Bedfont Gastro+ Gastrolyzer Скачать руководство пользователя страница 34

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Dispose of according to WEEE

Serial number

Manufacture by and date

Bedfont® logo

Environment

The Gastro

™ Gastrolyzer® product complies with the Medical Device Directive 93/42/EEC as

amended by 2007/47/EC and the Medical Device Electromagnetic Compatibility standard EN 60601-
1-2.

WARNING:

Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Gastro

™

Gastrolyzer®, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result. This equipment should be moved if necessary to avoid
interference.

Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2)

The Gastro

™

Gastrolyzer® is intended for the use in the electromagnetic environment specified below. The

customer or the user of the Gastro

™

Gastrolyzer® should assure that it is used in such an environment.

Test

IEC 60601 Test level

Compliance level

Electromagnetic

environment – guidance

Radiated Emissions:

FCC part 15 Subpart B

Class A & EN55011:2016 +

A1:2017 Class A

30MHz to 1GHz

Met or exceeded

Portable and mobile RF

communications

equipment should be used

no closer to any part of the

Gastro

™

Gastrolyzer®

including cables, than the

recommended separation

distance calculated from

the equation appropriate

to the frequency of the

transmitter.

Conducted Emissions:

FCC part 15 Subpart B

Class A & EN55011:2016 +

A1:2017 Class A

150KHz to 30 MHz

Met or exceeded

Radiated Immunity :

IEC 61000-4-3:2006 + A1

2007 + A2:2010 &

EN61000-4-3:2006 +

A1:2008 + A2:2010

3V/m (1kHz 80%) 80MHz –

2.7GHz

Spot Frequencies:

385MHz 27 V/m PM 18 Hz

450MHz 28 V/m FM 1 kHz

sine

710MHz 9 V/m PM 217 Hz

745MHz 9 V/m PM 217 Hz

780MHz 9 V/m PM 217 Hz

810MHz 28 V/m PM 18 Hz

Met or exceeded

Interference may occur in

the vicinity of equipment

marked with the following

symbol:

Содержание Gastro+ Gastrolyzer

Страница 1: ...Gastro TM Gastrolyzer USER MANUAL Helping to detect gastrointestinal disorders one breath at a time ...

Страница 2: ...te the monitor must be held upright at all times during a breath test WARNING Do not block the exhaust ports on the device at any time Blocking the exhaust ports may cause erroneous readings CAUTION Ensure the monitor is used within the stated operating temperature and humidity ranges Operating temperature is 15 35o C Operating humidity is 25 80 RH non condensing CAUTION Portable and mobile RF com...

Страница 3: ...rotocol pre set timings 21 Edit protocol timings 21 Edit protocol names 23 Protocol pre set thresholds 26 Edit protocol pre set positive thresholds 27 Reviewing history 29 Changing date and time 30 Technical Specification 32 Safety Information 32 Environment 33 Display symbols 35 Maintenance 37 Calibration 38 Troubleshooting 42 GastroCHART software connecting to the PC 42 Returns procedure 43 Spar...

Страница 4: ...gienically using single use disposable SteriBreath mouthpieces and disposable face masks The Gastro can be used to aid in the diagnosis of the following disorders Carbohydrate intolerance Carbohydrate malabsorption Intestinal bacterial overgrowth Investigation of intestinal transit time Definitions WARNING indicates a potentially hazardous situation which if not avoided may result minor or moderat...

Страница 5: ...a clinical environment Contraindications There are no known contraindications Instrument Layout 1 Display 2 Power button 3 Breath sampling D piece 4 D piece aperture 5 Exhaust port for breath sample 6 USB connector for use with GastroCHART software 7 Single use SteriBreath mouthpiece 8 Battery compartment 9 Battery compartment clip 10 Reset button 11 Programming switch 12 USB cable 1 0m ...

Страница 6: ...5 User Interface Home Screen 1 Battery status 2 Face mask breath test 3 Normal breath test 4 Multi patient air test 5 Patient profiles 6 Settings 1 2 3 4 5 6 ...

Страница 7: ...6 Taking a breath test Attach a breath sampling D piece and SteriBreath mouthpiece Turn on the monitor by pressing the power button once Press the breath test icon on screen ...

Страница 8: ...s stabilising Inhale and hold breath for the pre set 15 second countdown as shown on screen If unable to hold breath for full 15 seconds the timer can be adjusted in the settings Press the home button at any time to cancel the breath test ...

Страница 9: ...8 A beep will sound during the last three seconds of the countdown Blow slowly into mouthpiece aiming to empty lungs completely ...

Страница 10: ...ld onscreen When the test is finished the breath test home and save icons will appear at the bottom of the screen To repeat breath test press the breath test icon and repeat steps To return to the home screen press the home icon ...

Страница 11: ... to purge sensor with fresh air To switch off press and hold the power button for 3 seconds unit will also power off after 45 minutes of inactivity to save power Taking a face mask test Attach a new face mask sampling system Turn on the monitor by pressing the power button once Press the face mask breath test option ...

Страница 12: ...11 If the timer is shown the sensor is stabilising Inhale and exhale into the face mask the device will take the reading in real time ...

Страница 13: ...ask breath test home and save icons will appear at the bottom of the screen To repeat breath test press the face mask breath test icon and repeat steps To return to the home screen press the home icon Remove the face mask sampling system between tests to purge sensor with fresh air To switch off press and hold the power button for 3 seconds unit will also power off after 45 minutes of inactivity t...

Страница 14: ...inic This can be done by following these steps Press the multi patient icon on the main screen this will go to the patient database screen where patients can be selected that have been previously added To add patients follows instructions in adding a patient profile section of this manual Up to 10 patients can be selected for testing simply by pressing their name slot Selected patients will change...

Страница 15: ...al protocol has been selected and when selecting a patient during testing three options will appear for the first patient Their name will be shown at the top of the screen To perform a breath test please note if this is the base sample no substrate sugar should be given to patient before this point press and follow steps 4 8 of the taking a breath test section of this manual To perform a face mask...

Страница 16: ...tient profile press the save icon This is the base sample once the result has been saved a prompt will appear to give the patient the relevant substrate sugar Once the patient has done this press the right arrow to continue with the next patient this will also start the next breath test timer for the previous patient The device will prompt the next patient tested in the same way ...

Страница 17: ...ke the next reading for that patient by pressing their name and following above instructions Once each patient has finished their testing protocol their name slot will turn green and the readings will be saved in the profile The amount of tests performed and how many are left for any given patient can be viewed by selecting the profile in the session screen If the results are satisfactory before t...

Страница 18: ...17 Confirm the action by pressing the same icon on the next screen Once the complete patient session has finished all name slots will show as green ...

Страница 19: ...reference or printing follow instructions in GastroCHART software section of this manual Patient Profiles The Gastro Gastrolyzer allows up to 10 patient profiles to be set up on the device in order to record readings to a specific patient profile and then downloaded later using GastroCHART This can be done by following the steps below ...

Страница 20: ...19 Press the patient profile icon on the home screen Press a patient profile to go to the edit screen ...

Страница 21: ...ent using the keyboard provided Once name or ID has been edited press the save icon The patient profile has now been successfully set up More patient profiles can be set up by pressing the back arrow and repeating steps Return to the home screen by pressing the home icon ...

Страница 22: ...ose2 10g of Lactulose in 200ml of water 0 20 40 60 80 100 120 140 160 180 10 Fructose3 25g of Fructose in 250ml of water 0 15 30 60 90 120 6 Sorbitol3 12 5g of Sorbitol in 250ml of water 0 15 30 60 90 120 6 Xylitol3 25g of Xylitol in 250ml of water 0 15 30 60 90 120 6 Glucose3 50g of glucose in 250ml of water 0 15 30 45 60 5 Edit protocol timings The testing protocols timings can be edited with di...

Страница 23: ...22 Press the protocol icon Select the protocol to be changed this will change to green when selected Press the right arrow to continue ...

Страница 24: ... down arrows The base sample cannot be changed and will show as base active intervals will show in green Once the protocol has been edited press the save icon to save Return to the settings screen Edit protocol names The testing protocols names can be edited Press the settings icon on the home screen ...

Страница 25: ...24 Press the protocol icon Select the protocol to be changed this will change to green when selected Press the right arrow to continue ...

Страница 26: ...25 Press the protocol name at the top of the screen Enter the new or preferred protocol name using the keyboard provided Press the save icon to save ...

Страница 27: ...pm CH4 12ppm compared to base sample Lactulose4 H2 CH4 20ppm compared to base sample within 90 minutes of lactulose ingestion Lactulose2 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 Lactulose2 IITT Fast 20ppm peak is detected at 60 minutes Normal 20ppm peak is detected at 80 minutes Slow 20ppm peak i...

Страница 28: ...27 Edit protocol pre set positive thresholds The testing protocols names can be edited Press the settings icon on the home screen Press the protocol icon ...

Страница 29: ...28 Select the protocol to be changed this will change to green when selected Press the right arrow to continue Press the graph and ppm icon ...

Страница 30: ...own arrow to increase or decrease the threshold Press the save icon to save Reviewing history The Gastro Gastrolyzer will record every reading taken in its history up to 150 readings To access this press the settings icon ...

Страница 31: ...30 Press the history icon Changing date and time To change the date and time on the Gastro Gastrolyzer press the settings icon ...

Страница 32: ...ither d m y or m d y for the date format and 12h or 24h for the time format Dates and times are then adjusted by selecting the number and pressing the up or down arrows to increase and decrease Save the settings by pressing the save icon ...

Страница 33: ...0 mm Weight Approx 215g including batteries Materials Case polycarbonate ABS blend SteriTouch anti microbial additive D piece polypropylene SteriBreath polypropylene OneBreath Mouthpiece polypropylene CO cross interference 4 Readings of 200ppm at temperature between 26 35ᵒC can decrease accuracy to 15 Safety Information Degree of protection against electric shock Type BF applied part Type of prote...

Страница 34: ...d below The customer or the user of the Gastro Gastrolyzer should assure that it is used in such an environment Test IEC 60601 Test level Compliance level Electromagnetic environment guidance Radiated Emissions FCC part 15 Subpart B Class A EN55011 2016 A1 2017 Class A 30MHz to 1GHz Met or exceeded Portable and mobile RF communications equipment should be used no closer to any part of the Gastro G...

Страница 35: ...VAC 500mS 50 60Hz 70 0 240VAC 20mS 50 60Hz 100 0 240VAC 10mS 50 60Hz 100 240VAC 5S 50 60Hz 100 100VAC 500mS 50 60Hz 70 0 100VAC 20mS 50 60Hz 100 0 100VAC 10mS 50 60Hz 100 0 45 90 135 180 225 270 315 100VAC 5S 50 60Hz 100 Met or exceeded Power Frequency Magnetic Field IEC 61000 4 8 2012 EN61000 4 8 2010 30 A m 50Hz and 60Hz Met or exceeded Fast Transient Burst IEC 61000 4 4 2016 EN61000 4 4 2012 2k...

Страница 36: ...Battery condition low Battery condition empty Breath test Face mask test Automatic patient breath test Inhale Hold breath Edit countdown breath hold timer Countdown breath hold Exhale ppm reading Save Settings Home Patient profiles Patient profile slot Patient results chart ...

Страница 37: ...p Previous step Sensor change due soon Sensor change overdue Calibration due date Calibrate device Attach flow meter to gas canister Attach calibration adaptor to D piece Attach D piece to monitor and turn on gas flow System processing Calibration successful Calibration failed Retry calibration ...

Страница 38: ...ing a reset the device will need to have the date time set and be calibrated before it can be used 6 Replace batteries when indicated by the empty symbol 7 Bedfont recommend removal of the batteries when the device is not used for prolonged periods of time to prevent leakage 8 Replace breath sampling D piece every 30 days or if visibly soiled or contaminated The Gastro Gastrolyzer products will gi...

Страница 39: ...c solvents as long term exposure to these vapours will damage the H2 sensor inside 3 Under no circumstances should the instrument be immersed in liquid or splashed with liquid Calibration The Gastro Gastrolyzer is calibrated at 21 C 4 C before leaving Bedfont The instrument should be calibrated at 21 C 4 C as this is the temperature at which we recommend it is to be used The Gastro Gastrolyzer sho...

Страница 40: ...39 Press the cylinder icon once to proceed The monitor must be zeroed this will happen automatically Do not connect the gas at this stage Ensure the fine control valve is in the off position ...

Страница 41: ...crewing the gas can into the valve Once this has been successfully carried out the first step of the calibration process will be shown onscreen Allow the gas to flow at 0 5 litres per minute Allow the gas to flow through the instrument for the duration of the test again monitoring the rate of flow ...

Страница 42: ...return to the home screen A failed calibration will be indicated by the red cross icon press the rotating arrow icon to attempt calibration again if the problem persists see troubleshooting or call the local supplier of Bedfont products Return to the home screen by pressing the home icon ...

Страница 43: ...shown or replace the batteries Ensure that the batteries are inserted the correct way around matching the symbols moulded into the plastic GastroCHART software connecting to the PC Place one end of the connection lead into the USB socket on the top of the Gastro Gastrolyzer product Connect the other end to the USB port on the PC ...

Страница 44: ...d to the outside of the box Failure to do so will result in the product being subject to Bedfont decontamination procedure and will delay the service repair and may incur costs 3 Bedfont advises that a courier service is used when returning monitors This enables goods to be insured for loss or damage in transit When the goods are received an email stating so will be sent 4 If the device has been r...

Страница 45: ...h mouthpiece The OneBreath mouthpiece is a single use bacterial filter mouthpiece and can be attached directly to the monitor to take a breath sample The OneBreath incorporates a one way valve and an infection control filter which are proven to remove and trap 99 of viruses and bacteria7 Face mask sampling system This sampling system is single patent use and allows the patient to breathe normally ...

Страница 46: ... the product s life contact Bedfont or its distributor for disposal instructions References 1 Levitt M D 1969 Production and excretion of hydrogen gas in man New Engl J Med 281 122 127 2 Biolab Medical Unit Nutritional and Environmental Medicine London England Breath Hydrogen and Methane February 2012 Available at http www biolab co uk docs bhydro pdf 3 Ledochowski M Ledochowski E Hydrogen Breath ...

Страница 47: ......

Страница 48: ...ion Road Harrietsham Maidstone Kent ME17 1JA England Tel 44 0 1622 851122 Fax 44 0 1622 854860 Email ask bedfont com Web www bedfont com Bedfont GmbH Mitterbachweg 18 5081 Anif Austria Tel 43 662 635050 Fax 43 662 635050 50 Email bedfont gmbh bedfont com coVita USA Representative for Sales Service Support 212 Cottage Grove Ave Suite C Santa Barbara CA 93101 Tel 800 707 5751 Fax 800 721 2377 Email ...

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