2.0 Breath Biopsy
®
Discovery
VOC Kit
User Guide
00-0134
OW-015662-TM-3
Страница 1: ...2 0 Breath Biopsy Discovery VOC Kit User Guide 00 0134 OW 015662 TM 3 ...
Страница 2: ...nufacturer Catalogue or Reference Number Date of Manufacture Serial Number Do Not Reuse Lot Number Do not use if packaging is damaged Consult instructions for use This mark indicates approval for use in the European Union countries Fragile handle with care Use by date Storage Temperature Limit Humidity Limit DO NOT dispose of in household waste WEEE Directive ...
Страница 3: ...ral Information 4 2 Introduction to the 2 0 Breath Biopsy Discovery VOC Kit 6 3 Setup of the 2 0 Breath Biopsy Discovery VOC Kit 8 4 Instructions for Breath Collection 13 5 Disassembly Storage of the 2 0 Breath Biopsy Discovery VOC Kit 14 6 Troubleshooting 19 7 Contacts and Support 20 ...
Страница 4: ...siness to business basis for the purpose of research and development The 2 0 Breath Biopsy Discovery VOC Kit should only be used with ReCIVA If you wish to use an alternative please ensure you carry out your own risk assessment to prevent potential harm to the study subject It is essential that this instruction manual be read and understood before commencing any work with the 2 0 Breath Biopsy Dis...
Страница 5: ...ds can affect the results and may lead to cross contamination Wash your hands with soap and water do not use alcohol based gels e g Cutan foam as these leave volatile chemicals behind which may affect the breath collection Use a new 2 0 Breath Biopsy Discovery VOC Kit with each study subject Do not use the Breath Biopsy Cartridge Assembly if it is dropped or damaged prior to the breath collection ...
Страница 6: ... VOC Kit is intended for use with the ReCIVA Breath Sampler to collect samples of volatile organic compounds VOCs present in exhaled breath for subsequent laboratory analysis ReCIVA is intended for professional use only with study subjects aged 5 years or older who can follow verbal instructions It is supplied on a business to business basis for research and development only ...
Страница 7: ...t is supplied with the following parts PN Title Qty Picture 01 0867 Breath Biopsy Cartridge Assembly 1 01 0880 Breath Biopsy Mask Assembly Adult 1 50 1357 Cable Tie Green Nylon Non Releasable 300mm x 4 8 mm 1 50 0700 A4 Padded envelope 1 n a 50 1358 Bubble wrap bag 130mm x 185mm 1 n a 50 1376 Clear Ziplock Bags 230mm x 150mm GL11 1 n a ...
Страница 8: ...posed of between study subjects 3 1 Fitting the Mask and Breath Biopsy Cartridge Assembly Ensure the work surfaces for disassembling the Breath Biopsy Cartridge and Breath Biopsy Mask are clean free from particulates and free from chemical contamination Lipstick lip balm make up and aftershave should be removed prior to sampling as they can contaminate the sample They should be removed using unsce...
Страница 9: ...se DO NOT USE if the packaging is damaged Quarantine the Breath Biopsy Mask and contact Owlstone Medical Ensure that the filter in the Breath Biopsy Mask is correctly fitted prior to proceeding The filter should be securely seated and not wobble When you are ready for the breath collection cut the tie wrap if applied holding the travel end caps on the Breath Biopsy Cartridge and then remove the tr...
Страница 10: ...aging is damaged or the end caps are dislodged Quarantine the Breath Biopsy Cartridge Assembly and contact Owlstone Medical Do not leave the tubes uncapped for more than two minutes before or after the test as they will absorb chemicals from the air in the room Travel end caps Cable tie Tube clamp Sorbent tubes Cut cable tie Remove end caps Ready for insertion into mask ...
Страница 11: ... do not stop at the ridges in the tubes ensuring the barcode if used is at the front Next put the mask and Breath Biopsy Cartridge assembly into the ReCIVA Breath Sampler first inserting loosely into the ReCIVA Push Breath Biopsy Cartridges into the mask so that they are seated half way up the filter and aligned as per image Check filter is present ...
Страница 12: ...er side of the tube clamp push the Breath Biopsy Cartridge assembly firmly into the ReCIVA Breath Sampler Do NOT push the tubes in by touching the top of the tubes as this will contaminate them and the sample Finally gently push the Breath Biopsy Mask into position ensuring it is fully seated ...
Страница 13: ... Owlstone Medical Ltd 2018 2019 90 0819 003 14 SEP 2019 Page 13 of 20 4 Instructions for Breath Collection Follow the ReCIVA Breath Sampler User Manual to collect the breath sample ...
Страница 14: ...mbling the ReCIVA Breath Sampler and all associated components These gloves must be disposed of between study subjects Ensure the work surfaces for disassembling the Breath Biopsy Cartridge and Breath Biopsy Mask are clean free from particulates and free from chemical contamination The following components are single use and must not be re used between collections Breath Biopsy Mask Breath Biopsy ...
Страница 15: ...psy Mask with the Breath Biopsy Cartridge by gripping the ReCIVA with your thumbs along the top edge while using your fingers to pull up on the white tube clamp This can be quite stiff Now pull the tubes and mask with tubes still inserted forwards out of the ReCIVA They should come out easily ...
Страница 16: ...Breath Biopsy Mask by pulling them back through the holes Fit the end caps to the Breath Biopsy Cartridge Note that they only fit on in one orientation When they have BOTH been pushed on at least partially then to ensure they are fully home push them between your palms with fingers interlocked for more force if needed ...
Страница 17: ...tridge Assembly flat on the desk and making sure the jig goes over it Fit a cable tie if required to avoid the end caps being removed by accident or during transportation Place the Breath Biopsy Cartridge into the 50 1358 bubble wrap bag to protect it Place the bubble wrap bag containing the Breath Biopsy Cartridge into a 50 1376 zip lock bag ...
Страница 18: ... be affected if dropped or handled roughly If the sample is not being analysed on the same day place the Breath Biopsy Cartridge Assembly in a refrigerator at a temperature between 4 and 8 C Owlstone does not recommend storing breath samples in a freezer When ready to ship the Breath Biopsy Cartridge place it in the 50 0700 A4 padded envelope ...
Страница 19: ... Owlstone Medical Ltd 2018 2019 90 0819 003 14 SEP 2019 Page 19 of 20 6 Troubleshooting Please follow the troubleshooting guides in the ReCIVA and the CASPER User Manuals ...
Страница 20: ...he Owlstone Medical Ltd team is dedicated to providing excellent support For all technical and safe use questions relating to this manual contact us at Owlstone Medical Ltd 183 Cambridge Science Park Milton Road Cambridge CB4 0GJ United Kingdom Tel 44 0 1223 428200 Or email support owlstone com ...
