Codan IBPM DPT-6000 Gebrauchsanweisung Seite 62

Instructions for Use – English
16.3.6
16.4 Compatibility with electrosurgical units
The pressure monitoring sets can be used during the application of an electrosurgical unit. However this may lead to brief malfunc-
tions and a reduction in the essential performance characteristics of the pressure monitoring set (see section 16.3, page 61 –
Electromagnetic compatibility).
16.5 Compatibility with magnetic fi elds (magnetic resonance imaging)
16.5.1 ➡
16.5.2 ➡
16.5.3 ➡
➡
16.5.4
17 Storage and transportation
17.1
17.2
62
Using a pressure monitoring set without wearing medical protective gloves and/or outside the environment described
in the EMC guidance from the manufacturer CODAN pvb Critical Care may lead to a reduction or loss of the essential
performance characteristics due to harmful electrostatic discharge. The pressure monitoring set should only be used with
medical protective gloves and within the environment described in the EMC guidance from the manufacturer CODAN pvb
Critical Care in order to prevent harmful electrostatic discharge.
Non-clinical investigations have shown that the pressure monitoring sets with pressure transducers from series
DPT-6000 and DPT-9000 (Xtrans
Electrotechnical Commission (IEC 62570) and the American Society for Testing and Materials (ASTM F2503-20). A patient
can be scanned together with a pressure monitoring set within the MR environment, under the following conditions:
• Static magnetic fi eld of 1.5 Tesla, 3 Tesla and 7 Tesla with
• Maximum spatial gradient magnetic fi eld of 24,600 G/cm (246 T/m)
• Maximum gradient fi eld product of 1,033,000,000 G2/cm (1,033 T2/m)
It was possible to maintain the measuring accuracy of pressure transducers (± 4% / ± 4 mmHg), as required by the Euro-
pean standard EN 60601-2-34, during MR-induced malfunction tests in which the devices were exposed to the static fi eld
B0 at clinical level (200 mT), the time-varying magnetic fi eld gradient (dB/dt) and the RF fi eld (B1, E) of 1.5 Tesla, 3 Tesla
and 7 Tesla MR systems. The devices have passed all of the malfunction tests according to the proprietary test procedures
at CODAN pvb Critical Care GmbH.
All components made of plastic or other non-metallic materials in the pressure monitoring sets (e.g. pressure monitoring
lines, one-way or multi-way stopcocks and reservoir systems) are MR safe and can be safely placed in the MRI tube. The
MR image quality may be compromised by an incorrect proton signal if the plastic components are placed within or around
the imaging area.
The DPT-6000 and DPT-9000 (Xtrans
placed inside the MRI tube.
Non-clinical investigations have shown that the systems for fi lling using a micro drip chamber are MR conditional
according to the established terminology from the International Electrotechnical Commission (IEC 62570) and the American
Society for Testing and Materials (ASTM F2503-20). A patient can be scanned together with a fi lling system with micro drip
chamber within the MR environment, under the following conditions:
• Static magnetic fi eld of 1.5 Tesla, 3 Tesla and 7 Tesla with
• Maximum spatial gradient magnetic fi eld of 24,600 G/cm (246 T/m)
• Maximum gradient fi eld product of 1,033,000,000 G2/cm (1,033 T2/m)
The systems for fi lling using a micro drip chamber must not be placed inside the MRI tube.
Non-clinical investigations have shown that the following sterile accessories made of plastic or other non-metallic
materials are MR safe according to the established terminology from the International Electrotechnical Commission
(IEC 62570) and the American Society for Testing and Materials (ASTM F2503-20):
Systems for fi lling with a macro drip chamber, systems for fi lling with a spike, Heidelberger extensions, spiral lines, lines for
fi lling, blood sampling adapters, pressure monitoring lines, arterial blood sampling systems (ABSS), arterial blood sampling
systems XL (ABSS ), needle-free blood sampling systems (NBSS), needle-free blood sampling systems XL (NBSS
XL
reservoir systems, reservoir systems XL, sampling extensions, pressure monitoring set additions, CVP measuring limbs,
one-way stopcocks, multi-way stopcocks, and sampling ports.
The listed product groups can be safely placed in the tube of the MR system. The MR image quality may be compromised
by an incorrect proton signal if the plastic components are placed within or around the imaging area.
CODAN pvb Critical Care devices labelled with the symbol shown opposite are considered MR unsafe according to the
established terminology of the International Electrotechnical Commission (IEC 62570) and the American Society for Testing
and Materials (ASTM F2503-20). No medical device labelled with this symbol may be used within the MR environment.
For the correct storage and transportation of the pressure monitoring sets with pressure transducers of the DPT-6000
and DPT-9000/Xtrans
series, please observe the storage and transportation symbols on page 2 of these Instructions for
®
Use and on the protective or sterile packaging of the device. Storage or transportation of the pressure monitoring set and/or
accessories outside of the permitted environmental conditions is prohibited because it may lead to reduced useful life and
loss of the essential performance characteristics and basic safety.
Pressure monitoring sets and sterile accessories that are not immediately aseptically prepared, primed and used must not
be transported or stored if the sterile packaging has already been opened. They must be disposed of because it is no
longer possible to guarantee that the sterile condition has been maintained, and contamination with pathogens is possible
(see section 21, page 65 – Disposal).
) are MR conditional according to the established terminology from the International
®
) series pressure transducers and micro drip chamber fi lling systems must not be
®
),
XL
CODAN pvb Critical Care GmbH