Codan IBPM DPT-6000 Gebrauchsanweisung Seite 40

Instructions for Use – English
2.7
2.8
3 Intended use
3.1 Intended purpose
The pressure monitoring set is intended for use on a patient requiring continuous monitoring of their blood pressure via one or more vascular access
ports (IBPM) and/or requiring blood withdrawals.
3.2 Indication
The use of CODAN pressure monitoring sets is always indicated whenever the medical condition requires, at the discretion of the treating physician,
continuous monitoring of the blood pressure based on the patient presentation, specific diagnosis, diagnostic findings and/or pathophysiological
considerations, among other things.
3.3 Clinical benefi t
The pressure monitoring set allows for measurement of the blood pressure level in one or more compartments of a patient's circulatory system with
subsequent signal transmission to a patient monitor to make possible the visualisation of the measured values on a screen (in the form of digits and/
or curves). Furthermore, integrated sampling components or sampling systems (open or closed sampling systems) allow for blood sampling to take
place (see section 13, page 54 – Blood sampling).
Therefore, the clinical benefit of the pressure monitoring set is to enable the user to
• continuously monitor and document one or more blood pressure values of a patient in order to establish whether they are above or below defi ned
limit values and/or to detect any irregularities due to (pre-existing) illnesses or blood loss, and to react to them with appropriate treatment;
• make a diagnosis of (pre-existing) illnesses of the cardiovascular system and/or evaluate therapies with drugs that have a cardiovascular effect;
• collect one or more blood sample(s) for laboratory diagnosis, or for evaluation of a patient's metabolic, respiratory and/or haemodynamic situation.
3.4 Contraindication
• Allergies to residues from an ethylene oxide [EO] sterilisation process
• Electrolyte imbalances (if necessary, the saline solution must be adjusted prior to use)
• All contraindications to an arterial or venous puncture (e.g. blood coagulation disorders or occlusive diseases)
3.5 Intended patient group
Pressure monitoring sets with DPT-6003 or DPT-9003 pressure transducers in combination with a filling and irrigation system and a pressure cuff
are used on critically ill and/or ventilated patients from 2 years of age (12 kg) who require monitoring of their blood pressure levels in the intravas-
cular system and/or the withdrawal of blood samples.
Pressure monitoring sets with DPT-6003/6009 or DPT-9003/9009 pressure transducers in combination with a fi lling line and a syringe pump are
used on critically ill and/or ventilated patients from birth, without any weight restriction, who require monitoring of their blood pressure levels in the
intravascular system and/or the withdrawal of blood samples.
3.6 Intended user profi le
The pressure monitoring set may only be used by healthcare professionals and emergency medical personnel with the appropriate specialised training,
who have been trained in accordance with the Instructions for Use for this medical device. The user must not have any mental or physical disability (e.g.
colour blindness) that could prevent him/her from using the pressure monitoring set and/or accessories as intended, in accordance with the directions
in these Instructions for Use.
3.7 Type and duration of intended physical contact
Depending on the confi guration of the pressure monitoring set and the therapy for the specifi c medical condition/disease progression, the pressure
monitoring set is connected to one or more vascular access line(s). This/these vascular accessline(s) is/are connected to one or more arterial or
venous vessels in one or more area(s) of the patient's body, mainly the extremities and/or neck. The extended exposure time, i.e. the cumulative
sum of individual, multiple or repeated contact times, may exceed 24 hours but not 30 days.
3.8 Intended working environment
The pressure monitoring set is used within clinical healthcare institutions for monitoring, diagnostics, anaesthesia and intensive care. Additionally, it
may be used outside of clinical healthcare facilities within appropriate emergency vehicles during professional primary (emergency) and secondary
(intensive care and ambulance) transport, when going to or between clinical healthcare facilities. The envisaged primary and secondary emergency
vehicles include
• Ambulances, rescue vehicles and emergency doctor's vehicles;
• Rescue helicopters (piston engine and jet propulsion);
• Rescue aircraft (fi xed-wing turbojet or turbofan);
• Rescue ships, lifeboats, water ambulances.
Additionally, the pressure monitoring sets with pressure transducers from the DPT-6000 (DPT-6003 & DPT-6009) or DPT-9000/Xtrans
& DPT-9009) series are intended for use within a defi ned electromagnetic environment (see Section 16, page 61 – Technical Specifi cations
and Operating Conditions).
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In order to maintain the fl ow rate that is needed, depending on the patient population, to keep the catheter open when using
pressure transducer types DPT-6003/6009 & DPT-9003/9009, the occlusion pressure of a syringe pump must be adjusted
according to the desired output and clinical standards.
Before and during emergency use of the device within appropriate emergency vehicles (see 3.8 Intended working environ-
ment) during professional primary (emergency) and secondary (intensive care and ambulance) transport to or between
clinical healthcare facilities, it is important to ensure that the Luer connectors and the sampling ports of the pressure monito-
ring set are free of dust, fl uff and dirt which can lead to leaks and/or contamination. To prevent soiling or the ingress/leakage
of liquids, air and/or pathogens, open-end Luer connectors must be closed with non-vented protective caps.
(DPT-9003
®
CODAN pvb Critical Care GmbH