Medela Thopaz+ Mode D'emploi page 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.
– 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.
– The Thopaz + system is not designed for retransfusion.
8 |
Warnings and safety instructions