions of the **Consumer Protection Act, 2019** (India) and associated rules apply to the extent applicable.
**Nothing in these Terms limits or overrides any rights available to consumers under mandatory Indian consumer protection law.** In the event of any inconsistency between these Terms and mandatory consumer protection rights, the applicable law prevails.
### Consumer Remedies
Consumers who have a complaint or grievance in relation to the App or associated service should follow the steps below:
1. **Contact Phoenix’s Grievance Officer first** (see Section 16). We will acknowledge your complaint within 48 hours and aim to resolve it within 30 days.
2. If your complaint is not resolved to your satisfaction within 30 days, you may pursue remedies available under the Consumer Protection Act, 2019, including filing a complaint with the appropriate Consumer Disputes Redressal Commission.
3. Online complaints may also be filed through the **e-Daakhil portal** at [edaakhil.nic.in](https://edaakhil.nic.in), maintained by the Department of Consumer Affairs, Government of India.
## 15. Governing Law and Disputes
### Governing Law
These Terms and all matters arising from them are governed by and construed in accordance with the **laws of India**, without regard to conflict of law principles.
### Jurisdiction
The courts in **Chennai, Tamil Nadu, India** shall have exclusive jurisdiction over any dispute, claim, or matter arising out of or in connection with these Terms or the use of Picterus® Jaundice Pro, subject to the arbitration provision below.
### Dispute Resolution — Good-Faith Negotiation
Before initiating any formal legal proceedings, both parties agree to attempt in good faith to resolve any dispute or claim arising from or in connection with these Terms through direct negotiation. Either party may initiate this process by giving written notice to the other party, setting out the nature of the dispute and the outcome sought. The parties will meet (in person, by phone, or by video) within 15 days of such notice and attempt to resolve the matter in good faith.
### Arbitration
If a dispute is not resolved through good-faith negotiation within **30 days** of the written notice referred to above (or such longer period as the parties agree in writing), the dispute shall be referred to and finally resolved by **arbitration** in accordance with the Arbitration and Conciliation Act, 1996 (as amended). The seat and venue of arbitration shall be **Chennai, Tamil Nadu, India**. The proceedings shall be conducted in English. The arbitral tribunal shall consist of a sole arbitrator agreed upon by both parties, or failing agreement, appointed in accordance with the Act.
> **Note for consumers:** This arbitration clause does not prevent you from exercising your rights as a consumer under the Consumer Protection Act, 2019. Consumers may choose to file complaints with Consumer Disputes Redressal Commissions as described in Section 14.
## 16. Contact
For questions about these Terms, to report a complaint, or to exercise your rights, please contact Phoenix Medical Systems (P) Ltd.:
- **Address:** DP-42, SIDCO Industrial Estate, Thirumudivakkam, Chennai – 600132, Tamil Nadu, India
- **General Email:** [sales@pmsind.com](mailto:sales@pmsind.com)
- **Phone:** [+91 44 2478 1705](tel:+914424781705) / 2227 · Toll free (India): 1800 425 3503
- **Hours:** Monday – Friday, 9:00 AM – 5:30 PM IST (excluding public holidays)
### Grievance Officer
Under the Consumer Protection Act, 2019 and the DPDPA 2023, Phoenix has designated a Grievance Officer for complaints and data protection queries. The Grievance Officer can be reached at:
- **Name:** *[INSERT full name of Grievance Officer]*
- **Designation:** *[INSERT designation, e.g., Quality & Regulatory Affairs Manager]*
- **Email:** [rohan.g@pmsind.com](mailto:rohan.g@pmsind.com)
- **Phone:** [+91 44 2478 1705](tel:+914424781705)
- **Address:** DP-42, SIDCO Industrial Estate, Thirumudivakkam, Chennai – 600132, Tamil Nadu, India
- **Response Time:** Acknowledged within 48 hours · Resolved within 30 days
### Regulatory Complaint — CDSCO
If you have a complaint or adverse event report relating to Picterus® Jaundice Pro as a medical device, you may also report it to the Central Drugs Standard Control Organisation (CDSCO) through the [CDSCO website](https://www.cdsco.gov.in) or through the [Sugam portal](https://www.sugamportal.in).
---
**Phoenix Medical Systems (P) Ltd.** — Legal Manufacturer of Picterus® Jaundice Pro in India · CDSCO Class B SaMD · Licence No. *[INSERT]*
*These Terms & Conditions are effective from [INSERT EFFECTIVE DATE] · Version 1.0 · Governed by the laws of India · Jurisdiction: Chennai, Tamil Nadu*