Codan IBPM DPT-6000 Gebrauchsanweisung Seite 44

Instructions for Use – English
Overview (p. 3–9)
Blood
Column Row
sampling
NBSS A–F
XL
ABSS A–F
ABSS A–F
ABSS A–F
XL
ABSS A–F
XL
All A–Y
4.2 Sterile accessories
Sterile accessories (class IIa medical devices) are individual, sterile packaged components of a pressure monitoring set from the manufacturer CODAN
pvb Critical Care, not including individual pressure transducers of the DPT-6000 or DPT-9000/Xtrans
are used to supplement, extend or change the confi guration and/or components of a pressure monitoring set. These include fi lling systems, blood
sampling systems (only in combination with pressure transducer types DPT-6003, DPT-6009, DPT-9003 and DPT-9009), pressure monitoring lines and
one-way or multi-way stopcocks with or without connected pressure monitoring lines.
Additions, extensions or changes to the confi guration and/or components of a pressure monitoring set are always the
responsibility of the responsible organisation and must only be implemented using the sterile accessories from the manufacturer
CODAN pvb Critical Care. Additions, extensions or changes to the confi guration and/or components using third-party devices
are prohibited, because the basic safety and essential performance characteristics of the pressure monitoring set cannot then be
guaranteed. It is recommended that the components between the pressure transducer and patient access port should not exceed
240 cm in length, as this can possibly affect the quality of the signal transmission. Moreover, additions, extensions or changes to
the confi guration and/or components of the pressure monitoring set between the sampling port and patient access port may mean
that suffi cient volume can no longer be drawn using a reservoir (NBSS, NBSS
blood samples to be taken at the sampling port.
A list of all the available sterile accessories and other information will be provided by the distributor and/or manufacturer upon request.
4.3 Non-sterile accessories
Reusable mounting accessories, comprising holders, mounting plates and modular holder systems (mounting heads, claws and poles), are non-ster-
ile class I medical devices and they are used for assembling pressure monitoring sets and electrical accessories on round poles or rail systems.
Single-use mounting accessories, comprising velcro straps and fasteners, are non-sterile class I medical devices used for assembling pressure monitoring
sets, reservoirs and electrical accessories on the patient's arm or for securing pressure monitoring lines.
Reusable electrical accessories are non-sterile class I medical devices that enable the transmission of signals between one or more pressure transducers
and a control monitor. These include contact boards and monitor connectors for DPT-9000/Xtrans
A list of all the available non-sterile accessories and other information will be provided by the distributor and/or manufacturer upon request or can be down-
loaded from: https://www.codancompanies.com/downloadcenter/
4.4 Consumables
Consumables are required for the intended use of a pressure monitoring set on a patient within a monitoring system and may have to be used up,
disposed of or replaced before or during use. Illustrations in these Instructions for Use labelled with the following symbols inform the user about
➡
a used material that must be disposed of according to regulations (see section 21, page 65 – Disposal);
44
Designation Part of
1-way stopcock
VI
Reservoir (6 ml)
NBSS
XL
SWAN Switch
VII (Swabable Adaptor
Needle-free)
ABSS
VI–
(Arterial Blood -
VII
Sampling System)
VI Reservoir (2 ml)
1-way stopcock
ABSS
VII
Sampling port
ABSS
XL
VI–
(Arterial Blood -
VII
Sampling System)
1-way stopcock
VI
Reservoir (6 ml)
ABSS
XL
Sampling port
VII
1-way stopcock
Patient connec-
VIII tion with a male -
Luer connector
Component
Main functional & operating features
• Flow control (opening and closing the fl ow channel)
• Drawing, short-term storage (duration of a blood sampling
process) and return of mixed blood (6 ml)
• Protection against the ingress of pathogens
• Hygienically closed blood sampling
• Setting of four possible fl ow directions (360°)
• Transmission of the physical pressure (blood pressure)
to a pressure transducer
• Hygienically closed blood sampling
• Drawing, short-term storage (duration of a blood
sampling process) and return of mixed blood
• Drawing, short-term storage (duration of a blood sampling
process) and return of mixed blood (2 ml)
• Protection against the ingress of pathogens
• Flow control (opening and closing the fl ow channel)
• Hygienically closed blood sampling
• Transmission of the physical pressure (blood pressure)
to a pressure transducer
• Hygienically closed blood sampling
• Drawing, short-term storage (duration of a blood
sampling process) and return of mixed blood
• Flow control (opening and closing the fl ow channel)
• Drawing, short-term storage (duration of a blood sampling
process) and return of mixed blood (6 ml)
• Protection against the ingress of pathogens
• Hygienically closed blood sampling
• Flow control (opening and closing the fl ow channel)
Connecting the pressure monitoring set to a patient
access port
and interface cables and cable management for DPT-6000.
®
Quantity
1 -
1–3 -
Only in combination
with a (pulmo-
1 nary)-arterial set-up
of a pressure monito-
ring set
1 -
1–2 -
The blood sampling
adapter HG-01 is
1–2
required for blood
sampling
Only in combination
with a (pulmo-
1 nary)-arterial set-up
of a pressure monito-
ring set
1 -
1 -
The blood sampling
adapter HG-01 is
1–2
required for blood
sampling
1–2 -
1–4 -
series and consumables. The sterile accessories
®
, ABSS & ABSS confi gurations) for undiluted
XL XL
CODAN pvb Critical Care GmbH
Note