Codan IBPM DPT-6000 Gebrauchsanweisung Seite 39

Instructions for Use – English
1 Overview and foreword
Read this information carefully before use and keep it for future reference.
These Instructions for Use (IFU) contain important information about the intended use of the pressure monitoring set manufactured by CODAN pvb
Critical Care with pressure transducers from the DPT-6000 (DPT-6003 & DPT-6009), DPT-9000/Xtrans
sterile accessories. The confi guration of this pressure monitoring set may differ from the device confi gurations on pages 3–9 of these Instructions
for Use, and therefore the precise guidelines and procedures must be determined by the responsible organisation. The responsible organisation
(e.g. the ward manager, responsible doctor or clinical institution) designates the entity responsible for using the pressure monitoring set, the sterile
accessories and/or the entire monitoring system in which the CODAN pvb Critical Care pressure monitoring set and/or sterile accessories are com-
bined with other medical devices for invasive blood pressure monitoring.
Any serious incidents that occur during use of, or in connection with, CODAN pvb Critical Care devices and that have led, could have led or might
lead to the death or temporary or permanent serious deterioration in a patient's, user's or other person's state of health, or a serious risk to public
health must be reported to the manufacturer CODAN pvb Critical Care and to the competent federal authority.
Information labelled with one of the following symbols indicates a hazard,
If this hazard is not avoided, it can result in damage to property or the environment;
Hazard with a low risk level which, if not avoided,
can result in minor or moderate injury;
Hazard with a medium risk level which, if not avoided,
can result in death or severe injury;
Hazard with a high risk level which, if not avoided,
can result in death or severe injury.
Further explanations of the symbols used on the packaging and in the Instructions for Use can be found in the tables on Page 67.
2 Safety and protective measures
Read and comply with all of the following safety instructions. If these instructions are not observed/complied with, there are signifi cant safety risks
for patients, users and third parties.
Comply with all instructions (including safety instructions and warnings) for the intended use of all (third-party) devices
used in combination with the pressure monitoring set in order to guarantee the safe use of the pressure monitoring set and/
2.1
or accessories. Prior to use, carefully read all the accompanying information provided by the manufacturers of the (third-
party) devices.
Before performing any therapeutic interventions on a patient which are to be initiated on the basis of blood pressure
values displayed on the control monitor, the plausibility of the measured values must be checked to rule out a device error
or malfunction as the cause of measured values exceeding or falling below the set limit values. To do this, check the other
2.2
patient displays (e.g. electrocardiography, oxygen saturation) and vital functions (e.g. pulse, respiration check). In addition,
inspect the entire set-up of the pressure monitoring system at each change of shift (see section 23, page 66 – Trouble-
shooting and fault rectifi cation).
Exposed contacts of the electrical accessories must not be touched at the same time as the patient while the accessories
are making an electrically conductive connection to a control monitor. Risk of electric shock! Wear medical protective
2.3
gloves when preparing, using and disassembling the electrical accessories and ensure that an electrically conductive
connection cannot be established between the patient and the exposed contacts.
Spilling of liquids, whatever the quantity, onto electrical contacts can lead to the loss of basic safety, including the essen-
tial performance characteristics. Make sure that no liquids can wet the electrical contacts of the accessories and/or pressure
2.4
monitoring set during preparation, use or disassembly. In the event of liquid contact, replace the pressure monitoring set
immediately, clean and dry the electrical accessories and check their function.
When using a defi brillator, any contact with the pressure monitoring system is prohibited. Risk of electric shock! Avoid
2.5
any contact with the monitoring system when resuscitation is being performed using a defi brillator.
The use of a pressure monitoring set together with a saline bag and pressure cuff described in the illustrations of these
Instructions for Use only applies to pressure monitoring sets with fi lling system and pressure transducers of types DPT-6003
or DPT-9003 (see section 7.2, page 48 – Connecting a pressure monitoring set with fi lling system to a saline bag
(DPT-6003 & DPT-9003)). Pressure monitoring sets with pressure transducers of types DPT-6009 or DPT-9009 should
only be used with syringe pumps, as using them with a saline bag and pressure cuff may lead to a saline solution overdose
2.6
(see section 7.3, page 49 – Connecting a pressure monitoring set with fi lling line to an syringe (DPT-6003/6009
& DPT-9003/9009)). To avoid administering an overdose of saline solution to patients with a strict infusion limit (e.g. neo-
nates and children), the fl ow rate of the syringe pump must be adjusted in accordance with clinical standards. The male
Luer connectors of the pressure transducer types DPT-6009 and DPT-9009 have yellow union nuts to make them clearly
identifi able.
20.1028.00/2022-10
(DPT-9003 & DPT-9009) series and the
®
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