TERMS AND CONDITIONS FOR - PURCHASE OF SMARTHEART® PRO DEVICE AND ECG REVIEW SERVICE
Effective upon submission to Seller of the Purchase Order (defined below) for SMARTHEART® PRO, these Terms and Conditions establish a contract between Buyer and Seller and, where applicable, Smartheart Provider, and are incorporated into the Purchase Order.
Buyer understands that the Application can only be downloaded onto certain iOS or Android compatible devices and that use of the Device with the Application requires connectivity with active internet access.
The following defined terms apply to these Terms and Conditions:
means the entity or person submitting the Purchase Order for SMARTHEART® PRO to the Seller for order and use by a Health Professional (defined below).
means an authorized entity or person offering for purchase the SMARTHEART® PRO Device.
means the purchase order for the sale of SMARTHEART® Device between Seller and Buyer as may be further evidenced by Seller's final written offer, quotation or order acknowledgement and no prior proposals, statements, representations or condition will be binding on either party. The Purchase Order incorporates the Terms and Conditions stated herein.
means the SMARTHEART® PRO device, hardware and other electronic or mechanical items agreed to be supplied by Seller. The Device excludes any consumables and spare parts sold separately.
means an individual who is either a physician or other health professional whose state license permits the use of diagnostic devices such as the SMARTHEART® PRO device within the scope of the Health Professional's state license.
means these Terms and Conditions and Purchase Order(s).
means the iOS and Android compatible "Smartheart" mobile application available for download from the App Store or Google Apps Market Place. Please refer to www.smartheartpro.com for additional information.
means the registration of the Buyer or Health Professional with the Smartheart Provider which provides the Health Professional with a username and password for access to review and download the ECGs that were performed and receive ECG Review Service; permits the Health Professional to receive and forward these ECGs for review by others; enables the Health Professional to receive feedback, messages, reminders or other types of information provided by the Smartheart Provider. For registration please refer to www.smartheartpro.com.
ECG Review Service
means a feature that provides a technical analysis of the ECG. This analysis is performed via the Smartheart Provider algorithms and healthcare personnel reviewing the ECG and related information according to Smartheart Provider's policies and in accordance with standard cardiology guidelines and is not intended to be and does not constitute diagnosis, interpretation, treatment, or medical advice.
means SHL Telemedicine USA, Inc., its successors or assigns.
means the extension of certain warranty terms for the Device as set forth in a separate Extended Warranty Agreement.
Terms of Sales.
The purchase of the Device sold by Seller shall be subject to and expressly limited by the Contract and Buyer shall be deemed to accept the Contract by submitting a signed Purchase Order to Seller. Additional special terms and conditions may be applicable with respect to certain other products or services.
The price of the SMARTHEART® PRO Device will be Seller's quoted price unless otherwise set forth in the Purchase Order, inclusive of any duties, but exclusive of value added, sales, use or other taxes. If selected, the prices for the ECG Review Service and the Extended Warranty are those prices payable and currently in effect or as otherwise set forth on Purchase Order. Unless otherwise agreed in writing, extra charges will apply for handling, freight, and packaging. Seller reserves the right to change the prices of its products at any time without notice.
Unless otherwise agreed in writing, payment in full shall be made to Seller at the time of purchase and prior to shipment of the Device. Buyer's obligation to pay is absolute and unconditional and is not subject to any abatement, reduction, set-off, defense, counterclaim, interruption, deferment or recoupment for any reason whatsoever. Payment for the ECG Review Service shall be delineated in the Purchase Order.
Changes and Returns.
Smartheart Provider reserves the right, subject to prior written notice, to make any changes in the specifications of the Device which does not materially affect the performance, or use thereof. Devices may only be returned with Seller's prior authorization.
Delivery/Installation/Acceptance of Device
Seller will select the method of shipment of the Device and the carrier to be used. Any details of the shipment will be specified in the Purchase Order. Seller will use all reasonable efforts to avoid delay in delivery on the notified delivery dates. Failure to deliver by the specified date will not be a sufficient cause for cancellation, nor will Seller be liable for any loss or damage due to delay in delivery.
Buyer shall notify Seller in writing within five (5) working days of delivery of any omissions in delivery or defects reasonably discoverable on careful examination. Seller's sole obligation shall be, at its option, to replace or repair the Device or refund the purchase price.
Where delivery of the Device requires an export license or other government authorization before shipment, Seller shall not be responsible for any delay in delivery due to delay in, or refusal of, such license or authorization.
Risk and Title and Returns.
All the risks of loss of and damage to the Device and full legal and equitable title to the Device shall pass to the Buyer upon delivery to Buyer.
Access to ECG Data and Information.
In order for Buyer and Health Professional to use the Device and access ECGs, they must first download the Application and then register and create a Smartheart Account at www.smartheartpro.com and obtain a user name and password. Buyer acknowledges that the ECG related information and data held by Smartheart Provider are not part of Buyer's or Health Professional's records nor the patient's medical record and may be accessible from Smartheart Provider for only a limited time. Specifically, Buyer understands that an ECG may not be accessible or no longer available for review of download through the Smartheart Account after 30 days from when Smartheart Provider notifies Buyer (via email or otherwise) that the ECGs will no longer be accessible or available for review. Smartheart Provider is not responsible for the provision, storage or delivery of any ECG data after this 30 day period (if such notice is sent) or earlier upon Buyer's breach of these Terms and Conditions.
ECG Review Service
Access to the ECG Review Service will be available only through the Application and the Smartheart Account and shall be subject to the same restrictions as set forth herein and in the terms and conditions of the Application and of the Smartheart Account. In order to request the ECG Review Service, Buyer must purchase the service by selecting it in a Purchase Order (or other purchase method made available by Smartheart Provider) and when transmitting the ECG checking the button included in the Application that requests the ECG Review Service. Buyer's Health Professional receiving technical review of the ECG is responsible for interpreting the data, discussing the results with his or her patient, and making any diagnosis or medical conclusions as permitted under applicable law.
Smartheart Provider will use reasonable best efforts to make available the technical review of the ECG, for view in the Application and the Smartheart Account, within 15 (fifteen) minutes from receipt of the ECG performed by the Health Professional. In the event Health Professional receives a message indicating the ECG could not be reviewed (most likely due to incomplete data), Health Professional may perform the ECG again.
The price/fee for the ECG Review Service will be set forth in the Purchase Order, or described by Smartheart Provider at the time of submission of ECG data, or as otherwise agreed to in writing.
By submission of a Purchase Order, Buyer confirms that Smartheart Provider will process Health Professional's patients' personal data subject to federal healthcare privacy law (HIPAA) and other applicable law. Buyer and Smartheart Provider agree to enter into a Business Associate agreement required under HIPAA as part of the Application registration process..
Buyer is solely responsible to ensure compliance with any regulatory requirements related to use of the Device, including any clinical, medical or diagnostic use. Any warranty granted herein to the Buyer shall be deemed void if the Device is used for any purpose not permitted, is not used with the Application or the Smartheart Account, or the Device is modified in any way.
Limited Warranties by Smartheart Provider
Device Limited Warranty.
The Device is warranted by Smartheart Provider from date of delivery to Buyer to be free of defects in workmanship or materials under normal usage for a period of one (1) year and any claim shall be submitted in writing within such period. Smartheart Provider's sole liability and Buyer's exclusive remedy for a breach of this warranty is limited to repair, replacement or refund at the sole option of Smartheart Provider. Such repairs or replacement will not extend the warranty period. Smartheart Provider's warranty shall not apply if: (i) a product is not used in accordance with its instructions or if it is used for purpose not indicated on the labeling; (ii) any repairs, alternatives or other work has been performed by Buyer or others on such item, other than work performed with Smartheart Provider's authorization and according to its approved procedures; or (iii) the alleged defect is the result of abuse, misuse, improper maintenance, accident or negligence of any party other than Seller or Smartheart Provider.
No other express or implied warranty is made with respect to the products, including no implied warranties of merchantability and of fitness for a particular purpose.
Use of the Device requires the exercise of sound medical judgment, and clinical results may vary based on a health professional's skill and experience, patient suitability, and other factors beyond the control of Seller or Smartheart Provider. Warranty herein is conditioned upon proper storage, use and maintenance in accordance with the SMARTHEART® PRO policies, procedures and requirements.
ECG Review Service Acknowledgement; No Warranties.
Buyer and Health Care Professional acknowledge that the ECG Review Service will be carried out with reasonable care and skill. Smartheart Provider's sole liability for breach of this provision shall be at Smartheart Provider's option to give credit for or re-analyze the specific ECG in question. The terms of this provision shall only extend for a period of ninety (90) days after the report is provided to the Buyer or Health Professional.
Disclaimer and Exclusion of Representations and Warranties.
To the maximum extent permitted by applicable law, Smartheart Provider and Seller hereby expressly disclaim, and Buyer hereby expressly waives, any warranty except as provided herein including, without limitation, any claim of inaccurate, invalid, or incomplete results or reports. All other warranties, representations, terms and conditions (statutory, express, implied or otherwise) as to quality, condition, description, merchantability, fitness for purpose or non-infringement (except for the implied warranty of title) are hereby expressly excluded.
Limitation of Liability
Seller and Smartheart Provider, and their parents, affiliates and subsidiaries, shall have no liability under the warranties in section 12 with respect to any defect arising from the Device or ECG Review Service due to (i) specifications, or materials or services supplied by the Buyer; (ii) fair wear and tear of Device; (iii) inappropriate use of ECG Review Service or Application or Smartheart Account; (iv) willful damage or negligence of the Buyer or Health Professional or its employees or agents; (v) abnormal working conditions at the Buyer's or Health Professional's premises; (vi) failure to follow use restrictions or instructions (whether oral or in writing); (vii) misuse or alteration or repair of the Device without Smartheart Provider's approval; or (viii) if the Buyer is in breach of its payment obligations under the Purchase Order.
Smartheart Provider and Seller, and their parents, affiliates and subsidiaries, are not responsible for any damage, whether direct or indirect, that might be caused to Buyer or to a third party, as a result of the use of this Device, the Smartheart Account, the ECG Review Service (if provided) and/or Buyer's inability to use it. Without derogating from the aforementioned, Seller and Smartheart Provider, and each of their parents, affiliates and subsidiaries, shall not be responsible for any damage that might occur due to the inability to use the Device, and/or due to the lack of availability of the use of the ECG Review Service or Application or Smartheart Account, whenever these are the result of: (A) the shutdown of the Application or Smartheart Account or ECG Review Service to engage in regular maintenance work, and/or changes, and/or updates and/or amendments; (B) circumstances beyond Smartheart Provider's and Seller's reasonable control, such as electric power failures, telecommunications failures (inclusive of cellular or internet services), epidemic or a nature catastrophe; legislation, regulations or limitations due to governmental activity, civil unrest, protests, or as a result of terrorist threats or acts of war.
SELLER AND SMARTHEART PROVIDER, AND PARENTS, AFFILATES AND SUBSIDIARIES, SHALL NOT BE LIABLE FOR ANY INDIRECT OR CONSEQUENTIAL, OR PUNITIVE DAMAGES OR ANY KIND FROM ANY CAUSE ARISING OUT OF THE SALE, USE OR INABILITY TO USE ANY PRODUCT OR SERVICE, INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS, GOODWILL OR BUSINESS INTERRUPTION. SELLER WILL NOT BE LIABLE FOR ANY CLAIMS OF THIRD PARTIES, INCLUDING BUYER'S PATIENTS AND HEALTH PROFESSIONALS.
Any claim Buyer has against Smartheart Provider or Seller must be submitted to a court of competent jurisdiction within one year as of the date the claim arose.
The total liability of Seller and Smartheart Provider arising under or in connection with the Contract, including for any breach of obligations and/or any misrepresentation, misstatement or tortuous act or omission (including without limitation, negligence and liability for infringement or any third party intellectual property rights) shall be limited to damages in an amount equal to the amount paid to Seller under the Purchase Order.
The exclusion of liability in this Contract and the terms and conditions of the Application shall apply only to the extent not prohibited by applicable law.
Intellectual Property Rights
All intellectual property rights in the Device, Application and Smartheart Account shall at all times remain vested in Smartheart Provider, its parent, subsidiaries, affliates, or licensors.
Health and Safety
The Seller shall ensure that: (i) the Device is delivered in a safe manner, and (ii) packaging and labeling, where provided by the Seller, comply with all relevant federal, state and local safety regulations.
Buyer acknowledges represents and warrants to Seller that each of Buyer's Health Professionals are fully licensed without restriction in the state where the Health Professional's patients reside or as a similarly licensed professional and is authorized to use and order the SMARTHEART® PRO device to Health Professional's patients within the scope of the Health Professional's state license.
Discounts and Rebates
If the pricing offered by Seller to a Buyer constitutes a discount or other reduction in price under Section 1128(b)(3)(a) of the Social Security Act 42 U.S.C. 1320a-7b(b)(3)(a), and 42 C.F.R. § 1001.952(h), Buyer shall disclose the discount or reduction in price to the full extent required under any state or federal program that provides cost or charge-based reimbursement to Buyers for products. Buyer may also be required, upon request, to provide documentation of the discount or other reduction in price to the Secretary of Health and Human Services. Buyer acknowledges that this section is sufficient to effectively advise Buyer of its obligations under the laws noted above.
Seller and Smartheart Provider, and their parents, affiliates and subsidiaries, shall not be liable with respect to the non-performance of any of its obligations herein to the extent such performance is prevented by any circumstances beyond its reasonable control including, but not limited to, strikes, lock outs or labor disputes of any kind (whether relating to its own employees or others), fire flood, explosion, natural catastrophe, military operations, blockade, sabotage, revolution, riot, civil commotion, war or civil war, acts or threats of terrorism, plant breakdown, computer or other equipment failure and inability to obtain equipment. If an event of force majeure exceeds one (1) month Seller may cancel the Purchase Order without liability. The Contract may not be varied or waived except with the express written agreement of Seller.
This Contract shall be governed by and construed in accordance with the substantive laws of the State of New York and the parties hereby submit to the non-exclusive jurisdiction of the courts of the federal and New York State courts located in Manhattan (NYC). THIS CONTRACT IS NOT SUBJECT TO UN CONVENTION ON CONTRACTS FOR THE INTERNATIONAL SALE OF GOODS. Any data collected by Seller will be held and used in accordance with all applicable federal, state and local laws and regulations and in a matter that will maintain confidentiality.