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Summary of Contents for Gastrolyzer Gastro CH4ECK
- Page 1 GastroCH Gastrolyze r ® User manual 0086 Scientific contributions to health.
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Page 2: Table Of Contents
GastroCH Gastrolyzer® Contents Definitions ..............................2 Intended Use ............................. 2 Introduction .............................. 3 Safety Notes .............................. 3 Contraindications ............................3 Safety During installation and/or Maintenance ..................4 Electrical Safety ............................4 Safety against Risk of Fire .......................... 4 Mechanical Safety ............................. 4 Environment .............................. 5 Safety Information and Device Symbols ....................6 Monitor Installation ..........................7 Monitor Set-up ............................7 Temperature Requirements and Device Warm-up ................... 8 Performing a breath test ........................... 8 Breath bag sample collection ........................9 Analysing a breath bag test ........................10 Instrument Layout ........................... 11 Standard Pack Content ..........................11 Technical Specification . -
Page 3: Definitions
GastroCH Gastrolyzer® 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 advice in the Important adds benefit to the performance of a piece of equipment or to a process. NOTE is used to call attention to notable information that should be followed during installation, use, or servicing of this equipment Intended Use The GastroCH₄ECK™ 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 aide 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... -
Page 4: Introduction
GastroCH Gastrolyzer® Introduction and CH are generated in the intestinal lumen by bacterial action on carbohydrates in the small or large intestine. Once the resultant H and CH is diffused into the bloodstream it is transported to the alveoli and then can be detected in expiratory air. Levitt demonstrated the correlation between intestinal lumen H and CH production and H and CH excretion in expiratory air. Accurate measurement of H and CH in parts per million (ppm) in expiratory air reveals intolerance and/or malabsorption of carbohydrates; or bacterial overgrowth. 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. The operator should not touch the patient whilst in contact with either the computer or the USB connector parts. The GastroCH₄ECK™ 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... -
Page 5: Safety During Installation And/Or Maintenance
GastroCH Gastrolyzer® Safety During installation and/or Maintenance This GastroCH₄ECK™ Gastrolyzer® can be installed by a trained user as long as the instruction manual has been read. This GastroCH₄ECK™ Gastrolyzer® weighs 6kg. Do not open the GastroCH₄ECK™ Gastrolyzer®. This could result in a void in warranty. Servicing should only be carried out by a Bedfont trained representative. Electrical Safety To reduce the risk of electrical shock, this equipment uses a three-wire electrical cord and plug to connect the GastroCH₄ECK™ 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 GastroCH₄ECK™ Gastrolyzer®. Do not install the GastroCH₄ECK Gastrolyzer® on a ground fault-protected power source. Do not place containers holding liquid on or near the GastroCH₄ECK. If they spill, liquid may enter the GastroCH₄ECK Gastrolyzer® and damage electrical or mechanical components. Safety against Risk of Fire Fuses protect certain electrical circuits within this GastroCH ECK™ Gastrolyzer® against overcurrent conditions. For continued protection against the risk of fire, replace only with the same type and rating specified. This 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 30-cm (1-ft) area surrounding the GastroCH ECK™ Gastrolyzer®. Mechanical Safety For safe operation of the equipment, observe the following: Use only accessories designed for use in this GastroCH ECK™ Gastrolyzer®. • Do not lift or move the GastroCH ECK™ Gastrolyzer® while it is running. This could damage • the methane bench. -
Page 6: Environment
GastroCH Gastrolyzer® Environment The GastroCH ECK™ 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™ is intended for the use in the electromagnetic environment specified below. The customer or the user of the GastroCH ECK™ should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Conducted RF IEC 3 V rms 150 kHz ~ 3 V rms Portable and mobile RF 61000-4-6 80MHz outside ISM 3 V/m communications equipment should Radiated RF IEC bands* 80MHz to 2.5GHz be used no closer to any part of the 61000-4-3 10 V rms 150 kHz ~ GastroCH4ECK including cables, 80MHz in ISM than the recommended separation bands* distance calculated from the 10 V rms 80 kHz ~ equation appropriate to the 2.5 GHz frequency of the transmitter. -
Page 7: Safety Information And Device Symbols
GastroCH Gastrolyzer® CAUTION If the GastroCH₄ECK 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 GastroCH₄ECK Gastrolyzer® near areas containing flammable reagents or combustible fluids. Vapours from these materials could enter the GastroCH₄ECK Gastrolyzer® air system and be ignited. 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) Degree of protection against ingress of liquid IPXO – not protected against water 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 Caution – please refer to the warnings and safety notices in this manual Refer to Manual Alternating Current Direct Current CE Mark Type BF applied part Dispose of according to WEEE Serial Number Manufacture by and Date Bedfont Logo... -
Page 8: Monitor Installation
GastroCH Gastrolyzer® Monitor Installation Maintain a 30-cm (1-ft) clearance envelope above the GastroCH ECK™ Gastrolyzer® while it is running. The equipment should not be positioned such that it is difficult to operate the disconnection device (Mains Plug). If it is necessary to move the GastroCH ECK™ Gastrolyzer®, maintain the following conditions: 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® 6 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 15.2 cm (6-in.) 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™ via the socket on the rear of the panel and connect to the electricity supply: Bedfont Scientific Ltd Station Road, Harrietsham,... -
Page 9: Temperature Requirements And Device Warm-Up
GastroCH Gastrolyzer® 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 21°c +3°c (69.8°F +5.4°F). The unit requires a warm up time of 30 minutes before it can be used. The warm up screen can be bypassed after 2 minutes 30 seconds from the power being turned on, this bypass should only be used if the unit is accidently switched off or needs to be moved. The bypass must only 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 home screen. NOTE The instrument should be calibrated prior to first use, after transportation and every 4 weeks. Performing a breath test 1. Once warm-up has been completed, attach the sample line and a breath sampling mouthpiece. 2. Press 3. A timer will be shown onscreen, whilst the sensors are zeroing, this may take up to 60 seconds. 4. Inhale when prompted by and hold breath for the pre-set 15 second countdown, as shown on screen. 5. A beep will sound during the last three seconds of the countdown 6. Blow slowly into mouthpiece when prompted by 7. An indicator on-screen will illustrate how hard to blow ; keep the arrow pointing in the green section of this indicator throughout the test. 8. The arrow will change colour as the O2 level in the breath sample reduces to the target 14% at which point it will turn green and the test will stop. -
Page 10: Breath Bag Sample Collection
GastroCH Gastrolyzer® 9. 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 10. The final results will be shown on screen 11. Once the test is complete the final O2 concentration can be observed by pressing , this will show the O2 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 another test is recommended 12. Press to return to the results screen. 13. When you are finished press to return to the home screen. NOTE this will lose the reading, please ensure you have downloaded to GastroCHART™ or recorded manually. 14. Remove the mouthpiece and sample line between tests to purge sensors with fresh air Breath bag sample collection 1. Remove the blue plastic plugs from each end of the breath bag. 2. Place two bag clamps over the inlet and outlet tubes of the breath bag. 3. Insert a breath bag mouthpiece into the bag inlet tube of the breath bag. 4. Ensure both bag clamps are disengaged/open, allowing air to pass through the bag. 5. Exhale gently through the bag at a steady rate. 6. Continue exhaling until you feel you have nearly emptied your lungs. This clears the dead air in the upper airspace of the lungs in order to achieve a good end-tidal sample. 7. As soon as you feel your lungs are nearly empty, and end-tidal breath has almost been reached,... -
Page 11: Analysing A Breath Bag Test
GastroCH Gastrolyzer® 8. 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. 9. Engage the clamp at the inlet of the bag. 10. Replace 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 breath bag moisture filter to the device. 2. Press to start the bag test procedure. 3. A timer will be shown onscreen, whilst the sensors are zeroing, this may take up to 60 seconds. 4. The device will then illustrate to attach the breath bag. Ensure to carefully remove the blue plug on one end only, attach to the moisture filter and then open the clamp on that end only to preserve the sample. 5. Press at this point the device needs no further intervention until a reading is recorded. 6. The device will draw the breath sample for analysis, this will take 45 seconds, indicated on the screen. 7. The final results will be shown on screen 8. Once the test is complete the final O2 concentration can be observed by pressing , this will show the O2 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 another test is recommended 9. -
Page 12: Instrument Layout
GastroCH Gastrolyzer® Instrument Layout GastroCH Gastrolyzer ® Bag Sample connector Sampling Line Dock Zeroing Side Stream Exhaust Bedfont Scientific Ltd Station Road, Harrietsham, Maidstone, Kent Outlet ME17 1JA, UK Tel: +44(0)1622 851122 Fax: +44(0)1622 854860 Email:ask@bedfont.com Web: www.bedfont.com Exhaust DO NOT COVER... -
Page 13: Technical Specification
GastroCH Gastrolyzer® Technical Specification GastroCH₄ECK™ Gastrolyzer® Concentration Range 0-200 ppm 0-200 ppm 14-23% Power input 230V/50Hz/100mA [115V/60Hz/220mA compatible] Warm-up time 30 minutes Calibration Frequency Every 4 weeks Display Full colour touchscreen Detection Principle Electrochemical sensor (O & H Infrared (CH Resolution 1 ppm Accuracy +/- 10% of reading per annum Repeatability <5% difference on consecutive readings Resolution 1 ppm Accuracy Accuracy +/- 10% of reading per annum Repeatability <5% difference on consecutive readings Resolution 0.1% Accuracy +/- 10% of reading per annum Repeatability <5% difference on consecutive readings... -
Page 14: Display Symbols
GastroCH Gastrolyzer® Display Symbols Description GastroCH₄ECK™ Gastrolyzer® 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... - Page 15 GastroCH Gastrolyzer® Breath Bag Test Attach Breath Bag to Moisture Filter Bag Sample Countdown Next Step Previous Step Sensor Change Due Soon Sensor Change Overdue Device Calibration Due Start Calibration Procedure Device Zeroing Sensors Check Calibration Gas Requirements Attach Regulator to Gas Canister...
- Page 16 GastroCH Gastrolyzer® 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 Sensor...
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Page 17: Warnings And Maintenance
GastroCH Gastrolyzer® Sensor Sensor Zero Failure Sensor Zero Failure Sensor Zero Failure Sensor Failure 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. 5. Pressing and confirming a calibration reset will reset the calibration to factory settings. The device will then require calibration before it can be used again. Only after a calibration has been performed will the new settings be saved. Aborting the calibration reset at any stage will revert the calibration back to the previous settings. -
Page 18: Cleaning
GastroCH Gastrolyzer® Cleaning 1. Bedfont recommend wiping the instrument 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. Changing date and time 1. Press 2. Press you will then be asked for a 4 digit PIN code, this is available for service trained personnel. 3. Press you can then select either d-m-y or m-d-y for the date format and 12h or 24h for the time format 4. Dates and times are then adjusted by selecting the number you wish to change and pressing to increase and decrease 5. Press to save your settings. Routine Maintenance 1. The device must be calibrated once every 4 weeks with a Bedfont supplied calibration kit and associated gas, see ‘Calibration’. 2. Bedfont recommend 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. -
Page 19: Gastrochart™ Software - Connecting To The Pc
GastroCH Gastrolyzer® and will give a reminder during start-up when calibration is due. The calibration gas required is 100ppm H , 100ppm CH and 20.9% O 1. Turn on the monitor by pressing the power button once. 2. Press 3. Start the calibration process by pressing 4. First the monitor must be zeroed and this will happen automatically, showing this symbol once the calibration process has started, do not connect gas at this stage. 5. Once this has been successfully carried out the first step of the calibration process will be shown onscreen, indicating 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 show 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 . Then 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. -
Page 20: Returns Procedure
GastroCH Gastrolyzer® Returns Procedure If your equipment requires servicing, please contact your local Bedfont Customer Service Department, distributor or supplier before returning any goods. 1. When you have supplied the Customer Repairs Department with the monitor serial number and description of the fault, you will be issued with a returns/ ticket number. Please state the returns/ticket number on the outside of the box when returning the monitor, and ensure that your full details, telephone, fax numbers and return address are clearly stated. 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 advise 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 ‘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 (excluding H and sensors) to be free of defects in materials and workmanship for a period of two years from the date of shipment. The H... -
Page 21: Testing Protocol Thresholds
GastroCH Gastrolyzer® 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. Single use consumables and accessories should be disposed of in line with local clinical waste guidelines. Testing Protocol Thresholds Below is an interpretation table for general guidance on interpreting the H and CH values for supporting a diagnosis of conditions. Other factors through qualified judgement need to be taken in account by looking at the patient history, on-going symptoms and symptoms during test. H and CH readings can be interpreted as positive or negative using the following pre-set thresholds (this is the increase in reading compared to the base sample): Test Positive Interpretation 2, 3 Lactose >20ppm CH >12ppm compared to base sample Lactulose & CH >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... -
Page 22: Spares
GastroCH Gastrolyzer® Spares GASTROCHECK-MP 100 mouthpieces for GastroCH ECK™ on-line measurement GASTROCHECK-MP-XL 250 mouthpieces for GastroCH ECK™ on-line measurement GASTROCHECK-BAG 100 breath bags and 100 breath bag mouthpieces for GastroCH ECK™ GASTROCHECK-BAG-XL 250 breath bags and 250 breath bag mouthpieces for GastroCH ECK™ GASTROCHECK-DESS Moisture removal filter for GastroCH ECK™ (only required if using breath bags) last for 150 tests or 3 months GASTROCHECK-DESS-XL Moisture removal filters for GastroCH ECK™ 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™ 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™ breath bags TEST-LACTOSE Home care breath testing kit for lactose intolerance. Substrate not... - Page 23 Contact Bedfont or one of our worldwide Gastrolyzer ® distributors for a free demonstration www.bedfont.com Tel:+44 (0)1622 851122 Email: ask@bedfont.com A full list of our worldwide distributors can be found at http://www.bedfont.com/distributors/ Scientific contributions to health. Station Road, Harrietsham, Maidstone,...
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