Advanced Bipolar and Ultrasonic Energy Generator

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Description

Performance Parameters

System should have ultrasonic energy as well as Advance RF Energy/Bipolar energy device for cutting and tissue dissection and vessel sealing with a sinusoidal forced impedance output ` Yes
Mode of Provision of both Ultrasonic Energry and Radio Frequency energy Single generator unit Combining both
The switch and control systems provided Single in case of single unit
Type of activation available for operating ultrasonic energy and/or RF energy system as per requirement Both Hand Switch and Foot Switch
Should have the ability to change the power settings selections during the use Available
Type of Display LED
Type of control Touch Screen
Should have stand by mode to ensure safety Yes
System should’have onscreen graphical warning display system for generator overheating, generator software upgrade,hand piece errors and instrument errors Yes
Consumable compatibility with surgery type allowing simultaneous cutting and coagulation of tissues Both open and Laproscopic
Should be compatible with integrated ultrasonic energy instruments which can simultaneously seal and transect vessels , large pedicles and vascular bundles with ultrasonic energy with system feedback Yes
The capacity of ultrasonic energy instruments for working with Up to and including 5mm vessels
Should be compatible with integrated RF/bipolar instruments which can simultaneously seal and transect vessels, large pedicles and vascular bundles with RF energy with system feedback yes
The capacity of RF/Bipolar energy instruments for working with Upto and including 7 MM vessels
The frequency range of instruments ultrasonic device can power in KHZ 40-50
Nummber of power setting levels with power level display for ultrasonic energy instrument 5
Area of lateral thermal spread not to exceed 1 mm
Maximum shaft dimeter of ultrasonic instruments that can be connected 6 mm
Movement of shaft rotation for compatible energy consumables available during surgical procedures in degrees 360 degree
Total articulation ability (Left and Right side of distal portion of shaft) for RF consumables during a laparoscopic surgery for enhanced flexibility and maneuverability 0-109
Classifiction of System to provide adequate protection against electric shock Class 1
Temperature control feedback mechanism available to achieve minimal thermal spread to be specified ATT
instrument recognition system Automatic instrument recognition
Interface modality for allowance of software upgrades USB/Wired Interface
The equipment shall conform to standards such as EN (IEC 606001-1-1-2,EN (IEC 606001-1-1-2) Yes
Should come equipped with system diagnostics and troubleshooting guide to pin point any problem in the system Yes
Well-equipped service centre should present in India with company trained OEM Engineers/Technicians approved by OEM Yes
Generator cart, offered No
Adapters for ultrasonic and rafiofrequency instruments shall be supplied Yes
Separate Hand piece (transducers) with various ultrasonic hand instruments of OEM used as per applicability in Open and laparoscopic surgeries to last for upto 90 cases yes
Comprehensive Warranty in years for complete equipment which shall be from the date of installation, demonstration and training to consignee 1
Product Literature in original along with that of accessories and indigenous components if any to be supplied ( Photocopies/computer generated copies are not acceptable) Yes
” Comprehensive Maintenance Contract (CMC) which includes preventive maintenance including testing & calibration as per technical/ service /operational manual ,abour and spares, after satisfactory completion of Warranty period “ 1
Number of preventive maintenance visits during warranty period (Number per annum) 3
Certificate from OEM/principal regarding approval of service centre maintained by seller to be available Yes
All software updates should be provided free of cost during warranty and CMC if included Yes
“Complete technical training for personnel involved in the use and handling of the equipment on site at the buyer/consignee end immediately after its installation Yes
The unit shall be capable of being stored continuously in ambient temperature of 0 – 50 degree centigrade and humidity of 15-90% Yes
“The unit shall be capable of operating continuously in ambient temperature of 10 – 40deg C and relative humidity of 15-90%” Yes
Power supply 220-240 V AC, 50 Hz single phase

Additional Parameters

Ultrasonic 5 mm Laparoscopic hand activated curved tip coagulating probe supplied with maximum vessel sealing 0f 7mm 1
Ultrasonic 5 mm Laparoscopic hand activated curved tip coagulating probe supplied with maximum vessel sealing 0f 5 mm 1
Ultrasonic hand activated curved tip coagulating probe for open surgery supplied for up to 7mm vessel sealing NA
Ultrasonic hand activated curved tip coagulating probe for open surgery supplied for up to 5 mm vessel sealing 1
Advanced RF/Bipolar 5 mm Laparoscopic hand activated curved tip coagulating probe supplied for up to 7mm vessel sealing 1
Advanced RF/Bipolar 5 mm Laparoscopic hand activated curved tip coagulating probe supplied for up to 5 mm vessel sealing 1
Advanced RF/Bipolar hand activated curved tip coagulating probe for open surgery Suppliedfor 7mm vessel sealing” NA
Advanced RF/Bipolar hand activated curved tip coagulating probe for open surgery Suppliedfor up to 5mm vessel sealing 1
Main cable with power socket of standard indian make to be provided Yes
Suitable UPS with 30 min backup to be supplied with equipment Not supplied

Reports

Certifications for product European CE
Certification no and date to be indicated SZUTEST 2195 MED-381435801/24.12.2014-23.12.2019
Manufacturer should have ISO certification for quality standards Yes
ISO certification date and number (if no ISO certification provided then put NA) 9001:2015 EN ISO 13485:2012 AC:2012/24.04.2017
Complete system and all accessories except items like UPS,Cable, Adapters etc should be from same or OEM Yes

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