Technical Compliance Statement for

ADVANCE ELECTRO QUATERY MACHINE

S.No Description of Store Model Offered :- “Divlabs Trinity qRF” Complia

. Electrosurgical Unit Designed to meet UL, nce/
CSA, Certified to IEC-60601-1-2 and IS- 7583 deviation
1. Unit should have microprocessor controlled tissue feedback Yes ,The unit is microprocessor-controlled Meets
technology with LCD color touch screen. Dual setting specs
option with touch keypad & touch screen. Refer Cat. Page No.________
Col.______ row.____ Para. ___

And Regulated with impedance feedback with

Large Color Intuitive Touch Screen with Dual
Setting option .

Refer Cat. Page No.________

Col.______ row.____ Para. ___
See Figure On page . ___________

2. Unit should have pure sinusoidal output waveform Yes, It has pure sinusoidal output waveform HF Meets
HF power output in cut and bipolar modes. power output in cut and bipolar modes. specs

Refer Cat. Page No.________

See figure :________________

3. Unit should have multi menu facility for easy setting up the Yes, The System has dedicated windows for Meets
generator. Programs for easy setting of generators. specs

Refer Cat. Page No.________

See figure :________________

4. It should adjust power level automatically depending on Yes, The system tissue impedance feedback Meets
tissue type. technology which adjust power automatically specs
depending on tissue.

Refer Cat. Page No.________

Col.______ row.____ Para. ___

5. Unit should have Combo Generator Technology Yes, The system has on screen instruction Meets
manual, Dedicated programs for different cases specs
having conventional ESU, Saline Plasma Bipolar
as well as PoP Up Alarms for different
Module and Vessel Sealing System. conditions.

Refer Page No.________

Col.______ row.______ Para. ____
See Figure On Page.____________

6. Unit should suitable to do TURP in saline with Bipolar Yes, The System is suitable to do TURP in saline Meets
working element. with Bipolar working element. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

7. Unit should have to be supplied with reusable Bipolar Yes, Unit will be supplied with reusable Bipolar Meets
Cutting loops. Cutting loops. specs
.
Vide Page No. ____________

8. Unit should be useful for conventional underwater Yes, The system is useful for conventional Meets
procedures. underwater procedures. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

9. Unit should give an alarm in case of Saline Plasma Bipolar Yes, The system has on screen pop for different Meets
cable is broken. events. specs
Such as Seal Complete, Regrasp, Instrument
Check, Patient Plate Etc.
 Refer Cat. Page No.________
Col.______ row.______ Para. ______
See Figure On Page. ______________

10. Unit should have dedicated Vessel sealer output with FIVE Yes, The System has dedicated Vessel sealer Meets
different sealing level programs. output with Multiple Level Seling Outputs. specs
Refer Cat. Page No.________
Col.______ row.______ Para. __

Bipolar COAG- 250 W

Refer Cat. Page No.________

Col.______ row.______ Para. __

11. Two sealing output for independent activation of TWO Yes,The system has Two sealing output for Meets
vessel sealing accessories. independent activation of TWO vessel sealing specs
accessories.

Refer Cat. Page No.________

See Figure On Page .__________

12. Unit should have the capacity to seal the tissue vessel up to Yes, The system has the capacity to seal the Meets
7mm in diameter. tissue vessel up to 7mm in diameter. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

13. Seal should withstand to THREE times systolic pressure. Yes, Seal can withstand to 3 times systolic Meets
pressure. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

14. Sealing output should be in pulse mode sinusoidal current to Yes, The has Seal Mode in Pulse sinusoidal Meets
control thermal spreading less than 3mm current to control thermal spreading less than specs
3mm

Refer Cat. Page No.________

Col.______ row.______ Para. __

15. Unit should give an alarm after completion of sealing cycle Yes, The system has on screen Pop Up for seal Meets
& auto stop power Completion as well as Regrasp for Incomplete specs
Seal.

Refer Cat. Page No.________

Col.______ row.______ Para. __
See Figure On Page. __________

16. System should give an alarm if the tissue is not held Yes, The system has on screen Pop Up for Meets
properly in the sealer mode. Regrasp pop up alarm if the tissue is not held specs
properly in the sealer mode.

Refer Cat. Page No.________

Col.______ row.______ Para. _____

17. Unit should accept any make vessel sealing instruments. Yes, Unit will accept any make vessel sealing Meets
instruments. specs

Vide Page No.____________

18. Unit should have independent power display & activation for Yes, The system has dedicated windows for Meets
Bipolar & Monopolar when operate in vessel Sealing Mode. Monopolar, Bipolar & Vessel Sealer and each specs
window can be activated independently.

Refer Cat. Page No.________

 See Figure ________________

19. LCD display should indicate true power in Monopolar & Yes, The system has dedicated windows for Meets
Bipolar mode and level in seal mode. Monopolar, Bipolar & Vessel Sealer and each specs
window display the true power level
independently.

Refer Cat. Page No.________

See Figure ________________

20. It should have vessel sealing mode with vessel sealing , Yes, It has dedicated windows for vessel sealing Meets
Bipolar Cut & Bipolar Coagulation output available by choice mode with vessel sealing , Bipolar Cut & Bipolar specs
of Footswitch operation. Coagulation output which can be activated by
different Footswitch .

Refer Cat. Page No.________

See Figure On Page.________

21. Unit should supplied with 5mm reusable instrument with Yes, Unit will be supplied with 5mm reusable Meets
changeable blade. instrument with changeable blade. specs

Vide Page No.____________

22. It should complete self-testing during power on. Yes, It has self-check mode during power on. Meets
specs
Refer Cat. Page No.________
Col.______ row.______ Para. __

23. Unit should have error code function for fault conditions. Yes, Unit has 25 Error Message Display Facility. Meets
specs
Refer Cat. Page No.________
Col.______ row.______ Para. __

24. Unit should have tissue feedback, pulsed interval controlled Yes, Unit has Tissue Impedance feedback Meets
PULSE CUT function. Technology with Pulse cut Mode ( Endo Cut ) specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

25. It should accept dual area and single area patient return Yes, It accepts dual area and single area patient Meets
electrode. return electrode. specs

Vide Page No. __________________

26. It should accept Disposable and as well as Reusable Patient Yes, It accepts Disposable and as well as Meets
Plate. Reusable Patient Plate. specs

Vide Page No. __________________

27. It should have RANDOMIZED spray Coagulation for larger Yes, It has RANDOMIZED spray Coagulation Meets
area coverage. mode for larger area coverage. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

28. It should be upgradeable for Argon delivery Module. Yes, It is upgradeable to Argon delivery Module. Meets
specs
Refer Cat. Page No.________
Col.______ row.______ Para. __

29. Unit should have Dual Monopolar output with both the Yes, Dual Monopolar output with both the Meets
channel can used at different settings independently. channel can used at different settings specs
independently.

Refer Cat. Page No.________

See Figure.________________
30. Simultaneous TWO Monopolar Coag output on TWO channel Yes, Simultaneous TWO Monopolar Coag Meets
at same settings for CABG output on TWO channel at same settings specs
for CABG.

Refer Cat. Page No.________

Col.______ row.______ Para. __

31. It should have at least 100 user settable programs with Yes, It has 10 User Set of programs and 90 on Meets
surgeons & surgery name. Site User Settable Programs with surgeons & specs
surgery name.

Refer Cat. Page No.________

Col.______ row.______ Para. __

32. Power should change 1 to 40 by step of 1W, 40 to 100 Yes, Power should change 1 to 40 by step of 1W, Meets
40 to 100 specs
by step of 5W & 100 to max power by step of 10W
for fast setting of generator. by step of 5W & 100 to max power by step of 10W
for fast setting of generator.

Vide Page No.________

33. It should Bipolar Coagulation in Micro and Macro
power Range Coagulation present with micro power
range: 0.1 to 9.9watts, adjustable in 0.1 watt steps and
macro power range: 1 to 50W adjustable in steps of 1watt.
Yes, It should Bipolar Coagulation in Micro Meets
and Macro power Range Coagulation present specs
with micro power range: 0.1 to 9.9watts,
adjustable in 0.1 watt steps and macro
power range: 1 to 50W adjustable in steps of
1watt.

Vide Page No.________

34. It should have Alarm facility after completion of Bipolar Yes, it has Audio Visual Pop Alarms For Meets
coagulation Bipolar Coagulation . specs

Refer Cat. Page No.________

See Figure On page._______

35. Unit should have Time out function for automatic stop the Yes, Unit should have Time out function Meets
specs
HF output if prolong unintended activation.(Optional) for automatic stop the HF output if prolong
unintended activation.

Vide Page.__________________

36. Unit should operate from 180 V to 260V without using Yes, Unit can operate from 180 V – 260 V AC Meets
external stabilizer. without using external stabilizer . specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

37. It should have independent foot switch for Monopolar and Yes, It has independent foot switch for Meets
Bipolar functions. Monopolar and Bipolar functions. specs

Refer Cat. Page No.________

Col.______ row.______ Para. __

38. It should have separate and isolated sockets for Monopolar Yes, It has separate and isolated sockets for Meets
and Bipolar sealer. Monopolar and Bipolar sealer. specs

Refer Cat. Page No.________

See figure on page._________

39. It should follow IEC-60601-1-1, IEC 60601-2-2 safety and Yes, It should follow IEC-60601-1-1, IEC 60601- Meets
design standards Certification ISO 9001:2008 & ISO 2-2 safety and design standards specs
13485:2003 certified Company.
 Vide Page No.____________

ISO 13485:2016 certified Company.

Vide Page No.____________

40. It should have CE certified approved. Yes, The System is European CE Certified. Meets
specs
Vide Page No.____________

41. Unit with following Saline Plasma Bipolar technical Yes, Unit has following Saline Plasma Bipolar Meets
Specification. technical Specification. specs
A - Saline Plasma Bipolar Cut: TWO mode: Saline Low A - Saline Plasma Bipolar Cut: 300 W At 50
& Saline Standard: 300 W at 100 ohms. Ohm
B - Saline Plasma Bipolar Coag: TWO mode: Saline
Soft & Saline Force: 150 W at 100 ohms. Refer Cat. Page No.________
Col.______ row.______ Para. __

B - Saline Plasma Bipolar Coag: 250 W At 50

Ohm

Refer Cat. Page No.________

Col.______ row.______ Para. __

42. Unit with vessel Sealer with TWO Mode: Yes, Unit with vessel Sealer with Four Mode: Meets
Micro Seal & Standard Seal: Low ( Seal ) – 95 W specs
Level1 (80W) to Level 5 (150W) Medium ( Fusion ) – 125 W
High ( RF ) – 300W
RF Scalpel – 300 W

Refer Cat. Page No.________

Col.______ row.______ Para. __

43. Unit with following ESU (Diathermy) technical Yes, Unit with following ESU (Diathermy) Meets
specifications technical specifications specs
A) 7 Cut Modes:
Low Cut: 400W at 300ohms, A) 4 Cut Modes
Pure Cut: 400W at 300ohms
Pure Cut – 400W at 300 Ohm
Blend 1 Cut: 250W at 300ohms, Blend 1 – 200W at 500 Ohm
Blend Cut : 200W at 300ohms Blend 2 – 200W at 500 Ohm
Endo 1: 400W at ohms, Endo – 250W at 200 Ohm
 Endo 2: 400 W at 300ohms,
Hydro: 400W at 300ohms Refer Cat. Page No.________
Col.______ row.______ Para. __

B) 4 Coag Modes

Soft – 150W at 150 Ohm

B) 7 Coag Modes: Dessi – 150W at 150 Ohm
Soft: 300W at 300ohms, Desiccate: 200W at 500ohms, Swift: Fulgurate – 150W at 200 Ohm
120W at 500ohms. Fulgurate: 120W at 500ohms, Spray Coag: Spray – 150W at 200 Ohm
120W at 500ohms,
Refer Cat. Page No.________
Hi-Spray Coag: 120W at 500ohms, Hydro: 120W at Col.______ row.______ Para. __
500ohms.
C) Bipolar Cut & Coag Modes
C) 2 Bipolar Cut Modes:
Macro Bip: 120W at 100ohms, Bipolar Cut: 120W at Micro/Coag – 250W at 100 Ohm
100ohms. Macro/Cut – 250W at 100 Ohm
Plams Bipolar – 250W at 100 Ohm
Auto – 250W at 100 Ohm

D) 3 Bipolar Coag Modes Refer Cat. Page No.________

Macro Bip: 120W at 100ohms, Standard: 120W at 100ohms, Col.______ row.______ Para. __
Force: 120 W at 100ohms
D) Audio Visual Pop Alarms For
Coagulation
E) Bipolar Coag Alarm: Gives Audio indication when tissue
Refer Cat. Page No.________
gets coagulated reduces charring, tissue over coagulation &
See Figure On Page._________
tissue sticking to forceps.

F) Bipolar Cut: Macro mode can be effectively used for

bipolar cutting with hooks & other cutting devices in
laproscopic surgery

44. It should be supplied with All following accessories, should
be reusable and autoclavable:-
 Reusable patient Return electrode- 1 Nos
 Reusable cable for return electrode- 2 Nos
 Reusable Hand Switching pencil - 1 Nos
 Reusable Foot Switching Pencil- 1 Nos
 Monopolar / Two Paddle Foot Switch- 1 Nos
 Sealer / Bipolar Single Paddle Foot Switch- 1 Nos
 Universal Adaptor- 1 Nos
 Reusable Bipolar Forceps- 1 Nos
 Reusable Cable for Bipolar Forceps - 1Nos
 Reusable Steel sealing clamp with ratchet
&connecting
 cable - 1 Nos
 Reusable coated sealing clamp with ratchet &
connecting cable - 1 Nos
 Reusable 5 mm Lapro sealing Handle with ratchet
Yes, It Will be supplied with All following Meets
accessories, should be reusable and autoclavable: specs
 Reusable patient Return electrode- 1
Nos
 Reusable cable for return electrode- 2
Nos
 Reusable Hand Switching pencil - 1 Nos
 Reusable Foot Switching Pencil- 1 Nos
 Monopolar / Two Paddle Foot Switch- 1
Nos
 Sealer / Bipolar Single Paddle Foot
Switch- 1 Nos
 Universal Adaptor- 1 Nos
 Reusable Bipolar Forceps- 1 Nos
 Reusable Cable for Bipolar Forceps -
1Nos
 Reusable Steel sealing clamp with
 - 1Nos
 Reusable and autoclavable Lapro insert , 32cm,
5mm, straight jaw - 1 Nos
 Reusable and autoclavable open insert , 18 cm,
Angled jaw-1 Nos
 Reusable 10 mm Lapro Sealing Handle with
ratchet &
 cutting facility-1 Nos
 Reusable and autoclavable Lapro insert, 32 cm,
10mm, Straight jaw with cutter- 1 Nos
 Reusable and autoclavable Lapro insert, 18 cm,
10mm, Straight jaw with cutter- 1 Nos
 Cutting Blade for 10mm instrument- 10 Nos
 Lure Lock adaptor with RF Pole- 1 Nos
 Saline Bipolar Cutting Loops - 2 Nos
 Saline Vaporization loops - 2 Nos
 Trolley - 1 Nos
Vide Page No. _______
Thanks & Regards
For Divlabs Healthcare Pvt. Ltd.
Manoj Singh-Director
ratchet &connecting
 cable - 1 Nos
 Reusable coated sealing clamp with
ratchet & connecting cable - 1 Nos
 Reusable 5 mm Lapro sealing Handle
with ratchet - 1Nos
 Reusable and autoclavable Lapro insert ,
32cm, 5mm, straight jaw - 1 Nos
 Reusable and autoclavable open
insert , 18 cm, Angled jaw-1 Nos
 Reusable 10 mm Lapro Sealing
Handle with ratchet &
 cutting facility-1 Nos
 Reusable and autoclavable Lapro
insert, 32 cm, 10mm, Straight jaw
with cutter- 1 Nos
 Reusable and autoclavable Lapro
insert, 18 cm, 10mm, Straight jaw
with cutter- 1 Nos
 Cutting Blade for 10mm instrument-
10 Nos
 Lure Lock adaptor with RF Pole- 1
Nos
 Saline Bipolar Cutting Loops - 2 Nos
 Saline Vaporization loops - 2 Nos
 Trolley - 1 Nos