Definitions CAUTION, indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may be used to alert against unsafe practices. It may also be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products). IMPORTANT, is used for comments that add value to the step or procedure being performed. Following the IMPORTANT advice adds benefit to the performance of the equipment or to a process. NOTE, is used to call attention to notable information that should be followed during installation, use, or servicing of the equipment. Intended use The GastroCH ECK® Gastrolyzer® is a portable desktop monitor which measures hydrogen (H methane (CH ) and oxygen (O ) levels in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician’s surgery. The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis. The GastroCH ECK® Gastrolyzer® will be used by a single patient at a time, but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroCH ECK® Gastrolyzer® can be used as an aid to diagnose the following disorders: Carbohydrate breakdown deficiency • Carbohydrate malabsorption • Lactose intolerance • Bacterial overgrowth • Determination of time of passage through gut • Specific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient’s condition. Introduction and CH are generated in the intestinal lumen by bacterial action on carbohydrates in the small or large intestine. Once the resultant H...
The GastroCH ECK® Gastrolyzer® also measures O levels in the breath sample in order to correct for any tests that do not achieve an end-tidal breath sample. The end-tidal breath sample is that last portion of expired air and contains the most accurate levels of H and CH . End-tidal breath contains approx. 14-16% O and therefore corrections to the final result can be made if required by applying a correction factor if more than 14% O is recorded in the sample. Operation of the monitor is straightforward. A sampling system enables end-expired breath to be sampled easily and hygienically, using single-use disposable mouthpieces and single-use disposable face masks. Safety notes To avoid electric shock, this equipment must be connected to a mains supply with protective earth- grounding. The operator should not touch the patient whilst in contact with either the computer or the USB connector parts. The GastroCH ECK® Gastrolyzer® should only be connected to a computer that is manufactured in accordance with EN 60950 – Safety of information technology equipment. Please do not attempt to modify the equipment in any way or use accessories not specified for use by the manufacturer. Any attempt to do so will invalidate the warranty and may affect the safety of the device. Any modification to this equipment during the actual service life requires evaluation to the requirement of EN 60601-1. Contraindications If exhaling gently to produce a breath sample is physically demanding then it may cause contraindications in patients who have had a recent myocardial infarction. Also extensive exhalation might lead to syncope. Safety during installation and/or maintenance The GastroCH ECK® Gastrolyzer® can be installed by a trained user as long as the instruction manual has been read. The GastroCH ECK® Gastrolyzer® weighs 8kg.
Electrical safety To reduce the risk of electrical shock, this equipment uses a three-wire electrical cord and plug to connect the GastroCH ECK® Gastrolyzer® to earth-ground. To preserve this safety feature: Make sure that the matching wall outlet receptacle is properly wired and earth-grounded. • Check that the line voltage agrees with the voltage listed on the rear label affixed to the GastroCH ECK® Gastrolyzer®. Do not install the GastroCH ECK® Gastrolyzer® on a ground fault-protected power source. • Do not place containers holding liquid on or near the GastroCH ECK®. If they spill, liquid may • enter the GastroCH ECK® Gastrolyzer® and damage electrical or mechanical components. Only use properly rated safety fuses as described on the rear of the GastroCH ECK® (T 3.15 • AH 250V). Safety against risk of fire Fuses protect certain electrical circuits within the GastroCH ECK® Gastrolyzer® against overcurrent conditions. For continued protection against the risk of fire, replace only with the same type and rating specified. Only fuses with the following ratings should be applied: 250Vac, 3.15AH T, 1500A breaking capacity. The GastroCH ECK® Gastrolyzer® is not designed for use with materials capable of developing flammable or explosive vapours. Do not use/handle/store such materials (such as chloroform or ethyl alcohol) on or within the required 30cm (1ft) area surrounding the GastroCH ECK® Gastrolyzer®. Mechanical safety For safe operation of the equipment, observe the following: Use only accessories designed for use with the GastroCH ECK® Gastrolyzer®. Do not lift or move the GastroCH ECK® Gastrolyzer® while it is running. This could damage the methane bench.
Environment The GastroCH ECK® Gastrolyzer® complies with the directive EN 60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in EN 50082-1. Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2) The GastroCH ECK® Gastrolyzer® is intended for the use in the electromagnetic environment specified below. The customer or the user of the GastroCH ECK® Gastrolyzer® should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Conducted immunity 3 V rms 150 khz ~ 3V (1khz 80%) Portable and mobile RF 80mhz outside ISM 150khz – 80mhz communications equipment should bands* be used no closer to any part of the 3V (1khz 80%) GastroCH ECK® Gastrolyzer® 150khz – 80mhz including cables, than the recommended separation distance Radiated immunity calculated from the equation 3 V/m 80 mhz ~ 2.5 appropriate to the frequency of the ghz transmitter. 80 mhz to 2.5 ghz Interference may occur in the 3 V/m...
CAUTION: If the GastroCH ECK® Gastrolyzer® is used in a manner other than that specified in this manual, the safety and performance of this equipment could be impaired. Further, the use of any equipment other than that recommended by Bedfont® has not been evaluated for safety. Use of any equipment not specifically recommended in this manual is the sole responsibility of the user. CAUTION: Degree of safety of application in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide: Equipment not suitable for use in the presence of flammable mixtures. CAUTION: Do not place the GastroCH ECK® Gastrolyzer® near areas containing flammable reagents or combustible fluids. Vapours from these materials could enter the GastroCH ECK® Gastrolyzer® air system and be ignited. CAUTION: Do not apply pressures greater than 4 bar to the direct sample line connector, at a maximum flow rate of 3 LPM. Doing so could result in the disconnection of internal tubing to protect against sensor damage. Safety information and device symbols Degree of protection against electric shock Type BF applied part Type of protection against electric shock Class I equipment; (earthed) IPX0 – not protected against water Degree of protection against ingress of liquid ingress Degree of safety application in the presence of a Equipment not suitable for use in the flammable anaesthetic mixture with air, oxygen or presence of flammable mixtures. nitrous oxide Consult instructions for use Alternating current CE mark Type BF applied part Dispose of according to WEEE Serial number Manufactured by and date Bedfont® logo...
Monitor installation Maintain a 30cm (1ft) clearance envelope above the GastroCH ECK® Gastrolyzer® while it is running. The equipment should not be positioned in such a way that it is difficult to operate the disconnection device (mains plug). If it is necessary to move the GastroCH ECK® Gastrolyzer®, then the following conditions need to be maintained: 1. Select a location away from heat-producing laboratory equipment, with sufficient ventilation to allow heat dissipation. 2. Position the GastroCH ECK® Gastrolyzer® on a level surface, such as a sturdy table or laboratory bench that can support the weight of the GastroCH ECK® Gastrolyzer®, 8 kg, and resist vibration. 3. Place the GastroCH ECK® Gastrolyzer® at least 5 cm (2 in) from the front edge of the surface. 4. In addition to space for the GastroCH ECK® Gastrolyzer®, allow 15cm (6in) clearances at the sides and back to ensure sufficient air circulation. The GastroCH ECK® Gastrolyzer® must have adequate air ventilation to ensure compliance to local requirements for vapours produced during operation. 5. Relative humidity should not exceed 75% (non-condensing). Monitor set-up 1. Connect the power lead to the GastroCH ECK® Gastrolyzer® via the socket on the rear of the panel and connect to the electricity supply: 2. Switch the monitor on using the on/off switch on the back of the unit. The screen will light up and the unit will proceed to the warm up screen. If any warning screens are displayed, these should be checked in the warnings and errors section of the manual. The GastroCH ECK® Gastrolyzer® monitor warm up takes 30 minutes, see ‘temperature requirements’, and a countdown timer will be shown onscreen for the duration of the warm up as shown: NOTE: The warm-up time can be shortened if the unit is already warmed-up.
3. 5 minutes before the completion of the warm up, the GastroCH ECK® Gastrolyzer® will begin a purge cycle to clear any residual gas in the tubing. 4. Connect the sample line to the direct sample line connector for breath samples, ensuring the connecter ‘clicks’ fully into place or push the moisture filter onto the bag sample connector for breath bag sampling. Temperature requirements and device warm up Temperature should not exceed those stated in the specifications section of this document. The monitor should be calibrated at the same temperature at which it would be used, ideally 23°c ±3°c (69.8°F ± 5.4°F). NOTE: At 25°c ambient temperature the expected lifetime of the unit is at least 30,000 hrs. For every 10°c rise in temperature, the lifetime is reduced by half. The unit requires a warm up time of 30 minutes before it can be used. After 2 minutes, the unit periodically does a self-check in order to know if it is ready to be used. In the case it is detected to be ready, a bypass option is provided.This bypass should only be used if the unit is accidently switched off or needs to be moved after it has already warmed up. The bypass must be done within 2 minutes of the unit being switched off, as using the device without the correct warm-up time will compromise accuracy. The bypass is carried out by pressing on the warm-up screen. You will be asked to confirm this decision by again pressing on the next screen; this will take you to the device’s home screen. NOTE: The instrument should be calibrated prior to first use, after transportation and every 4 weeks. Performing a breath test 1. Once the warm up has been completed, attach the sample line and a breath sampling mouthpiece. 2. Press to begin. 3. A timer will be shown onscreen, whilst the sensors are zeroing. This may take up to 75 seconds if a test has just been carried out. 4. If you are using GastroCHART™ to record the readings, make sure you are on the patient’s profile and click ‘capture reading’ now. 5. Inhale when prompted by and hold breath for the pre-set 15 second countdown, as shown on screen.
7. Blow slowly into mouthpiece when prompted by 8. An indicator on-screen will illustrate how hard to blow ; keep the arrow pointing in the green section of this indicator throughout the test. 9. The arrow will change colour as the O level in the breath sample reduces to the target 15%, at which point it will turn green and the test will automatically stop after 3 seconds 10. If the patient feels they are unable to exhale for any longer and the test has not finished they can end the test at any time by pressing 11. The final results will be shown on screen 12. Once the test is complete, the final O concentration can be observed by pressing . This will show the O concentration in % and the correction factor applied to the reading if it was required. A visual indicator will help interpretation of the result: Good test, little or no correction factor applied Satisfactory test, correction factor applied Poor test, high correction factor applied and another test is recommended 13. Press to return to the results screen. 14. When you are finished, press to return to the home screen. NOTE: this will lose the reading; please ensure you have downloaded the results to GastroCHART™ or recorded them manually. 15. Remove the mouthpiece and sample line between tests to purge sensors with fresh air. Breath bag sample collection 1. Place two bag clamps over the inlet and outlet tubes of the breath bag, but keep them open 2. Insert a breath bag mouthpiece into the bag inlet tube of the breath bag 3.
5. As soon as you feel your lungs are nearly empty, and end-tidal breath has almost been reached, engage/close the clamp at the outlet of the bag 6. Whilst still maintaining a steady flow, fill up the breath bag COMPLETELY with your end tidal breath, ensuring you do not inhale whilst doing this 7. Engage the clamp at the inlet of the bag. 8. Insert the blue plastic plugs in each end of the breath bag to ensure no breath is lost from the sample. Following these steps should ensure that a valid sample has been collected. Analysing a breath bag test 1. Once warm up has been completed, attach the moisture filter to the device. 2. Press to start the bag test procedure. 3. The device will then illustrate to attach the breath bag. Ensure to carefully remove the blue plug on one end only and attach the bag to the moisture filter, then open the clamp on that end only to preserve the sample. 4. Press to begin. 5. A timer will be shown onscreen, whilst the sensors are zeroing. This may take up to 75 seconds if a test has just been carried out. 6. If you are using GastroCHART™ to record the readings, make sure you are on the patient’s profile and click ‘capture reading’ now. 7. Once zeroed, breath bag sampling will begin automatically – make sure that the clamp is open. At this point, the device needs no further intervention until a reading is recorded. 8. The device will draw the breath sample for analysis; this will take 45 seconds, as indicated on the screen. 9. The final results will be shown on screen 10.
Satisfactory test, correction factor applied Poor test, high correction factor applied and another test is recommended 11. Press to return to the results screen. 12. When you are finished, press to return to the home screen. NOTE: this will lose the reading; please ensure you have downloaded the results to GastroCHART™ or recorded them manually. Instrument layout Standard pack contents 1. GastroCH ECK® Gastrolyzer® monitor 7. Direct sample line 2. Operating manual 8. Quick start guide 3. Mains cable 9. Patient preparation guide 4. GastroCHART™ software on USB 10. Interpretation wheel 5. USB cable 11. Ledochowski book 6. Moisture filter Technical specification GastroCH ECK® Gastrolyzer®...
900-1100mbar Storage 800-1200mbar Humidity range Operating 30-75% non-condensing Storage 15-90% non-condensing 5 years Sensor operating life 2 years 2 years Dimensions Approx. 474 x 310 x 167 mm Weight Approx. 8kg Monitor construction Case: aluminium Classification Class I ME equipment: (externally powered) Type BF applied part Method of sterilization (not suitable for sterilization) Not suitable for use in an oxygen rich environment Intended for continuous use Response time ≤45 seconds Warranty GastroCH ECK® without 2 years sensors and O sensors 1 year Display symbols Description GastroCH ECK® Gastrolyzer®...
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Breath test Inhale Hold breath Countdown (breath hold) Exhale ppm reading reading Correction factor Check test quality Settings Home Exhalation speed gauge Good test (little or no correction factor applied) Satisfactory test (correction factor applied) Poor test (high correction factor applied another test is recommended) Breath bag test...
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Bag sample countdown Next step Previous step Sensor change due soon Sensor change overdue Device calibration due Reset calibration Are you sure you want to reset? Confirm reset Start calibration procedure Device zeroing sensors Check calibration gas requirements...
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Attach regulator to gas canister Attach calibration adaptor to device and turn on gas flow System processing Calibration successful Calibration failed Retry calibration/zero Service area (pin protected) Sensor servicing Troubleshooting Diagnostics Calibration servicing Edit date/time Day-month-year Month-day-year 24 hour format 12 hour format...
Sensor installation date Sensor renewal date Sensor renewal date overdue Save settings Firmware version V2.23 Serial number Warnings and maintenance 1. Mouthpieces should be replaced after every patient. 2. Hands should be washed regularly in accordance with infection control practice. 3. Please do not attempt to modify the equipment in any way or use accessories not specified by the manufacturer. Any attempt to do so will invalidate the warranty and may compromise the safety of the device. 4. Bedfont® will make available, upon request, service training to appropriately qualified persons.
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5. Pressing the reset button will prompt the device to calibrate without taking into account the sensor’s safety windows. You will be asked to confirm your choice; click to confirm. If completed, new safety windows and calibration coefficients are saved. The next calibration needed is in 4 weeks. To abort, click . Aborting the reset calibration before the gas is sampled will revert the calibration back to the previous settings.
NOTE: Only available if the unit has been on for 1 hour, from switch on. If not, the reset button is in grey 6. The GastroCH ECK® should we switched off once every 24 hours. Cleaning 1. Bedfont® recommends wiping the instrument’s external surfaces with a product specifically developed for this purpose. Bedfont® provides instrument cleaning wipes. The device or consumables cannot be sterilised. 2. NEVER use alcohol or cleaning agents containing alcohol or other organic solvents as long term exposure to these vapours will damage the sensors inside. 3. Under no circumstances should the instrument be immersed in liquid or splashed with liquid. Routine maintenance 1. The device must be calibrated once every 4 weeks with a Bedfont® calibration kit and associated gas, see ‘calibration’. 2. Bedfont® recommends an annual service in order to check sensor and component parts performance. 3. The H sensor should be replaced every two years. 4. The O sensor should be replaced every two years. 5. The CH sensor should be replaced every five years. 6. The monitor will provide daily reminders, , via the reminder screen after turning on the GastroCH₄ECK® Gastrolyzer® for 1 month leading up to the sensor change due date. 7. Once this date has elapsed the date will turn red to indicate that sensor replacement is overdue. IMPORTANT: This may compromise result accuracy.
4. First the monitor must be zeroed and this will happen automatically, showing this symbol . Once the calibration process has started, do not connect the gas at this stage. 5. Once this has been successfully carried out, the first step of the calibration process will be shown onscreen indicating for you to use the correct gas mixture . Then select the arrow at the bottom right of the screen to move to the next instruction. 6. The next instruction on screen will ask you to attach the regulator to the gas cylinder, as shown . Then select the arrow at the bottom right of the screen to move to the next instruction. 7. The next instruction onscreen will indicate for you to attach the calibration adaptor to the end of the direct sample line and then open the gas regulator Select the arrow at the bottom right hand side of the screen to start the calibration process 8. Gas flow should be set to 1 litre per minute. 9. A successful calibration will be indicated by the ; press to return to the home screen. 10. A failed calibration will be indicated by ; press to attempt calibration again. If the problem persists see ‘troubleshooting’ or call your local supplier of Bedfont® products. Return to the home screen by pressing GastroCHART™ software – connecting to the PC The GastroCHART™ software can be downloaded and installed from the USB that comes with the GastroCH ECK® Gastrolyzer®. Place one end of the connection lead into the USB socket at the rear of the GastroCH ECK® Gastrolyzer®, connecting the other end to the USB port on the PC. Before starting the software, ensure that the GastroCH ECK® Gastrolyzer® is connected to the PC and switched on. Double click the GastroCHART™ icon on the PC to start the programme. Refer to the supplied documentation for how to operate GastroCHART™. (GastroCHART™ is also available to download for FREE at www.bedfont.com)
Troubleshooting procedure Please refer to the following table for troubleshooting any error codes: sensor zero failure Reattempt breath or breath test. If failure persists contact Bedfont® or your distributor for support. sensor zero failure Reattempt breath or breath test. If failure persists contact Bedfont® or your distributor for support. sensor zero error Reattempt breath or breath test. Wait longer for the unit to warm up. If failure persists contact Bedfont® or your distributor for support. sensor communication Reattempt breath or error breath test or calibration. (appears from test screens) If failure persists contact Bedfont® or your distributor for support. Calibration failed Check calibration gas tubing is connected to (appears from calibration the breath sampling port. screen) Reattempt calibration. If failure persists contact Bedfont® or your distributor for support.
2. The product must also be decontaminated before it is returned according to your local regulations. Bedfont® can provide you with a decontamination certificate to complete, which also needs to be attached to the outside of the box. Failure to do so will result in the product being subject to Bedfont® decontamination procedure and will delay your service/repair and may incur costs to yourself. 3. Bedfont® advises that you use a courier service when returning monitors. This enables you to insure goods for loss or damage in transit. When your goods are received, you will be sent an email stating so. 4. If the device has been returned for repair it will then be examined and you will be sent an ‘engineer’s report’ and a quotation for the repair, which will include an authorisation form. Complete the authorisation form, and ensure that you include the ‘official purchase order number’. Please contact the customer repairs department if you are unable to supply an ‘official purchase order number’. 5. If your monitor is still in warranty and the fault is covered by warranty, see the ‘warranty’ section of this manual; Bedfont® will repair it and return it to you with an ‘engineer’s report’, free of charge. 6. If you choose not to proceed with the repair, a handling fee will be charged. Ensure that you return the completed authorisation form with an ‘official purchase order number’. 7. The equipment will be returned to you as soon as Bedfont® has received all relevant paperwork. A carriage fee will be charged if the monitor is no longer in warranty. Warranty Bedfont® Scientific Limited warrants the GastroCH ECK® Gastrolyzer® product, sensors excepted, to be free of defects in materials and workmanship for a period of 2 years from the date of shipment. The H and CH sensors are guaranteed for a period of 1 year only from the date of shipment from Bedfont®. Bedfont’s sole obligation under this warranty is limited to repairing or replacing, at its choice, any item covered under this warranty when such an item is returned, intact and prepaid, to Bedfont® Scientific Limited or the local representative. This warranty is automatically invalidated if the products are repaired; altered, void labels removed or otherwise tampered with by unauthorised personnel, or have been subject to misuse, neglect or accident. At the end of the product’s life, contact Bedfont® or its distributor for disposal instructions.
>20ppm compared to base sample within 90 minutes of lactulose ingestion Lactulose SIBO* A) Early increase of at least 20ppm for the sum of the two gases B) Increase >20ppm corresponding to the appearance of lactulose in the colon Lactulose IITT** Fast >20ppm peak is detected at 60 minutes Normal >20ppm peak is detected at 80 minutes Slow >20ppm peak is detected 100 minutes or later Fructose >20ppm CH >12ppm compared to base sample Sorbitol >20ppm compared to base sample Xylitol >20ppm compared to base sample Glucose >10ppm CH >10ppm compared with base sample *SIBO = Small Intestinal Bacterial Overgrowth **IITT = Impaired Intestinal Transit Time References 1. Levitt, M. (1969). Production and Excretion of Hydrogen Gas in Man. New England Journal of Medicine, 281(3), pp.122-127. 2. Biolab Medical Unit, (2012). Breath Hydrogen and Methane Testing for SIBO. Nutritional and Environmental Medicine. London: Biolab Medical Unit. Available at http://www.biolab.co.uk/docs/bhydro.pdf 3. Ledochowski, M. And Ledochowski, L. (2011). Hydrogen Breath Tests. 2nd ed. Anichstrasse: Akadmed-Verlag. Available from Bedfont® Scientific. 4. Pimental, M. Et al. (2003). Methane Production during Lactulose Breath Test is Associated with Gastrointestinal Disease Presentation. Digestive Diseases and Sciences, 48(1). Spares GASTROCHECK-MP 100 mouthpieces for GastroCH₄ECK® Gastrolyzer® online measurement.
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GASTROCHECK-MP-XL 250 mouthpieces for GastroCH₄ECK® Gastrolyzer® online measurement. GASTROCHECK-BAG 100 breath bags and 100 breath bag mouthpieces for GastroCH₄ECK® Gastrolyzer®. GASTROCHECK-BAG-XL 250 breath bags and 250 breath bag mouthpieces for GastroCH₄ECK® Gastrolyzer®. GASTROCHECK-DESS Moisture removal filter for GastroCH₄ECK® Gastrolyzer® (only required if using breath bags) last for 150 tests or 3 months. GASTROCHECK-DESS-XL Moisture removal filters for GastroCH₄ECK® Gastrolyzer® pack of 5 (only required if using breath bags) filters last for 150 tests or 3 months. GASTROCHECK-CAL-KIT 34*ltr calibration kit - 100ppm Hydrogen, 100ppm Methane, 20.9% Air with regulator. GASTROCHECK-CAL 34*ltr replacement canister 100ppm Hydrogen, 100ppm Methane, 20.9% Air. GASTROCHECK- Calibration adapter for GastroCH₄ECK® Gastrolyzer®. CALIADAP REG1.0L-V 1 ltr Regulator for use with 34* & 112 ltr cylinders. WIPE-V Pack of 50 wipes. ISSA-BB Face mask sampling system for use with GastroCH₄ECK® Gastrolyzer® breath bags. TEST-LACTOSE Home care breath testing kit for lactose intolerance. Substrate not included. TEST-FRUCTOSE Home care breath testing kit for fructose intolerance. Substrate not included. TEST-LACTULOSE Home care breath testing kit for small intestinal bacterial overgrowth (SIBO). Substrate not included.
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