Technical specification

Name THE ELECTRIC SURGERY HIGH FREQUENCY DEVICE «FOTEK»

ONYX
Image

Manufacturer, country FOTEK OOO, Russia

Dimension of unit, mm (l*w*h) 420*420*200
Weight of unit, max, kg 10
Power sources, VAC/Hz 220±10%/50,0±0,5
Nominal output power (max), W 400
The device with accessories provides HF energy for monopolar and bipolar
surgical applications, and tissue-fusion and vessel-sealing applications. The
Intended use device is intended for use in general surgery and such surgical specialties as
urologic, vascular, thoracic, plastic, gynecologic, reconstructive, and
colorectal surgery.
- 2 monopolar outputs (MONO 1, MONO 2);
Output - 2 bipolar outputs (BIPOLAR 1 and BIPOLAR 2);
- “BIPOLAR 2” is compatible with instrument of ligation clamps
(Medtronic-Covidien)
- 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, size,
Accessories configuration
Instruments for vessel sealing, non-stick CLEANTips series
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
Abdominal surgery surgery
Neurosurgery Dermatocosmetology
Cardiac surgery Ophthalmology
Fields of application Urology Traumatology
Gynecology Purulent surgery
 Technical specification

NOMINAL RATING
MODES DESCRIPTION
POWER, W
CUTTING Monopolar cutting without spark formation and without discernible 400
coagulation
BLEND Monopolar cutting with medium spark formation and with a thin 400
coagulated layer
BLEND 1 Monopolar cutting with heavy spark formation and with a frank 150
coagulated layer
TUR Monopolar cutting with coagulation in liquid medium 400
VAP Monopolar vaporization, among other things in liquid medium 400
SOFT Monopolar contact coagulation without spark formation, without 300
carbonization, with fluent thickening of coagulated tissue
SOFT AUTOSTOP Monopolar contact coagulation without spark formation, without
carbonization, with fluent thickening of coagulated tissue, with 300
automatic stopping
FORCE Monopolar forced coagulation with heavy spark formation and with 150
fast formation of coagulated layer
FULGUR Monopolar forced noncontact coagulation with heavy spark
formation and with fast formation of coagulated layer; with 150
possibility of contact cutting with frank coagulation
SPRAY Monopolar noncontact coagulation with heavy spark formation; 70
with fluent thickening of coagulated tissue
ENDO- CUTTING 300
Cutting with coagulation by endoscopic loop instrument; cutting
LOOP
SOFT and coagulation phase rotation 20
ENDO- CUTTING 150
Cutting with coagulation by endoscopic spicular instrument and
KNIFE
SOFT papillotomes; cutting and coagulation phase rotation 20
BI-BLEND Bipolar cutting with coagulation with medium spark formation 75
BI-TUR Bipolar cutting with coagulation by specialized tools for bipolar 325
resectoscopes in liquid medium.
BI-ARTHRO Bipolar cutting with coagulation by specialized tools for 325
arthroscopes in liquid medium.
BI-HYSTERO Bipolar cutting with coagulation by specialized tools for 325
hysteroscopes in liquid medium
BI-COAGDISSECT Bipolar coagulation without spark formation, without 150
carbonization, with possibility of tissue dissections
BI-COAG Bipolar coagulation without spark formation, without tissue 150
carbonization
BI-COAG AUTOSTOP Bipolar coagulation without spark formation, without tissue 150
carbonization; with automatic stopping
BI-COAG AUTO- Bipolar coagulation without spark formation, without tissue 150
STARTSTOP carbonization; with automatic start and automatic stopping
THERMOSEAM Bipolar coagulation high tissue volume by special bipolar clamps 200
without spark formation, with automatic stopping
 Technical specification

Delivery set - Customized set of instruments (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 CE certificate 14963-2019-CE-CZS-NA Rev. 0.0
ISO certificates ISO 13485: 2016
Application component type CF
according to EN 60601-1 defibrillator proof

Russian Registration Certificate № РЗН 2019/9220 dd. 13.11.2019

Advantages
1. Wide range of modes:
- standard mono-, bipolar modes for cutting and coagulation
- AUTO-STOP, AUTO-START-STOP for bipolar modes;
- vessel sealing;
- mono- and bipolar resection in liquid medium;
- special endoscopic modes;

2. Touch screen display

3. Saving of customized configuration of modes and powers
4. Preset recommended modes and adjusted power for specific types of
operations (simplified access to the required program)
5. Neutral (return) electrode control
6. Instruments of any manufacturer could be connected to the unit
7. Instant response to commands
8. Stable performance
9. Audio-visual signals of alarm
10. Compact size