Medela Thopaz+ Gebruiksaanwijzing pagina 8
WARNINGS
– "Pressure" generally implies "negative pressure"
– Consult this manual prior to use�
– Data transfer via USB is not allowed during therapy�
– After each use, the parts that have been in contact with aspirated secretions are to be
cleaned and disinfected or disposed�
– Before cleaning the device, pull the plug out of the fixed mains socket�
– Thopaz + was validated in combination with the accessories listed in Appendix A�
For a correct and safe operation use Thopaz + with these accessories only�
Further information is supplied with the individual accessory�
– Do not use Thopaz + in MRT (Magnetic Resonance Tomography)�
– Do not dry Thopaz + with microwaves�
– The device is not suitable for use while bathing, showering or in a hazardous explosive
environment�
– The pressure range to be set must be determined by a physician in accordance with the
age and weight of the patient�
– Do not use Thopaz + if the drainage therapy indicates a pressure greater than
max� pressure range of –10 kPa�
– Do not use Thopaz + if the drainage therapy indicates a flow rate greater than
max� flow capacity of 5 l/min�
– Do not use Thopaz + if the drainage therapy indicates no pressure should be applied
to the patient�
– Do not connect bilateral thoracic drains to one Thopaz + unit� In such cases, the use of
two Thopaz + units is recommended�
– To ensure Thopaz + can reduce the pressure, it is essential to wait 30 seconds between
taking a drainage sample and unclamping the patient catheter (drain)�
– For pediatric patients adapt pressure settings according to hospital guidelines�
– The use of Thopaz + for any other indication than intended is neither desired nor
allowed�
– For use only by medically trained and qualified persons who have been adequately
trained in the use of Thopaz + �
– Wear gloves for all operations�
– The canister is replaced on the basis of a visual check or according to the instructions
on the Thopaz + display (warning signal)�
– If a persistent air leak is shown, check the system is assembled correctly before taking
further corrective actions� Ensure the system is air tight by clamping the catheter and
observing the air leak decrease to zero�
– Thopaz + system is regulated and controlled between the pump and the patient
connector� Blockage and leakage at the catheter may not be detected by the Thopaz +
system, see chapter Troubleshooting and alarms� Regular patient monitoring is required
by healthcare professionals�
– Leakage alarm may not be triggered with set pressure below 0�4 kPa�
– Leakage alarm is not triggered in case of disconnection of one catheter at the small
double connector (079�0024)�
– The catheter/connector interface is a location where clotting may occur� We recom-
mend regular monitoring of this interface and appropriate removal procedure in case
of occurance�
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Warnings and safety instructions
