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©Owlstone Medical Ltd. 2018 - 2019

95-0010-001

14 AUG 2019

Page 14 of 18

Now remove the Breath Biopsy Cartridge from the 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.

Содержание 00-0130

Страница 1: ...1 0 Breath Biopsy Collection Kit User Guide 00 0130 ...

Страница 2: ... 2019 95 0010 001 14 AUG 2019 Page 2 of 18 1 Contents 1 Contents 2 2 Introduction 3 3 Safety Instructions 4 4 Identification of Parts 5 5 Instructions 7 6 Recycling and Disposal 16 7 Table of Symbols 17 8 Contacts and Support 18 ...

Страница 3: ...iness to business basis for the purpose of research and development The 1 0 Collection Kit should 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 1 0 Breath Biopsy Collection Kit Read and un...

Страница 4: ...trile examination gloves when handling the Breath Biopsy Cartridge Assembly as chemicals from your hands 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 1 0 Collection Kit with each study subject Do not use the Breath ...

Страница 5: ...4 Identification of Parts The 1 0 Breath Biopsy Collection Kit is supplied with the following parts PN Title Qty Picture 50 1949 Sorbent Tube Markes Inert Coated Stainless Steel Tenax TA Carbograph 5TD Conditioned 4 01 0622 Tube Clamp Assembly 1 02 0603 Travel End Cap 2 ...

Страница 6: ... Medical Ltd are also required in order to use the 1 0 Breath Biopsy Collection Kit Part No Name Title Additional accessory for the 1 0 Collection Kit to enable disassembly for re conditioning and reassembly of the TD tubes 01 0967 Breath Biopsy Starter Kit Support Pack Additional consumable required for each patient 01 0880 Breath Biopsy Mask Assembly ...

Страница 7: ...eCIVA Breath Sampler and ALL associated components These gloves must be disposed of between study subjects 5 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 Remove the Mask Assembly from the vacuum packaging ...

Страница 8: ...ior to proceeding The filter should be securely seated and not wobble Assemble the Breath Biopsy Cartridge as per 95 0009 1 0 Breath Biopsy Collection Kit Support Pack User Guide The sorbent tubes are supplied preconditioned by the tube manufacturer Before first use the user should confirm that the tubes have been conditioned appropriately for the intended application When you are ready for the br...

Страница 9: ...ging 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 10: ...n 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 in place ...

Страница 11: ...y Cartridge assembly firmly into the ReCIVA Breath Sampler Do NOT Push the tubes in by push on the top of the tubes as this will contaminate them and the sample Finally the Breath Biopsy Mask is now gently pushed back into position ensuring it is fully seated 5 2 Breath Collection Follow the ReCIVA User Manual to collect the breath sample ...

Страница 12: ...h 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 samplings Breath Biopsy Mask Breath Biopsy Cartridge Assembly ...

Страница 13: ...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 14: ...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 15: ...aking sure the jig goes over it Fit a cable tie if required to avoid the end caps being removed by accident or during transportation Handle the tubes with care the inside is fragile and test performance can be affected if dropped or handled roughly If the sample is not being analysed on the same day place the Cartridge Assembly in a refrigerator at a temperature between 4 and 8 C ...

Страница 16: ...Page 16 of 18 Owlstone does not recommend storing breath samples in a freezer 6 Recycling and Disposal The Breath Biopsy Mask is a single use only item and should be disposed of in clinical waste For disposal of packaging please follow local recycling rules ...

Страница 17: ...s Manufacturer 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 18: ...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 ...

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