IDOMAN TEORANTA Thermablate Bedienungsanleitung Seite 3

Instructions for Use
Only medical professionals who have experience in performing
procedures within the uterine cavity, such as IUD insertions or dilation
and curettage, are suitably trained, have adequate know ledge and
familiarity with the Thermablate EAS system, should perform
endometrial ablation using this device.
Read all directions, cautions, and warnings prior to use. These
Instructions for Use provide directions for using the Thermablate EAS
system.
Failure to follow any instructions or to heed any warnings or
precautions could result in serious injury to the patient.
These Instructions for Use are complemented and reiterated by the
―Operator's Manual‖ included with the Treatment Control Unit (TCU) kit.
Use caution not to perforate the uterine wall during dilation, sounding,
or cutterage (if performed). If a perforation is suspected, a
hysteroscopy must be performed. Do not initiate the procedure if
perforation of the uterine wall or the creation of a false passage is
confirmed during the hysteroscopy performed just prior to the insertion
of the balloon.
Do not perform same day Thermablate EAS procedure and hysteroscopic tubal
occlusion/sterilization.
Thermablate EAS procedure can be safely and effectively performed with nickel
titanium inserts in place, however the procedure should only be performed after
the 3 month tubal occlusion confirmation test.
The outside temperature measured on the disposable cartridge sheath can
reach a maximum of 80°C during treatment cycle. It has been confirmed from
clinical studies and historical data, that the heat lacks sufficient energy to cause
any heat transfer to surrounding area.
To eliminate any potential for patient discomfort in some circumstances Medical
Equipment should not to be placed against exposed flesh during treatment
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