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Manual LactoFAN

2

Index

accessories ................................................................. 20
batteries .............................................................. 5, 7, 19
breath test protocols ................................................... 23
calibration gas ............................................................ 21
calibration set ............................................................. 21
components ................................................................ 20
declarations

CE Declaration ...................................................... 28
Declaration of Quality ........................................... 29
Electromagnetic Compatibility ............................. 25

disinfectant agents ....................................................... 3
environmental conditions ............................................. 6
manufacturer .............................................................. 20
mouthpiece................................................................. 19

mouthpiece - how to use .............................................. 9
nose clip ..................................................................... 10
operating temperature ................................................ 24
risk of infection .......................................................... 19
sampling ..................................................................... 11
solvents ........................................................................ 3
sterilant......................................................................... 5
storage .......................................................................... 3
storage temperature .................................................... 24
support ....................................................................... 20
technical data ............................................................. 24
view data ...................................................................... 7
warnings and notes on safety ..................................... 19

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Содержание LactoFAN2

Страница 1: ...Instructions for Use H2 Breath Test Device LactoFAN2 V 1 16 1 21...

Страница 2: ...ect data and the consequences arising thereof In case of doubt the German version shall apply Copyright Copyright 2010 2014 Fischer ANalysen Instrumente GmbH All rights reserved Duplication modificati...

Страница 3: ...ironment 20 Spare parts consumables and service 20 H2 breath test protocols with LactoFAN2 23 Specifications 24 Manufacturer declaration of electromagnetic compatibility of H2 breath test device Lacto...

Страница 4: ...ported then lactose intolerance may be diagnosed The LactoFAN is based on an electrochemical fuel cell which works through the reaction of hydrogen with an electrolyte at one electrode and oxygen from...

Страница 5: ...No LF2 AC 01 xxx 1 pcs mouthpiece adapter with one way valve translucent plastic Order No HZ ADV 1 pcs one way cardboard Mouthpiece Order No HV MU150 Additional included in delivery mini USB cord sof...

Страница 6: ...t is feasible but after that the device have to be stored in a well aired room again Do not touch the device with hands just disinfected 1 display with touch screen 2 flange with mouthpiece detection...

Страница 7: ...own low change main battery soon 2 sensor back up battery charge indicator shown low device service needed 3 remaining days until next calibration press to start calibration 4 start measurement 5 chan...

Страница 8: ...ion If there are any warnings displayed e g battery low please follow the instructions in the regarding chapter of this manual Check whether the device is in a calibrated state see page 7 If not perfo...

Страница 9: ...of 30 Explain to the subject the right usage of the mouthpiece Correct The mouthpiece fits closely to the subject s lips no breath escapes Wrong The rim indents the subject s lips the respiratory air...

Страница 10: ...o set the table into which the measurement data of the current patient will be stored This button will abort the measurement always Data table Verify to have selected the right patient table then pres...

Страница 11: ...Wait for maximum reading There may be a delay of some seconds before any reading appears Do not turn off the unit during this time Because of there is a certain delay in the chemical sensor s output t...

Страница 12: ...account not only the next measurement time according to your breath test protocol but the time needed to call the patient too Press the cancel button if you finished the measurements for the current p...

Страница 13: ...ailable So you can save print and process your data easily Functional tests In daily operation it is not necessary to submit the LactoFAN2 any functional tests This does not affect the requirements fo...

Страница 14: ...knob anti clockwise until the ball in the flow indicator is between the two marks This will then supply a gas flow of approximately 0 3 l min Now slowly turn the Apply this flow for 50 seconds and the...

Страница 15: ...Manual LactoFAN2 15 of 30 100 ppm hydrogen in nitrogen Flow indicator Control valve Reducing connector for calibration Plastic tubing...

Страница 16: ...ilability of the device Please take the batteries out of the device in case you intend not to use it for a longer period of time You have to set the internal clock when the device is returned to opera...

Страница 17: ...measurement range of 300 ppm H2 is not possible to be acquired Cause Same as for 001 016 calibration range exceeded The sensors sensitivity alteration in respect to the last calibration is out of the...

Страница 18: ...tery exhausted 256 sensor battery empty Send the device to the FAN service workshop see page 20 device temperature too high or low 032 temperature too low 064 temperature too high Wait a sufficient ti...

Страница 19: ...ant in your country concerning dealing with and disposal of the batteries you use to run the device Keep the device out of reach of the patient while it is connected to a PC The LactoFAN should only b...

Страница 20: ...in the range from 470 MHz to 800 MHz by cellular phones and by electromagnetic interferences see declaration of conformity Spare parts consumables and service Orders for spare parts and consumables or...

Страница 21: ...N2 21 of 30 1 LactoFAN2 LF2 2 battery or accumulator set LF2 AE 04 LF2 AE 01 3 one way filter mouthpiece LF2 AC 01 xxx 4 CD with software and manuals H soft 5 USB cable LF2 AE 03 6 carry case LF2 AM 0...

Страница 22: ...22 of 30 Manual LactoFAN2 7 calibration gas 100ppm H2 HV Lacto CG 8 regulator for calibration gas with reducing connector HZ CV HZ RedC 9 reducing connector for calibration HZ RedC 7 8 9...

Страница 23: ...tion 0 5 12 5 30 180 HOB 15 ppm H2 malabsorption Glucose Bacterial Overgrowth 1 50 20 120 HOB 15 ppm H2 overgrowth Lactulose Bacterial Overgrowth 0 5 10 20 120 HOB 20 ppm H2 overgrowth Lactulose Intes...

Страница 24: ...etreibV or into another equivalent directory Range 0 to 300 ppm vol vol Resolution 1 ppm Display 2 8 color AMOLED panel with capacitive glass touch field Shell Polycarbonate ABS elastomeric coating Di...

Страница 25: ...uding living quarters and such ones which are connected directly to a public power supply that supplies also buildings used for living purposes Table 2 Guidelines and manufacturer declaration Electrom...

Страница 26: ...e applicable for all cases The propagation of electromagnetic values is influenced by absorptions and reflections of buildings objects and people a The field strength of stationary transmitters such a...

Страница 27: ...ion in the corresponding column P is the maximum nominal power of the transmitter in watt W according to the specifications of the transmitter manufacturer NOTE 1 For 470 MHz and 800MHz the higher ran...

Страница 28: ...28 of 30 Manual LactoFAN2 CE declaration...

Страница 29: ...f the FAN GmbH is a Medical Device Class Im in the scope of the valid European laws regarding medical devices The Act on Medical Devices Medical Devices Act Medizinproduktegesetz MPG of 7th August 200...

Страница 30: ...n 28 Declaration of Quality 29 Electromagnetic Compatibility 25 disinfectant agents 3 environmental conditions 6 manufacturer 20 mouthpiece 19 mouthpiece how to use 9 nose clip 10 operating temperatur...

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