Table of Contents
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Table of Contents
Summary of Contents for FAN LactoFAN2
- Page 1 Instructions for Use Breath Test Device LactoFAN2 V. 1.16 – 1.21...
- Page 2 Trademarks All trademarks or registered trademarks are the property of their respective owners. All rights reserved. Credits The firmware of this device was created using the IAR Systems’ Embedded Workbench® software. Edition 2015-09-07 2 of 30 Manual LactoFAN2...
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Page 3: Table Of Contents
Warranty ..........................19 Training ..........................19 Symbols ..........................20 Environment ........................20 Spare parts, consumables and service ................20 breath test protocols with LactoFAN2 ................23 Specifications ........................24 Manufacturer declaration of electromagnetic compatibility of H breath test device “LactoFAN2” ........................25 CE declaration ........................ -
Page 4: Basics
The LactoFAN2 is used in the malabsorption diagnosis of lactose or other sugars. Additional the investigation of intestinal transit time and bacterial overgrowth of is possible. Basics In case of malabsorption, sugar (e.g. Lactose) undigested passes into the large intestine where action by bacteria causes the release of hydrogen, which is absorbed through the intestinal wall and dissolves into the blood stream. -
Page 5: Unpacking, Check For Completeness
Take all parts contained out of the transport box and check the consignment regarding completeness. In case of transit damages immediately inform the sender. Do not use damaged parts. The LactoFAN2 is shipped in a carry case, containing the items below: LactoFAN2 (Order No. LF2) nose clip (Order No. HZ–NK) ... -
Page 6: Environmental Conditions
8. on/off switch Short description The H breath test device LactoFAN2 is designed as handheld device powered by batteries or accumulators. You can switch it on/off with (8). Operation, user guide and measuring data output is done via (1) completely. For sampling, a special mouthpiece (see page 5) is inserted in (2) and breath blown onto (3). -
Page 7: Commissioning
Pressing the green OK button you’ll take over the settings and leave the screen. If the screen “set clock” is displayed from the start, proceed accordingly. The device will switch off after some minutes of inactivity if you didn’t turned it off before by long-pressing the on/off knob. Manual LactoFAN2 7 of 30... -
Page 8: Preparations For Work
To measure breath samples you need: the nose clip a one-way filter mouthpiece the H monitor LactoFAN2 a protocol suitable for the test performed to record the H concentration in breath chronologically, created by your responsible doctor (example protocols you can find at the software CD delivered or in the FANh2 software) ... - Page 9 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 may escape sideways. Manual LactoFAN2 9 of 30...
- Page 10 Press it when finished. Take breath Breath normally (do not inhale more deep than usual) and stop after inhaling. The patient should sit down during the whole procedure; also ask the subject to use the nose clip delivered. 10 of 30 Manual LactoFAN2...
- Page 11 Pull the filter mouthpiece out of the device. Instruct the subject to keep the mouthpiece for the following measurements of the breath test. Was the mouthpiece detection disabled in the settings, the OK-button is shown. Press it when finished. Manual LactoFAN2 11 of 30...
- Page 12 This is necessary to allow the sensor surface to dry and to enable a zero point adjustment using ambient air. Previously the next use you have to convince yourself of all condensed humidity has vaporized off the sensor surface. 12 of 30 Manual LactoFAN2...
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Page 13: Pc Connection
Functional tests In daily operation it is not necessary to submit the LactoFAN2 any functional tests. This does not affect the requirements for calibration and maintenance. If you suspect results to be incorrect, (e.g. if you get zero readings despite of malabsorption symptoms incidence during the breath test), please ask the FAN service for help (see page 20). -
Page 14: Calibration
To achieve measurements of the greatest accuracy we recommend the unit be calibrated after always one month. FAN can supply calibration gas (100 ppm H in Nitrogen) complete with a control valve for simple and economic user calibration (see page 22). - Page 15 Plastic tubing Control Flow valve Reducing connector indicator for calibration 100 ppm hydrogen in nitrogen Manual LactoFAN2 15 of 30...
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Page 16: Maintenance
Maintenance FAN recommends an annual inspection of the device. During this inspection performed by the FAN service – as well as after any repair – the device is revised regarding proper functioning, adherence to specifications and technical limit guidelines, stability and operational safety. Besides this, worn parts are replaced as necessary. -
Page 17: Errors
Cause: Same as for 002. If you got no success, send the B) calibration error device to the FAN service workshop (see page 20). 004 – ADC resolution too low The sensors' sensitivity is too low; it's not possible to resolute the measurement signal sufficiently detailed. - Page 18 Send the device to the FAN service workshop (see page 20). 256 – sensor battery empty device temperature too high or low Wait a sufficient time to let the device reach room temperature. 032 – temperature too low 064 –...
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Page 19: Warnings
Electrical Business Equipment’. The FAN GmbH considers itself as responsible for basic safety, reliability and performance of the LactoFAN2 only in case the device is used in accordance with the manual. Only qualified personnel shall avail of the device. -
Page 20: Symbols
+49 341 24450 22 E–Mail fan@fan–gmbh.de www.fan–gmbh.de Contact addresses for hard– and software support: Phone +49 341 24450 17 E–Mail service@fan–gmbh.de Suggestions and proposals for improving this manual in hand or for correction of mistakes are gladly welcome. 20 of 30 Manual LactoFAN2... - Page 21 1. LactoFAN2 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-01 Manual LactoFAN2 21 of 30...
- Page 22 7. calibration gas 100ppm H HV-Lacto-CG 8. regulator for calibration gas with reducing connector HZ-CV + HZ-RedC 9. reducing connector for calibration HZ-RedC 22 of 30 Manual LactoFAN2...
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Page 23: H 2 Breath Test Protocols With Lactofan2
LactoFAN2 Dosage Interval Length Substance, Test Type Criterion Diagnosis [ g / kg ] maximum [ g ] [ min ] [ min ] HOB ≥ 20 Lactose Malabsorption malabsorption ppm H HOB ≥ 15 Fructose... -
Page 24: Specifications
Specifications Active, non-implantable diagnostic medical device class I with a measuring function according directive 93/42/EEC. For Germany only: Is not listed in app. 1 or 2 of MPBetreibV (Medizinprodukte–Betreiberverordnung) and therefore need: no field check by the manufacturer (§ 5) ... -
Page 25: Manufacturer Declaration Of Electromagnetic Compatibility Of H "Lactofan2
Table 1 Guidelines and manufacturer declaration – Electromagnetic emission The „LactoFAN2“is intended for use in an electromagnetic environment as described below. The customer or user of the „LactoFAN2“should ensure that the device is used in such an environment. Emission Measurements... - Page 26 Table 4 Manufacturer's Declaration - Electromagnetic Interference Resistance The „LactoFAN2“is intended for use in an electromagnetic environment as described below. The customer or user of the „LactoFAN2“should ensure that the device is used in such an environment. IEC 60601-T NTERFERENCE...
- Page 27 NOTE 1: For 470 MHz and 800MHz the higher range is valid. NOTE 2: These guidelines may not be applicable for all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects and people. Manual LactoFAN2 27 of 30...
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Page 28: Ce Declaration
CE declaration 28 of 30 Manual LactoFAN2... -
Page 29: Declaration Of Quality
(Place, date) (Name) The breath test analyzer LactoFAN2 of 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 2002 (Federal Law Gazette I, p. -
Page 30: Index
Electromagnetic Compatibility ......25 support ............... 20 disinfectant agents ............3 technical data ............. 24 environmental conditions ..........6 view data ..............7 manufacturer .............. 20 warnings and notes on safety ........19 mouthpiece..............19 30 of 30 Manual LactoFAN2...