Bedfont GastroCH4ECK Gastrolyzer User Manual
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Bedfont GastroCH4ECK Gastrolyzer User Manual

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GastroCH
ECK Gastrolyzer
®
®
4
USER MANUAL
Helping to detect gastrointestinal disorders, one breath at a time.

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Summary of Contents for Bedfont GastroCH4ECK Gastrolyzer

  • Page 1 GastroCH ECK Gastrolyzer ® ® USER MANUAL Helping to detect gastrointestinal disorders, one breath at a time.

  • Page 2: Important Information/Reminders

    Important Information/Reminders WARNING: Please read the manual before use. WARNING: Breath tests must only be carried out with Bedfont® accessories. Failure to do so may cause incorrect readings. WARNING: The mouthpieces are single patient use only. Further re-use could cause incorrect readings and could increase the risk of cross infection which may result in decreased accuracy of results.
  • Page 3 ECK® device temperature needs to be at 21°C ± 4°C (69.8°F ± 39.2°F) to be able to perform a calibration. NOTE: Bedfont® recommends an annual service in order to check sensor and component parts performance. NOTE: Servicing should only be carried out by a Bedfont® trained representative NOTE: Bedfont®...

  • Page 4: Table Of Contents

    Contents Important Information/Reminders ......................1 Definitions ............................... 4 Introduction ............................4 Intended Use ............................4 Contraindications ............................ 5 Compliance ............................. 5 Instrument Layout........................... 5 Parts and accessories ..........................6 Installation and Set-up ..........................7 User Interface ............................8 Breath Testing ............................9 Analysing a Breath Bag Test ........................

  • Page 5: Definitions

    Definitions WARNING: indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. CAUTION: indicates a potentially hazardous situation, which, if not avoided, may result in damage to the device. NOTE: used to call attention to notable information that should be followed during use. Introduction The User Manual provides instructions on how to operate GastroCH₄ECK®...

  • Page 6: Contraindications

    professional to diagnose a patient’s condition. Contraindications There are no known contraindications. Compliance Please refer to the following sections of this manual for more information on the compliance of the GastroCH ECK® Gastrolyzer® monitor • Glossary of Symbols and Safety Information •...

  • Page 7: Parts And Accessories

    Parts and accessories 1. Sampling line 9. Breath bag clips 2. Mouthpiece 10. Face mask 3. USB with GastroCHART™ software 11. Patient Preparation guide 4. Hydrogen Breath Tests book by Ledochowski 12. Moisture removal filter 5. Breath bag 13. Power cable 6.

  • Page 8: Installation And Set-Up

    WARNING: When selecting an accessory for the GastroCH₄ECK® Gastrolyzer® monitor, please be advised that an accessory not recommended by Bedfont® may result in loss of performance and may compromise the safety of the device. WARNING: The mouthpieces are single patient use only. Further re-use could cause incorrect readings and could increase the risk of cross infection which may result in decreased accuracy of results.

  • Page 9: User Interface

    User Interface Home Screen 1. Start Breath Test button 2. Start Bag Test 3. Go to Settings Menu Settings Menu 1. Go to Diagnostic Page 2. Start Calibration procedure 3. Go to Service Area 4. Home Button NOTE: The Service Area is PIN protected and must only be accessed by trained personnel:...

  • Page 10: Breath Testing

    Breath Testing Attach the sample line to the GastroCH ECK® via the sample connecter. Then attach a new mouthpiece to the other end of the sample line. Press the breath test icon to begin. A timer will be shown onscreen whilst the sensors are zeroing.
  • Page 11 A beep will sound during the last three seconds of the countdown. Exhale slowly into mouthpiece when prompted onscreen. An on-screen dial will help to guide the exhalation rate; keep the arrow pointing in the green section of this indicator throughout the test.

  • Page 12: Analysing A Breath Bag Test

    This will show the O concentration in % and the correction factor applied to the reading if it was required. A visual indicator will help to interpret 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 Press the back arrow to return to the results screen.
  • Page 13 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. NOTE: If GastroCHART™ is being used to record the readings, on the patient’s profile click ‘capture reading’ now. Once zeroed, breath bag sampling will begin automatically –...

  • Page 14: Maintenance

    2 years. c. The CH sensor should be replaced every 5 years. CAUTION: Sensor use beyond the specified component lifetime without servicing may compromise result accuracy. NOTE: Bedfont® recommends an annual service in order to check sensor and component parts performance.

  • Page 15: Calibration

    Cleaning Bedfont® recommends wiping the instrument external surfaces with a product specifically developed for this purpose. An EPA registered alcohol free disinfectant should be used, such as Sani-Cloth AF3 Germicidal Disposable Wipe. Cleaning should be performed following the instructions for use specified by the manufacturer of the EPA registered disinfectant. The device or consumables cannot be sterilized.
  • Page 16 First the monitor must be zeroed and this will happen automatically. NOTE: Do not connect the gas at this stage. The temperature of the GastroCH ECK® is above 25°C (77°F) and is too hot to be calibrated. Please move the device to a cooler area and try again later.
  • Page 17 Screw the gas canister into the regulator. Attach the CaliAdaptor to monitor via the sample line and open the gas canister. Press the arrow to begin the calibration. NOTE: Gas flow should be set to 1 litre per minute. A successful calibration will be indicated by the green tick; return to the home screen.
  • Page 18 A failed calibration will be indicated by the red cross; press the retry icon to attempt calibration again. If the problem persists, see ‘Troubleshooting’. Alternatively, return to the home screen.

  • Page 19: Technical Specification

    Technical Specification GastroCH ECK® Gastrolyzer® Concentration range 0-200 ppm 0-200 ppm 14-23% Power input 230V/100V, 50Hz – 60 Hz, 0.5 – 1.0 A Fuse T 3.15 AH Start-up time ≤2 minutes Calibration frequency Every 4 weeks Display Full colour touchscreen Detection principle Electrochemical sensor (O &...

  • Page 20: Buttons

    Classification and Regulatory Information 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 2 years* *Subject to maintenance and service.

  • Page 21: Troubleshooting

    Troubleshooting When the GastroCH ECK® encounters an error, it will be recorded in the log for referrals when seeking troubleshooting assistance. To access the log, go to the settings menu and then select the log icon. NOTE: All errors logged are not saved in the device’s memory and therefore the log is reset every time the monitor is restarted Please refer to the following list to troubleshoot any error codes:...
  • Page 22 Calibration due – please refer to the ‘Calibration’ section of this manual. Sensor change due in 30 days. Sensor change overdue. The unit has been running for more than 16,000 hours.
  • Page 23 If failure persists contact Bedfont® or their distributor for support. sensor connectivity error: Press the retry button. If the error occurs more than 3 times, please restart the unit. If failure persists contact Bedfont® or their distributor for support.
  • Page 24 Press the retry button. If the error occurs more than 3 times, please restart the unit. If failure persists contact Bedfont® or their distributor for support. sensor error: Check that the ambient temperature is within range and that the unit is plugged correctly.

  • Page 25: Glossary Of Symbols And Safety Information

    Calibration failed: Check calibration gas tubing is connected to the breath sampling port. Reattempt calibration. If failure persists contact Bedfont® or their distributor for support. Glossary of Symbols and Safety Information Glossary of Symbols and Safety Information Symbol & Standard...
  • Page 26 Consult instructions for (NOTE: The eIFU indicator can be a ISO 7000 – 1641 manufacturer’s website URL or some other appropriate indication www.bedfont.com IEC 60601-1, Table that the instructions for use are D.1, Symbol 11 available in an electronic format.) ISO 15223 –...
  • Page 27 ISO 15223 – 1. Clause Indicates the manufacturer’s 5.1.6 Catalogue number catalogue number so that the medical device can be identified ISO 7000-2493 Manufacturer’s declaration of compliance to all relevant European Directive CE mark European Medical Device 93/42/EEC Regulations Bedfont® logo Manufacturers logo...
  • Page 28 To indicate that the items shall not be vertically stacked, either because of the nature of the Do not stack ISO 7000-2402 transport packaging or because of the nature of the items themselves. To indicate that the marked item General symbol for or its material is part of a recovery ISO 7000-1135 recovery/recyclable...
  • Page 29 Environment Electromagnetic Immunity The GastroCH ECK® Gastrolyzer® complies with the directive IEC/EN 60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in IEC/EN 61000-4. Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2) The GastroCH ECK®...
  • Page 30 240VAC 500ms (50Hz/60Hz) 70% @ 0° 240VAC 20ms (50Hz/60Hz) 100% @ 0° 240VAC 10ms (50Hz/60Hz) 100% @ 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° Voltage Dips and Interrupts: 240VAC 5s (50Hz/60Hz) 100% Met or EN61000-4-11:2004 100VAC 500ms (50Hz/60Hz) 70% @ 0° exceeded IEC61000-4-11:2005 100VAC 20ms (50Hz/60Hz) 100% @ 0°...
  • Page 31 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.

  • Page 32: Warranty

    2 years from the date of shipment, subject to maintenance and service. 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®...
  • Page 33 Email: ask@bedfont.com Web: www.bedfont.com © Bedfont® Scientific Limited 2022 Issue 7 - September 2022, Part No: LAB723_AX_USA Bedfont® Scientific Limited reserves the right to change or update his literature without prior notice. Registered in: England and Wales. Registered No: 1289798...

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