Echosens

FibroScan 430 MINI User Manual Ver 1 SW H 3.1 July 2016

User Manual

64 Pages

File Type: PDF

File Size: 5.67 MB

File Name: Echosens - FibroScan 430 MINI User Manual Ver 1 SW H 3.1 July 2016 - 2016-07.pdf

Preview

Page 1

User manual for the FibroScan 430 MINI ®

E330M001.1 – Version 1 – 07/2016 (software version H 3.1) EN

EN FIBROSCAN USER MANUAL 430 MINI

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

TABLE OF CONTENTS

PURPOSE OF THE USER MANUAL... 6

1.1. Symbols used in the manual ... 7 1.2. Property and copyright ... 7

WARNINGS ... 8

2.1. Electrical safety ... 8 2.2. Electromagnetic safety ... 8 2.3. Using the device ... 9 2.4. Deleting measurements... 9 2.5. Switching off the unit ... 9 2.6. Cleaning and maintenance... 9 2.7. Cleaning ... 9 2.8. Interpreting the result... 10

MISCELLANEOUS INFORMATION ... 11

3.1. Guarantee... 11 3.2. Liability... 11 3.3. Essential performance characteristics... 11 3.4. Product life... 11 3.5. Reverse engineering ... 11 3.6. Registered trademarks ... 12 3.7. Patented technology... 12

INDICATIONS AND PRECAUTIONS FOR USE... 13

4.1. Intended use... 13 4.2. Probe and examination selection criteria... 13 4.3. Precautions for use... 14 4.4. User training ... 14 4.5. Electrical safety ... 14 4.6. Maintenance-related safety ... 15

EXTERNAL PRESENTATION ... 16

5.1. Hardware supplied... 16 5.2. Accessories ... 16 5.3. Front view ... 17 5.4. Right side view ... 18 5.5. Rear view... 18 5.6. Stand ... 20 5.7. Battery hatch ... 20 5.8. Description of probes... 21

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

SOFTWARE INTERFACE... 23

6.1. Home screen ... 23 6.2. Using the keypad... 24 6.3. Login window... 24 6.4. Status bar ... 25 6.5. The patient record screen... 26 6.6. Acquisition screen ... 27 6.6.1. Patient data... 28 6.6.2. Ultrasound images ... 28 6.6.3. Pressure indicator ... 29 6.6.4. Elastogram... 30 6.6.5. Counters: Valid and invalid measurements ... 30 6.6.6. Stiffness results area ... 31 6.6.7. Deleting measurements ... 31 6.6.8. Adding a comment ... 32 6.6.9. Integrate the measurement conditions... 32 6.6.10.Message area ... 33 6.6.11.Examination type selection area ... 33 6.6.12.View and print the result of the examination ... 35 6.7. Management of patient file archives... 36 6.7.1. Advanced file search... 37 6.7.2. Select and view a patient file ... 37 6.7.3. Details of the examination... 37

STANDBY AND SHUTTING DOWN THE MACHINE ... 39

7.1. Between sessions... 39 7.2. At the end of the day ... 39

CLEANING, MAINTENANCE AND REPAIRS ... 40

8.1. Cleaning ... 40 8.1.1. Cleaning the machine (painted, metallic, glass, or plastic surfaces and screen) ... 40 8.1.2. Cleaning the probe (housing, cable and transducer) ... 41 8.1.3. Recommended cleaning products ... 41 8.1.4. Recommended decontamination solutions ... 42 8.2. Calibrating the probe ... 43 8.3. Replacing the battery... 43 8.4. Troubleshooting... 43

CONFIGURING THE FIBROSCAN... 44

9.1. Entering configuration mode... 44 9.2. Localization Tab ... 44 9.3. Institution tab ... 44 9.4. Printer tab ... 45 9.5. Data Tab... 45 9.6. User Tab... 46 9.7. Connectivity Tab... 46 9.8. Examination tab... 47 9.9. System tab... 47

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

9.9.1. Information ... 47 9.9.2. Logs ... 47 9.9.3. Service ... 48 9.9.4. General ... 48

10. SYMBOLS ON THE DEVICE ... 50 10.1. Markings on the device... 50 10.2. Note: ... 52

11. TECHNICAL CHARACTERISTICS... 53 11.1. Characteristics of the device ... 53 11.1.1.Computer characteristics ... 53 11.1.2.Metrological performance ... 53 11.1.3.Electrical characteristics ... 54 11.1.4.Mechanical characteristics... 54 11.1.5.Environmental characteristics ... 54 11.1.6.Additional information ... 55 11.2. Battery characteristics ... 55 11.2.1.Electrical characteristics ... 55 11.2.2.Mechanical characteristics... 55 11.3. External power supply characteristics ... 55 11.3.1.Electrical characteristics ... 55 11.3.2.Mechanical characteristics... 55 11.4. Wi-Fi/Bluetooth module characteristics ... 55 11.5. Consumables... 56

12. REGULATIONS... 57 12.1. Electromagnetic emissions... 57 12.2. Electromagnetic immunity (1) ... 58 12.3. Electromagnetic immunity (2) ... 59 12.4. Recommended separation distances ... 60 12.5. Wi-Fi/Bluetooth connectivity ... 60

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

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. After carefully reading the manual, operators shall be able to: Connect peripheral elements (mains lead, USB devices, probes) and power up the FibroScan instrument, Configure the device, Navigate the machine's user interface, Perform basic maintenance. Echosens SA publishes this manual "as is'", without guarantees of any nature, whether explicit or implicit, including, but not limited to, implicit guarantees concerning merchantability or fitness for a particular use, for the purpose of providing simple and accurate information. Consequently, Echosens SA cannot accept any responsibility for any incorrect interpretation of the manual. Though all efforts have been made to offer a manual that is as accurate as possible, the 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, business interruption, or for any indirect, specific, accidental or consecutive damages of any kind. In the event of damages arising from a defect (imperfection) or error contained in the present User Manual, Echosens undertakes to send the physician, as rapidly as possible, a hard copy or electronic document containing all corrections made to the present manual. This manual is updated on a regular basis. The most recent version of this manual is available from Echosens on simple request. Should any major modifications be made to the manual, however, Echosens undertakes to send the physician, as rapidly as possible, a new copy of the manual in hard copy or electronic format. Note that this does not involve updating the hardware and/or software in your possession. The product owner must keep the present manual for as long as the product is used. The present manual contains a chapter for troubleshooting the most commonly encountered problems. Any information or modification requests pertaining to this manual should be sent to: Echosens, 30 place d’Italie, 75013 Paris, France.

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

1.1. SYMBOLS USED IN THE MANUAL This symbol means: ATTENTION Instructions preceded by this symbol may cause injuries or damage the medical device and installation if not correctly followed.

This symbol means: INFORMATION Additional information with no impact on instrument use.

1.2. PROPERTY AND COPYRIGHT All manuals and documents of all kinds are the property of 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 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. Copyright © – 07/2016 – 07/2016 – Echosens – All rights reserved.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

2. WARNINGS

2.1. ELECTRICAL SAFETY To avoid the risk of electric shock, this device must be connected to an earthed power supply only.

Multi-socket adapters and extension leads must not be connected to the device.

The power cable socket is intended for use as an isolating device and must be easily accessible to prevent connection problems.

All peripherals connected to signals input/output must be certified according to standard IEC 60950-1.

Any parts not specified in the user manual must not be connected to the system.

Correct grounding operation can only be guaranteed if the system is connected to a socket compliant with safety standards.

Make sure that the vents are not obstructed. If they are, the electronic equipment could overheat, causing irreversible damage.

2.2. ELECTROMAGNETIC SAFETY The use of accessories not specified in the user guide may cause a noncompliance in terms of electromagnetic compatibility (EMC).

Avoid using the FibroScan device when placed upon or near a machine that generates electromagnetic disturbance.

The FibroScan 430 MINI device requires special precautions to be taken regarding to electromagnetic compatibility (EMC). It must be installed and put into service in accordance with the EMC information given in this guide.

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

2.3. USING THE DEVICE Do not push or lean on the top of the FibroScan unit.

If the housing of the device is chipped or cracked by mechanical impact, do not use the device until it has been repaired by Echosens.

If the device is not sufficiently charged, it may cut out during an examination. This power outage may lead to loss of unsaved data.

2.4. DELETING MEASUREMENTS All measurements taken before the one chosen for deletion will be eliminated from the examination after confirmation.

2.5. SWITCHING OFF THE UNIT Never switch the unit off during an examination or whilst in configuration mode. Never switch off the main power supply or disconnect the battery when the unit is switched on. Failure to comply with these instructions could cause a malfunction of the machine and/or loss of data.

2.6. CLEANING AND MAINTENANCE These maintenance operations must not be performed by a third party other than a technician authorised by Echosens.

The opening or modification of the device by a person other than an authorised Echosens technician is strictly prohibited.

The probe must be calibrated periodically. Beyond the period indicated on the calibration certificate, the manufacturer no longer guarantees the performance characteristics of the probe.

2.7. CLEANING To prevent electric shock, switch off the unit before cleaning.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

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.

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

3. MISCELLANEOUS INFORMATION

3.1. GUARANTEE The terms of guarantee are stated in the Echosens terms of sale documents. For any claims, Echosens is at the disposal of the physician and their assistants and shall, if necessary, pass the aforementioned claim on to the competent local representative.

3.2. LIABILITY The information displayed on the FibroScan screen is the result of complex calculations performed by the software application built into the FibroScan. These results are then interpreted by the physician in charge. Under no circumstances, and even if Echosens had been notified, can Echosens be held responsible for the incorrect interpretation of these results; Echosens' liability being limited to making the measurements, displaying them and printing them via the FibroScan. The data from each examination are saved on the machine's hard disk. The user is responsible for saving the data on a regular basis. Echosens cannot under any circumstances be held responsible for the partial or total loss of FibroScan data.

3.3. ESSENTIAL PERFORMANCE CHARACTERISTICS When a stiffness value is displayed by FibroScan, this value is correct within the range of error specified by Echosens. Free from the production of unintended or excessive transducer assembly surface temperature.

3.4. PRODUCT LIFE Echosens guarantees the specification and performance characteristics of the FibroScan device for seven years, provided that all necessary precautions for use and maintenance have been taken in accordance with the recommendations of the user manuals provided. The battery product life is defined by: 60% of initial capacity at 500 cycles, with standard charge and discharge at 40°C (104°F).

3.5. REVERSE ENGINEERING The software license is individual and cannot, under any circumstances, be transferred in any manner to a third party. This software cannot be distributed, reproduced, translated, disassembled, decompiled, analysed, modified, incorporated or combined with another software application, with the exception of cases allowed by law.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

Resale of the software built into the FibroScan is prohibited.

3.6. 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.

3.7. PATENTED TECHNOLOGY FibroScan is covered by one or more patents, both in the United States and in other countries. Patents: www.echosens.com/patents

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

4. INDICATIONS AND PRECAUTIONS FOR USE

4.1. INTENDED USE The FibroScan and its probes make up an active, non-implantable medical device using ultrasound. This device is designed to be used in a doctor's office to measure liver stiffness in patients with liver disease. It does so in a painless and completely non-invasive manner. The FibroScan device operates based on the vibration-controlled transient elastography method. The FibroScan probe comprises a single-element ultrasound transducer mounted on the shaft of an electrodynamic actuator. This transducer generates a transient vibration, which in turn generates an elastic shear wave. This wave propagates through the skin, the subcutaneous tissues, and then the liver. During shear wave propagation, the ultrasound transducer performs a series of ultrasound acquisitions (emission/reception) to measure the speed of s-wave propagation in the liver. Stiffness in kPa of the liver is calculated from this s-wave propagation speed value.

How to use a probe: A: Ultrasonic transducer. B: Electrodynamic actuator. C: Liver.

4.2. PROBE AND EXAMINATION SELECTION CRITERIA The recommendations for examination type are defined based on the following data concerning patient morphology: TP: Thoracic perimeter measured at the xiphoid using a tape measure. SCD: Skin-to-Capsule Distance measured by ultrasound at the liver stiffness measurement point or using the probe recommendation tool (refer to the chapter on Examination type selection area). Two examination types are available: M and XL. They correspond to specific measurement depths that take into account the liver's depth beneath the skin.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

In all cases, Echosens recommends taking 10 valid measurements. Use of the M+ probe is not approved for patients under the age of 14 years, and use of the XL+ probe is not approved for patients under the age of 18 years.

4.3. PRECAUTIONS FOR USE The following instructions must be followed in order to ensure patient safety. The FibroScan must not be used in the following situations: On patients under 14 years old. On patients with a thoracic perimeter of less than 75 cm. On an organ other than the liver. The eyes and mucosa must absolutely be avoided. On wounds. Moreover, the presence of ascites between the probe and the liver may prevent measurements from being obtained. Personnel must follow the user precautions.

4.4. USER TRAINING 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 essential for correct equipment use and in order to obtain reliable and reproducible measurements. This manual is not intended to provide user training.

4.5. ELECTRICAL SAFETY FibroScan is manufactured and tested in accordance with IEC electromagnetic compatibility (EMC) and electrical safety standards. It leaves the plant in full compliance with safety and

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

performance requirements. In order to maintain this compliance and to guarantee the safe use of the medical device, the user must conform to the indications and symbols contained in this manual. Prior to installation, ensure that the operating and mains voltage values match. The power lead provided must be connected to the external FibroScan mains connector and to an earthed socket. Correct earthing operation can only be guaranteed if the FibroScan is connected to a power supply network compliant with safety standards. Refer to the warnings in Chapter 2 concerning electrical safety.

Safe use is no longer guaranteed in the following main, non-exclusive cases: The device is visibly damaged, The device is inoperative, After prolonged storage in unfavourable conditions, After serious damage incurred during transport, In the operating theatre. When the safe use of the FibroScan is no longer possible, the device must be taken out of operation. Steps must be taken to prevent its inadvertent use. The medical device is entrusted to authorised technicians for inspection.

4.6. MAINTENANCE-RELATED SAFETY For all maintenance operations, the physician and their appointees should contact 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 the user precautions.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

5. EXTERNAL PRESENTATION

5.1. HARDWARE SUPPLIED When opening the package, ensure the contents match the following list: FibroScan device installed Case(s) fitted with probe(s) Sealed envelope (Windows EULA license and the present User manual) Battery External power supply and power cable Probe holder

5.2. ACCESSORIES The available accessories are: M+ probe XL+ probe Set of elements that can be connected to the FibroScan unit:

Peripherals not included: A: USB storage device. B: USB printer. Accessories: C: M+ probe. D: XL+ probe. E: Other accessories.

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

5.3. FRONT VIEW The machine contains the electrical power supply, dedicated electronics and a computer. It also serves as support for a monitor and a probe holder. The following figure presents the instrument's different user-accessible parts.

General arrangement of the FibroScan: A: Battery charge level indicator. B: Power supply indicator. C: Touch screen. D: Probe holder. To switch the device on or off, press the button at the rear of the device (see Rear View paragraph). This button loads the application. After a few seconds, the home window is displayed.

Battery charge indicator The battery charge indicator may show the following statuses: Not lit: Connected to external power source, not battery-powered. Flashing green: Connected to external power source, battery charging. Steady green: Not connected to external power source and battery charge above 33%. Orange: Not connected to external power source and battery charge between 20% and 33%. Red: Not connected to external power source and battery charge below 20%.

Power indicator The status of the power indicator is defined as follows: Not lit: device off. Green: device on.

The screen and the software This is a 12.1-inch colour touch screen.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

To protect the screen from any risk of damage, take care not to hang the power cable on the top of the machine. The FibroScan runs on dedicated software. The software is automatically launched when the FibroScan is switched on. It is used to: perform examinations, manage examinations saved in archives.

5.4. RIGHT SIDE VIEW Probe connectors.

Location of probe connectors: A: Probe connectors. B: USB connectors. The probe connectors are fragile.

5.5. REAR VIEW The following figure presents the instrument's different user-accessible parts.

E330M001.1

FIBROSCAN USER MANUAL 430 MINI EN

Rear view: A: Standby button. B: Battery hatch. C: Side handle. D: External power supply connector. E: Computer connectors.

The standby button This button is only active if the external power supply is connected to the power network and to the FibroScan, or if it is battery-powered.

Moving the device Use the FibroScan's side handle to move it.

External power supply and computer connectors

External power supply and computer connectors: A: External power supply KPJX-4SS connector. B: RJ45 network connector. C: USB connectors. Ethernet connector: also used for connectivity. Used by Echosens maintenance staff. Two USB 2.0 sockets: to connect an external hard disk for backups, a USB key, or a USB printer.

E330M001.1

EN FIBROSCAN USER MANUAL 430 MINI

Echosens recommends using encrypted hard drives or USB keys protected by logon code entered using integrated keypad.

External power supply primary connector. The external power supply must be connected to a 100 V or 240 V AC single-phase 50-60 Hz grounded mains socket using the power cord supplied.

5.6. STAND The FibroScan device is mounted on a fold-away stand. The figure below shows the device with the stand in folded-out position.

Use of device on its stand: A: Stand in folded-out position.

Fold-away stand Before resting the device on its stand, always make sure that the stand is fully folded out to keep the device stable and prevent it from falling over.

5.7. BATTERY HATCH The FibroScan is battery-powered. The following figure presents the access to the battery.

E330M001.1

Previous Page Next Page