IMPORTANT SAFETY ADVISE
Before the first use of THD EVOLUTION, cfieck carefully if the setting of the voltage
value corresponds to that available in your country. Eventually, proceed to change the
voltage level of the power supply, as per instructions of Chapter 6 of this manual.
SUMMARY
INTRODUCTION
8,
1. UNPACKING
page 1
9.
2. SPECIFICATIONS
1
10.
3. TECHNICAL DATA
1
11.
4. SAFETY PRECAUTIONS
2
12.
5. UNIT DESCRIPTION
5
13.
6. INSTALLATION
6
14.
7. MODE OF USE
7
INTRODUCTION
CLEANING
_
__
STERILIZATION
maintenance'
STORING
DISPOSAL
________________
CONDITIONS OF WARRANTY
TROUBLESHOOTING
DECLARATION OF CONFORMITY
10
'12
~ 1 2
~12
14
30
Thdnkyou for the purchdse of this THD EVOLUTION. THD EVOLUTION consists of a Doppler unit and a
light source; it is intended for use in the treatment by qualified medical specialists, to perform
the haemorrhoidai dearterialisation in all o f the four degrees (GoHgher) of the haemorrhoidal
disease.
1. UNPACKING
When opening the carboard box containing the THD EVOLUTION, check that all of the items
below are present and undannaged;
1. User's Manual and certifications
2. Main Unit (cod. 7000.0037)
3. Doppler Probe (cod. 7000,0031 - pic.2)
4. Fibre-optic cable (cod. 7000.0036 - pic.3)
5. Power cable (4800.0010)
6. Foot pedal (cod. 7000.0004 - pic.5)
2.SPECIF1CATI0NS
THD EVOLUTION
Is a medical equipment designed for an innovative and minimally invasive surgical treatment of
the haemorrhoidal disease: theTransanal Haemorrhoidal Dearterialisation (T.H.D.)
The procedure , using the THD EVOLUTION with THD KIT for the Transanal
Haemorrhoidal Dearterialisation is easy and fast to perform and is a minimally invasive
surgical procedure. It is highly effective with wide indications.
Post-operative pain is greatly reduced and possible complications are very rare and not severe.
It can be performed in local anesthesia, in an outpatient clinic or day-surgery and the patient
can return to his normal activity the next day. Recurrence rate is ven/ low, < 7%.
The latter procedure shows several advantages over traditional surgical techniques
since, although it is resolutive, is not marred by the same problems such as: pain, post
operative complications and delayed return to normal life-style.
THD EVOLUTION must be used with dedicated accessories, as the dearterializer THD, fibre-
optic cable and Doppler Probe. The technical characteristics of this unit and of the accessones
guarantee a safe and effective procedure.
DOPPLER PROBE fPic.2}
It consists of an electro-medical instrument complying with the following normatives lEC/EN
60601-1/CEI 62-5: class I, type BF (elechtrical shocking hazard protection) and designed for a
1) For what concerns the disposable dearterializer THD KIT, refer to its own user manual.
6
Информация получена с официального сайта
Федеральной службы по надзору в сфере здравоохранения
www.roszdravnadzor.ru
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