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Verfügbare Sprachen
Verfügbare Sprachen
IBPM
DPT-6000 (DPT-6003 & DPT-6009)
DPT-9000 / Xtrans
18
Residual risks
Based on the completed risk assessment in accordance with the EN ISO 14971:2019 + A11:2021 standard, the following residual risks arise with
regard to the use of pressure monitoring sets and sterile accessories from the manufacturer CODAN pvb Critical Care: ventricular fi brillation,
cardiovascular failure or crisis, drop in blood pressure, drop in cardiac output, drop in oxygen saturation, blood loss, severe systemic damage,
chronic long-term damage to tissues and organs, tissue necrosis, thrombosis, (air) embolisms, spread of pathogens, local or systemic infections,
vasospasms, sepsis, transient fever, local and allergic reactions, hypersensitivity reactions, pulmonary oedema, malignant tumors, genetic damage,
hypervolaemia, malpuncture, vascular injuries, damage to visual organs, burns, or death of the patient.
All residual risks as well as the overall risk fall within the acceptable range after risk mitigation and cannot be reduced any further. The medical/
clinical benefi t of the pressure monitoring sets and sterile accessories far outweighs the remaining residual risks or the remaining overall risk. It is
the responsibility of the attending physician to inform the patient about possible residual risks.
19
Replacing the pressure monitoring set/sterile accessories
During replacement, the safety of the patient must be ensured. Before a pressure monitoring set or accessories can be replaced, the new one(s)
must be primed such that they are free of air bubbles. After the patient access port has been closed, the pressure monitoring set or accessories
can be disconnected by hand (without tools) and the new one(s) connected. Please follow the instructions in sections 6 –13 concerning safe provi-
sion, preparation, fi lling, initial operation and use. The replaced pressure monitoring set and/or accessories must be disposed of (see section 21,
page 65 – Disposal).
20
Ending use of a pressure monitoring set
20.1
General
To end use, follow the hygiene guidelines specifi ed by the responsible organisation and wear medical protective gloves
20.1.1
to prevent the spread/transmission of pathogens.
When the use of a pressure monitoring set has to be terminated, for example because there is no longer a medical indi-
cation, or in the case of damage or a change in performance, or if the duration of use is exceeded, and the set has come
20.1.2
into contact with potentially infectious substances/materials (e.g. blood, saliva and/or bodily excretions), it poses a risk
and must be disposed of according to the regulations for contaminated/infectious medical waste (biohazard) to prevent the
spread/transmission of pathogens (see section 21, page 65 – Disposal).
20.2
Uncoupling a pressure monitoring set from the patient access port
Disconnecting a pressure monitoring set from an unsecured patient access port can lead to uncontrolled bleeding, a
severe drop in blood pressure and the need for a blood transfusion. Before uncoupling a pressure monitoring set, make
20.2.1
sure that the patient access port is closed to prevent uncontrolled bleeding and to guarantee that it can be disconnected
safely.
1
–
CLC
SWAN
A–Y
20.2.2
VIII
NBSS
NBSS
XL
ABSS
ABSS
XL
A–F
VIII
20.3
Uncoupling a reservoir from non-sterile accessories
1
DPT-6000 (DPT-6003 & DPT-6009)
20.3.1
NBSS
NBSS
XL
ABSS
ABSS
XL
A–F
VI
20.1028.00/2022-10
(DPT-9003 & DPT-9009)
®
2
20.2.1
2
3
1
3
1
2
1
1
63
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