Technical specification

Name THE ELECTRIC SURGERY HIGH FREQUENCY DEVICE

«FOTEK», Е352М
Image

Manufacturer, country FOTEK OOO, Russia

Dimension of unit, mm (l*w*h) 485*446*180

Weight of unit, max, kg 7
Power sources, V/Hz 220±22/50±0,5
Nominal output power (max), W 400
For cutting, monopolar and bipolar coagulation of biological
Intended use
tissue using high-frequency electric current.
- 1 Bipolar output
Output
- 1 Monopolar output
- By footswitch
Activation - By electrodes’ handle with pushbuttons
- AUTOSTOP, AUTO-STARTSTOP for bipolar modes
Reusable (autoclavable) and disposable
Wide range of mono-/bipolar instruments of different shapes,
Accessories size, configuration
Availability of accessories’ sets for: general surgery, flexible
endoscopy, urology, gynecology, neurosurgery, cosmetology etc.
Classification according to EC Directive IIb
93/42/EEC
General surgery Endoscopy
Oncology Laparoscopy
ENT Thoracic surgery
Plastic surgery Oral and maxillofacial surgery
Fields of application Abdominal surgery Dermatocosmetology
Neurosurgery Ophthalmology
Cardiac surgery Traumatology
Urology Purulent surgery
Gynecology
 Technical specification

MODES NOMINAL RATING

DESCRIPTION
POWER, W
CUT Monopolar cutting without spark formation and 400
without discernible coagulation
BLEND Monopolar cutting with medium spark formation and 400
with a thin coagulated layer
BLEND 1 Monopolar cutting with heavy spark formation and 150
with a frank coagulated layer.
TUR Monopolar cutting with coagulation in liquid 400
medium.
VAP Monopolar vaporization, among other things in liquid 400
medium.
SOFT Monopolar contact coagulation without spark
formation, without carbonization, with fluent 300
thickening of coagulated tissue.
FORCE Monopolar forced coagulation with heavy spark
formation and with fast formation of coagulated 150
layer.
FULGUR Monopolar forced noncontact coagulation with heavy
spark formation and with fast formation of 150
coagulated layer; with possibility of contact cutting
with frank coagulation.
SPRAY Monopolar noncontact coagulation with heavy spark 70
formation; with fluent thickening of coagulated tissue
BI-BLEND Bipolar cutting with coagulation with medium spark 150
formation
BI-COAG Bipolar coagulation without spark formation, without 150
tissue carbonization
BI-COAG AUTOSTOP Bipolar coagulation without spark formation, without 150
tissue carbonization; with automatic stopping
BI-COAG AUTO- Bipolar coagulation without spark formation, without
tissue carbonization; with automatic start and 150
STARTSTOP
automatic stopping
Delivery set - Customized set of accessories (according to the field of
application)
- Possible to equip with the transportation trolley made by
FOTEK
Warranty 6 (six) months for storage
12 (twelve) months for operation
Certificates 14963-2019-CE-CZS-NA Rev.
CE certificate
0.0
ISO certificates ISO 13485: 2016
Application component type CF
according to EN 60601-1 defibrillator proof

Russian Registration
ФСР 2010/07372 dd.31.12.2020
Certificate

Advantages
1. High-power device with set of modes includes:
- mono- and bipolar resection in liquid medium
- AUTO-STOP, AUTO-START-STOP for bipolar modes
2. Can be applied in any sphere of surgery with a specially
selected instruments
3. Instruments of any manufacturer could be connected to the unit
4. Neutral (return) electrode control
5. Stable performance
6. Audio signals of alarm