IBPM
DPT-6000 (DPT-6003 & DPT-6009)
DPT-9000 / Xtrans
5.4.2.2
Medical protective gloves
Medical protective gloves intended to be worn before, during and after use of CODAN pvb Critical Care accessories and/or pressure monitoring sets
must verifi ably meet the current requirements of the European standard EN 455-1.
5.5
Other (third party) devices
5.5.1
Pressure cuffs
The manometers of pressure cuffs intended to be combined with CODAN pvb Critical Care pressure monitoring sets with fi lling and irrigation system
and a saline bag within a monitoring system for invasive blood pressure monitoring must verifi ably meet the current requirements of the European
standard EN ISO 81060- 1. Moreover, the manometers must have a measurement range of 0 mmHg – 300 mmHg (or greater) and a measurement
accuracy of at least ± 3 mmHg/± 2%.
5.5.2
Mounting poles & rails
Mounting rails intended to be combined with CODAN pvb Critical Care reusable mounting accessories within a monitoring system for invasive blood
pressure monitoring must verifi ably meet the current requirements of the European standard DIN EN ISO 19054 and have a maximum width of 25 mm
and a maximum thickness of 10 mm. The tubing of the mounting poles or infusion stands must have a diameter of between 15 mm and 35 mm. The
rectangular profi le of the mounting poles or infusion stands must measure 30 mm x 30 mm.
6
Provision
To prepare correctly, follow the instructions below.
6.1
Unpacking
Pressure monitoring sets and sterile accessories with damaged protective and/or sterile packaging (sterile barrier
:
system) must not be used. They must be disposed of because the basic safety and essential performance characteristics
➡
6.1.1
and sterility of the contents can no longer be guaranteed and contamination with pathogens is possible (see section 21,
page 65 – Disposal). Before unpacking, make sure that the protective and sterile packaging is undamaged and inspect
the integrity of the sealed seams.
Pressure monitoring sets and sterile accessories must not be used after the expiry date has passed. They must be dispo-
8
sed of because the basic safety and performance characteristics and sterility of the contents can no longer be guaranteed
➡
6.1.2
and contamination with pathogens is possible (see section 21, page 65 – Disposal). Before unpacking, make sure that
the expiry date stated on the protective and/or sterile packaging of the device has not passed.
1
IFU
–
6.1.3
CLC
SWAN
NBSS
NBSS
XL
ABSS
ABSS
XL
–
–
Using the monitoring system and its components without observing the hygiene guidelines specifi ed by the responsible
organisation may lead to the spread/transmission of pathogens and thus pose a danger to patients, users and third parties.
6.1.4
The entire monitoring system and its components should only be used in accordance with the specifi ed hygiene guidelines
and wearing medical protective gloves.
After the sterile packaging is opened, the pressure monitoring set and/or sterile accessories must immediately be pre-
pared aseptically, fi lled and used in order to minimise the time that the device is exposed to potential pathogens. The
responsible organisation must determine the appropriate length of time that may pass after the device is removed from the
sterile packaging and before it is used.
6.1.5
If the packaging is opened by mistake, the pressure monitoring sets and/or sterile accessories must be aseptically pro-
cessed, primed and used immediately in accordance with the specifi cations of the responsible organisation. Otherwise
they should be disposed of because the sterility of the devices cannot be guaranteed and contamination with pathogens is
possible (see section 21, page 65 – Disposal).
Pressure monitoring sets and accessories with visible defects and/or mechanical damage must not be used. They must
6.1.6
be disposed of because the essential performance characteristics and basic safety can no longer be guaranteed (see sec-
tion 21, page 65 – Disposal). After unpacking, make sure that the devices are undamaged.
Loose Luer connections may allow the ingress/leakage of liquids, air and/or pathogens during fi lling and/or use. Before
connecting the pressure monitoring set to the patient, check that all the Luer connections are tight and, if necessary, tighten
6.1.7
them by hand (without tools). It is prohibited to use tools/instruments to tighten the Luer connections because they may
break if excessive force is applied, resulting in an open fl ow channel.
20.1028.00/2022-10
(DPT-9003 & DPT-9009)
®
2
IBPM
6.1.1-.2
3
6.1.4-.5
1
1
6.1.6-.7
2
47