6
BPAro
ENG Revision A
General Information
General Information
•
The product fulfills the requirements of the standard
EN/IEC 60601-1 "Medical Electrical Equipment, Part
1: General Requirements for Basic Safety and
Essential Performance" as well as the safety standard
for automatic sphygmomanometers 80601-2-30 and
the electromagnetic immunity requirements of the
standard EN/IEC 60601-1-2 "Medical electrical
equipment – Collateral standard: Electromagnetic
compatibility – Requirements and tests" and
applicable amendments.
•
It has a type BF applied part
•
The product is clinical validated. The validation ful-
fills the standard ISO 81060-2:2013 “Non-invasive
sphygmomanometers - Part 2: Clinical investigation
of automated measurement type” and the protocol
ESH-IP 2010 from the European Society of Hyper-
tension.
•
The radio-interference emitted by this product is
within the limits specified in CISPR11/EN 55011,
class B.
•
This manual is an integral part of the equipment. It
will be enclosed in electronic form. The data medium
with the electronic manual or the manual in paper
form, which can be requested free of charge from the
manufacturer, must be available to the equipment
operator at all times. Close observance of the
information given in the manual is a prerequisite for
proper equipment performance and correct operation
and ensures patient and operator safety.
Please note that information pertinent to several
chapters is given only once. Therefore, carefully read
the manual once in its entirety.
•
The symbol means: Follow the instructions given
in the operator manual. It indicates points which are
important to avoid faulty measurements or injuries
like strangulation of the arm.
•
This manual reflects the equipment specifications and
applicable safety standards valid at the time of
printing. All rights are reserved for devices, circuits,
techniques, software programs, and names appearing
in this manual.
•
On request, CardiAI will provide a Field Service
Manual.
•
The safety information given in this manual is
classified as follows:
•
To ensure patient safety and interference-free operation
and to guarantee the specified measuring accuracy, we
recommend using only original accessories available
through CardiAI. The user is responsible for application
of accessories from other manufacturers.
Danger
Indicates an imminent hazard. If not avoided,
the hazard will result in death or serious injury.
Warning
Indicates a hazard. If not avoided, the hazard
can result in death or serious injury.
Caution
Indicates a potential hazard. If not avoided, the
hazard may result in minor injury and/or
product/property damage.
