Codan IBPM DPT-6000 Gebrauchsanweisung Seite 41

IBPM
DPT-6000 (DPT-6003 & DPT-6009)
DPT-9000 / Xtrans
3.9 Intended monitoring system (physical functionality)
The physical functionality of the monitoring system consists of conducting a pressure transmitted via intravasal access  and pressure measure-
ment lines  through a fl uid column  to a pressure transducer  and converting it into electrical signals via a Wheatstone full bridge. With the aid
of reusable electrical accessories , these signals are transmitted to a control monitor .
4 Device description
The medical devices from the manufacturer CODAN pvb Critical Care are developed, manufactured and placed on the market in accordance with the
fundamental safety and performance requirements of the Regulation (EU) on Medical Devices 2017/745 (MDR), the Regulation 1907/2006 (REACH),
the Directives 2011/65/EU and (EU) 2015/863 (RoHS) and the requirements of the European Standards EN 62366-1:2015 + AC:2015 + A1:2020, and
they carry CE marking. The electrical accessories and pressure monitoring sets with pressure transducers from the DPT-6000 or DPT-9000/Xtrans
series meet the requirements of the European Standards EN 60529:1991 + A2:2013/AC:2019-02, EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 +
A1:2013/AC:2014 + A12:2014 + A2:2021, EN 60601-1-2:2015, EN 60601-1-6:2010 + A1:2015 + A2:2021, EN 60601-1-12:2015 + A1:2020, EN 1789:2020.
EN 13718-1:2014+A1:2020, EUROCAE ED-14G:2015/RTCA/DO-160G:2010 + Cor.1:2014 (Section 8.5 Category S, Section 8.8 Category U, Section 20,
Section 21 Category M) and EN 60601-2-34:2014. The Luer connectors of the sterile accessories and pressure monitoring sets are manufactured in
accordance with the requirements of the Standards EN ISO 80369-1:2018 and EN ISO 80369-7:2021. CODAN pvb Critical Care medical devices are
delivered in protective/transport packaging validated according to EN ISO 11607-1:2020 and EN ISO 11607-2:2020 to protect the devices from mechanical
damage and general soiling during storage and transportation. Moreover, the pressure monitoring sets and sterile accessories are delivered in a single or
double sterile barrier system (sterile packaging) validated according to the specifi ed standards to protect against contamination with pathogens after the
sterilisation process (in accordance with EN ISO 11135:2014 + A1:2019) and to maintain the sterile condition of the devices.
For a better understanding of the following information about the medical devices of the manufacturer CODAN pvb Critical Care, refer to
the confi guration overviews on pages 3–9 of these Instructions for Use.
4.1 Pressure monitoring set
The pressure monitoring set is a sterile, active and portable class IIb medical device. The essential performance characteristics of the pressure moni-
toring set in accordance with EN 60601-2-34:2014 include accuracy of the pressure measurements, defi brillation-proof and resistance to electrosurgery
interference. The basic safety features of the pressure monitoring set include:
• Leak tightness;
• Pressure resistance;
• Tensile/electrical strength;
• Disinfectant resistance;
• Protection against mechanical stresses;
• Electrical safety.
A fully confi gured pressure monitoring set comprises
• Components for connecting the pressure monitoring set to a liquid medium for filling and irrigation (I–III);
• One or more pressure transducers for converting one or more physical pressures (blood pressure) into one or more electrical signals (IV);
• Additional components for pressure transmission (V);
• Components for transmitting one or more physical pressures (blood pressure) to one or more pressure transducers and, if applicable, for the
collection of blood samples (VI–VIII).
The smallest possible confi guration for a pressure monitoring set is a single pressure transducer (IV) of the DPT-6000 (DPT-6003 & DPT-6009) or
DPT-9000/Xtrans series (DPT-9003 & DPT-9009). All other sections (I–III & V–VIII) are optional and must be supplemented with the sterile accesso-
®
ries from the manufacturer CODAN pvb Critical Care (see section 4.2, page 44 – Sterile accessories). The following table lists the components of
a pressure monitoring set and their main functional and operating features, based on the confi guration overviews on pages 3–9 of these Instructions
for Use.
Pressure monitoring lines are required to connect different components and for pressure transmission. The pressure monitoring lines can be made from
PVC (polyvinyl chloride), PE (polyethylene), or PUR (polyurethane) with different Luer connectors, lengths and (internal/external) diameters and they
can be installed at various positions on the pressure monitoring set. Due to their versatility, the pressure monitoring lines are not explained in further
detail in the following table. More information about the pressure monitoring lines from the manufacturer CODAN pvb Critical Care will be provided by
the distributor and/or manufacturer upon request.
Overview (p. 3–9)
Blood
Column Row Designation
sampling
All - -
20.1028.00/2022-10
(DPT-9003 & DPT-9009)
®
Part of
Protective/ • Protects the medical device from mechanical damage
transport - and general soiling during storage and transportation
packaging • Identifi ability and traceability
0,9%
NaCl
Component
Main functional & operating features
IBPM
120
80
®
Quantity Note
A sterile barrier
system with external
1 protective packaging
is labelled with the
symbol 20
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