By signing below, I hereby give my consent to receive the services detailed below from the Alpha Bio Tech Company Ltd. “(The Company)”, in accordance with and subject to the following engagement terms:
Pursuant to the Dentist’s request from time to time, and subject to the terms below, the Company will provide the following services:
- Surgical apparatus that the Dentist verified and confirmed pursuant to his sole medical discretion the implant plan;
- The surgical tool kit to be provided will be on a sale or lease basis (hereinafter: Surgical Kit)
The Work Process. The work process for the Dentist to receive the auxiliary services is as detailed in the general terms document below. The Company reserves its right to update the document subject to apprising the Dentist.
The Dentist’s Declarations:
The Dentist hereby declares and agrees to the following:
- Holds a valid medical license to engage in Dentistry and it has the certification, know-how and experience required to perform dental implant surgeries.
- He is the holder of a valid professional liability insurance policy covering this activity.
- He is aware that although the design software may include various medical parameters, they are not necessarily all the parameters that are to be taken into account and that they do not constitute a substitute to his medical discretion.
- The Dentist has the exclusive and only medical discretion and he is the only one with sole and exclusive authority to approve all the medical processes associated with and deriving from ordering the auxiliary services.
- Responsibility to produce the implant design and to approve it, to examine the standardization of the surgical apparatus and it being suitable for the implant software, as well as carrying out the implant on the basis of the implant design lies solely with the Dentist. It is hereby clarified that the Company does not have the ability nor will it be liable for the implant software, to examine whether it is suitable for the surgical apparatus, or carrying out the implant, its success or results.
In the event the Dentist’s professional liability insurance policy is cancelled or ends, the Dentist will cease, forthwith, to use the Company’s auxiliary services, will not carry out any implants in reliance upon the auxiliary services and will inform the Company thereof in writing, forthwith. The Dentist undertakes to indemnify the Company and/or directors, shareholders, officers, employees, partners or its subsidiary companies or
companies affiliated with the Company, for any liability, damage and/or expense they incur as a result of not upholding the terms in this section which is a material term in these engagement terms.
The Dentist undertakes to undergo training on the Company’s behalf in respect to the manner of receiving and using the auxiliary services and this before receiving and carrying out the implants pursuant thereto.
The Dentist undertakes that any other Dentist on his behalf intended to use the auxiliary services will also undergo the foregoing training before using the auxiliary services and before carrying out any implants pursuant thereto.
Pursuant to invoices that the Company will issue to the Dentist from time to time, the Dentist will pay the Company, in accordance with the payment terms agreed with him,
the rates detailed in in the Company’s relevant price list for the service the Dentist requires. The Company reserves the right to update, from time to time the rates subject to notifying the Dentist in advance.
The Company and/or directors, shareholders, officers, employees, partners or its subsidiary companies, will not be liable toward the Dentist or his patients for any loss, damage, harm and/or expense of any type, including but not limited to direct or indirect, pecuniary or otherwise, special or general, consequential or secondary, that are sustained as a result of or in connection with the medical liability for producing or using the implant design, surgical apparatus and/or the surgical kit and/or in connection with the design and choosing the implant design and carrying out the medical treatment pursuant thereto.
If it is found that the Company is liable to compensate the Dentist and/or anyone on his behalf and/or a third party for damage that any one of them sustain in connection with the activity deriving from this agreement – the Company’s maximum liability will be limited to payment of an amount equal to double the consideration amount paid by the Dentist for the service and/or the product in respect of which liability manifested.
The Dentist undertakes to indemnify the Company and/or anyone on its behalf as detailed above, for any liability or expense they incur due to claims by patients based on any grounds including but not limited to medical malpractice.
The Dentist is not entitled to transfer and/or assign to any other entity, his rights pursuant to these engagement terms. The headings of the sections in these engagement terms are solely for convenience purposes and will not serve as an aid to interpreting the terms. Any waiver of any of these engagement terms will not constitute a waiver of the rest of the terms. Any of these engagement terms being rendered invalid or unenforceable will not prejudice the validity or enforceability of the rest of the terms. Any change or amendment to these engagement terms will only be made in writing and will be valid only after it is approved in writing by all the parties. The laws of the State of Israel will govern these engagement terms and the courts in the Tel Aviv district and/or Central district will have exclusive and only jurisdiction to entertain any matter connected to and/or deriving from them.
Auxiliary Services To Position Implants – General Terms:
The Alpha Bio Tech Ltd. Company (“The Company“) will provide, on the basis of a designated computer software imaging services that will serve as an aid by the Dentist to determine the position of the dental implants within the framework of the preparation process that it carries out for implant surgeries. The service is based on the “Model Guide to produce surgical apparatuses using designated computer software, enabling: simulation of implant positioning through the aid of CT imaging; two dimensional and three dimensional presentation and illustration of the patient’s anatomy; locating and marking critical structures (such as: the Inferior alveolar nerve, sinuses and nose floor); and generating a surgical apparatus for the Dentist’s use during the course of the surgery.
Positioning the implants is done in accordance with the requested implant design by the attending Dentist. The service includes adapting the CTimages that are received from the Dentist to the software systems, consulting about the position of the implants in accordance with the attending Dentist’s requirements, and subject to his approval, preparing the surgical apparatus to perform the surgery.
Registering for the Service
The use of the service requires early registration. A Dentist interested in using the service must register in advance on the service’s website.
Registering for the service is personal. The Dentist is not entitled to transfer and/or assign his rights to any other entity.
In the Dentist’s request to use the Company’s services, by signing or approving the auxiliary services order agreement attached hereto and the limits on liability sections
included therein and in accordance with his declarations in the agreement, the Dentist understands, agrees and declares that he has the know-how, training and approvals necessary to design and perform implant surgeries. Similarly, he agrees that since all the circumstances and the full information pursuant to which the Dentist orders the service are within the exclusive control of the Dentist , he will be exclusively liable under these circumstances and use of the service in accordance thereto. The Dentist is also aware and agrees that to in order to perform the service the Company makes use of additional software, tools and aids supplied to it by third parties and it is not liable for the standardization and/or accuracy of the foregoing aids and that he must verify the standardization, suitability and accuracy before using them. For the purpose of rendering the service, the Dentist transfers to the Company, information, digital files, radiology apparatus and a plaster model manufactured by the institutes and laboratories selected by the Dentist in accordance with his instructions. The Dentist agrees that he is exclusively liable for the standardization, suitability and accuracy of these items.
Privacy Statement – Delivery, Processing and Saving Personal and Medical Details Approval
For the purpose of supplying the service the Company collects and saves private information about the Dentist and/or patient including inter alia contact details and clinical information. The Company will take all suitable technological and organizational measures for the purpose of protecting the information and all this in accordance with the privacy protection rules practiced by the Company and pursuant to the law. The Company reserves the right to change, from time to time, the rules practiced by it.
The Dentist hereby confirms that he hereby consents to remitting his details to the Company for the purpose of this engagement to render the service and that he obtained the consent of the patient to remit clinical, medical and personal details to the Company to render the service and for patient and Dentist identification, to use the information for this purpose and to save it for approximately 7 years after the engagement between the Dentist and the Company ends.
Termination of the engagement will be in writing by the Dentist.
Additionally, the Dentist hereby consents to the Company contacting him and offering additional products and services including but not limited to courses and training events of the Company and of companies affiliated with it, through its representatives, distributors or the representatives of the companies affiliated with the Company.
As part of the registration process for the service, the Dentist undertakes to undergo designated training regularly held by the Company.
Participating in the training sessions is a condition precedent to the Dentist receiving the service. The training will be conducted frontally or over the internet of the Company’s choice.
The Surgical Kit
Performance of the guided surgery requires designated tools suitable for work with the surgical apparatus. The Company will make available to the Dentist (by way of sale or lease) suitable sets of designated surgical tools. The set includes a variety of tools including designated drills, setting pins, various keys and aids. The tools are supplied to the Company by a third party including CE approval and are under its sole responsibility.
The Surgical Apparatus
The purpose of the surgical apparatus, placed and affixed in the patient’s mouth is to assist the Dentist to position the implants
as best as possible to the location that he determined in the implant plan. The apparatus is manufactured from acrylic compounds approved for medical use (Biocompatible) in a steriletography process and titanium sleeves positioned therein replicating the location
of the implants by guiding the drilling and penetrating the implants in the location and direction proposed by the software and approved by the Dentist.
The surgical apparatus is likely to also include titanium sleeves that serve to position the setting pins that are appropriate for the setting pins supplied with the surgical kit. The apparatus is unique for each patient and cannot be transferred or used again other than for the specific design for which it was produced.
The Work Process
The Work Process may be updated from time to time due to improvements that the Company wishes to make and become part of the service.
- Ordering the Work: After the Dentist examined the patient and decided that the case is suitable for the positioning of computerized implants, the Dentist will issue a work order [subject to registration and training as detailed above for each case separately]. The work order will be done by completing a special form available on the Company’s website and includes inter alia the case details, guidelines and relevant requirements and contact details. Upon completing the work order the Dentist will specify the exact design it requests and the service will be given in accordance with the work order and will not include professional consults and/or proposals for changes and/or design guidelines that are different from that requested by the Dentist. In cases in which it is clarified that it is not possible to render the service in accordance with the requested design, the Company will inform the Dentist and he can change the work order accordingly or alternatively, cancel it. For each work order a unique work order number will be generated that will accompany the case throughout the entire service process.
- Items required to execute design: for the purpose of the Company rendering the service, the following items will be required:
- A complete and approved work order.
- CT files in DICOM format.
- Plaster model.
- The Dentist signing the design and approving it.
- Preparation for Design
Before ordering the work form the Company, the Dentist must perform the following actions:
Taking impressions of the case.
Preparing a Master Model.
CTimage in accordance with the requisite protocol.
Quality and accuracy of each one of the procedures is likely to impact the overall accuracy of the design. The Company is not liable for faults and/or inaccuracies deriving from these items.
- Designing the case: Designing the case will begin upon receiving all the requisite items. The Dentist knows and confirms that generating the design proposal for the positioning of the implants will be done by a technician of the Company who will have undergone training specific to this matter (The Positioner). The Company does not undertake that the software will be operated by a Dentist, and the proposed positioning of the implants is solely a recommendation in reliance upon the information and items the Dentist remitted to the Company and in accordance with the work order issued by the Dentist.
The positioner has no discretion in regard to the design requirements in the work order and will carry out the design solely in accordance with the work order. In cases in which due to technical reasons and the system restrictions it is not possible to carryout the design in accordance with the work order the positioner will draw the Dentist’s attention to the restrictions and the Dentist may change the work order accordingly or alternatively cancel the order. Upon completing the design the designer will remit a file to the Dentist containing the designed case in PDF format for approval, and if necessary, the positioner will schedule a time for a virtual meeting for the purpose of presenting and explaining the proposed design.
- Fine tuning and approval thereof during the course of the virtual meeting between the Dentist and the positioner, the positioner will present its proposal to the Dentist. The Dentist can see the proposed design. In the event corrections / slight changes are required to the proposed design, the Dentist will issue a correction/ change demand accordingly. The positioner will make the necessary changes and/or corrections, will send a corrected file to the Dentist and will schedule an additional
meeting to verify and approve the new design.
- Ordering New Work: Upon completing the explanations and changes/ corrections round to the Dentist’s satisfaction the final cost of the service will be determined including special characteristics if applicable. The Dentist will sign the approval of the design form and surgical apparatus order that will be sent to him to sign. By signing this approval and approving these terms, the Dentist confirms that he viewed and understood the proposed design and it is suitable for his needs in accordance with the work order and the Dentist knows and accepts full and exclusive responsibility for the decision to carry out the design in the proposed manner
and that he confirms the final cost of the service as presented to him.
- Supplying the Surgical Apparatus: Once the design is approved by the Dentist the surgical apparatus will be manufactured. The apparatus will be sent to the Dentist together with the plaster model, the radiological apparatus (if necessary), together with the final design, a copy of the work order and an invoice. Each case will be sent packaged separately. Upon receiving the apparatus the Dentist must ensure to verify that the unique order number matches the number appearing on the apparatus package.
- The Dentist hereby undertakes that he read and will act in accordance with the attached instructions for use for each consignment of a surgical apparatus. [Eli: I recommend reinstating:
- The Dentist hereby undertakes
to comply with the National Health Regulations (Saving Records), 5737 – 6791, National Health Ordinance ,6791, The Patient’s Rights Law, ,6771, or the Ministry of Health’s guidelines pertaining to medical management of Dentist clinics appearing in the dental hygiene procedure that is valid at that time.