4. SAFETY PRECAUTIONS
I n d i c a t i o n s :
The THD (THD Evolution & THD Щ is a system born for the surgical treatment of the haemor
rhoids o f r 2 \ 3 ° and r degree. It is based on Transanal Haemorrhoidal Dearterialisation techni-
cat guided by a Doppler probe. The Doppler system, contained into THD EVOLUTION and DI
SPOSABLE, is used to detect terminal brench of the superior haemorrhoidal artery, in order to
performing their ligature by proctocope, suture and needle holder contained into THD KIT
THD is to be used by physicians in hospitals, clinics, and physicians offices by prescriptions or
doctors orders.
C o n t r o i n d i c a t i o n s :
None
S p e c i a l P a t i e n t p o p u l a t i o n :
The THD (EVOLUTION & KIT) is not to be used in patients below 14 years of age or in patients
with a severe rectal inflannmation.
The use of the device on pregnant women has to be carefully evaluated by the referring physi
cian.
Warnings:
• Failure to follow these instructions could lead to damages or malfunctioning of this unit.
• The instrument contains of the sophisticated electronic members who of it guarantee the
elevated sensibility and can therefore be disturbed from the fields of frequencies particu
larly strong radios. The existence of such disturbs comes indicated from unusual sounds
emitted from the loudspeaker or temporary mute mode of the audio. It is advised to iden
tify and to eliminate the source of the interferences.
• The THD EVOLUTION unit and its accessories can only be connected with sockets compli
ant with the CEI 64/8 normative (sockets protected against the micro shock risk).
• THD EVOLUTION must be used only according to what is specified at the paragraph
"Environmental Conditions sub: Environmental conditions" in the TECHNICAL DATA
above: otherwise there could be risks of lesions, damages or malfunctioning.
• Make sure that both the fibre-optic cable and the Doppler Probe HAVE BEEN CLEANED
AND STERILISED BEFORE CONNECTING THEM. The connection has to be done safe
guarding the sterility.
• THD EVOLUTION IS INTENDED FOR USE WITH Transanal Dearterialiser THD (Pic.1), Dop
pler Probe (Pic.2), Fibre-optic Cable (Pic.3), Foot pedal (Pic.5) and Knot-pusher (Pic.4).
• Never pull, rotate or press on the power cable too strongly, so to damage it;
• Never use the THD EVOLUTION in proximity of flammable gases. The use in such an envi
ronment could start a fire.
• Keep the THD EVOLUTION away from liquid substances to prevent electric shock or mal
functioning. Although the unit is protected from the accidental contact with liquid sub
stances, in the event of a contact, disconnect the unit from the power supply. Dry the
external shell (See "Cleaning and Maintenance" paragraph 8) and make sure that those
liquid substances eventually penetrated inside have not damaged the functionality.
• Burn hazard; Make sure that the unit be switched off for at least 30 minutes before open
ing the external shell.
• the ultrasound Doppler probe utilization time has to be as short as possible (ALARP), con
sistently with the use indication.
Информация получена с официального сайта
Федеральной службы по надзору в сфере здравоохранения
www.roszdravnadzor.ru
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