Owlstone Medical Breath Biopsy 1.0 User manual

1.0 Breath Biopsy®
Collection Kit
User Guide
00-0130

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
Page 2 of 18
1Contents
1Contents 2
2Introduction 3
3Safety Instructions 4
4Identification of Parts 5
5Instructions 7
6Recycling and Disposal 16
7Table of Symbols 17
8Contacts and Support 18

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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2Introduction
The 1.0 Breath Biopsy®Collection Kit (PN 00-0130) provides the
consumable items required for the ReCIVA®Breath Sampler to
collect samples of Volatile Organic Compounds that are present in
breath for subsequent laboratory analysis. It is supplied only on a
professional business-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 understand the various
precautionary notes and symbols contained
inside this manual pertaining to the safe use
and operation of this product before using it.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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3Safety Instructions
Safety instructions for the use of ReCIVA and the 1.0 Breath Biopsy
Collection Kit are provided in the ReCIVA Breath Sampler User
Manual (PN 90-0796). It is essential that these safety instructions
are read and understood before commencing any work with the 1.0
Breath Biopsy Collection Kit.
Always observe the following standard safety precautions:
Wear clean nitrile 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 Biopsy Cartridge Assembly 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 in this guide.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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4Identification 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

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95-0010-001 14 AUG 2019
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01-0880 Breath
Biopsy Mask
Assembly (Adult)
1
The following items, supplied by Owlstone 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

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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5Instructions
Always wear clean nitrile examination gloves
when assembling, operating and
disassembling the ReCIVA 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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Inspect the packaging of the Breath Biopsy
Mask to ensure that it is not damaged prior to
use.
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.
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 breath collection cut the tie wrap (if
applied) holding the travel end caps on the Breath Biopsy Cartridge
and then remove the travel end caps.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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Inspect the end caps to ensure that they have
not become dislodged before use.
DO NOT USE if the packaging 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

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Push the Breath Biopsy Cartridge Assembly into the Breath Biopsy
Mask as shown (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

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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Using fingers on either side of the tube clamp, push the Breath
Biopsy 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
Page 12 of 18
5.3 Disassembly
Always wear clean nitrile examination gloves
when assembling, operating and
disassembling 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 samplings:
Breath Biopsy Mask
Breath Biopsy Cartridge Assembly

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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Remove the Breath Biopsy 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.

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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.

©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 between +4
and +8°C.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
Page 16 of 18
Owlstone does not recommend storing breath
samples in a freezer.
6Recycling 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.

©Owlstone Medical Ltd. 2018 - 2019
95-0010-001 14 AUG 2019
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7Table 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
95-0010-001 14 AUG 2019
Page 18 of 18
8Contacts 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]
428200
Or email [e-mail]