CUSTOMER GUIDE
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The CE marking on a medical product is a manufacturer's declaration that the product complies with the essential requirements of the European Medical Directive 93/42 EEC regarding the quality and usage safety.
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Starting from 01.05.2004 – the day of Poland’s accession to the European Union, only the medical products with a CE marking can be sold on the Polish market.
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Every medical product which has been purchased on the territory of Poland since 01.10.2002, i.e. the day the Act on Medical Products came into force, should be submitted for registration in the Register of Healing, Medical and Biocidal Products.
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Pursuant to Art.3 of the Act on Medical Products, a foreign manufacturer of medical products must have an authorised representative in order to obtain an entry to the register.
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Our company and the products included in our offer meet all the above mentioned legal requirements. What is more, the products we offer have additional certificates and recommendations which confirm their highest quality: ISO, GNP, TUV, BHS, AAMI.
How to choose a BP monitor?
To ensure a proper blood pressure measurement at home, the patient must closely follow the rules of measurement and use precise and reliable measuring devices, commonly known blood pressure monitors.
A wide range of such appliances is currently available on the market but, unfortunately, their quality is often low. To make sure we make the right choice and buy a BP monitor, which will in the future meet our expectations, we should pay attention to such features of the device as:
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clinically validated – it is the highest measurement accuracy grade A/A awarded in accordance with BHS (British Hypertension Society) protocol A/A or accuracy evaluation in accordance with the international AAMI/ESH protocol ( The Association for the Advancement of Medical Instrumentation and European Society of Hypertension). The devices with these attests can be considered as precise and their measurement readings are reliable.
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BP measurement in case of arrhythmia – BP monitors equipped with IHB system (Irregular Heartbeat-Indicator) make proper blood pressure measurement even when the pulse rate is irregular (arrhythmia). This feature is very useful, because even the people who do not have a diagnosed arrhythmia may sometimes have an irregular heartbeat, which may, to a great extent, distort or even unable a blood pressure reading.
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an appropriate cuff – it is important for a BP monitor to have a cuff of the appropriate size, which could be easily fitted to our arm. The cuffs produced with the application of Slimfit technology, adjust to arm size and are very resistant to damage during inflation. A damaged or inappropriately fitted cuff makes a proper blood pressure reading impossible.
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automatic result classification – this additional feature enables automatic classifying of the reading into a suitable category: optimal pressure, mild hypertension, moderate hypertension or severe hypertension. Measurement result classification conforms to WHO (World Health Organization) recommendations. Thanks to this innovative method we can always be sure of the right interpretation of the measurement result.
Blood pressure monitors with all the above features guarantee precise measurements for many years of infallible usage.
Inhalers – how to choose right?
To ensure a proper nebulization at home, the patient must closely follow the instructions included in the instruction manual, and use precise and reliable inhaling devices. There is a wide range of such devices currently available on the market and it is very difficult to make the right choice. If we want the device to meet our future expectations, we should, first of all, take into account the following features:
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the size of the sprayed particles – the regulation of the size of the sprayed medication may be from 0,1 to 7 micrometer, depending on the device
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the working tension – the amount and the tension of the air blown out by the device
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noise level –i.e. how loudly the inhaler works, quiet work is recommended when the device is to be used by children.
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the maximum amount of the produced compressed air - the amount of air produced by the inhaler in one minute.
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automatic switch-off function
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long continuous operation – how long can the device work from the moment it is switched on for the first time and what is the average rest time before it can be re-used
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a mouthpiece for children – inhalations can be done by children
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easily changeable filter – a simple replacement of an important part of the inhaler, which cleans the air before it is compressed together with the medication
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secondary batteries – additional power supply enabling inhalations without the external power supply
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network power supply
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speed regulation – setting the speed or the inhaler’s work – minimum or maximum
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a possibility of buying a longer air tube - a cable connecting the inhaler with the atomizer
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the option of additional medication compartments – in ultrasound devices
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compatibility with other appliances, e.g. a child’s bed
Information for customers
Duties of a Vendor
There are certain responsibilities imposed upon the vendor, including the vital obligation to provide information. The vendor is obliged to inform the purchaser about the following:
- The price of the offered merchandise (as well as the, so-called, unit price, i.e. the price for one unit of measurement, such as one item, metre, kilogram, litre etc).
- In case of special sale types (e.g. instalment sale, indent sale) the vendor is obliged to confirm in writing all the important stipulations of the contract, such as the type of merchandise, its price and the date of sale.
- In the remaining cases, the consumer may request a written confirmation of contract conclusion (including, for instance, the vendor’s reference with their address, the date of sale, merchandise specification, its amount and price).
- The vendor is also obliged to provide the purchaser with clear and comprehensible information in Polish (concerning e.g. the name of the merchandise, its producer or importer, its country of origin, safety mark, admission into circulation, energy consumption).
- Moreover, at purchaser’s request, the vendor is obliged to explain the meaning of particular provisions of the contract.
The vendor is also obliged to provide the purchaser with all the elements of equipment pertaining to the merchandise as well as an instruction and maintenance manual in Polish and all other documents connected with the merchandise.
Another responsibility imposed on the vendor is to ensure proper technical and organizational conditions at the place of sale, which would enable the purchaser to choose a merchandise and verify its quality, completeness and the functioning of main mechanisms and basic sub-parts.
Sale of consumer goods
It is the sale (conducted within the scope of a company’s activity) of movables to a natural person, who purchases this product for a purpose unconnected with their professional or business activity. Such products are referred to as consumer goods. To the category of consumer goods belong such products as a motor vehicle or an automatic washing machine, but also a loaf of bread.
There are certain features of the sale of consumer goods which differentiate it from the contract of sale regulated by the Civil Code:
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The parties in the sale of consumer goods are: the consumer (a natural person entering into a contract for a purpose unconnected with their professional or business activity) and the entrepreneur – vendor.
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The sale of consumer goods includes only the sale of movables. It is not applicable to purchasing a flat.
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The sale of consumer goods does not include the sale of electrical energy, gas and water (unless they are sold in limited amount or defined volume). Neither does it include execution sale or the sale at bankruptcy proceedings or other court proceedings.
The provisions of the Act on the sale of consumer goods also apply to distant sale (e.g. orders placed via the Internet or from a mail-order catalogue) as well as the contracts made outside the company’s premises (purchase from a door-to-door salesman). The Act applies to a wide range of situations, because its stipulations also refer to purchases in commission shops and in case there is a contract for specific work, e.g. when we order a piece of furniture in a service workshop, which they manufacture on their own.
Guarantee
Guarantee is the declaration of the guarantor (e.g. the vendor or the producer)included in the guarantee document, which is presented at the moment of purchase. It defines the responsibilities of the guarantor and the rights of the purchaser in case when the features of the sold merchandise do not conform to the features described by the guarantor in the above mentioned declaration. The vendor gives the consumer a guarantee without any separate payment. Moreover, the guarantee document should contain: the scope of the guarantee regarding time and place, the guarantor’s address and the address of the person receiving a guarantee, the contents of the guarantee (these are obligatory requirements).
Repriced goods
Whether we can make complaints about the goods which have been repriced depends on the reason for repricing. In most cases, the repricing refers to standard value goods which the vendor has problems selling. In such a situation, we have the same rights as it is the case with the goods which have not been repriced. It may, however, happen that the vendor lowers the price because a given merchandise has a certain defect, which we are informed about while buying the product. Then, there is no possibility of making a complaint as regards this particular defect.
Inconformity of the merchandise to the contract
The merchandise does not conform to the contract if:
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it is not suitable for the purpose it is usually used for, e.g. a thermometer for measuring temperature,
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does not have the features which a merchandise of this kind should have and which the vendor or the producer claimed it to have (during individual contacts concerning the qualities of the merchandise or in public declarations, such as advertisements or product marking), e.g. the purchased washing powder does not remove persistent stains even though such declarations have been made in the advertisement,
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the merchandise has been inappropriately fitted or started, providing that these actions have been conducted by the vendor as part of the contract of sale, or by the purchaser in accordance with the instruction manual received at the moment of purchase, e.g. the vendor had fitted an extractor cooker hood, which appeared to be incorrectly connected to power supply.
If the merchandise does not comply with the contract, the purchaser may demand that it is put into a state conforming to the contract by means of a free-of-charge repair or replacement unless the repair or replacement are not possible or would entail excessive costs. If, for the above reasons, the purchaser cannot demand repair or replacement or else if:
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the vendor cannot manage to satisfy such a requirement in reasonable time,
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or if the repair or replacement can cause significant inconvenience for the purchaser,
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the purchaser is entitled to an appropriate discount or can withdraw from the contract.
If the vendor, within 14 days, does not respond to the purchaser’s demand to put the merchandise inconsistent with the contract into a state conforming to the contract by means of a free-of-charge repair or replacement, it is considered that the vendor has accepted the complaint as well-grounded.
The above rights cannot be excluded or limited by means of a contract concluded prior to informing the vendor about the inconformity of consumer goods to the contract. In particular, it cannot be done by a declaration of the purchaser that he/she is aware of the inconformity of the merchandise to the contract, or by choosing the legislature other than the Polish one.
Can we return a product which fully conforms to the contract and works well?
The vendor is not obliged to take such a product back. It depends entirely on their good will. One exception from this rule has been specified in the Act on the protection of certain consumer rights. It is a situation when we have purchased a given product on the basis of:
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a contract made outside the company’s premises (for instance buying a product from a door-to-door salesman) or
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a contract of distant sale (e.g. form an Internet store). In such situations we can withdraw from a contract without stating the reasons by making an appropriate written declaration within the period of 10 days since the date of concluding the contract. To keep this deadline it is enough to send the declaration before due time. In such a situation, the vendor is obliged to immediately (within a maximum of 14 days) refund the whole sum of money we have paid.
Can we make complaints about healing and medical products?
Pursuant to the Pharmaceutical Law Act dated 6 September 2001 (The Journal of Laws No.126, item 1381 with later amendments) healing and medical products purchased in a pharmacy cannot be returned. However, making complaints is possible. If a healing or medical product has:
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a quality defect,
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has been incorrectly sold (e.g. for an incorrect price, in a wrong dose or form), we can make a complaint in accordance with the Act on special terms of the sale of consumer goods and on the amendment to the Civil Code.
Legal basis
The Act of 27 July 2002 r. on special terms of the sale of consumer goods and on the amendment to the Civil Code(The Journal of Laws dated 5 September 2002, No.141, item 1176).
European Customer Centre
Customers Association
www.oznaczenie-ce.pl
www.halat.pl
www.uokik.gov.pl
www.infoobywatel.gov.pl
www.skp.pl
www.giih.gov.pl