General Information
The product PHYSIO-PORT UP bears the CE
marking CE 0482 (notified body MEDCERT
GmbH) indicating its compliance with the
provisions of the Regulation (EU) 2017/745
(Medical Device Regulation MDR) about medical
devices and fulfills the essential requirements of
Annex I of this regulation. The devices have an
internal power source and are MDR class IIa
devices. The devices fulfill the requirements of the
Directive 2011/65/EU of the European Parliament
and of the Council and its amending Directive (EU)
2015/863 of the European Parliament and of the
Council. The cuffs listed in Chapter 10 are a class I
device and fulfill the General Safety and
Performance Requirements of Annex I of the
Regulation (EU) 2017/745 (Medical Device
Regulation MDR). They are marked with the CE
symbol.
It has a type BF applied part.
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.
The product is clinically validated. The validation
fulfills the standard ISO 81060-2 “Non-invasive
sphygmomanometers - Part 2: Clinical
investigation of automated measurement type” and
the protocol ESH-IP 2010 from the European
Society of Hypertension.
The radio interference emitted by this product is
within the limits specified in CISPR11/EN 55011,
class B.
The CE marking covers only the accessories listed
in the "Order Information" chapter.
This manual is an integral part of the equipment. It
should 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’s 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, PAR Medizintechnik will provide a
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 GE Healthcare. The
user is responsible for application of accessories
from other manufacturers.
Any serious incident occurring in relation to the
device should be reported to the manufacturer and
the competent authority of the Member State in
which the user and/or patient is established.
