Owlstone Medical Breath Biopsy 1.0 User manual

1.0 Breath Biopsy®
Collection Kit Support
Pack:
User Guide
01-0967

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 2 of 18
1Contents
1Contents 2
2Introduction 3
3Safety Instructions 3
4Identification of Parts 4
5Breath Biopsy Cartridge Assembly 7
6Breath Biopsy Cartridge Disassembly 12
7Maintenance instructions 12
8Table of Symbols 17
9Contacts and Support 18

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 3 of 18
2Introduction
This user guide explains how to use the Breath Biopsy Collection Kit
Support Pack (PN: 01-0967) to assemble, disassemble and maintain
the parts of the Breath Biopsy Cartridge required for use with the
ReCIVA®Breath Sampler. Use of the Breath Biopsy Cartridge will
allow a user to collect samples of Volatile Organic Compounds
(VOCs) that are present in breath for subsequent analysis.
It is supplied only on a professional business-to-business basis 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.
3Safety Instructions
Safety instructions for the use of this Support Pack are given in the
ReCIVA Breath Sampler User Manual PN 90-0796.
In addition, always observe the following standard safety
precautions:
Wear clean nitrile examination gloves when handling the
Breath Biopsy Cartridge as chemicals from your hands can
affect the results and may lead to cross contamination.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 4 of 18
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
Do not use the Breath Biopsy Cartridge if it is dropped or
damaged prior 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
4Identification 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 to 0.25Nm
1
74-00058 Hexagon
Bit, 2 mm
1
74-0052 O-ring
Removal Tool
1
74-0053 O-ring
Insertion Tool
1

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 5 of 18
02-1898 Sorbent
Tube End Cap Jig
1
50-1283 O-ring, 6.35
x 1.78mm, Viton, 60
Shore, Black, Baked
clean
18
50-1550 Cable tie,
Blue, 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:

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 6 of 18
PN & Title
Qty
Picture
50-1949 Sorbent
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.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 7 of 18
5Breath Biopsy Cartridge Assembly
Ensure that the Breath Biopsy Cartridge is
correctly assembled before use
Wear gloves when handling the Breath
Biopsy Cartridge
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 description used within OML is
shown below.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 8 of 18
Prepare all the material required for this task. Ensure the
worksurface is clean and free from dust or liquids and is low in
VOCs.
Place one 01-0603 Travel End Cap flat on the surface with the holes
facing up.
Remove the storage caps (usually brass caps) from each of the
tubes in turn.
Once the storage 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
assembly, if required.
Once all tubes have been loaded the 01-0622 Tube Clamp
Assembly (Tube Holder) can be fitted.
Backside
Frontside
Backsid
e
Frontside
1
2
3
4
1
2
3
4

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 9 of 18
The screw may need to be loosened if the holder is too tight to fit to
slide onto the tubes.
The 01-0622 Tube Clamp 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

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 10 of 18
The torque driver is set to 0.25 Nm and will click once the screw has
been sufficiently tightened. The screw cannot be overtightened as
the torque driver will just continue to click 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, push the Travel
End Caps together with your palms.

©Owlstone Medical Ltd. 2018 - 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 12 of 18
Handle the tubes with care; the inside is
fragile and test performance can be affected
if dropped or handled roughly
6Breath Biopsy Cartridge Disassembly
The disassembly process is essentially the reverse of the assembly
process.
Cut any tie wrap if applied.
Pull off one of the 01-0603 Travel End Caps
Use the torque screwdriver to sufficiently 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
7Maintenance 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
Black debris in the bottom of the hole will also probably indicate that
the Travel End Cap should be cleaned using mechanical cleaning,
by removing the o-ring first, and the o-ring should be changed at the
same time.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 13 of 18
7.2 Removal of 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 14 of 18
Remove o-rings
Replace 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 15 of 18
7.4 Baking O-rings
Note: o-rings must NEVER be greased or coated as this will add
contaminants or could change the sealing properties of the o-ring.
Note: The o-rings supplied with this kit have been pre-baked.
Any o-rings not supplied by Owlstone Medical should 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 the 01-0603 Travel End Caps
Travel End Caps should be cleaned after EVERY USE OR after
changing the o-rings by baking in an oven

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 16 of 18
Use mechanical cleaning first to remove 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 17 of 18
8Table of Symbols
Description
Symbol
Description
Symbol
Caution, Consult
Accompanying
Documents
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)

©Owlstone Medical Ltd. 2018 - 2019
95-0009-001 10 July 2019
Page 18 of 18
9Contacts and Support
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: [phone]
Or email [e-mail]