echosens FibroScan 502 touch - Precautions for Use; Electrical Safety; User Training

FibroScan
FIBROSCAN 502 TOUCH USER MANUAL ERETE]
4.4. PRECAUTIONS FOR USE
The following instructions must be followed in order to ensure patient safety. The FibroScan
should not be used in the following situations:
On any organ other than the 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, the presence of ascites between the probe and the liver may prevent from
obtaining measurements with the device.
The clinical personnel must follow normal safety procedures.
The FibroScan examination should be performed carefully using the principle of
ALARA (As Low As Reasonably Achievable).
4.5. USER TRAINING
Only persons having received training in the use of the FibroScan and in possession of a user
certificate are authorized to conduct an examination using the 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.
4.6. ELECTRICAL SAFETY
The 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 performance requirements. In order to maintain this compliance and to guarantee
the safe use of this medical device, the user must comply with the indications and symbols
contained in this manual.
A Refer to the warnings in Chapter 2 concerning electrical safety.
Prior to installation, ensure that the operating and mains voltage values match.
The electrical power cable provided must be connected to the FibroScan mains connector
and to a grounded socket. Correct grounding can only be guaranteed if the FibroScan is
connected to a socket compliant with safety standards.
Safe use is no longer guaranteed in the following main, non-exhaustive cases:
the device is visibly damaged,
the device is inoperative,
after prolonged storage in unfavorable conditions,
after serious damage incurred during transport,
in the presence of flammable or anesthetic gases. This may cause an explosion. Do not
take the device to the operating room.
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 17