A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y
MyLab
- G E T T I N G S T A R T E D
2 - 10
orientate the display so that it can be comfortably observed
while scanning,
take rest breaks after a long scanning session.
Information about ultrasound residual
risks
In conformity to the requirement set by the European Regulation 2017/745/
EU (Medical Device Regulation) in Annex I General Safety and Performance
Requirements, art 23.4 Information in the instruction for use, comma (g), this
paragraph draws to the attention of ultrasound practitioners to the following
residual risks that, even though not directly related to the technical
implementation of this medical device itself, can be encountered during its
professional use.
As such, to the best of its current knowledge on the state of the art in
ultrasound diagnostic imaging, Esaote has identified the following additional
potential residual risks that are hereafter grouped for main applications.
Cardiac
Stress Echocardiography
Absolute and relative contraindications as indicated by American Society of
Echocardiography must be applied to avoid serious complications.
The incidence rate of serious complications (e.g., serious arrhythmias,
myocardial infarction) has been reported to be 0.04% during stress exercise
testing, 0.01% after stress exercise testing, and
≤
0.2% for overall
complications.
Stress echocardiography should be performed in a sufficiently spacious room
with the following equipment readily available: an emergency cart with
emergency drugs and airway management devices, exercise stress monitoring
system (automated sphygmomanometer, 12-lead ECG monitor),
defibrillator, and oxygen tanks.
Contrast Echocardiography
Contrast Agents increase risk of capillary hemorrhaging in soft tissues
through mechanical effect of ultrasound.
Summary of Contents for MyLabX75VET
Page 1: ...Rev 03 June 2021 MyLabX75VET GETTING STARTED 350080800 ...
Page 2: ......
Page 5: ...MyLab G E T T I N G S T A R T E D v GETTING STARTED RED Declaration of Conformity ...
Page 6: ...MyLab G E T T I N G S T A R T E D vi ...
Page 61: ...S Y S T E M O V E R V I E W MyLab G E T T I N G S T A R T E D 3 17 GETTING STARTED ...
