GENERAL CONDITIONS OF SALE
Version: V10.04.00 – last updated 08.10.2020
1 – SCOPE
These general conditions of sale shall apply to all sales of products entered into by the FIM MEDICAL company. These general conditions are expressly agreed upon and accepted by the Buyer, who declares and recognises full knowledge upon signing the quote and/or upon receipt of the acknowledgement of receipt of order.
Consequently, the placing of an order implies the full and unconditional acceptance by the Buyer of these general conditions of sale which represent all the provisions which apply to the sales made by FIM MEDICAL, notwithstanding any other documents provided by the seller, such as prospectus and catalogues which only have an indicative value.
Any contrary conditions imposed by the Buyer are non-opposable to FIM MEDICAL, unless it expressly agrees, beforehand, to such conditions.
The fact that, at any given point in time, FIM MEDICAL may not have imposed one or several of the present general conditions of sale shall not constitute a waiver of its right to impose these conditions at a later date.
2 – PURCHASE ORDERS
Except where provided for otherwise, quotes issued by FIM MEDICAL are solely valid for 30 days from their date of issuance. FIM MEDICAL reserves the right to refuse an order in the event of non-compliance of the order with FIM MEDICAL conditions of sale. Any change made to an order already received by FIM MEDICAL is subject to prior approval by FIM MEDICAL, which reserves the right to accept or refuse such change. Online orders are exclusively reserved for Purchasers whose legal entity making the order is located within the European Union and also at delivery of the products within the European Union: Shipping costs are automatically calculated according to quantity ordered, weight and volume, and place of delivery, and are mentioned in the offer issued by FIM MEDICAL, and this where the products are delivered to premises designated by the Buyer.
For FIM MEDICAL to efficiently process online orders, the Buyer must fill in each section as well as the compulsory fields identified by an asterisk, in a precise and complete manner. As soon as the order is registered, the Buyer will receive, by email, an order confirmation indicating prices, quantities and availability of the products ordered, shipping costs, and estimated delivery date to the premises designated by the Buyer.
If the Buyer changes their mind or makes a mistake, they have 14 days from receipt of order to return the unsuitable product in its original packaging; the Buyer shall bear the cost of returning the product to the FIM premises, which shall remain entirely at their expense.
No returns will be accepted without the prior agreement of our Customer Service Department, which can be reached on: + 33 4 72 34 89 89 or at the following email address: email@example.com. FIM shall only accept a refund if the product is returned complete in its original, functional and new packaging.
If the returned product is not in its original condition (incomplete, deteriorated, non-functional, having undergone any kind of handling or use, etc.), FIM MEDICAL reserves the right to apply a reduction of up to 50% of the value of the returned product, excluding shipping costs attached to the first shipment. Any reimbursement will be made according to the means of payment used at the time of the order.
3 – MODIFICATION OF PRODUCTS
FIM MEDICAL reserves the right to modify its goods at any time that it deems necessary, without the obligation to modify the goods already delivered or ordered. FIM MEDICAL further reserves the right to alter, without prior notice, models appearing in the prospectus and catalogues.
4 – DELIVERY
Goods shall be delivered either by direct handing over of the goods to the Buyer, by simple availability notice, or by the delivery to a consignor or carrier on the FIM MEDICAL premises. For online orders, delivery is made only by direct delivery of the product to the Buyer at the premises designated by the latter.
Deliveries are operated according to the availability of the products and in the order of arrival of orders. FIM MEDICAL is authorized to make full or partial deliveries. Delivery dates are indicated as accurately as possible and depend on the production and transport possibilities of FIM MEDICAL, and these deadlines are not binding. Under no circumstances shall late delivery entitle the Buyer to cancel the contract or to claim damages or deductions. However, if 10 weeks after the indicative date of delivery the product has not been delivered for any reason whatsoever, unless in the case of force majeure, the sale can be terminated at the request of one of the contracting parties, to the exclusion of any other compensation or damages.
In any case, goods can only be delivered if the Buyer has fully complied with all its obligations to FIM MEDICAL.
4.3 Transport– Transfer of Risks – Products – New Products
All goods are shipped on the basis of shipping and packing costs at the Buyer’s expense, except where provided for otherwise under special terms. The said costs are invoiced EX-VILLEURBANNE based on the cost schedules applicable on the date of delivery.
The person receiving the merchandise has the responsibility of checking the condition of the goods upon arrival, and, in the event of damage or shortages, shall make all the necessary verifications and express its reserves with the carrier within two (2) days of delivery by certified letter with confirmation of receipt with a copy to FIM MEDICAL within the same period. The Buyer must be covered by a multi-risk insurance policy (fire, theft, water damage) either from departure of the merchandise by a transporter, or from the date the Buyer acquires the merchandise at the FIM MEDICAL premises. 4.4 Transfer of risks – Return of Goods
Products should be returned to the FIM MEDICAL premises, in Villeurbanne. All goods are shipped on the basis of shipping and packing costs at the Buyer’s expense, except where provided for otherwise under special terms. The cost by FIM MEDICAL for the return of a Buyer’s device is invoiced EX-VILLEURBANNE based on the cost schedules applicable on the date of delivery.
It is the Buyer’s responsibility to take out any insurance covering the risk of loss or deterioration to the products, who, in the case of damage or missing items, shall make all the necessary checks and express its reserves with the carrier, according to procedures, with a copy to FIM MEDICAL within the same period.
It is the Buyer’s responsibility to take out all insurance to cover the risks of loss or deterioration of the goods.
In addition to the arrangements made with the carrier, all claims relating to a visible defect or non-conformity of the delivered goods to the product ordered, must be formulated in writing sent by recorded delivery within two (2) days of receipt of goods.
No claims can be made against FIM MEDICAL for loss or damage of the merchandise if precautions against deterioration upon receipt of the goods have not been formulated with the carrier and if this attestation has not been made with the carrier upon receipt of goods and if this attestation has not been sent to the carrier and to FIM MEDICAL within the above-mentioned deadline.
5 – GUARANTEE
All devices, except the TABATABA® V2 and the 3-litre calibration syringe, which are guaranteed for one (1) year, are guaranteed against any material or manufacturing defect for two (2) years from the date of delivery of the device. Guarantee claims do not extend the guarantee term. The following list of consumables do not come under this guarantee (non-exhaustive list): Earpad covers, SP1®, SP1M®, Qflow®, pipette, trapper, nose-clip, rings, black cones, transportation elements and rolls of thermal paper. As part of its activities, FIM MEDICAL distributes various products such as weight and height body scale, blood pressure monitors, stethoscopes, etc. Each of these products has its own manufacturer’s guarantee.
The sole obligation binding FIM MEDICAL shall be the replacement or repair free of charge of the product or of the part recognised as defective by its services.
All products returned under guarantee must have the prior agreement of FIM MEDICAL, with attribution of a Return Merchandise Authorization (RMA). For such purpose, the Buyer must send an email request to the FIM MEDICAL After Sales Service department, noting the device serial number and an accurate as possible description of the nature of the problem.
The defective product must be returned in its original packaging with the supplied RMA and include the entire product and its accessories. Any shipping and transport costs are assumed by the Buyer, who cannot make any claim whatsoever for product immobilization resulting from guarantee-related services.
In the event that the Buyer does not have the original packaging, FIM MEDICAL shall offer to send the Buyer new packaging at the Buyer’s expense. If no new packaging is ordered, the Buyer will accept responsibility for any damage resulting from poor packaging when goods are re-shipped.
This guarantee does not cover patent defects. The following defects and deteriorations are also excluded when caused:
– by force majeur or by normal wear and tear of mechanical parts;
– by negligence, faulty maintenance or abnormal use of the product, even if momentary, or non-conform use for which it is intended.
– whenever modifications or outside service has been made on the equipment.
The Buyer may, if desired, take out a guarantee extension of three (3) years, bringing the total length of the guarantee to five (5) years from the date of delivery of the Product, by checking the appropriate box on the quotation and the order form.
For the TABATABA, a guarantee extension may be taken out for one (1) or two (2) years from the date of delivery of the Product.
This guarantee extension is granted upon receipt of a supplementary fee, the sum of which is due the date of delivery of the Products. The terms and conditions of this extension, notably the rates, are available upon simple request to FIM MEDICAL. This offer is valid only for metropolitan France.
AFTER SALES SERVICE GUARANTEE:
Following annual maintenance or repair by FIM MEDICAL, device benefit from a 6-month after-sales guarantee. If, within this period, the device requires return to our workshop, then the maintenance-adjustment package will be paid for by FIM MEDICAL, if the breakdown is attributable to the latter. If breakdown is linked to wear and tear of one or more parts not covered by the fixed price (see list in chapter 10 – After-Sales Service), an additional estimate will be issued after expert appraisal, with the parts to be changed. If the return is linked to incorrect handling by the user and to a fact, in general, attributable to the Buyer (e.g.: device dropped, soaked in a solution, etc.) this guarantee does not apply. A preliminary estimate will be issued with the cost of the maintenance-adjustment package and the parts to be changed.
If you have chosen an “All Inclusive” maintenance-adjustment package, the 6-month guarantee will also apply to the replacement of worn parts not covered by the standard package.
6 – MAINTENANCE
Only persons agreed upon expressly by FIM MEDICAL are authorized to carry out work on FIM MEDICAL equipment without jeopardizing the CE marking. FIM MEDICAL has designed and made available utility software required for the maintenance of its devices. Non-authorized persons, and thus those not referenced by FIM MEDICAL, do not have in their possession this software. The Buyer may, if it wishes, take out a maintenance contract with FIM MEDICAL for the products for a duration of 2, 3 or 4 years. Related products: VISIOLITE®, VISIOCLICK®, ADL10®, ADL20®, SPL10®USB and the Q13®. The terms and regulations of this maintenance, notably tariffs, are available upon request to FIM MEDICAL. This offer is valid only for metropolitan France.
Distributors of FIM MEDICAL products are not authorized to carry out interventions on FIM MEDICAL devices without express authority. A certificate must be supplied by FIM MEDICAL for authorization.
7 – PRICES – PAYMENT
Products are sold at the prices in effect at the time orders are placed. Prices are given ex-works, net of taxes. Any duties, taxes, rights or other services to be paid applying to the laws and regulations in force in France or in the importer’s country or of transit are at the Buyer’s expense.
Invoices are to be paid on the delivery date (with the exception of online orders payable at the time of order confirmation ). No discount shall be granted for cash payment. In the event of non-payment, even partial, on the due date, the seller can suspend all deliveries and demand the immediate payment of all remaining sums due by the seller to the Buyer. Any summons for payment issued by the seller to the Buyer, which remains unpaid after a period of 48 hours will cause the lawful termination of the sale contract, should the seller desire so, without prejudice of all the other damages it could claim. FIM MEDICAL may also definitively suspend all other orders in progress and all previous unpaid orders regardless of whether they have already been delivered and regardless of whether the payment thereof has fallen due.
Page 1 sur 2
8 – LATE CHARGES
For late payments, and in accordance with legal measures in force, FIM MEDICAL has the right, with no other formality, to apply interest charges at the rate of 3 times the legal interest rate. This interest will accrue from the date of due payment on the amount including VAT until the date that actual payment is cleared.
A fixed compensation fee of the sum of 40€ shall also be applied for recovery costs.
Further, in compliance with Section 1226 of the Civil Code, in the event of failure of payment, any amounts due recovered by forced collection will be increased by a fixed penalty fee, in addition to late payment fees, of 15% of the amount due including VAT.
9 – TITLE OF OWNERSHIP
Products are sold under a clause expressly subjecting the transfer of ownership thereof to full payment of the principal price and ancillary charges, as provided for under the French Act 80-335 of 12th May, 1980. The simple issuance of a financial instrument creating an obligation to pay, including drafts, does not constitute a payment under this clause and FIM MEDICAL’s original claim over the Buyer subsists with all of the guarantees attached thereto, including retention of ownership, until the said financial instrument has actually been paid. The above provisions do not prevent the transfer of the risks of damage or loss to the Buyer upon delivery of the products subject to the ownership reservation, as well as any damage which they may cause. The Buyer shall take out comprehensive insurance (fire, theft, water damage) covering risks that may occur as from the time of delivery.
In the event of attachment or any other action taken by a third party involving the products, the Buyer shall immediately inform FIM MEDICAL in order to enable FIM to contest the action and maintain its rights. The Buyer shall further refrain from pledging or assigning ownership of the products as a guarantee.
It is expressly agreed that in the event of failure to remit any payment instalments whatsoever, the full price will be immediately due and may result in products being immediately reclaimed.
10 – AFTER SALES SERVICES
All After Sales Service returns must have an RMA attributed. For more information on the returns procedure, refer to Chapter 5: Guarantee.
FIM MEDICAL proposes After Sales Services standard rates depending on the date of last return of the device to the After Sales Service department. Rates include checking device parts and vital functions, verification and calibration, firmware and external software update, replacement of used parts (with the exception of certain parts listed above), labour costs and shipping costs to a France mainland address. Not included are rates for replacing the following parts:
– Spirometer SPL10®USB: motherboard and pressure sensor, laminar tube if clogged or damaged;
– Spirometer Q13®: motherboard and pressure sensor;
– Audiometer ADL20®: motherboard, headphones and headband;
– Visiolite®: different electronic boards, optical motors;
– Audiometer ADL10®: motherboard, headphones and headband;
– Visioclick®: of the main board, electronic board and support.
For these cases, an extra quote will be sent.
In the event of breakdown, whether during or outside of the guarantee period, FIM MEDICAL will make its best endeavour and take any action necessary to service such breakdowns with all due dispatch. However, under no circumstances may FIM MEDICAL be held liable for any delay whatsoever nor assume any costs or consequences whatsoever in connection with the length of immobilisation of the equipment within its departments.
11 – APPLICABLE LAW – DISPUTES
All clauses present in these general sales conditions, as well as all buying and selling operations are governed under French law.
In the event of dispute relating to such conditions or sales, it shall be referred to the Commercial Court of LYON.
12 – RESPONSIBILITY OF COLLECTING AND PROCESSING ELECTRICAL AND ELECTRONIC EQUIPMENT WASTE
FIM MEDICAL supports the Directive 2002/96/EC of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE).
At the time of purchase of an electric or electronic product from FIM MEDICAL, FIM MEDICAL offers to take back the equipment sold in France once it has become electrical and electronic waste material. In such case, the Buyer shall return such equipment to FIM MEDICAL at its own cost.
At the time of purchase in France of an electric or electronic product from FIM MEDICAL to be sold in a foreign country, all duties, taxes and declarations relating to the regulation on waste electrical and electronic equipment in force in such country shall be the sole liability of the Buyer.
As such, you make a friendly gesture for the environment, the conservation of natural resources and health protection.
13 – TRACEABILITY OF FIM MEDICAL DEVICES AND SOFTWARE
Within the framework of materiovigilance, FIM MEDICAL ensures the traceability of devices and software, from sale to Buyer delivery.
– Upon receipt, the Buyer commits to ensure traceability of the devices/consumables/software from the serial numbers and/or batch numbers on the label of the product purchased from FIM MEDICAL, provided for this purpose. If, for internal reasons, the Buyer must establish internal traceability, please provide a double marking on the label in order to enter your internal reference as well as the FIM MEDICAL reference.
– For distributor sales and deliveries, all distributors agree to directly ensure their own traceability to the final customer, and to ensure follow-up for stock returns, standard exchanges and/or updates, in compliance with EU Medical Devices Regulation 2017/745. Distributors agree to set up an effective traceability tool and to implement all the means required to ensure the safety of users in the event of equipment recall, upon the request of FIM MEDICAL or the ANSM. So as not to effect the traceability system set up by FIM MEDICAL, or the performance of FIM MEDICAL devices, distributors agree not to carry out interventions on the devices (see point 6). Export distributors (outside Metropolitan France) are not authorized to sell FIM MEDICAL products outside their national territory.
– All transfers of ownership of equipment or its place of use shall be communicated to FIM MEDICAL, for the purposes of updating traceability files. This transfer shall only be authorized by FIM MEDICAL if the device concerned was returned to FIM MEDICAL After Sales Service for annual servicing and that the new owner or user has at their disposal the device user manual, its software and the approved licence contract. Maintenance contracts may be transferred on the condition that they have been paid in whole.
– All software updates shall be applied according to the conditions in the licence contract. All supplied updates must be installed immediately upon receipt by the user, otherwise the FIM MEDICAL After Sales guarantee will become void.
14 – CLIENT CLAIMS AND INCIDENTS
FIM MEDICAL must be informed of all client claims and incidents as soon as possible, in compliance with EU Medical Devices Regulation 2017/745. Contact the switchboard on (+33) 04 72 34 89 89.
15 – DOCUMENTATION
FIM MEDICAL is responsible for the translation of the documentation concerning its devices from this (non-exhaustive) list: commercial documentation, user manual, response form, client information sheet. Documentation concerning the FIM MEDICAL devices is translated into the languages of the countries to which the goods are delivered. If a language is unavailable, documents are automatically delivered in English. Distributors agree to not deliver documents concerning FIM MEDICAL devices other than that supplied by FIM MEDICAL, and to not translate them. All translation requirements in the language of the country to which the goods are delivered must be agreed upon between FIM MEDICAL and the distributor, before the sale.
Apart from the TABATABA®, the user manuals for the FIM MEDICAL devices are directly available in PDF version on the CD supplied with the device.
If a paper user manual is desired, a request must be made to FIM MEDICAL. This shall be delivered at no cost in approximately 7 days.
The Distributor is not authorized to compromise the integrity of the device, which includes any modification of packaging elements, unpackaging/repackaging, and modification, including translation, or addition of labels or instructions for use that would be likely to modify the texts present on the product or accompanying it, in compliance with EU Medical Devices Regulation 2017/745.
16 – PERSONAL DATA
In accordance with Law 78-17 of 6 January 1978 and EU Regulation 2016/679 of 25 May 2018, it is reminded that personal data requested from the customer is necessary for processing orders and executing contracts. This data may be communicated to any of our company partners responsible for the handling, processing, management and payment of orders. This data is kept for a period of 10 years. In accordance with national and European regulations in force, the customer has the right of permanent access, modification, rectification, opposition, erasure and portability of information concerning him/herself. This right may be exercised under the terms and conditions that will be communicated to you by our Sales Department, by Mrs. Derei, who may be contacted by email at the following address: firstname.lastname@example.org.. The File Manager has a 1-month response period from the date of receipt of the request. If the request cannot be met immediately, a dated and signed acknowledgement of receipt will be provided to the applicant. If the request is incomplete (surname, first name, email address, customer code and client company), the File Manager is entitled to request additional information: the deadline is then suspended and runs again once these elements are provided.
17-EU REGULATION 2017/745 MEDICAL DEVICES
Any Distributor of Medical Devices undertakes to read and comply with the requirements of the EU Regulation 2017/745 Medical Devices which comes into force on 26 May 2021.
Page 2 sur 2