ReCIVA-RD Breath Sampler Instruction Manual


Contents

1.0 Introduction 3

2.0 Technical Specifications 3

3.0 Safety Instructions 3

4.0 Setting up ReCIVA-RD Breath Sampler 5

5.0 ReCIVA Software 6

6.0 Taking a Breath Sample 8

7.0 After the breath collection 12

8.0 Servicing 12

9.0 Troubleshooting 13

10.0 Recycling and Disposal 14

11.0 Table of Symbols 14

12.0 Contacts and Support 14

Appendix 1 – Standard Settings for ReCIVA-RD Breath Sampler 15

Appendix 2 – Adjusting the breath collection parameters 15


1.0 Introduction

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

 

2.0 Technical Specifications

 

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.)

 

3.0 Safety Instructions

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 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 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

4.0 Setting up ReCIVA-RD Breath Sampler

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

5.0 ReCIVA Software

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).

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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.

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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 CO2 sensor in ReCIVA-RD Breath Sampler time to equilibrate and flushes it with air ready to take a breath sample.

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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.

6.0 Taking a Breath Sample

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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 = start button; 2 = message box; 3 = CO2 Concentration; 4 = Mask Pressure; 5 = Software close button

 

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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 CO2 sensor to warm up, preventing condensation which causes it to read full scale (20%)

  1.  To run a breath collection click Start, select theBreath sampler controller folder and click on BSC. This will launch the breath collection software.
  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.
  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.

  1. 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.
  2. 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
  3. 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.
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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

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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.

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.

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7.0 After the breath collection

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.

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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.

8.0 Servicing

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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.

 

9.0 Troubleshooting

Problem

Solution

CO2 sensor 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.

 

10.0 Recycling and Disposal

 

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.

11.0 Table of Symbols

Description

Symbol

Description

Symbol

Caution, Consult Accompanying Documents

image002.png

Manufacturer

image014.jpg

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

12.0 Contacts 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:

image014.jpg

Owlstone Medical Ltd.

Unit 183

The Cambridge Science Park

Milton Road

Cambridge CB4 0GJ

United Kingdom

Tel: +44 (0) 1223 428200

Or email support@owlstone.zendesk.com for our service desk

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:

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.

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.

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