Pelvocheck® Swab Collection Kit - Greiner Bio-one

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PelvoCheck® Swab Collection Kit Rev. December 2014 / 453103_00_01 BQ-408-02 Content Kit storage 60 x PelvoCheck® Swab Collection Kit each comprising: V078 (non-sterile) • 1 PelvoCheck® Swab Collection Tube with 5 ml Specimen Collection Medium • 1 Copan CLASSIQSwabs™ 0123 MDD 1640KS01 The PelvoCheck® Swab Collection Kit is ready for use and needs no further preparation. Store unopened PelvoCheck® Swab Collection Kits in the original package at temperatures between 15 and 30 °C in a clean and dry place until the expiration date. Symbols Product Description STERILE R Use by expiration date Catalogue number Batch code Consult instructions for use Single use only H226 Flammable fluid and vapour H319 Causes serious eye irritation P210 Keep away from heat/sparks/open flames/hot surfaces. — No smoking. P240 Ground/bond container and receiving equipment. P241 Use explosion-proof electrical/ventilating/lighting/equipment. P280 Wear protective gloves/protective clothing/eye protection/face protection P305+P351+P338 IF IN EYES: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. WARNING In Vitro Diagnostic Medical Device CE conformity marking Temperature limitation Manufacturer STERILE R Method of sterilisation using irradiation Not to be used in case package is damaged Instructions for use Before using PelvoCheck® Swab Collection Kit, carefully read the entire instructions for use. The instructions for use printed on each plastic pouch package provide only reduced information pertaining to kit handling. It is also important to inform non-laboratory personnel of proper specimen collection procedures, to improve the collection and handling of specimens. (en) Download up-to-date instructions for use, available in multiple languages: (de) Laden Sie die aktuelle, in mehreren Sprachen verfügbare Gebrauchsanweisung herunter: / (fr) Téléchargez le tout dernier mode d‘emploi, disponible dans plusieurs langues: / (es) Descargue instrucciones de uso actualizadas, disponibles en varios idiomas: / (it) Download delle istruzioni per l’uso aggiornate, disponibili in diverse lingue: / (pt) Descarregar instruções de utilização actualizadas, disponíveis em várias línguas: / (nl) Download de meest actuele gebruiksaanwijzing, beschikbaar in verschillende talen: / (da) Download aktuel brugsanvisning, der er tilgængelig på forskellige sprog: / (sv) Ladda ned aktuell bruksanvisning, som finns tillgänglig på olika språk: / (pl) Pobierz aktualną instrukcję obsługi, dostępną w różnych językach: / (no) Last ned oppdaterte instrukser for bruk, tilgjengelig på ulike språk: / (el) Κατεβάστε τις ενημερωμένες οδηγίες χρήσης, διαθέσιμες σε διάφορες γλώσσες: / (tr) Farklı dillerde mevcut olan kullanma talimatlarını indirin: www.gbo.com/bioscience/biochips_download Intended Use PelvoCheck® Swab Collection Kit For the collection, transport and storage of vaginal and cervical specimens to be analysed by PelvoCheck® CT/NG. (de) Für Entnahme,Transport und Lagerung von vaginalen und zervikalen Proben zur Analyse mit PelvoCheck® CT/NG / (fr) Pour le prélèvement prélèvement, le transport et le stockage d’échantillons vaginaux et cervicaux à analyser avec PelvoCheck® CT/NG. (es) Para la extracción, el transporte y el almacenamiento de las muestras vaginales y cervicales que se analizarán con PelvoCheck® CT/NG. (it) Per la raccolta, il trasporto e la conservazione di campioni vaginali e cervicali da analizzare con PelvoCheck® CT/NG. (pt) Para a coleta, transporte e armazenamento de amostras vaginais e cervicais a serem analisadas com PelvoCheck® CT/NG. (nl) Voor het maken, het transport en de opslag van vaginale en cervicale uitstrijkjes die door PelvoCheck® CT/NG geanalyseerd worden. (da) Til indhentning, transport og opbevaring af cevixprøver til analyse vha PelvoCheck® CT/NG. (sv) ) För provtagning, transport och förvaring av vaginala och cervixprover som ska analyseras med PelvoCheck® CT/NG. (pl) Do pobierania, transportu i przechowywania próbek do analizy pobranych z pochwy i szyjki macicy za pomocą zestawu PelvoCheck® CT/NG. (no) For innsamling, transport og oppbevaring av vaginal- og cervikalprøver som skal analyseres med PelvoCheck® CT/NG. (el) ) Για τη λήψη, τη μεταφορά και την αποθήκευση των προς εξέταση κολπικών δειγμάτων και δειγμάτων εκ του τραχήλου της μήτρας με το PelvoCheck® CT/NG.(tr) ) PelvoCheck® CT/NG ile analiz edilecek vajinal ve servikal örneklerin alınması, taşınması ve saklanması içindir. Intended Use PelvoCheck® Swab Collection Tube: For the transport and storage of vaginal and cervical specimens to be analysed by PelvoCheck® CT/NG. Intended Use Copan CLASSIQSwabs™: A sterile and ready-for-use system intended for clinical samples drawing. The swab is suitable for short contact with the human body. Product should be used as directed. Sampling Swab: The Sampling Swab is separately packed in a peel pouch. It is a polyester swab to sample the vagina or the cervix. The moulded break-point allows snapping off the head, which remains in the storage vial after collecting the specimen, thus ensuring that the entire specimen is collected. Vial with Specimen Collection Medium: 5 ml Specimen Collection Medium guarantee optimal storage conditions and a transport free of contamination and DNA degradation. The dimensions of the storage vial ensure an easy and secure handling of the specimen for downstream analysis even with the snap-off head remaining in the vial. Warnings and Precautions • DO NOT USE FOR SAMPLING THE ENDOMETRIUM! • PelvoCheck® Swab Collection Kit is a product for single use only. Do not reuse any parts of the kit. Do not re-sterilise the swab. • Do not use PelvoCheck® Swab Collection Kit beyond their expiration date printed on the plastic pouch. • Do not use PelvoCheck® Swab Collection Kit, if any component is damaged or leaking. • Do not re-pack any component. • The fibre adhesion to the stick of the swab is made for instantaneous sampling: a longer contact between the swab and the sampling area might cause the fibre to come out. • Handle all biological specimens and used collection devices according to the policies and procedures of your facility. • Pay appropriate medical attention when handling biological specimens, as they may transmit infectious diseases. • Wear disposable gloves and a laboratory coat to reduce the risk of infection. • An individual package of this product or test kit has a moderate hazardous potential (Specimen Collection Medium) as classified according to European Directive 1999/45/EC. A Safety Data Sheet (SDS) is available upon request. Disposal Decontaminate and dispose all specimens and used materials following general hygiene guidelines and local, state and federal legal regulations for the proper disposal of infectious material. Sample storage Transport the PelvoCheck® Collection Tube with the stabilised specimen at 2 - 30 °C. Upon arrival in the laboratory, test immediately or store at 2 - 8 °C for up to 3 months. Cervical Specimen Collection WEAR GLOVES WHEN HANDLING CERVICAL SPECIMENS TO MINIMISE EXPOSURE HAZARD. 1 1. Open the paper peel pouch and extract the swab. Take a transport vial. Vaginal Specimen Collection WEAR GLOVES WHEN HANDLING VAGINAL SPECIMENS TO MINIMISE EXPOSURE HAZARD. 1 NOTE: Do not touch the swab head. Do not lay down the swab on any surface. 2a 2. Collect specimen from cervix: Hold swab with two fingers covering the moulded break-point. Insert the white tip of the swab gently into the cervix canal and rotate one half to one whole turn. Withdraw swab. NOTE: Sample before applying acetic acid or iodine during colposcopy. Do not use excessive force, pressure or bending when collecting swab specimens from patients as this may result in accidental breakage of the swab shaft. The swab shaft has a moulded break-point designed for intentional breakage of the swab into the transport tube. Do not make contact with skin upon withdrawal of the swab from the cervix. 2b 3 3. Open the vial containing the specimen collection medium. Insert the tip end of the swab and break the snap-off head of the swab at breaking point. NOTE: Do not touch the swab head. Do not lay down the swab on any surface. 2a 2. Collect specimen from vagina: Hold swab with two fingers covering the moulded break-point. Insert the white tip of the swab gently into the opening of the vagina (about 2 inch / 5 cm) and rotate it against the walls of the vagina so that moisture is absorbed. Withdraw swab. 2b NOTE: Do not use excessive force, pressure or bending when collecting swab specimens from patients as this may result in accidental breakage of the swab shaft. The swab shaft has a moulded break-point designed for intentional breakage of the swab into the transport tube. Do not make contact with skin upon withdrawal of the swab from the vagina. 3 4 453 103 30°C 15°C WARNING Greiner Bio-One GmbH Maybachstrasse 2, 72636 Frickenhausen, Germany Phone: +49 (0)7022 948-0 Fax: +49 (0)7022 948-514 [email protected] www.gbo.com/diagnostics Made in Austria 3. Open the vial containing the specimen collection medium. Insert the tip end of the swab and snap the head off the swab shaft at breaking point. NOTE: For easy snapping of the swab head, insert the swab into the vial with the moulded break-point at the tube edge and bend the shaft. Bend and break the swab at the break-point holding the tube away from your face. Avoid splashing and contamination of tube outside. Discard the remaining shaft end. NOTE: For easy snapping of the swab head, insert the swab into the vial with the moulded break-point at the tube edge and bend the shaft. Bend and break the swab at the break-point holding the tube away from your face. Avoid splashing and contamination of tube outside. Discard the remaining shaft end. 4. Replace and firmly close the cap of the vial and label the sticker with patient information and date of sampling. Send the closed vial in compliance with all national, state and local transport regulations to your partner laboratory. 1. Open the paper peel pouch and extract the swab. Take a transport vial. 4 4. Replace and firmly close the cap of the vial and label the sticker with patient information and date of sampling. Send the closed vial in compliance with all national, state and local transport regulations to your partner laboratory.