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In Vitro Diagnostic Medical Device For professional use only

Q PATH ADHESIVE SLIDE

According to standard ISO 18113-2 : 2009, Point 7 Requirements for instructions or use and consolidated Directive 98/79/EC

PRODUCT NAME

Cat. No Description Pack Size

10048001 Q path Adhesive Slide white Box of 72 slides

10048002 Q path Adhesive Slide blue Box of 72 slides

10048003 Q path Adhesive Slide green Box of 72 slides

10048004 Q path Adhesive Slide yellow Box of 72 slides

10048005 Q path Adhesive Slide pink Box of 72 slides

INTENDED PURPOSE

These slides may be used for the routine diagnosis of suspensions of cells and samples of tissue. Given that the possibilities for their use are highly varied, these slides should only be handled by users who hold a professional qualification that complies with national legislation. These microscope slides are intended for single use only. Any re-use or inappropriate treatment of their surface could lead to inaccurate results, the deterioration of preparations, and erroneous diagnoses.

WARNING AND PRECAUTIONS

Before use, please read all this information carefully.

Microscope slides and cover slips are intended for single use by qualified personnel. They must under no circumstances be used more than once, and must be disposed of after use or at the end of the archive period in an appropriate manner as potentially infectious waste.

If you observe any damage to the packaging, or any signs of glass fragments, the slides and cover slips must not be used, due to the risk of injury from glass splinters.

Recommendation: In order to reduce the risk of injury due to sharp edges as much as possible, we strongly recommend the use of our microscope slides with polished edges.

01/2011 VWR International SAS 201 rue Carnot 94126 Fontenay-sous-bois France Rev. Date: 08/2015 IFU_ADHSIVESLIDEQPATH_V03_EN Page 1 of 4

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In Vitro Diagnostic Medical Device For professional use only

Q PATH ADHESIVE SLIDE

COMPOSITION

Microscope slides for in vitro diagnosis are slides with a thickness of approx. 1 mm, made of glass with a soda and lime base, for the microscopic study of human tissue samples. They are manufactured for single use by professionals, complying with norm ISO 8037/1, and are used in the study of suspensions of cells and tissue samples and the manufacturing and archiving of preparations. The refractive index ne = 1.53 ±0.02 where e = 546.07 nm (green mercury line) describes the optical characteristics of the soda and lime based glass, important for .

STORAGE AND SHELF LIFE AFTER FIRST OPENING

These products must be stored in their original packaging in a dry environment at a constant ambient temperature, preferably protected from light and heat sources. Any necessary change in temperature should take place gradually. Please comply with the stated maximum stacking heights. Avoid violent shocks, even during internal transportation. Observe the expiry date on the packaging – the shelf life does not change once opened.

• Store slides in a dry place • Store slides in a place with a stable temperature. Changes in temperature may cause condensation • Store slides in a place with a low level of humidity • Slides must be at ambient temperature for a period of 24 hours before the box is opened. • Protect slides from mould by not storing them on the ground. • FIFO (first in first out) – use oldest slides first.

ADDITIONAL SPECIAL EQUIPMENT

The operating instructions for the diagnostic equipment used must be followed. Traceability of the patient’s sample must be guaranteed by the ; appropriate methods of marking and archiving must be selected.

SPECIMENS

Microscope slides should only be used by qualified personnel who have received appropriate training. Given that slides should not be used by non-professionals or for private purposes, we have not described the multiple possibilities for their use and refer you instead to specialised literature for general and professional training.

MODE OF OPERATION

Microscope slides are normally ready for use, and may, having been brought gradually to ambient temperature, be used without any preparatory work. If the diagnostic processes that you use necessitate any preparatory measures involving the microscope slides, these must take place in accordance with the operating instructions provided by the respective suppliers of the systems or samples, or under the application of your own approved procedure. Labelling areas on microscope slides are used for the unambiguous identification of preparations, and you should use suitable pencils, solvent-resistant if necessary, for this purpose.

METHODOLOGY

• PRINCIPLE OF THE METHOD The method using preparations on microscope slides must take place in accordance with the operating instructions provided by the respective suppliers of the systems or samples, or by applying those contained in your own approved procedure. When choosing a

01/2011 VWR International SAS 201 rue Carnot 94126 Fontenay-sous-bois France Rev. Date: 08/2015 IFU_ADHSIVESLIDEQPATH_V03_EN Page 2 of 4

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In Vitro Diagnostic Medical Device For professional use only

Q PATH ADHESIVE SLIDE procedure for microscopic study, you should comply with the operating instructions provided by the supplier of the laboratory glassware or the instructions contained in your approved in-house procedure. You should take care to ensure that are used with appropriate light sources or wavelengths.

• METHOD CHARACTERISTICS AND PERFORMANCE LIMITATIONS Establishment of a diagnosis on the basis of preparations may only be carried out by a doctor who has completed his studies or a person with comparable authorisation. When the diagnosis is being made, you should take into account any instructions provided by suppliers of laboratory glassware. In the interest of the doctor making the diagnosis, it should be ensured using other diagnostic measures. In the event of insufficient identification or quality of the sample, a diagnosis should not be made.

Q path Adhesive slides are based on the fundamental research work and tests of Dr. Stöcker. Our special surface treatment with silane-coating forms permanent, free polar bonds on the surface, which also through electrostatic attraction ensures cell-and-tissue- adhesion and supports the forming of covalent bonds between the tissue and the glass surface. Tissue and cell substrates stick rapidly on our Q path adhesive slides without using further adhesives or protein coating media. This saves costly and time consuming preparation-techniques.

In the meantime, these adhesive slides have proved themselves a million times and came out on top as a real alternative for cell- adhesion, e.g. on tissues, formalin-fixed and paraffin sections. The advantage of our Q path adhesive slides is the restriction of the adhesive coating to the top surface of our slides and therefore to the usable area only. On our adhesive slides the under side is untreated therefore the slides do not tend to stick when stacked or transported as with other competitive products and difficulties with marking are also avoided.

Q path adhesive slides do not show striae and disturbing background colouration such as the blue or red background obtained with Haematoxylin and Eosin-staining of tissues on Albumin coated glass, or the brown background obtained during the Immunoperoxidase or In-situ-DNS-Hybridisation process. During these procedures our adhesive slides allow stronger enzyme-induction without losing the tissue. For molecular-hybridization, washing with chromic-acid is redundant, due to our RNSase-free adhesive slides.

REAGENT PREPARATION

Not applicable

LITERATURE REFERENCES

Not applicable.

HANDLING WASTE

Used microscope slides must be treated as infectious waste. Laboratory glassware may also contain substances that are to be treated as special waste. In doing so, it is necessary to comply with the respective regional legislation.

AFTER-SALES SERVICE

We pay the utmost attention in the quality of our products. However, if you are not satisfied, please contact our Customer Service ([email protected]) and indicate the reference and batch number of the product concerned.

This instruction for use was established on 05/08/15 and cancels all previous instructions. The information is based on our knowledge and our experience this day. The attention of the users is drawn on the eventual risks when the product is used for another use for

01/2011 VWR International SAS 201 rue Carnot 94126 Fontenay-sous-bois France Rev. Date: 08/2015 IFU_ADHSIVESLIDEQPATH_V03_EN Page 3 of 4

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In Vitro Diagnostic Medical Device For professional use only

Q PATH ADHESIVE SLIDE which is dedicated. It is not exempt the user to know and implement all the texts regulating his activity. He will take under his responsibility the precautions bound in the use that he does of the product.

01/2011 VWR International SAS 201 rue Carnot 94126 Fontenay-sous-bois France Rev. Date: 08/2015 IFU_ADHSIVESLIDEQPATH_V03_EN Page 4 of 4

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