Owlstone Medical Breath Biospy ReCIVA-RD Breath Sampler User manual

©Owlstone Medical Ltd. 2018
90-0796 Issue 2 OCT 2018
Page 1 of 17
OWLSTONE MEDICAL LTD
183 Cambridge Science Park
Cambridge CB4 0GJ, UK
T: [phone]
E: [email protected]
owlstonemedical.com
ReCIVA-RD Breath Sampler
User Manual

©Owlstone Medical Ltd. 2018
90-0796 Issue 2 OCT 2018
Page 2 of 17
Contents
Contents 2
Introduction 31.0
Technical Specifications 32.0
Safety Instructions 33.0
Setting up ReCIVA-RD Breath Sampler 54.0
ReCIVA Software 65.0
Taking a Breath Sample 96.0
After the breath collection 127.0
Servicing 128.0
Troubleshooting 139.0
Recycling and Disposal 1410.0
Table of Symbols 1411.0
Contacts and Support 1412.0
Appendix 1 –Standard Settings for ReCIVA-RD Breath Sampler 15
Appendix 2 –Adjusting the breath collection parameters 15

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Introduction1.0
The intended use of the ReCIVA-RD Breath Sampler is to collect samples of volatile organic
compounds (VOCs) present in exhaled breath for subsequent laboratory analysis. The
device is intended for use by operators with study subjects aged 5 years or older who can
understand and act on instructions from the operating professional. It is only for use with the
CASPER-RD Portable Air Supply. 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 ReCIVA-RD
Breath Sampler.
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.
Using the ReCIVA-RD Breath Sampler system in a way that is
not specified in this manual could be harmful to health of the
operator and co-workers.
This symbol is used to highlight a section explaining
particularly important safety considerations
Technical Specifications2.0
Operating Condition
Description
Input Voltage
5 V
Power consumption
4.5W (USB 3.0)
Storage Temperature range
15 - 30°C
Operating Temperature range
15 - 30°C
Weight
250g (approx.)
Size
120 x 100 x 140mm (approx.)
Safety Instructions3.0
ReCIVA-RD Breath Sampler should only be used with
CASPER-RD Portable Air Supply
Using the product outside of this intended use may lead to
user’s harm. The manufacturer is not responsible for harm
caused by misuse
It is recommended that use of ReCIVA-RD Breath Sampler should be supervised by a
medical professional trained to use the device. It is the responsibility of the person carrying
out the research to monitor the subject’s wellbeing at all times while using the ReCIVA-RD

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Breath Sampler. ReCIVA-RD Breath Sampler does not monitor the health of the study
subject during sampling. If there is any doubt about the health or wellbeing of the study
subject then the breath collection should be stopped immediately.
We advise monitoring of the breathing frequency of the study subject throughout the breath
collection.
Always observe the following standard safety precautions:
Ensure that the system is correctly assembled before use
Do not disassemble any of the individual system components
Wear clean nitrile examination gloves when handling ReCIVA Breath Sampler and
the Breath Biopsy Mask assembly; 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
Do not use the mask if the packaging is damaged or the vacuum seal broken.
Use a new collection kit with each study subject (this includes a disposable mask
assembly and sorbent tube assembly) and do not use the collection kit if the
packaging is damaged
Do not use the sorbent tube assembly if it is dropped or damaged prior to the breath
collection commencing
It is recommended to only use the ReCIVA-RD with the collection kits supplied by the
manufacturer. If you wish to use an alternative, please ensure you carry out your own
risk assessment to prevent potential harm to the study subject
Only use ReCIVA-RD Breath Sampler with the USB lead provided
The study subject must be monitored at all times when using ReCIVA-RD Breath
Sampler
If the study subject shows any signs of distress remove ReCIVA-RD Breath Sampler
and allow them to recover
Do not allow the study subject to breath into ReCIVA-RD Breath Sampler without the
mask and sorbent tube assemblies fitted
Do not commence the breath collection until the headset is attached to the patient
Do not block the exhaust ports in the base of ReCIVA-RD Breath Sampler
Always ensure the ReCIVA is used with the head strap to ensure a valid sample
collection.If the study subject wishes to hold the ReCIVA-RD Breath Sampler as
well, ensure that they hold it by the sides and not with their fingers or hand over the
base of the unit as this could block the exhaust ports
While the ReCIVA-RD Breath Sampler can be wiped down with standard
chlorhexidine cleaning wipes, it must be left for at least an hour between wiping down
and being used on the next study subject to allow any residual cleaning solution to
evaporate. Always clean down the Breath Sampler at the end of each sampling
session
Run ReCIVA-RD Breath Sampler on a USB3 port on the laptop/PC. It will not run on
a USB1 or USB2 port as these do not provide sufficient electrical current.
The ReCIVA-RD Breath Sampler is not to be used on children who are too young to
understand and act on instruction from the operator or on children too young to

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clearly inform the medical professional that the breath collection is causing them
discomfort. For the avoidance of doubt, it is not to be used on children < 5 years old
The Breath Sampler is specifically not to be used on subjects who have undergone
biopsy of lung parenchyma within the last 36 hours.
If you encounter any problems with the equipment or this procedure please contact
Owlstone Medical Ltd immediately using the contact details below
Setting up ReCIVA-RD Breath Sampler4.0
The ReCIVA-RD Breath Sampler is supplied with the following parts:
01-0587
ReCIVA-RD Breath Sampler
50-1251
ReCIVA Headstrap
50-1229
Non-Return Valve
50-1257
USB 2.0 Cable
01-0741
USB with ReCIVA software
02-1898
Sorbent Tube End Cap Jig
90-0796
ReCIVA-RD Breath Sampler –Instruction Manual
Ensure that the system is correctly assembled before use
Wear gloves when handling ReCIVA-RD
The following items, supplied by Owlstone Medical Ltd, are also required in order to use the
ReCIVA-RD Breath Sampler:
00-0141
CASPER-RD Portable Air Supply
00-0137
Breath Biopsy Support Pack
Plus, one of the following (other options may also be available)
00-0130
1.0 Breath Biopsy Collection Kit
00-0132
2.0 Breath Biopsy Discovery VOC Kit
00-0133
3.0 Breath Biopsy Target VOC Kit
00-0134
2.1 Breath Biopsy Discovery VOC Kit
ReCIVA-RD Breath Sampler requires a computer for operation. A laptop is included as part
of the Support Pack, but if additional computers are needed, the following minimum
specifications are required:
Windows 7 or 8 or 8.1 or 10
One USB3 port to run ReCIVA Breath Sampler
1 GB free disc space
1 GB RAM
Pentium 4M or faster processor

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ReCIVA Software5.0
The ReCIVA-RD Breath Sampler is usually bought in conjunction with the Breath Biopsy
Support Pack, and therefore a laptop is provided with the software preloaded onto it, ready
for use.
However, ReCIVA-RD Breath Sampler also comes with a USB preloaded with the ReCIVA
software. To install the software, follow these steps:
Go to the LabVIEW Runtime 2012 folder and run setup.exe accepting all the standard
options.
1. Go to the FTDI folder and run the file CDM v2.12.10 WHQL Certified as administrator by
right clicking the file and selecting Run as Administrator. If you do not run it as
administrator you will get the error message “The requested operation requires elevation.”
2. Go to the HDF5 installer folder and run the HDF5 installer. This is used to write the
ReCIVA Breath Sampler log files in HDF5 (hierarchical data format).
3. Go to the Breath Sampler Controller folder, select the Volume subfolder and run
setup.exe.
4. If you want to view the HDF log files install an HDF viewer –for example from
https://www.hdfgroup.org/products/hdf5_tools/#tools
5. The computer must be rebooted once the installation is complete.
6. Once the computer has rebooted, run Breath Sampler Controller once as administrator
(right click the Breath Sampler Controller icon in the start menu and select Run as
Administrator).
7. Go to c:\program files (x86)\breath sampler
controller and check the security permissions
on the file samplersettings.ini. If the user
permissions aren’t as shown for Users below
click edit and set them. Without these set the
system will not allow you to store settings.

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5.1. Non-Return Valve
The non-return valve ensures that the study subject breathes air
supplied by CASPER-RD portable air supply and excess exhaled air not
collected onto the sorbent tubes is exhausted into the room. This
minimizes contamination of your breath samples from VOCs present in
ambient room air. ReCIVA-RD Breath Sampler comes with an additional
5 spare valves, if required and additional valves can be ordered from
Owlstone Medical Ltd (part number 50-1229).
The valves are shipped in cardboard tube packaging,
which needs to be disposed of before the valve is
fitted. When inserting the valve into the ReCIVA-RD,
ensure the clear film is on the outside so that it can
open outwards.
5.2. Mask Assembly and Sorbent Tube Assembly
The mask and sorbent tube
assemblies are provided as part
of our Breath Biopsy Kits.
Instructions on how to fit these
into the ReCIVA-RD Breath
Sampler are provided in the User
Guide which comes with each
kit. Once correctly installed, the
ReCIVA-RD Breath Sampler is
ready for use.

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5.3. Connection to CASPE-RD PortableAir Supply
Connect the air supply tubing from the CASPER-RD Portable Air
Supply into the port on the side of the unit.
Switch on the CASPER-RD. This gives the CO2sensor in ReCIVA-
RD Breath Sampler time to equilibrate and flushes it with air ready
to take a breath sample.
5.4. Connection to Computer
Connect the ReCIVA-RD Breath Sampler to the laptop/PC with the
USB cable. The USB connector can be found on the base of the
ReCIVA-RD.
5.5. Fitting the Head Strap
The head strap is fitted once the study subject is comfortable breathing whilst holding
ReCIVA-RD to their face (see Section 6.0). With the secondary Velcro strap adjusters on top
of the subject’s head, attach the hook on one side of the head strap to the attachment point
on the ReCIVA-RD –for most people, the hook needs to be in the uppermost position.
Taking the strap around the study subject’s head hook it to the corresponding attachment
point on the other side of the ReCIVA-RD. Using the primary and secondary Velcro
adjustment straps, fit the ReCIVA-RD so that the mask forms a comfortable seal against the
subject’s face with no gaps. To ensure a good fit, it may be necessary to change the hook
position on the ReCIVA-RD as follows:
Move the straps up if the mask is falling away from the bridge of the study subject’s
nose.
Move the straps down if the mask is coming away at the bottom of the mask.

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Taking a Breath Sample6.0
Do NOT launch the ReCIVA software until the ReCIVA-RD Breath
Sampler is fully assembled, including mask and sorbent tube
assemblies; the pumps are calibrated when the software starts up
and this is not optimal without the sorbent tubes and mask
1. To run a breath collection click Start, select the Breath sampler controller folder and
click on BSC. This will launch the breath collection software.
1 = start button; 2 = message box; 3 = CO2Concentration; 4 = Mask Pressure;
5 = Software close button
If the ReCIVA-RD Breath Sampler is cold (lower than 15°C), allow it to
run for at least 5 minutes before putting it on the study subject. This
allows the CO2sensor to warm up, preventing condensation which
causes it to read full scale (20%)
2. Give the ReCIVA-RD Breath Sampler to the study subject and allow them to breathe
through it without putting on the head strap, giving them time to get used to the unit and
get comfortable with it. Ask them to breathe normally and check that they are
comfortable doing this.
3. Check that the non-return valve on the rear of the ReCIVA-RD Breath Sampler is
opening as the study subject breathes, to vent any excess air. The valve should be
replaced if it is no longer opening freely.
5
3
1
4
2

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4. Once the study subject is comfortable fit the head strap (See Section 5.5)
Note: most study subjects need the head strap almost at the top of the
ReCIVA-RD Breath Sampler attachment points.
5. In addition to the head strap, the study subject may hold the ReCIVA-RD Breath Sampler
during the breath collection if they wish, taking care not to cover the exhaust ports on the
bottom of the unit with their fingers.
6. Once the head strap is in place and the study subject is comfortable and breathing
normally press the Start Breath Collection button. At this point ReCIVA-RD Breath
Sampler will automatically do the following:
Wait for a few seconds (default 3 seconds) - ‘stabilizing’ is shown in the
message box
Learn the study subject’s breathing pattern (default 25 seconds) – ‘learning’ is
shown in the message box
Start collecting the study subject’s breath – ‘collecting’ is shown in the
message box
7. During the breath collection, remind the study subject to breathe normally; slower,
comfortable breaths are more effective than rapid breathing patterns. Continue to
monitor the subject to ensure that they are not distressed. If the study subject appears
distressed remove the ReCIVA-RD Breath Sampler immediately. The study subject may
subsequently re-continue the breath collection if they wish to.
Make sure the study subject does not block the two exhaust ports on
the base of the ReCIVA-RD Breath Sampler during the breath
collection
If at any time the study subject shows any signs of distress remove
ReCIVA-RD Breath Sampler and allow them to recover
Note: The study subject may talk during the breath collection. However,
talking will slow the collection down so it is preferable to request that study
subjects remain silent during the breath collection.

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8. During the breath collection the display on the right shows the proportion of the collection
that has been done. The two lights show when the collection pumps are on or off (light
blue on, dark blue off). The unit also displays the collection time and the study subject’s
breathing rate.
1 = Proportion of sample collected; 2 = Pumps on; 3 = time taken and breath
rate
9. When the collection is complete the message box will show Collect Complete and the
collection bar will flash blue and green. Remove ReCIVA-RD Breath Sampler from the
study subject and then close the software by clicking the red X.
3
1
2

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After the breath collection7.0
Having removed the ReCIVA-RD Breath Sampler from the study subject, detach and
dispose of the mask assembly as clinical waste. Carefully remove the sorbent tube
assembly for analysis (see Breath Biopsy kit User Guide for instructions on how to return
sorbent tubes to Owlstone Medical).
If the ReCIVA-RD Breath Sampler is not to be used again that day, wipe down all its
surfaces with a chlorhexidine cleaning wipe and allow to dry thoroughly. For storage return
the ReCIVA-RD Breath Sampler (and the USB lead) to its shipping case, making sure to put
the ReCIVA-RD Breath Sampler back in its storage bag.
ReCIVA-RD Breath Sampler must be allowed to dry thoroughly
between being wiped down with a chlorhexidine cleaning wipe
and being used on another study subject; Any fumes from the
wipe will invalidate the next study subject collection.
Servicing8.0
ReCIVA-RD Breath Sampler does not contain any user
serviceable parts. All servicing must be carried out by
Owlstone Medical Ltd. Do not disassemble any of the
individual system components. If you encounter any problems
with the equipment or this procedure please contact Owlstone
Medical Ltd immediately using the contact details below.

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Troubleshooting9.0
Problem
Solution
CO2sensor reads 20%
Water has condensed in the sensor, leave
ReCIVA-RD Breath Sampler with the
CASPER-RD Portable Air Supply running
and allow time for the sensor to warm up
before using again. Note that this does not
affect the running of the breath collection.
Non-return valve is damaged
Replace valve.
Mask falls away from bridge of study
subject’s nose or ReCIVA-RD Breath
Sampler feels heavy against their chin
Raise the head strap hooks
Mask falls away from the study subject’s
chin or cuts into their nose
Lower the head strap hooks.
Breath sampler software fails to work
correctly
Unplug ReCIVA-RD Breath Sampler, close
software, run Breath Sampler Controller from
the Windows start menu.
Study subject wants to take a break during
sampling
This is OK –remove the ReCIVA-RD Breath
Sampler from the study subject, let them
have a break and then put ReCIVA-RD
Breath Sampler back on. The sampling will
pause when ReCIVA-RD Breath Sampler is
not on the study subject.
Study subject’s face, lips or nose are in
contact with the sample tubes
Adjust the mask until comfortable for the
study subject. Direct contact should be
minimised where possible, but does not pose
a problem for sample collection.
Unable to store breath sampling
parameters
Windows file permissions are not set
correctly in the file samplersettings.ini;
contact Owlstone Medical for help to fix this
problem.
Unable to write h5 log file
The hdf5 libraries are not installed. Please
run the hdf5 library installer from the supplied
software.
"USB error" warning message displayed
Check that the ReCIVA-RD Breath Sampler
is securely connected to the laptop/PC.

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Recycling and Disposal10.0
This Product has been designed and manufactured with high quality
materials and components, which can be recycled and reused. As a
responsible manufacturer Owlstone Medical Ltd has chosen to
voluntarily adhere to the European Union's Waste Electrical &
Electronic Equipment (WEEE) Directive 2002/96/EC guidelines for this
product so it should not be disposed of in normal waste. Please consult
Owlstone Medical Ltd for details of our recycling and disposal program
for this product. For users outside the European Union consult local
authorities for correct disposal or contact Owlstone Medical Ltd.
Table of Symbols11.0
Description
Symbol
Description
Symbol
Caution, Consult Accompanying
Documents
Manufacturer
Catalogue Number
Date of Manufacture
Serial Number
Do Not Reuse
Do not use if packaging is
damaged
This mark indicates approval
for use in the European
Union countries
Contacts and Support12.0
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.
Unit 183
The Cambridge Science Park
Milton Road
Cambridge CB4 0GJ
United Kingdom
Tel: [phone]
Or email [e-mail] for our service desk

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Appendix 1 –Standard Settings for ReCIVA-RD Breath Sampler
ReCIVA-RD Breath Sampler can be configured to collect different portions of breath as
described above. The choice of breath will vary from application to application. Below are
the Owlstone Medical Ltd standard collection settings. They are provided here as a guide
only.
Item
Value
Both pumps
2 Tubes
Both pumps
200 mL/min per tube
Both pumps
500 mL collection volume
Pump A
Bronchial enriched
Pump B
End-tidal enriched
End bronchial enriched threshold
1
Start bronchial enriched threshold
5
Start end-tidal enriched threshold
7
Initial wait before learn
3 seconds
Maximum learn time
25 seconds
Appendix 2 –Adjusting the breath collection parameters
ReCIVA-RD Breath Sampler has two pumps that can be configured independently. Pump A
is on the study subject’s left and Pump B on the study subject’s right when they are wearing
ReCIVA-RD Breath Sampler.
To adjust the breath sampling parameters, click on the spot (bottom left corner) to bring up
the menu and click on Collection Settings.
ReCIVA-RD Breath Sampler allows you to configure zero, one or two sorbent tubes for each
pump:

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ReCIVA-RD Breath Sampler also allows you to select for each pump the collection rate, the
collection volume and which portion of the study subject’s breath to collect.
These breath portions are based on the mask pressure, and should be used as a systematic
guide as to the origin of the breath (some mixing within airways will occur). Please contact
Owlstone Medical if you are in any doubt about the collection settings that you require.

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Pump Locations
Pressing the button bottom left of the screen shows the pump positions as shown
below:
There is also an advanced options screen to provide fine adjustment of the collection
parameters. Please contact Owlstone Medical before using any of these settings.