Related Manuals for echosens FibroScan 402
Summary of Contents for echosens FibroScan 402
- Page 1 User Manual for FibroScan ® E200M002.10 – Version 10 – 04/2015 (software version B 2.1)
- Page 2 USER MANUAL FIBROSCAN 402 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10...
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Page 3: Table Of Contents
5.4. Rear view........................18 5.5. Description of the probe .................... 19 SOFTWARE INTERFACE.................... 21 6.1. Home screen ......................21 6.2. Using the keypad....................... 22 6.3. Login window......................22 E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... - Page 4 9.11. Software update ......................41 . SYMBOLS ON THE DEVICE ..................42 10.1. Connectors ........................ 42 10.2. Warnings ........................42 10.3. Marking and electrical safety ..................43 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10...
- Page 5 . REGULATIONS......................48 12.1. Electromagnetic emissions..................48 12.2. Electromagnetic immunity (1) ..................49 12.3. Electromagnetic immunity (2) ..................49 12.4. Recommended separation distances ................ 51 E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED...
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Page 6: Purpose Of The User Manual
1. PURPOSE OF THE USER MANUAL The present User Manual has no contractual value whatsoever and under no circumstances may Echosens be held responsible on the basis of the information contained in the present manual. The present User Manual details, on the one hand, all of the information required for the implementation, use and maintenance of the FibroScan instrument and, on the other hand, the list of information displayed. -
Page 7: Symbols Used In The Manual
These manuals cannot be distributed, translated or reproduced, either in whole or in part, in any manner or in any form, without prior written consent from Echosens. Hence, the reproduction, adaptation or translation of the present manual without prior written consent is prohibited, within the limits provided by copyright law. -
Page 8: Warnings
(EMC). Avoid using the FibroScan device when placed upon or near a machine that generates electromagnetic disturbance. 2.3. USING THE DEVICE Risk of burns: 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 9: Deleting Measurements
2.8. INTERPRETING THE RESULT Results must only be interpreted by a physician specialising in liver diseases, who is aware of the patient's pathology and clinical context. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... - Page 10 USER MANUAL FIBROSCAN 402 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10...
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Page 11: Miscellaneous Information
FibroScan. These results are then interpreted by the physician in charge. Under no circumstances, and even if Echosens had been notified, would Echosens be held responsible for the incorrect interpretation of these results;... -
Page 12: Registered Trademarks
Echosens and FibroScan are registered trademarks of Echosens. Microsoft Excel and Windows Embedded are registered trademarks of Microsoft Corporation in the United States and other countries. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 13: Indications And Precautions For Use
TP: Thoracic perimeter measured at the xiphoid using a tape measure SCD: Skin-to-Capsule Distance measured by ultrasound at the point where liver stiffness is measured. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 14: User Precautions
Only persons who have received training in the use of the FibroScan unit and who possess a user certificate are authorised to conduct an examination using FibroScan. Training is 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 15: Electrical Safety
Echosens, which will send an authorised technician: service@echosens.com For correct and safe use and for all maintenance operations, the personnel must conform to normal safety procedures. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 16: External Presentation
Set of elements that can be connected to the FibroScan unit: Peripherals not included: A: USB storage device. Accessories: B: M probe. C: Other accessories. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 17: Front View
The FibroScan runs on dedicated software. The software is automatically launched when the FibroScan is switched on. It is used to perform examinations. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 18: Rear View
This switch assembly has a removable part. It provides access to the two FibroScan protection fuses. The bottom part of the switch unit receives the mains lead plug connection outlet. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 19: Description Of The Probe
Lead Probe lead: A: Connection cable. B: Connection jack. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... - Page 20 The probe jack has a red dot that should be aligned with the red dot on the FibroScan socket before insertion. The serial number marked on the connector identifies the probe uniquely. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10...
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Page 21: Software Interface
Access to the exam. The following messages can be displayed in the home window: No probe connected Probe out of calibration (see the Probe Calibration section) E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 22: Using The Keypad
The activation of the login window is configurable. See the Configuration section. User name / Password The user name and password were defined when the device was installed. To change the password, see the Configuration section. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 23: The Patient Record Screen
After data input, if the probe is out of calibration the following message appears: Probe calibration days overdue: n. Contact your local support team. Where n is the number of days. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 24: Acquisition Screen
USER MANUAL FIBROSCAN 402 6.5. ACQUISITION SCREEN The main data displayed in an acquisition window are presented below. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 25: Patient Data
The other in A mode (current ultrasound signal amplitude). The gain on the display of both modes can be adjusted using the cursor under the ultrasound images. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 26: Pressure Indicator
The pressure level is given by: The software: pressure indicator (green/red). The probe: blue LEDs. Measurements may only be made when the pressure indicator is in the green zone. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 27: Elastogram
6.5.5. Counters: valid and invalid measurements, success rates Valid measurements From top to bottom: first to last measurement in kPa. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 28: Stiffness Results Area
Some or all of the measurements in the current examination may be cancelled at any time during the exam. The patient's data, displayed in the left-hand part of the window, are saved. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 29: Add A Note
Desk Solution The "Note" field cannot be modified after completion of the exam. 6.5.9. Message area The following main messages can be displayed above the elastogram. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 30: Automatic Probe Recommendation
You are strongly advised to use the recommended tool, to guarantee reliable results. The decision whether or not to apply this recommendation, however, rests with the user. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 31: View And Print The Result Of The Examination
Back to the home window. Exports the patient exam result in .fibx format (a proprietary Fibroscan format) to a removable USB storage device. Starts a new examination. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 32: Switching Off The Machine
Cut the power supply by setting the main switch to 0. Refer to the warning in Chapter 2 concerning switching off the device. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 33: Cleaning, Maintenance And Repairs
USER MANUAL FIBROSCAN 402 8. CLEANING, MAINTENANCE AND REPAIRS In the event of malfunction, only the staff of Echosens or its local representative is authorised to work on the FibroScan and its accessories. Any work performed by an unqualified person will terminate the guarantee. -
Page 34: Cleaning The Probe (Housing, Cable And Transducer)
Dry, if necessary, using a soft dry cloth. Examine the transducer and probe cable for any damage such as cracks, breakage, or liquid leakage. If any damage is observed, stop using the probe and contact Echosens or its local representative: service@echosens.com Precautions Do not submerge or soak the probe. -
Page 35: Recommended Decontamination Solutions
In addition to the list of recommended decontamination products, any alcohol-free decontamination product using quaternary ammonium as its active ingredient may be used to decontaminate the probe. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 36: Calibrating The Probe
The standby pushbutton is on, Turn the machine off, then on again. but the software is not booting. In the event of a failure or malfunction, please contact Echosens or its local representative: service@echosens.com 8.4. CHANGING THE PRINTER ROLL To change the paper: Open the cover and remove the empty roll. - Page 37 USER MANUAL FIBROSCAN 402 Close the cover (completely, until you hear a click). Type of paper: see the section on 'Technical Characteristics'. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED...
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Page 38: Configuring The Fibroscan
Internationalisation From the list, select the language normally used in the country concerned. Click [OK] to confirm the input and save the new data. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 39: For Biomedical Engineers
Report Press [Enabled] to display the last 10 elastograms of the exam on the exam report printed via ® the FibroScan Desk Solution software. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 40: System Tab
9.9.1. For Doctors [Excel export] Exports the entire exam database to an .xls file. [Format database] Deletes the entire database from the machine’s hard disk. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 41: For Biomedical Engineers
Do not use this key in a PC, because if the PC boots on the key, the PC's system partition may be overwritten. The system is then updated. This update does not delete any data. E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 42: Symbols On The Device
General safety symbol. The associated symbols must be read carefully. Do not cover the vents (WARNING: This symbol does not appear on machines manufactured before 2013). 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 43: Marking And Electrical Safety
Fibroscan unit and its probe(s) must not be discarded with ordinary household waste. Contact the local electrical and electronic waste processing service for instructions. Equipotential terminal. Alternating current 1.6-A accessible time-delay fuses E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 44: Note
Note: the following symbols appear on machines manufactured before 2013. Do not cover the vents 1.6-A accessible time-delay fuses The serial number marked on the device identifies the FibroScan uniquely. 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 45: Technical Characteristics
11.1.4. Mechanical properties Dimensions 275 mm x 434 mm x 252 mm (H x W x D) Weight 8 kg (without accessories) 11.1.5. Environmental properties E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 46: Additional Information
From 25 mm to 65 mm 11.2.2. Electrical characteristics See the following chapter 11.2.3. Mechanical properties Dimensions 158 mm x 52 mm (L x diameter) Weight 500 grams 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10... -
Page 47: Environmental Properties
Thermal paper roll (the type used for bank machines, etc.) Quality 55 g/m² Width x length 57 mm x 25 m Outside diameter 46 mm Mandrel diameter 12 mm E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED... -
Page 48: Regulations
12.1. ELECTROMAGNETIC EMISSIONS The FibroScan 402 is designed for use in the electromagnetic environment defined below. FibroScan 402 customers or users must ensure that it is indeed used in such an environment. Emission test Compliance... -
Page 49: Electromagnetic Immunity (1)
12.2. ELECTROMAGNETIC IMMUNITY (1) The FibroScan 402 is designed for use in the electromagnetic environment defined below. FibroScan 402 customers or users must ensure that it is indeed used in such an environment. Immunity IEC 60601 test Compliance... - Page 50 To assess the EM environment caused by fixed emitters, a site EM study must be conducted. If the strength of the fields measured at the location where the FibroScan 402 is used exceeds the above-mentioned compliance levels, correct operation of the FibroScan 402 must be checked. If any abnormal performance is observed, additional measurements may be necessary, e.g.
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Page 51: Recommended Separation Distances
12.4. RECOMMENDED SEPARATION DISTANCES (between portable or mobile RF communication devices and the FibroScan 402) The FibroScan 402 is designed for use in an electromagnetic environment in which RF disturbance is controlled. FibroScan 402 customers or users may prevent interference by... - Page 52 Troubleshooting , 36 Warning message , 29 IQR , 28 Vibrator , 19 IQR/med , 28 Probe pressure , 26 Jack , 18 Product life , 11 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E200M002.10...
- Page 53 USER MANUAL FIBROSCAN 402 blank E200M002.10 04/2015 - ECHOSENS® AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED...
- Page 54 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 Email: info@echosens.com...
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