Owlstone Medical 00-0130 User Manual Download Page 15

Page: 15 / 18

©Owlstone Medical Ltd. 2018 - 2019

95-0010-001

14 AUG 2019

Page 15 of 18

Make sure the end caps are on correctly by placing the Breath
Biopsy Cartridge 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.

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 b4
and +8°C.

Summary of Contents for 00-0130

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

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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 ...