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IBPM
DPT-6000 (DPT-6003 & DPT-6009)
DPT-9000 / Xtrans
16
Technical specifications and operating conditions
16.1
Electrical safety
The pressure transducers of the DPT-6000 and DPT-9000/Xtrans
➡
16.1.1
are therefore protected against accessing dangerous parts with a tool and against the harmful penetration of solid foreign
bodies with a diameter ≥ 2.5 mm as well as water in the event of temporary submersion (30 minutes in water 1 m deep).
The pressure transducers of the DPT-6000 and DPT-9000/Xtrans
➡
16.1.2
the measuring function and essential performance characteristics to be maintained after severe mechanical impact stress
of up to 0.5 joule.
The pressure transducers of the DPT-6000 and DPT-9000/Xtrans
➡
16.1.3
on-protected applied parts of the CF (Cardiac Float) type, and thus fulfi l the strictest requirements for the insulation of
accessible parts.
16.2
Conditions for continuous operation
For the correct continuous operation of the pressure monitoring set with pressure transducers of the DPT-6000 and DPT-9000/Xtrans
16.2.1
series, please take note of the technical specifi cations on page 2 of these Instructions for Use.
It is prohibited to use the pressure monitoring set and/or the accessories outside the permitted conditions for continu-
16.2.2
ous operation (for example, in the event of transient operating conditions with irregular or severely fl uctuating environmen-
tal parameters) because it may lead to loss of the essential performance characteristics and basic safety.
16.3
Electromagnetic compatibility (EMC)
The pressure monitoring sets with pressure transducers of the DPT-6000 and DPT-9000/Xtrans
standards EN 60601-1-2:2015 and EN 60601-2-34:2014, which are required as proof of electromagnetic compatibility (EMC), as well as the addi-
tional requirements in accordance with EN 60601-1-12:2015 + A1:2020 for the use of medical electrical equipment in an emergency setting. They
are intended for operation within a defi ned and controlled electromagnetic environment. This environment and the tests required as proof of elec-
tromagnetic compatibility in accordance with EN 60601-1-2:2015, 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 were
successfully performed and are presented in the manufacturer's EMC guidance. The EMC guidance will be provided by the distributor and/or manu-
facturer upon request.
Temporary impairments due to electromagnetic interference are permissible, but normal operation must be ensured again
after a maximum of 10 seconds. A reduction or loss of the essential performance characteristics due to use outside the
defi ned environmental conditions and signifi cantly greater electromagnetic interference can lead to an unacceptable risk
for patients, users or third parties, for example:
• the loss of essential performance characteristics during use may lead to the patient experiencing circulatory crisis if there
is a lack of monitoring;
• an electric shock may lead to the patient experiencing ventricular fi brillation and/or cardiovascular failure;
16.3.1
• the malfunction of other equipment may lead to cardiovascular failure or death of the patient due to the failure of vital
equipment;
• if incorrect values are displayed (falsely high/falsely low), this may lead to severe systemic harm to the patient due to the
incorrect or omitted administration of medication.
The responsible organisation must ensure that the pressure monitoring set with pressure transducers of the DPT-6000
or DPT-9000/Xtrans
CODAN pvb Critical Care.
Using the pressure monitoring sets with pressure transducers of the DPT-6000 or DPT-9000/Xtrans
and/or immediately next to other stacked equipment must be avoided because this may cause a reduction in the essen-
16.3.2
tial performance characteristics. However, if such an application is clinically necessary and unavoidable, all the equipment
must be observed during use to make sure that it is functioning as intended.
The use of electrical accessories from other companies may result in increased electromagnetic interference emis-
sions and/or decreased electromagnetic immunity of the pressure monitoring set, and lead to a reduction in the essential
16.3.3
performance characteristics. Only use original CODAN pvb Critical Care accessories together with pressure monitoring
sets with pressure transducers of the DPT-6000 or DPT-9000/Xtrans
accessories).
Portable radio equipment and other RF communications equipment (for example, mobile telephones including their
antenna cables, external antennas and/or other accessories) must not be used within 30 cm of the electrical accessories
16.3.4
and pressure monitoring sets with pressure transducers of the DPT-6000 or DPT-9000/Xtrans
this distance may lead to a reduction in the performance characteristics of the pressure monitoring set.
The pressure monitoring sets can be used during the application of electrosurgical units (300 W monopolar cutting,
100 W monopolar soft coagulation, 337 kHz). However this may lead to brief malfunctions and a reduction in the essential
16.3.5
performance characteristics of the pressure monitoring set. All equipment must be observed during use to ensure that it is
functioning as intended.
20.1028.00/2022-10
(DPT-9003 & DPT-9009)
®
series are only used within the environment described in the EMC guidance from the manufacturer
®
series have an IP37 enclosure protection rating. They
®
series have an IK04 impact rating and thus enable
®
series are electrically isolated and have defi brillati-
®
series meet the requirements of the European
®
series (see section 4.3, page 44 – Non-sterile
®
series. Failure to observe
®
®
series together with
®
61
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