1.0 Breath Biopsy® Collection Kit Support Pack:
User Guide
01-0967
Страница 1: ...1 0 Breath Biopsy Collection Kit Support Pack User Guide 01 0967 ...
Страница 2: ...age 2 of 18 1 Contents 1 Contents 2 2 Introduction 3 3 Safety Instructions 3 4 Identification of Parts 4 5 Breath Biopsy Cartridge Assembly 7 6 Breath Biopsy Cartridge Disassembly 12 7 Maintenance instructions 12 8 Table of Symbols 17 9 Contacts and Support 18 ...
Страница 3: ...for the purpose of research and development It is essential that this instruction manual be read and understood before commencing any work with the Breath Biopsy Collection Kit Support Pack Read and understand the various precautionary notes and symbols contained inside this manual pertaining to the safe use and operation of this product before using it 3 Safety Instructions Safety instructions fo...
Страница 4: ...or to the breath collection commencing If you encounter any problems with the equipment or this procedure please contact Owlstone Medical Ltd immediately using the contact details below 4 Identification of Parts 4 1 Parts Supplied in this Support Pack The Breath Biopsy Collection Kit Support Pack PN 01 0967 contains the following parts PN Title Qty Picture 74 0056 Wera 1 4 in Hex Torque Driver Set...
Страница 5: ...ue Nylon 270mm x 4 6 mm 10 Tools to remove brass storage caps such as the Markes CapLok tools will also be required if this is the storage method chosen 4 2 Parts Supplied as part of 00 0130 As part of 00 0130 1 0 Breath Biopsy Collection Kit you will receive the components of a Breath Biopsy Cartridge This is supplied assembled and ready to use for breath collection This part consists of ...
Страница 6: ...bent Tube Inert Coated Conditioned 4 01 0622 Tube Clamp Assembly Tube Holder 1 01 0603 Travel End Cap 2 The 50 1949 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 ...
Страница 7: ... The assembly of the Sorbent Tubes into the Breath Biopsy Cartridge is a time critical process which should not be started unless there is time for completion There is a risk of contamination to the tubes if uncapped tubes are exposed to air for too long Use only conditioned and blanked tubes Each tube in a kit has its own location The standard hole position numbering and part orientation descript...
Страница 8: ...torage caps are removed the tubes can be loaded into the 01 0603 Travel End Cap Ensure the arrow is pointing downwards and the notch is at the top of tube The tubes should be loaded in the same order each time and a record made of their position using the barcode Load the tubes such that the barcode and the numbers are facing the outside side of the tube holder so that they are accessible after as...
Страница 9: ...p Assembly Tube Holder should be positioned about midway along covering the bar codes Fit the second 01 0603 Travel End Cap on the top of four tubes ensuring the cap is orientated the correct way The Travel End Cap may need to be applied with some force to ensure it is fitted all the way onto the tubes Tighten the 01 0622 Tube Clamp Assembly Tube Holder using the torque screwdriver ...
Страница 10: ...lick without tightening further The Tube Holder should be tightened after securing the second end cap as sealing both ends of the tube should be prioritized over other tasks Once the Breath Biopsy Cartridge has been assembled use the 02 1898 Sorbent Tube End Cap Jig to check if the set easily passes through it to ensure caps are correctly fitted If the Breath Biopsy Cartridge does not fit through ...
Страница 11: ...2019 95 0009 001 10 July 2019 Page 11 of 18 Then fit a cable tie if required and tighten it to avoid the end caps being removed during transport A bubble wrap bag can be used to protect the Cartridge Assembly during any handling ...
Страница 12: ...ently release the screw in the 01 0622 Tube Clamp Assembly so that the tubes will slide out ready for application of brass caps or DiffLok caps etc as required 7 Maintenance instructions 7 1 Check for damage and wear after every use The images below show some typical defects when o rings become damaged The o ring should also be changed if there are silver particles on the surface of the o ring Bla...
Страница 13: ... O rings The o rings are removed by using the 74 0052 o ring Removal Tool to carefully pierce the o ring as shown below left Do not push through into the metal surface as you could scratch this which can mean the seal is less effective Pull the o ring forward and then upwards to remove ...
Страница 14: ...lace o rings 7 3 Replacement of O rings The o rings are replaced by slightly squeezing them between your fingers and forming a banana shape as shown above right This o ring is then inserted as shown above and finally pushed home into the inset groove using the 74 0053 o ring Insertion Tool ...
Страница 15: ...ould also be baked to reduce the contaminants they hold This is done by arranging them on a clean stainless steel try slightly overlapping to decrease the area touching the tray Bake in a clean oven preferably only used for this purpose at 180C for 12 16 hours preferably with carbon scrubbed or zero air flowing through the oven to remove the contaminants that evolve from the o rings 7 5 Cleaning t...
Страница 16: ...e particles that may be stuck to the surface To do this arrange the Travel End Caps in a clean stainless steel tray hole side up Bake in a clean oven at 180C for 12 16 hours preferably with carbon scrubbed or zero air flowing through the oven to remove the contaminants that evolve from the end caps and o rings ...
Страница 17: ...ts 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: ...The 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 ...
