echosens FibroScan XL+ Probe, User Manual

Page 1: ...FibroScan XL Probe User manual CE 0459 E117M009 7 Version 7 02 2016...

Page 2: ...EU XL PROBE USER MANUAL 2 02 2016 ECHOSENS AND FIBROSCAND ARE REGISTERED TRADEMARKS COPYRIGHT ECHOSENS ALL RIGHT RESERVED E117M009 7...

Page 3: ...ee 14 4 6 Electrical Safety ee 14 4 7 Maintenance related safety ee 14 5 EXTERNAL PRESENTATION 15 5 1 Hardware supplied sine 15 5 2 Probe description sise 15 6 USE DURING AN EXAMINATION 17 6 1 User re...

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Page 5: ...he manual may nevertheless contain some technical inaccuracies and or typographical errors Echosens cannot under any circumstances be held responsible for any loss of profit loss of business data loss...

Page 6: ...e property of the company Echosens and are protected by copyright all rights reserved Your right to copy this documentation is limited to legal copyright These manuals cannot be distributed translated...

Page 7: ...holder on the FibroScan In the event of prolonged non use the probe should be stored in its case 2 3 MAINTENANCE Maintenance operations must not be performed by a third party other than a technician a...

Page 8: ...Echosens remains available to the physician and his her appointees and shall if applicable transfer the request to a competent local representative 3 2 REGISTERED TRADEMARKS Echosens and FibroScan ar...

Page 9: ...n of interest which can be approximated by a cylinder with a diameter of 1 cm and a length of 4 cm which corresponds to about 3 cm In addition assuming that the liver is a pure elastic linear and isot...

Page 10: ...r shear wave speed and stiffness Table 1 parameters related to shear wave speed and stiffness Parameter Reference Liver fibrosis cirrhosis 1 9 Acute hepatitis inflammation ALT flares 10 13 Portal pres...

Page 11: ...liver stiffness values measured by transient elastography Hepatology 2008 47 2 p 380 4 11 Coco B et al Transient elastography a new surrogate marker of liver fibrosis influenced by major changes of tr...

Page 12: ...hoid using a tape measure m SCD Skin to Capsule Distance assessed with an ultrasound scanner or by the automatic probe selection tool In case of using an ultrasound scanner SCD should be measured at t...

Page 13: ...he liver The eyes and mucosa must absolutely be avoided On patients with active implants such as pacemakers defibrillators pumps etc On wounds On pregnant women Moreover presence of ascites between th...

Page 14: ...ical device the user must conform to the indications and symbols contained in this manual Safe use is no longer guaranteed in the following main non exclusive cases m the probe is visibly damaged the...

Page 15: ...d transducer of the probe is a Type B applied part and is the only component of the FibroScan unit in contact with the patient Measurement button As soon as this button is pressed if sufficient pressu...

Page 16: ...commended that you view the pressure exerted by looking at the on screen pressure indicator Lead A B Probe lead A Connection cable B Connection jack This 1 5 m lead connects the probe to the FibroScan...

Page 17: ...after use in one of the holders or in its case 6 2 CONNECTING DISCONNECTING THE PROBE Location of the probe connector user manual m To insert the probe jack align the probe lead jack s red dot with t...

Page 18: ...the probe A Socket B Splined sleeve 6 3 HANDLING THE PROBE Refer to the warnings in Chapter 2 concerning the handling of the probe 6 3 1 Probe resting position When the probe is not in use it must be...

Page 19: ...itable product indicated in paragraph Cleaning maintenance and repairs 4 Place the probe head pointing up onto the FibroScan probe holder If the device is no longer required Press the on off button ne...

Page 20: ...mination solutions Ensure that the contact time and concentration of the cleaning product and decontamination solution are appropriate for the equipment used Carefully apply the instructions given on...

Page 21: ...e cleaning product and decontamination solution to the soft cloth not directly on the surface to be cleaned The probe must be cleaned after every use or between patients Prior cleaning is necessary in...

Page 22: ...izer Quaternary ammonium Thericide Plus USA Liquid Quaternary ammonium Thericide Plus USA Vaporizer Quaternary ammonium Clinell Wipes United Wipes Quaternary Kingdom ammonium Tristel Wipes System Unit...

Page 23: ...tion Despite the presence of the icon the operator can perform examinations as usual We strongly recommend however sending the probe for calibration as rapidly as possible x Calibration icon 7 3 TROUB...

Page 24: ...ode and Elastography acquisition mode Acoustic Output MI ISPTA 3 ISPPA3 mWicm W cm Pre amendments Global Maximum Value 0 44 48 11 9 95 T L for 99 of measurements values Associated Pr3 MPa 0 56 7 acous...

Page 25: ...ght 500 grams 8 4 ENVIRONMENTAL PROPERTIES Operating temperature 10 C to 40 C 50 F to 104 F Operating humidity 30 to 75 relative humidity non condensed Storage temperature 20 C to 70 C 4 F to 158 F St...

Page 26: ...tions 9 13 14 Pr cautions precaution for use 13 Probe 15 Calibrating 23 23 cleaning 20 indicators 16 Lead 16 measurement button 15 troubleshooting 23 Vibrator 15 Probe troubleshooting hardware problem...

Page 27: ...XL PROBE USER MANUAL RS E117M009 7 02 2018 ECHOSENSO AND FIBROSCAND ARE REGISTERED TRADEMARKS COPYRIGHT ECHOSENS ALL RIGHT RESERVED 27...

Page 28: ...ecHosens Echosens 30 place d Italie 75013 PARIS FRANCE Tel 33 1 44 82 78 50 Fax 33 1 44 82 78 60 Web Site www echosens com E mail info echosens com...