Medela Thopaz - Page 7

7 | Warnings and safety instructions
WARNINGS
– Consult this manual prior to use.
– Data transfer via USB is not allowed during therapy.
– Before cleaning the device, pull the plug out of the fixed mains socket.
– 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 se
t must be determined by a physician in accordance with
the age and weight of the patient.
– The secretions gathered must be monitored more regularly or frequently in accordance
with the age and weight of the patient.
– To ensure Thopaz can reduce the pressure, it is essential to wait 30 seconds between
taking the sample from the sample port and unclamping the patient catheter (drain).
– Do not use Thopaz if the drainage th
erapy indicates a pressure greater than Thopaz
max. pressure range of -10 kPa.
– Do not use Thopaz if the drainage therapy indicates a flow rate greater than Thopaz
max. flow capacity of 5 L/min.
– Do not use Thopaz if the drainage therapy indicates no pressure should be applied to
the patient.
– The catheter/connector interface is a location where clotting may occur.
We recommend regular monitoring of this interface and appr
opriate removal
procedure in case of occurance.
– Do not connect bilateral thoracic drains to one Thopaz unit. In such cases, the use of
two Thopaz units is recommended.
– The use of Thopaz for any other indication than intended is neither desired nor allowed.
CAUTIONS
– No modification of all articles related to the Thopaz system is allowed.
– Before connecting Thopaz to the power supply, please verify that the supply v
oltage
corresponds to that given on the device specification plate.
– Incorrect use can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– For patients for whom a breakdown of the device can lead to a critical situation
a replacement device must always be available.
– Caution: Federal US law restricts this device to sale by or on the order of a health
pro
fessional.