Owlstone Medical Breath Biopsy 2.0 User manual

2.0 Breath Biopsy®Discovery
VOC Kit
User Guide
00-0134
OW-015662-TM-3

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 2 of 20
Symbol Key
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
90-0819-003 14 SEP 2019
Page 3 of 20
Contents
1General Information 4
2Introduction to the 2.0 Breath Biopsy Discovery VOC Kit 6
3Setup of the 2.0 Breath Biopsy Discovery VOC Kit 8
4Instructions for Breath Collection 13
5Disassembly & Storage of the 2.0 Breath Biopsy Discovery
VOC Kit 14
6Troubleshooting 19
7Contacts and Support 20

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 4 of 20
1General Information
1.1 Introduction
The 2.0 Breath Biopsy®Discovery VOC Kit (PN 00-0134) contains
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 2.0 Breath Biopsy Discovery VOC Kit should only 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 2.0 Breath Biopsy Discovery
VOC 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
90-0819-003 14 SEP 2019
Page 5 of 20
1.2 Safety
Safety instructions for the use of ReCIVA and the 2.0 Breath Biopsy
Discovery VOC 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 2.0
Breath Biopsy Discovery VOC 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 2.0 Breath Biopsy Discovery VOC 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.
1.3 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.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 6 of 20
2Introduction to the 2.0 Breath Biopsy
Discovery VOC Kit
2.1 Intended Use
The 2.0 Breath Biopsy Discovery VOC Kit is intended for use with
the ReCIVA Breath Sampler to collect samples of volatile organic
compounds (VOCs) present in exhaled breath for subsequent
laboratory analysis. ReCIVA is intended for professional use only
with study subjects aged 5 years or older who can follow verbal
instructions. It is supplied on a business-to-business basis for
research and development only.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 7 of 20
2.2 Identification of Parts
The 2.0 Breath Biopsy Discovery VOC Kit is supplied with the
following parts:
PN & Title
Qty
Picture
01-0867 Breath
Biopsy Cartridge
Assembly
1
01-0880 Breath
Biopsy Mask
Assembly (Adult)
1
50-1357 Cable Tie,
Green Nylon, Non-
Releasable, 300mm x
4.8 mm
1
50-0700 A4 Padded
envelope
1
n/a
50-1358 Bubble wrap
bag, 130mm x 185mm
1
n/a
50-1376 Clear Ziplock
Bags, 230mm x
150mm (GL11)
1
n/a

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 8 of 20
3Setup of the 2.0 Breath Biopsy Discovery VOC
Kit
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.
3.1 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.
Lipstick, lip balm, make up and aftershave
should be removed prior to sampling as they
can contaminate the sample.
They should be removed using unscented soap
and water or a tissue. Do not use make up
wipes as these will leave residual VOCs.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 9 of 20
Remove the Mask Assembly from the vacuum packaging.
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.
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
90-0819-003 14 SEP 2019
Page 10 of 20
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

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 11 of 20
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 is present

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 12 of 20
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 touching the top of
the tubes as this will contaminate them and the
sample
Finally, gently push the Breath Biopsy Mask into position ensuring it
is fully seated.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 13 of 20
4Instructions for Breath Collection
Follow the ReCIVA Breath Sampler User Manual to collect the
breath sample.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 14 of 20
5Disassembly & Storage of the 2.0 Breath
Biopsy Discovery VOC Kit
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 collections:
Breath Biopsy Mask
Breath Biopsy Cartridge Assembly

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 15 of 20
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.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 16 of 20
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
90-0819-003 14 SEP 2019
Page 17 of 20
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.
Place the Breath Biopsy Cartridge into the 50-1358 bubble wrap bag
to protect it.
Place the bubble wrap bag containing the Breath Biopsy Cartridge
into a 50-1376 zip lock bag.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 18 of 20
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
Breath Biopsy Cartridge Assembly in a refrigerator at a temperature
between +4 and +8°C.
Owlstone does not recommend storing breath
samples in a freezer.
When ready to ship the Breath Biopsy Cartridge, place it in the 50-
0700 A4 padded envelope.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 19 of 20
6Troubleshooting
Please follow the troubleshooting guides in the ReCIVA and the
CASPER User Manuals.

©Owlstone Medical Ltd. 2018 - 2019
90-0819-003 14 SEP 2019
Page 20 of 20
7Contacts 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]