pre-bid minutes e-tender no. 183 to e-191 ( meeting...

Sr.

No

Tender

No.

Name of Bidder Equipment Name Tender Specification Query raised by Company Remark

Light Source : High intensity with Halogen light source

of 12Volts, 100W power with back lamp in fast action

lamp changer with fiberoptic transmission cable.

JUSTIFICATION:- Please incorporate "Optional: 2 LED Illumination with average

life is of 60000 hours"

Reason for the amendement:- LED is latest technology with minimum maintenance

cost and longer life.

Accepted

Binocular Tube : Straight tube with focal length

170mm, 0°-180° Tiltable tube with focal length 170 mm

or 200mm with 10x or 12.5x widefield eyepieces.

JUSTIFICATION:-Titable tube is not normally used in ENT surgeries as per our

experience and hence can be taken as optional to reduce cost of the basic equipment.

Accepted

Field of view : 60mm to 10mm. JUSTIFICATION:- The Surgeons will have better field of view at the same cost. Not Accepted

2 3.1 Light Source : High intensity with Halogen light

source of 12Volts,100W power with back lamp in fast

action lamp changer with fiberoptic transmission cable.

LED Light Source (1.LED Light source is much brighter than the Halogen Light

Source. 2. LED Light Source consumes very less power and produces very less heat as

compared to the Halogen Light Source which consumes more power and produces

much more heat. 3. LED is having a warranty of 25000hours where as the Halogen

Lamp has a warranty of only 500 hours. 4. LED Light Source runs on Universal Input

Voltage range of 120v to 260v where as Halogen Light Source runs on a voltage input

of 220v to 260v. Thus LED Light Source can withstand extreme voltage fluctuation

where as Halogen Lamp will fuse the moment voltage increases beyond 240v. )

Accepted

11. Should be CE & US FDA approved Either CE & USA FDA Approved. (The vary basic purpose of applying for the CE

Certiñcation and the US FDA is thc same i.e. the "PRODUCT SAFETY". None of the

certification classifìes thc quality of the product. The procedure to test the Product

Safety is almost identical in both CE & US FDA. Any one of the certification either

CE & US FDA will ensure the same extent of product safety: Going ahead with both

the approvals will unnecessary increase the

product cost only Where the purpose of ensuring the product safety is ensured by

taking

any one of the approvals.)

Should be CE or US FDA

approved.

3 E-183 M/s. Carl Zeiss

India.ENT Operating

Microscope

11. Should be CE & US FDA approved Should be European CE or US FDA approved. And Microscope should have RED

DOT design award ( Either of the one approval may be considered, as standard.)


approved.

4 E-183 M/s. Toshbro

Medicals

ENT Operating

Microscope

11. Should be CE & US FDA approved CE approved. No FDA approval. Should be CE or US FDA

approved.

5 E-183 M/s.Allied

Meditek/ M/s. Carl

Zeiss India.

ENT Operating

Microscope

4.2 Binocular Tube : Straight tube with focal length



Clarify which tubes you require. It should be either straight or Tiltable. Generally for

ENT Operating Microscope the Straight tubes are used and the Tiltable tubes are used

for the Neuro Microscope.

Accepted




Straight tube with focal length; 0 deg. - 160deg. Tiltable with 10x or 12.5x widefield

eyepiece.

Accepted for straight tube

with focal length 170mm,

0deg- 180deg.

4.3 Eye Piece : 10X - 12.5X wide field. Eye Piece : 10X - 12.5X. Not Accepted

4.4 Field of view : 60mm to 10mm. Field of view : 42mm to 11mm. Not Accepted

4.5 Fine Focus : Manual via focusing knob Fine Focus : Motorized via Footswitch Not Accepted

4.6 Magnification :Manual 5-step apochromatic

Magnification changer, Magnification factor

0.4/0.6/1/1.6/2.5

5x…20x (5 steps) Manual 5-step apochromatic

Magnification changer

4.7 Co-observation / Demonstration : Monocular /

Binocular.(can be optional.)

Binocular only. Accepted

Pre-Bid Minutes E-Tender No. 183 To E-191 ( Meeting Held on 30.8.2013)

1 E-183 M/s. DHR Holding

India Pvt. Ltd.

(Leica)

ENT Operation

Microscope

M/s. Toshbro

Medicals

ENT Operating

Microscope

E-183

E-183 M/s.Allied Meditek

ENT Operating

Microscope

6

Sr.

No

Tender

No.


4. Optics Should be fully Apochromatic. (This details are required to specifiy the optics

requirement- Due to Apochromatic coatings, more light is transferred to the viewers

eye, ensuring sighnificant increase in image resolution, contrast and depth

perception.)

Accepted




Binocular Tube : Strainght tube with focal length 170 mm OR o-180 Tiltable tube

with focal length 170 mm or 200 mm with 10x or 12.5 x widefield eyepieces (The

specification in the tender is confusing)

Accepted for straight tube

with focal length 170mm,

0deg- 180deg.

11 Shound be CE & FDA approved Should be European CE or US FDA approved. And Microscope should have RED

DOT design award ( Either of the one approval may be considered, as standard.)


approved.

8 E-183 M/s. Toshbro

MedicalsENT Operating

Microscope

5.1 Mobility : Should be movable on 4 or 5 castors on a

sturdy circular or 'H' shaped base.

4 castors on Z shaped base Not Accepted

Stand should have ''Red Dot

Design''award having 4

lockable castors on 'H'shape

design.

9 E-183 M/s. Gunjan

Surgical

ENT Operating

Microscope

4.7 Co-observation / Demonstration : Monocular /

Binocular.(can be optional.)

Please clarify which co-observation tube required Monocular or Binocular. Binocular

10 E-183 M/s. Midas

Associates ENT Operating

Microscope

Light Source : High intensity with Halogen light source

of 12Volts, 100W power with back lamp in fast action

lamp changer with fiberoptic transmission cable.

Kindly include LED light source, since LED Light doesn’t require changing of Lamp

and hence no need of backup lamp.

Accepted

11

E-183

ENT Micromotor

Drill System with

Handpiece & Burrrs

Should be CE & US FDA approved Should be CE or US FDA

approved.

ENT Micro drill system

1. High speed not less than 80000 rpm

suggested top speed of 50000rpm, since in otology & ENT surgeries speed over

35000-40000rpm is not necessary, unless in case of neuro, spine or skull base surgery.

This will help reduce cost of equipment & its wear n tear.

Accepted

Micro Motor Handpieces:

1. Rated for minimum 80000rpm

2. Ball bearing type as to generate minimum heat &

vibration.

1. Changed to 50000rpm for above sted reason.

2. This more of an obsolete technology, most of the major companies now a days offer

Brushless DC technology. Advantage of this is long life span, low maintenance cost,

less frequent break downs, ensuring better up-time & hassle free usage.

1. Accepted

2. Accepted

Burs

3. Oil spray for hand pieces with Nozzel

4. Should be CE approved

3. In case of brushless DC Motors you do not need this, thereby decresing the

consumable cost.

4. Recommended for US FDA approval too, since on date many chinese/Korean

companies can offer CE approval with below par products. Thereby endangering both

quality & patient health.

3. Accepted

4. Should be CE or US FDA

approved.

7. Lateral Tilt Right/Left : +/- 25 Deg. Lateral Tilt Right/Left : +/- 21 Deg Lateral Tilt Right/Left : +/-

21 Deg (accepted)

8. Trendlensberg: +/- 20 Deg. Trenlenberg : +/- 26 Deg suitable for MIS Procedure Trenlenberg : +/- 26 Deg.

(accepted)

10. Leg Section- up down : Fixed Leg Section should be split type : Up +15 deg / Down -91 deg Leg Section should be split

type : Up +15 deg / Down -

91 deg.(accepted)

13. Four double swivel castors for easy movement of

the operation table

Two swivel castors for easy movement of the operation table Two swivel castors for easy

movement of the operation

table.(accepted)

M/s. BET Medical

M/s. Carl Zeiss

India.

M/s. Midas

Associates

ENT Operating

Microscope

E-183

E-183

12

ENT Micromotor

Drill System with

Handpiece & Burrrs

7

13 E-183 C-Arm compatible

Operation Table

with Fracture

attachment

Sr.

No

Tender

No.


14. Should be able to take a patient weight 250 to

270Kg.

Should be able to take a patient weight 150kg or above Minimum 250kg must.

15. Possibility of Beach chair position of 30deg. For

shoulder surgery

Beach chair position of 80deg. Should be possible For shoulder surgery Beach chair position of

80deg. Should be possible

For shoulder surgery.

(accepted)

For table to be compatible for fluoroscopy procedures with C-arm, Table top sliding at

least 300mm should be achievable. Slide should be both Head side and Leg Side to

achieve 100% fluoroscopy coverage

14 E-183 M/s. Smit Medimed

Pvt. Ltd.

C-Arm compatible

Operation Table

with Fracture

attachment

24 Should be CE & US FDA approved Should be CE or US FDA Approved. Should be CE or US FDA

Approved.

2.It should be Electrohydraulic (3-4) Chambers No chambers are use for lifting. It should have Maintenance free lifting system:

State-of-the- art lifting system comprising of YST310 Grade SHS Tube and and hi-

precision bearings with large contact surface which ensures the highest rigidity for

heavy loads ensures the highest rigidity for heavy loads and reduces the friction force

thus making the table up-down movements extra smooth and enable it to carry more

eccentric load without overloading the control system. Furthermore, There is virtually

no backlash(sideways play) which is a common problem with lifting system

comprising of cylinders or chambers with key-way. All bearings are permanently

grease lubricated thus making this lifting system almost maintenance free for lifetime.

It should have Maintenance

free lifting system. It should

be electric motorized oil

pump hydraulic with manual

foot pump i-e

electricohydraulic.(accepted)

4. Tabletop: 500mm x 1900mm Radiolucent, Table top

with horizontal excursion 25cm

Horizontal excursion 25 cm is not clear.

Tabletop: 500mm x 1900mm

Horizontal excursion is not

required.

6. Back Section: (-) 60 Deg. To (+) 90 Deg.

Whereas normally it is 30 degree down and 90 degree up

30 degree down and 90

degree up

11. System should have hand remote control system for

patient positioning & table Up- down adjustment and

another mounted on body of table

If the remote is mounted on body of the table, it is great disadvantaage. There is every

chance of water splitting on remote while cleaning the OT with water, which is usual

practice.

System should have wired

remote control system for

patient positioning & table

Up- down adjustment and

another panel control

mounted on body of table for

same purpose.

14. Should be able to take a patient weight 250 to

270Kg.

Worldwide load capacity is maximum 150kg if the load capacity is 250Kg-270Kg, it

is for bariatric surgery.

Minimum 250kg must

24. Should be CE & US FDA approved It should be CE or US FDA so more number of bidders can be participate. It should be CE or US FDA

C-Arm compatible Operation Table with Radio luscent

top

JUSTIFICATION:- "Any material of radio-luscent nature will do?

Usually acrylic table top is supplied as low cost substitute for radio-lucent purpose.

This material on use becomes opaque & low permeability; later gives hazy image.

Kindly confirm which material is your actual requirment & to be offered.

Carbon fiber prefered.

It should be Electrohydraulic (3-4) Chambers JUSTIFICATION:- Kindly clarify what mechanism shall be offered for the table to

function as Electro-hydraulic out of three types:-

a) Electric Motorised Actuator based system or

b) Electric Motorised Oil pump Hydraulic system or

c) Electric Motorised Oil Pump Hydraulic with Manual foot pump i.e Electrical and

Manual hydraulic dual function for emergency= Electro hydraulic.

Which type is your requirement & to be offered.

It should have Maintenance

free lifting system. It should

be electric motorized oil

pump hydraulic with manual

foot pump i-e

electricohydraulic.

15

16

E-183

M/s. Unimmedss

M/s. BET Medical

M/s. Gunjan

Surgical

C-Arm compatible

Operation Table

with Fracture

attachment

C-Arm compatible

Operation Table

with Fracture

attachment

E-183

13 E-183 C-Arm compatible

Operation Table

with Fracture

attachment

Sr.

No

Tender

No.


(3-4) chambers JUSTIFICATION:- "3-4 chambers" are for Mechanical hydraulic design. Last 15

years it is single encased system for any electric or electro hydraulic table. Kindly

amend.

Addressed in above points.

3. Table with C Arm Fluoroscopy Compatibility JUSTIFICATION:- For optimum result, the table top is essential & ideal to be made

of highest X-Ray permeable quality material i.e. CARBON FIBRE which is actually

radio-lucent acclaimed Nationally & Internationally.

If this is not specified, then Acrylic top will be offered as mentioned in # 1 above.

Kindly clarify.

Carbon fiber prefered.

4.Four double swivel castors for easy movement of the

operation table

JUSTIFICATION:- The casters shall be Anti-static or ordinary quality? Kindly

confirm.

Anti static prefered.

5. Should be CE & US FDA approved JUSTIFICATION:- US FDA approval for OT Tables under Class-I category is not

statutory in INDIA. CE mark is enough. This requires to be amended else NO Indian

manufacture will quality & could be single tender.

In the past for all tables purchased by DHS are with CE mark only. So, kindly amend

as "CE" or US FDA.

It should be CE or US FDA

17 E-183 M/s. Smit Medimed

Pvt. Ltd.

C-Arm Compatible

Operation Table

with Urology

attachment

26 Should be CE & US FDA approved Should be CE or US FDA Approved. Should be CE or US FDA

Approved.

1. Eccentric Pillars JUSTIFICATION:- No details of Urology attachment exist in the tender

specification. Kindly furnish the details of Urology Attachment specificatio & qty

reqd on each.

No Change.

1a. Eccentric Pillars JUSTIFICATION:- "Eccentric Pillars" generally means Pillar at Head end under back

section. If so, then Back section Up/down as per Sr.23 is mentioned adjustable; HOW

would it be technically possible when the Back section is fixed with pillar? Hence,

Specification Sr.No. 23 is required to be deleted? Kindly clarify

No Change.

2. Detachable, head, leg & pelvic section JUSTIFICATION:- "Pelvic Section" is never detachable & is reqd. to be clarified.

Under Sr. 10 only Head & leg section is demanded as Interchangeable i.e. detachable.

So, other way Pelvic section detachable is not demanded. Hence, Kindly clarify.

Detachable, head, leg

section.

13.It should have SFC paddings with multi-layer

construction.

JUSTIFICATION:- The term "SFC" padding with multi-layer construction. Kindly

remove the Brand RESTRICTION to Generic name "Latex Free quality multi-layer

construction mattress"

It should have latex free

multilayer construction

mattress.

4. Should be CE & US FDA approved JUSTIFICATION:- US FDA approval for OT Tables under Class-I category is not

statutory in INDIA. CE mark is enough. This requires to be amended else NO Indian

manufacture will quality & could be single tender.

In the past for all tables purchased by DHS are with CE mark only. So, kindly amend

as "CE" or US FDA.


Approved.

3.Detachable, head, leg & pelvic section Pelvic section is fixed. It can not have detachable. Please clarify. Detachable, head, leg section.

5.Fine sectional radio – translucent It should be five sectional ratio- translucent Five sectional radio –

translucent.

13.It should have SFC paddings with multi-layer

construction.

Please clarify the mattress depth. Generally it is 50mm & it shold be foam mattress

which is easily washable.

It should have latex free

multilayer construction

mattress.

25.Load Capacity: 250Kg to 270Kg. Worldwide load capacity is maximum 150kg if the load capacity is 250Kg-270Kg, it

is for bariatric surgery.

No Change.

16

E-183

E-18318

M/s. Unimmedss

19

C-Arm Compatible

Operation Table

with Urology

Attachment

Gunjan Surgical

M/s. Unimmedss C-Arm Compatible

Operation Table

with Urology

Attachment

C-Arm compatible

Operation Table

with Fracture

attachment

E-183

Sr.

No

Tender

No.


26. Should be CE & US FDA approved It should be CE or US FDA so more number of bidder can be participate. Should be CE or US FDA

Approved.

Houmium: Yag Laser with minimum power setting

100W

Holmium YAG Laser with minimum power setting should be 50 to 100W Want minimum 100W.

Laser Power: 100W Laser Power should be 50 to 100W instead of 100W. Want minimum 100W.

JUSTIFICATION- There are different size of foot prints (0.22NA to 0.35NA) of

lasers in the market. Our laser is 50 watts but it out performs a 100 watts laser. It can

do everything which a 100 watts laser does, with the same efficiency. In fact it can do

certain additional procedures which are not possible by other 100 watts lasers. (Like

LITT). This has been possible dure to fourth generation advancements, wherein we

can use a narrow foot print of laser & fibre wiht 0.22NA (numeric aperture), as

against 0.35 NA which is used by the 100 watts laser. It actually means that our laser

beam acts as a sharper knife, thus requiring lesser wattage (force) to give the same

cutting efficiency. Actually theuse of laser energy for achieving same cutting

efficeincy provides gentle treatment to the patient leading to lesser desiccation and

faster recover. So our 50W is parallel to 100W. Machine can do prostate

Enucleation, Prostate Vaporescetion, Prostate LITt, Uteric Stones, Renal Stones,

Stricture Tumor, Endopyelotomy, Bladder Neck Incision etc.

Fibre sizes should be 220, 365,600 microns Fibre sizes should be 230, 365,600 microns 200/220/230,365, 550/600

microns.

JUSTIFICATION- Sizes indicate the core diameter of the fibers and core diameter are

direclty proportionally to the delivery of energy.

Outer continuous irrigation sheath "e-line"26.5fr. Outer continuous irrigation sheath "e-line"26fr. Outer continuous irrigation

sheath "e-line"26 fr.

The equipment should have single laser head The single laser head is not sufficient for output power of 100W. The minimum laser

heads should be two.

The minimum laser heads

should be two.

The equipment should have single flash lamp For two laser heads, there should be two flash lamps. There should be two flash

lamps.

The equipment should have single Set of mirrors For each set of laser head and flash lamp, there should be 2 mirrors each ( one full

reflection & another partial reflection.

there should be 2 mirrors

each ( one full reflection &

another partial reflection.)

Point no 14 a says 220 um fiber. The 220 um fiber is very fragile. And currentl 273 um fibre is in use worldwide. Should provide Fibre

200/220/230/,365,550/600.

Point no. 10- Faclity of Holvop Holvop means Holmium Laser vaporisation of Prostate. But Vaporisation proedure is

not possible with Homium Laser as it is a pulsed laser.

Accepted

Point no. 11 - Equipment should be Air cooled The new technology of refrigerant cooling is used. Should provide proper

cooling system.

POINT No.1, Holmium YAG Laser with minimum

power setting should be 50 to 100W instead of 100W

Want minimum 100W.

19

20 E-184 M/s. Jay Pharma

Laboratories

Holmium YAG

Laser

C-Arm Compatible

Operation Table

with Urology

Attachment

Gunjan Surgical

M/s. Healthware

Pvt. Ltd.


lasers in the market.Our laser is 50 watts but it out performs a 100 watts laser. It can



LITT). This has been possible due to fourth generation advancements, wherein we can

use a narrow foot print of laser & fibre with 0.22 NA ( numeric aperture), as against

0.35 NA which is used by the 100 watts laser. It actually means that our laser beam

acts as a sharper knife, thus requiring lesser wattage (force) to give the same cutting

efficiency. Actually the use of laser energy for achieving

same cutting efficiency provides gentle treatment to the patient leading to lesser

desiccation and faster recovery. So our 50W is parallel to 100W. Machine can do

prostate Enucleation, Prostate Vaporescetion, Prostate LITT, Uteric Stones, Renal

Stones, Stricture Tumor, Endopyelotomy, Bladder Neck Incision etc.

Ho-YAG laser

specifications for

tender

E-18421

E-183

22 E-184 M/s.

InterkardioHealthca

re Techologies

Holmium YAG

Laser

Sr.

No

Tender

No.


POINT No.13 b. Laser Power should be 50 to 100W

instead of 100W.

Want minimum 100W.

POINT No.14 a). Fibre sizes should be 230, 365, 600

microns instead of 220, 365 & 550 microns.

JUSTIFICATION- Sizes indicate the core diameter of the fibers and core diameter

are directly proportionally to the delivery of energy.

200/220/230,365, 550/600

microns.

POINT No.15 B) b. Outer continuous irrigation sheath

“e-line” 26 fr. instead of 26.5 fr.

26 fr. instead of 26.5 fr. Outer continuous irrigation

sheath "e-line"26 fr.

POINT No.15 B) c. Inner continuous irrigation sheath

“e-line” 24fr. instead of 23.5fr.

24fr. instead of 23.5fr. Inner continuous irrigation

sheath “e-line” 24fr.

23 E-184 M/s. Midas

Associates

Holmium YAG

Laser

All Products quoted should be CE approved & FDA

USA approved of Single Parent Company.

Edoscope part which includes (b) morcoscope, © Laser Resectoscope (d) Fiber optic

Flexible Uretrorenoscope, € Flexible Video Cystoscope, (f) Flexible Nephroscope

should be floated as a separate tender all together. Manufacturers/Sole distributors for

the Holmium Yag laser are not the same manufacturers for the endoscope component

& vice-versa.

All Products quoted Should

be CE or US FDA approved.

Endoscpes part which

included in tender

specification can be of one

company and laser unit can

be of other company.Both

should be quoted together in

one tender. Bidder should be

also responsible for service

support during warranty &

after warranty period for both

parts(Enscopes as well as

Holmium laser.)

24 E-184 Holmium YAG

Laser

The equipment should have a narrow foot print

(Numeric Aperture) of 0.22NA.

The equipment should have a

narrow foot print (Numeric

Aperture) of minimum

0.22NA.

13. c.Max. Laser Energy: 4500mJ at tissue level Laser Energy: 0.2 to

3.5Joules.

13. d.Repetition rate: 8-30Hz Repetition rate: 5-50Hz


lasers in the market.Our laser is 50 watts but it out performs a 100 watts laser. It can



LITT). This has been possible due to fourth generation advancements, wherein we can

use a narrow foot print of laser & fibre with 0.22 NA ( numeric aperture), as against

0.35 NA which is used by the 100 watts laser. It actually means that our laser beam

acts as a sharper knife, thus requiring lesser wattage (force) to give the same cutting

efficiency. Actually the use of laser energy for achieving

same cutting efficiency provides gentle treatment to the patient leading to lesser

desiccation and faster recovery. So our 50W is parallel to 100W. Machine can do

prostate Enucleation, Prostate Vaporescetion, Prostate LITT, Uteric Stones, Renal

Stones, Stricture Tumor, Endopyelotomy, Bladder Neck Incision etc.

22 E-184 M/s.

InterkardioHealthca

re Techologies

Holmium YAG

Laser

Sr.

No

Tender

No.


13.f.Aiming Beam, green : 635nm, >1mW, adjustable

for better contrast at tissue level.

Aiming Beam,

green(532)/Red (635 or 650)

, >1mW, adjustable for better

contrast at tissue level.

13.h. Power required : 230VAC with 30Amps at single

phases

Power required : 230VAC

with 30Amps at single

phases. Electrical output

requirement should be born

byCompany.

14. a) Fibre 220,365,550 microns :- 05Nos. each Fibre 220,365,550 microns :-

10Nos. each

14. b) Vaporization fibre 800mocron (Reusable) :- 1

No.

Vaporization fibre

800micron (Reusable) :- 5

No.

14. c) Fibre for LITT ( Laser Induced Thermo Therapy)

:- 1 No

Fibre for LITT ( Laser

Induced Thermo Therapy) :-

2 No

The equipment should be from standard manufacturer

preferably from European/USA country.


approved.

Accessories:-

a) Goggles:- 2no.

b) Diamond Cutter:- 1 no.

c) Stripper/clipper:- 1no.

d) Manual:- 1set

Accessories:-

a) Goggles:- 4nos.

b) Diamond Cutter/ Ceramic

Scissor:- 1 no.

c) Stripper/clipper:- 1no.

d) Manual:- 1set

e) Fibre Inspection scope-

01no.

c. Rotation morcellator reusable, diameter 4.75mm,

working length 350mm comprising outer and inner

blade (2no.).

c. Rotation morcellator

reusable, diameter 4.75mm,

working length 350mm

comprising outer and inner

blade (2 sets of blades).

19.The company should have service backup with

trained engineer in the region.

The company should have

service backup with trained

engineer in the region.

Service should be given in

seven working days after

reporting complaint. For

delay penalty of Rs. 5000/-

per day will be charged.

Sr.

No

Tender

No.


Should provide adequate &

proper training to the end

user.

Printer: Facility to print on Inbuilt thermal printer Facility to print on Inbuilt thermal printer as well as on plain paper via any

Deskjet/Laser printer. JUSTIFICATION-

In government hospitals, once the initially supplied thermal paper is consumed, there

is always a scarcity of thermal papers. To utilize the device even when there is no

thermal paper available, we recommend there should be facility of printing via

deskjet/laser printer on plain A4 papers which are readily available.

Inbuilt thermal printer as well

as on plain paper via any

Deskjet/Laser printer.

System should be upgradable Explain in detail. To avoid confusion kindly explain, System should be upgradable to

what?

Should be upgradable

features like internet

connectivity,wireless central

monitoring upto 4 bed.

Should be CE & FDA approved Should be CE/FDA approved

JUSTIFICATION-CE and FDA are equivalent to each other which represent

performance & safety of medical products. Hence, either of the standards will ensure

the product quality, functionality & safety. Specifying both the standards will restrict

the tender only to Multinational Companies and will cause injustice to many of the

reputed Indian manufacturers. Hence we recommend the requirement should be

CE/FDA approved.

CE or US FDA approved.


System should be Virus Protecting (Firewall, C/C++) Kindly remove this point . JUSTIFICATION-

Fetal monitor will work on proprietary firmware/software and hence there will be no

access to internal software. Hence this requirement is not valid.

24 E-184 M/s. Maestros

Mediline Systems

Limited

Featal Monitor

Display minimum 5.6” Display should be minimum 7.1” color display JUSTIFICATION-

Monochrome displays are outdated hence difficult to source & repair. Specification

leaves a scope of quoting this outdated technology as display type is not mentioned.

Hence we recommend, “Color Display” should be specified.

Also the size asked i.e. 5.6” will be insufficient for monitoring of twin babies. 7.1”

screen size will be more suitable for viewing of twin FHR pattern, which also comes

in less cost than that of 5.6” screen.

Patient Database: It should store more than 10 hours,

memory to store all data.

Facility of Inbuilt Analysis of the FHR pattern JUSTIFICATION-As

many a times, gynecologist may not be present near the patient and inbuilt analysis

will help the technician to understand Fetal distress on time and report accordingly.

25 We would like to bring it to your attention that there is

no local manufacturer for patient monitors & fetal

monitors who has both CE & USFDA certificate. This

means no Indian manufacturer will able to quote this

tender.

The USFDA is required only in the USA and more than 50 countries accept CE

certifications. Moreover products under tender consideration are not self certified

products & they require notifying body to certify it. Getting USFDA certification is

difficult not because of local products are of inferior quality but because of cost

involved in getting each model certified and lack of government support.

E-184 M/s. Maestros

Mediline Systems

Limited

Fetal Monitor

No Change.

System should be Virus

Protecting.

No Change.

Sr.

No

Tender

No.


Delivery Period &Place of Delivery: The goods should

be delivered within 45 days from the date of receipt of

supply order to the consignee.Should Provide Training

to the end user

Kindly amend it to 75days for imported items from the date of receipt of purchase

order

JUSTIFICATION:-In case of imported items like ours and multiple nsignees involved,

75 days is the minimum time for arranging delivery from the date of receipt of

confirmed supply order to the various locations as per tender.

It should have clinical event marker It should have clinical event marker and automatic fetal movement detection.

JUSTICATION:- This is a very important feature and must be

available in a fetal monitor.

Some times, during labor pains or due to wage perceiving power, events marked by

the patients with the help of marker are not correct.

Therefore, availability of automatic fetal movement detection helps linician to have an

exact idea of gross fetal movement and crosschecking

the perceiving power of the patient.

No Change.

5. It should have battery back up of 4-6 hours. It should be supplied with a suitable rated UPS with 30 minutes

backup.

JUSTIFICATION:- The fetal monitor is diagnostic equipmentmeant to conduct 20

minutes NST (Non-Stress Test) and not an equipment to be used during

transportation.

Due to continuous usage of thermal printer,integrated battery backup is not available

with most of the reputed vendors.

Hence, this point seems to be a vendor specific and need to be amended as requested.

A UPS will also protect the equipment with sudden fluctuations / failures of power.

No Change.

Accessories

Should provide rechargeable battery along with

recharging unit (Charger/Adaptor).

To be deleted

JUSTIFICATION:- As per request above

No Change.

1.Display Minimum 5.6” 1. High Resolution Colored Display Minimum 5.6”

JUSTIFICATION:- Now days, for all monitoring equipments color

display is essential for better visibility and easy

differentiation in waveforms and numerics.

Available with most of the vendors and hence,

must be the part of specification to prevent an

inferior product with poor resolution and

visibility.

No Change.


26 E-184 M/s.

PhilipsElectronics

India Limited

Foetal Monitors

25 We would like to bring it to your attention that there is

no local manufacturer for patient monitors & fetal

monitors who has both CE & USFDA certificate. This

means no Indian manufacturer will able to quote this

tender.

The USFDA is required only in the USA and more than 50 countries accept CE

certifications. Moreover products under tender consideration are not self certified

products & they require notifying body to certify it. Getting USFDA certification is

difficult not because of local products are of inferior quality but because of cost

involved in getting each model certified and lack of government support.

E-184 M/s. Maestros

Mediline Systems

Limited

Fetal Monitor

Sr.

No

Tender

No.


Patient Database:It should store more than 10 hours,

memory to store all the data. In case the printer goes out

of order, machine should continue monitoring and then

download to printer afterwards for printing or be

viewed.

Patient Database:

It should store more than one hour, memory to store all the data. In case the

printergoes out of order, machine should continue monitoring and then ownload to

printer afterwards for printing.

JUSTIFICATION:- This is a vendor specific point and need to be amended to make it

generalized and encouraging healthy competition. Normally, one hour storage in a

Foetal monitor is more than sufficient as the Fetal monitor is used for a 15-20 minutes

non-stress test only, for which one hour memory is sufficient. There is no significance

of much data in memory as the hard copy of an NST is must for prevention against

medico-legal cases

No Change.

Computer interface through RS232 connection Computer/ Central Station interface through RS232/ LAN connection

JUSTIFICATION:- The mentioned point in specification is vendor

specific and need to be made generalized as

requested to encourage more reputed bidders

and healthy competition.

No Change.

System should be Upgradable System should be Upgradable for triplet monitoring and NST through telemetry.

JUSTIFICATION:- It is essential to define upgradability requirement, else, this point

may be misunderstood by the vendors and will be taken in their own convenient ways

to manage the specification.Triplet monitoring & fetal monitoring through telemetry is

an advanced but important feature

and available with all reputed vendors for this product.Looking at the trends in a

particular area features like triplet monitoring and telemetry transducers can anytime

be upgraded.

Should be upgradable

features like internet

connectivity,wireless central

monitoring upto 4 bed.

27 E-184 M/s. Paramount

Enterprise

Foetal Monitor keep both USFDA and CE approval as must for

equipment

Please note that CE and USFDA certification are two different processes. CE

certification is a one of the constituent of USFDA market approval process but the

device is allowed market in US only if one of the above stated accredited organization

certify performance standards within the acceptable limit set by USFDA

CE certification guidelines states that The CE marking shall be affixed only by the

manufacturer. By affixing or having affixed the CE marking, the manufacturer

indicates that he takes responsibility for the conformity of the product with all

applicable requirements set out in the relevant Community harmonisation legislation

providing for its affixing. The point to be noted here is “manufacturer indicates that

he takes responsibility for the conformity of the product” and performance standards

are not tested and accredited by any above listed third party accredited organization.

Hence, we appeal to honorable jury not to fall prey to misleading request made by

some companies to change USFDA & CE approved term to USFDA or CE in lieu of

patient interest.


26 E-184 M/s.

PhilipsElectronics

India Limited

Foetal Monitors

Sr.

No

Tender

No.


28 E-184 M/s. Biomedicon Foetal Monitor USFDA and CE approval JUSTIFICATION:-

In view of United States Food and Drug Administration, fetal ultrasonic monitor is the

device used to represent some physiological condition or characteristic in a measured

value over a period of time (e.g., perinatal monitoring during labor) or in an

immediately perceptible form (e.g., use of the ultrasonic stethoscope). This device

designed to transmit and receive ultrasonic energy into and from the pregnant woman,

usually by means of continuous wave (doppler) echoscopy.

Looking at the potential risk associated transmit and receive ultrasonic energy into

and from the pregnant woman and fetus, USFDA has categories this device under

TITLE 21--FOOD AND DRUGS; CHAPTER I--FOOD AND DRUG

ADMINISTRATION; DEPARTMENT OF HEALTH AND HUMANSERVICES;

SUBCHAPTER H--MEDICAL DEVICES; Subpart C--Obstetrical and Gynecological

Monitoring Devices; Sec. 884.2660 Fetal ultrasonic monitor and accessories

&Classification, Class II & is must to take performance standards accredited from any

one of the following organization to seek marketing clearance in United States.

Please note that CE and USFDA certification are two different processes.CE

certification is a one of the constituent of USFDA market approval process but the

device is allowed market in US only if one of the above stated accredited organization

certify performance standards within the acceptable limit set by USFDA CE

certification guidelines states thatThe CE marking shall be affixed only by the

manufacturer. By affixing or having affixed the CE marking, the manufacturer

indicates that he takes responsibility for the conformity of the product with all

applicable requirements set out in the relevant Community harmonisation legislation

providing for its affixing. The point to be noted here is “manufacturer indicates that

he takes responsibility for the conformity of the product” and performance standards

are not tested and accredited by any above listed third party accredited organization.

Hence,we appeal to honorable jury not to fall prey to misleading request made by


4. As “ CE” is based on international standards more than 50 countries accepts CE

certification including Europe , Latin America, Australia , Canada, Middle East Asia

& South East Asia & USFDA is only required for the USA only.



Mediline Systems

Limited

Foetal Monitor We appreciate DHS’ intension & effort to improve

overall quality & effectiveness of the products

purchased through above tenders. However making

both CE & FDA compliance mandatory may not

guarantee intended results. Moreover it will severely

impact local manufacturers as none of the Indian

company will be able to bid & DHS will end up

purchasing devices at huge premium in foreign

exchange.

1. In recent past, performance & inaccuracy in FDA approved machines (under this

tender requirement) has resulted in death of patients & company has withdrawn all the

devices from market (REF: USFDA website).

2. The devices (under this tender) are not self certified. For “CE “it requires

notifying body to certify it. The process of certification is similar to FDA. The

difference is CE is based on international standards & FDA is based on American

standards (REF: USFDA website).

3. China’s regulatory requirement called SFDA is based on USFDA (REF: USFDA

website). So it is easy for Chinese manufacturer to comply the requirement. Hence

DHS might end up purchasing all Chinese devices ignoring all Indian manufacturers.

Sr.

No

Tender

No.


5. WHO recommends governments of countries without national regulation of

medical devices to follow certification based on international standards like ISO

13485 & IEC. Which is covered under CE certification (REF: WHO guidelines for

medical device regulation).

6. Indian device companies do not go for FDA is not because their products are

substandard. This is because getting USFDA for each model is very expensive & there

is no government support. (NOTE: Not all the devices even from most reputed MNC’s

are FDA approved)

7. FDA is enforced law in USA. Companies pay huge money to get certified &

maintain it. However the law cannot be enforced in INDIA. So DHS will only end up

paying premium to purchase.

29 Considering above points we requires DHS to consider changing specification to CE

OR FDA.

1. GENERAL DESCRIPTIO

Modular & Suitable for Adult/Paediatric/ Patients

monitoring .Minimum 15 inches multi-colour TFT

display screen.

Eight Channel digital and waveforms/ traces display.

Capability of storage of patient data and printing of

patient reports.

Please make it Touch Screen

JUSTIFICATION:- Tocuh screen is easy to operate & it is latest technology.

No Change.

3.ECG

Multichannel (up to 12 lead) ST segment analysis

3 or 5 lead with cascade waveform facility.

Monitoring, Diagnostic & OT modes of monitoring of

ECG

Simultaneous Multi-lead ECG monitoring of 7 ECG

lead

HR range 20-350 BPM

HR/PR Source selection facility from Automatic,Spo2

IBP and NIBP.

Please make it as- Simultaneous Multi-lead ECG monitoring of 8 ECG lead

JUSTIFICATION:- There is no logic for 7 leads. Where as if you have 8 leads- along

with 6 leads you can get addition 2 chest leads. With lead II, V4 & V5 one can detect

96% of ischemia changes

No Change.

Automatic arrhythmia detection & alarm for standard &

lethal arrhythmia

Please mention the no. of arrythmias as >20.

JUSTIFICATION:- The same is asked for in the central monitor specs. If monitor has

the capacity of detecting >20 arrythmias, then only it will come to central monitor

No Change.

4. PULSE OXYMETRY

Nellcor or Masimo technology.

please add- Nihon Kohden Technology

JUSTIFICATION:- Nihon Kohden is the Inventor of Pulse Oximetry

No Change.

10. TRENDS & ALARMS

72 Hrs. non-volatile graphical/tabular trends with zoom

facility and separate dedicated trend for storing min 200

NIBP readings

As 72 hrs memory is asked for, the NIBP reading should be stored for 72 hrs

JUSTIFICATION:- The 72 hrs data of NIBP will give you the complete picture.

No Change.

Should have Alarm recall facility for last 24 Alarm

events with date,time and Message

As 72 hrs memory is asked for, the alarm events should be stored for 72 hrs

JUSTIFICATION:- The 72 hrs data of alarms will give you the complete picture.

No Change.



Mediline Systems

Limited

Foetal Monitor

Item : 4 Multi Para

with Central Work

Station - Qnty 20

nos.

M/s.Nihon KohdenE-18430

We appreciate DHS’ intension & effort to improve

overall quality & effectiveness of the products

purchased through above tenders. However making

both CE & FDA compliance mandatory may not

guarantee intended results. Moreover it will severely

impact local manufacturers as none of the Indian

company will be able to bid & DHS will end up

purchasing devices at huge premium in foreign

exchange.

Sr.

No

Tender

No.


Please add - Monitor should be upgradaeable to Sepsis protocol

JUSTIFICATION:- With Sepsis Protocol, the fluid management is better in sepsis and

patients under septic shock in an ICU

No Change.

11.RECORDER

Inbuilt dual channel thermal array recorder

Please remove this line

JUSTIFICTION:- The Printer is asked for at the central monitor and the print out can

be taken from Bedside Monitor. Hence no need of Recorder or printer at every bed.

Can be removed

Include Laser Printer and dual channel strip chart

recorder


JUSTIFICTION:-Same as above

No Change.

12. OTHERS

Should have facility to download trend data on USB

and SD Card.


JUSTIFICTION:-The monitors are being connected to Central Monitor and Central

mnoitor has memory and USB port. No need of transfering the data from monitor.

No Change.

13.ACCESSORIES

5 Lead ECG with clips – 2 sets Please add 12 Lead ECG Cable to be quoted as an option

JUSTIFICTION:-12 Lead ECG is asked for in the Central Monitor Specs

No Change.

16.STANDARDS, SAFETY & TRAINING

Should be USFDA & CE approved product

Shall meet the safety requirements as per IEC 60601 – 2-

27: 1994 – Medical electrical equipment – Part 2:

Should have local service facility. The service provider

should have the necessary equipments recommended by

the manufacturer to carry out preventive maintenance

test.

Back to back warranty to be taken by the supplier from

the principal to supply spares for a minimum period 10

years.

Comprehensive warranty for 2 years and provision of

CMC for next 8 years.

Please add - The manufacturer should quote their latest model not introduced before

the year 2008.

JUSTIFICATION :- The technology changes every 5 years. Older model will phase

out fast. The Govt should get the latest technology & models.

No Change.

17.DOCUMENTATION

CNS should have 24 hr stored patient data monitoring –

trends

The storage should be 72 hrs. Same is asked for in the monitor

JUSTIFICATION:- 72 hrs. is better than 24 Hrs.

No Change.

CNS should have 24 hr event review facility CNS

should have multi lead arrhythmia and ST review

facility.

The storage should be 72 hrs. Same is asked for in the monitor

JUSTIFICATION:-72 hrs. is better than 24 Hrs.

No Change.

Item : 4 Multi Para

with Central Work

Station - Qnty 20

nos.


Sr.

No

Tender

No.


CNS should have 50 alarms strips storage per bed CNS

should offer wave review with 24 hr full disclosure

CNS should support HL7 output

wave review also should be 72 hr full disclosure

JUSTIFICATION:- Memory should be common

No Change.

CNS should have option for 12L ECG monitoring for

detailed analysis of individual bed without

compromising on full ICU monitoring.

Please add 12 Lead ECG monitoring & analysis

JUSTIFICATION:- 12 lead ECG analysis reduces the need of taking ECG print outs

from ECG machines

No Change.

CNS should have facility for interfacing Holter data for

analysis, in case of the Holter from the same brand is

available.


JUSTIFICATION:-Every hospital may not have Holter or may not have it from the

same company

No Change.

CNS should export the ICU patient data to Holter for

analysis


JUSTIFICATION:-Every hospital may not have Holter or may not have it from the

same company

No Change.

CNS should have advanced arrhythmia analysis

package (more than 20 arrhythmia analysis should be

possible) Should have 12 LECG Monitoring & view

possible at CNS.

please add 12 Lead ECG Monitroing , Analysis & View

JUSTIFICATION:-same as above

No Change.

CNS should operate on Microsoft Windows NT

workstation operating system.


JUSTIFICATION:- The operating system of Linux is better.

No Change.

2.1 (iv) Bill of entries to access that the product is

imported in India since last 3 years


JUSTIFICATION:-The product may be available in India thru privious distributor.

The Bill of Entries cant be given.

No Change.

2.5 The eligible Bidder must submit particulars of

quantity of the past supplies made as per the

performance statement Format provided in the

tender document without any alteration, during the

last Three calendar years, out of this at least 25 %

quantity for similar Product as specified in the

Technical Specification and in the Schedule of

Requirements & must have been supplied in any one

of the last 3 (Three) calendar years,

Please allow the performance certificate from any country as the product is imported No Change.

Last date of Tender Submission- 11/09/2013 Please Extend the date. The time remaining is too short. The digital Signature is to be

acquired.

Modular & Suitable for Adult/Paediatric/ Patients

monitoring .

Modular & Suitable for Adult/Paediatric/ Patients monitoring

JUSTIFICATION :- Kindly specify as to what does user mean by modular. Does it

mean that modules should be removed from one monitor and plugged into another by

user freely

Modular means detachable

modules which are freely

exchangable between two

monitors and the same model

and not exchangable cable.

Item : 4 Multi Para

with Central Work

Station - Qnty 20

nos.


31 E-184 M/s. Schiller

Healthcare India

Pvt.Ltd.

4 Multipara Monitor

Sr.

No

Tender

No.


Minimum 15 inches multi-colour TFT display screen. we request that atleast 14 inches or more should be accepted and the screen should be

touchscreen

JUSTIFICATION:-As nowadays all reputed brands have touchscreen display

12" and above display

screen.

Display of Plethysmograph with Pulse Strength

indicator & SpO2 values & perfusion index.

Display of Plethysmograph with Pulse Strength indicator & SpO2 values & perfusion

index bar graph.

JUSTIFICATION:-Perfusion is shown as bar graph in monitors

No Change.

ETCO2

Should be Main Stream capnography with display of

CO2 and digital Values of EtCO2, FiCO2 & RR

No Change.

Flow rate :- 50ml/min

Include Laser Printer and dual channel strip chart

recorder

This should be deleted as already the same has been asked below in Central Station No Change.

Should have facility to download trend data on USB

and SD Card.

Facility to download on USB OR SD Card

JUSTIFICATION:- Request for storage on either of one should be accepted as data

storage is already available in central station as well

No Change.

Suitable ONLINE UPS with maintenance free batteries

for minimum one-hour back up should be supplied with

the system

It should be online UPS OR internal rechargeable battery

JUSTIFICATION:- As monitors have internal rechargeable battery

No Change.

Central station should have facility to display upto 20

real time waves at a time and upgradable upto 32 beds

in future

Central station should have facility to display upto 16 real time waves at a time

JUSTIFICATION:- The monitors are asked for 4 bed and each bed there are only 3

parameters where waveforms are seen. Hence the maximum each bed will show is 9

or if 12 Lead ECG option is taken that 15 waveforms can be seen.

No Change.

CNS should have option for 12L ECG monitoring ECG asked in monitors is 5 Lead & hence maximum 7 lead ECG can be seen per bed No Change.

CNS should have facility for interfacing Holter data for

analysis, in case of the Holter from the same brand is

available.

should be deleted

JUSTIFICATION:- As holter is different machine

No Change.

CNS should export the ICU patient data to Holter for

analvsis

should be deleted

JUSTIFICATION:- As holter is different machine

No Change.

CNS should have advanced arrhythmia analysis

package (more than 20 arrhythmia analysis should be

possible) Should have 12 LECG Monitoring & view

possible at CNS.

CNS should have advanced arrhythmia analysis package (more than 15 arrhythmia

analysis should be possible)

No Change.

Should have 12 LECG Monitoring & view possible at

CNS.

Should have 7 lead ECG monitoring

JUSTIFICATION:- As monitor is been asked for 5 lead ECG cable

No Change.

Modular & Suitable for Adult/Paediatric/Patients

monitoring

The monitor should be modular suitable for adult/pediatric patient monitoring.

Modules/ servers should be freely exchangeable within monitors across the ICU

without any technical help by the end user.

JUSTIFICATION:- This is highly important to define ‘modularity’ to its true and ideal

sense to avoid confusions,so that it is not misunderstood by the vendors in their own

different ways to manage the specification. Minimum 15 inches multicolour TFT

display screen. Minimum 10 inches multicolour TFT display screen.

Modular means detachable

modules which are freely

exchangable between two

monitors with the same

model and not exchangable

cable.

Kindly note main stream ETCO2 will not have flow rate whereas Side stream /

microstream ETCO2 will have flow rate.

JUSTIFICATION:-Hence ETCO2 should be microstream measurement type

32 E-184 M/s. PacketBio 4 Multi-para with

Central Work

Station

31 E-184 M/s. Schiller

Healthcare India

Pvt.Ltd.

4 Multipara Monitor

Sr.

No

Tender

No.


Minimum 15 inches multicolour TFT display screen. Minimum 10 inches multicolour TFT display screen.

JUSTIFICATION:-For parameters required to be monitored (ECG, espiration, NIBP,

SpO2, Temperature, ETCO2) as per tender specifications, even 10 inch display size of

the monitor is sufficient. This will help your esteemed institution to save money on the

procurement. Eight Channel digital and waveforms/ traces display. Six Channel

digital and waveforms/traces display. For parameters required to

12" and above display

screen.

Eight Channel digital and waveforms/ traces

display.

Six Channel digital and waveforms/traces display.

JUSTIFICATION:- For parameters required to be monitored as

per tender specifications, even 6 channels/waveforms are sufficient. This will help

your esteemed institution to save money on the procurement.

No Change.

2. PARAMETERS

Eight digital and waveforms/traces display Six digital and waveforms/traces display.

JUSTIFICATION:- For parameters required to be monitored as per tender

specifications, even 6 channels/waveforms are sufficient. This will help your esteemed

institution to save money on the procurement.

No Change.

Facility to monitor and display –ECG,

Respiration,NIBP, SpO2, EtCO2, Temp

Facility to monitor and display –ECG, Respiration,NIBP, SpO2,EtCO2, Temp and 2 x

invasive pressure.

JUSTIFICATION:- The investment on procuring ICU monitors being made by the

Government of Maharashtra should at least suffice for 8-10

years. 2 x invasive pressure monitoring is a routine practice now days in critical care

monitoring for most of the critical cases/diseases.

Hence, the equipment must be ready to monitor 2 x invasive pressure and 1 x

temperatures monitoring any time to handle all kind of medical mergencies and

critical cases.

No Change.

Should be upgradable to monitor advance parameters

like Continuous Cardiac Output, AGM and BIS at any

time.

Should be upgradable to monitor advance parameters like Continuous Cardiac Output,

AGM and BIS at any time.

JUSTIFICATION:- Looking at modularity requirement, we appreciate the vision of

No Change.

3. ECG

Simultaneous Multi-lead ECG monitoring of 7 ECG

lead

Simultaneous Multi-lead ECG monitoring of 12 ECG lead

JUSTIFICATION:- 12 lead ECG monitoring is essential for handling cardiac

diseases and emergencies and hence, very important to have this facility.

Feature available with many vendors in the industry.

No Change.

4. PULSE OXIMETRY

Nellcor or Masimo technology. Nellcor or Masimo or FAST technology.

JUSTIFICATION:- Philips has its own patented technology with brand name Philips

FAST SpO2 (Fourier Artifact Supression Technique), which is well accepted and

being used with its over 5,00,000 patient monitors world vide. Philips FAST SpO2 is

considered to be equivalent to

Masimo Technology and works very well in low perfusion conditions.

A detailed comparative & clinical study is enclosed herewith for your immediate

reference. We request you to please help with your acceptance on the same and amend

the specification accordingly

Nellcor or Masimo

technology./equivalent

technology which is without

motion artifacts & accuratly

measures during

hypothermia,hypotension,bra

dycardia &low perfusion

state

PR Range: 20 to 230 BPM PR Range: 30 to 230 BPM

JUSTIFICATION :- The required limits in specifications are company specific.

Kindly amend as per

request to accommodate more bidders and healthy competition.

No Change.

8 TEMPERATURE


Central Work

Station

Sr.

No

Tender

No.


Two channels and with two units (0c and 0F) 0F)

selectable

Single channels and with two units (0c and 0F) selectable

JUSTIFICATION:- Having single temperature monitoring facility is

more than sufficient and normally practiced in various clinical conditions.

This will help reducing the cost of procurement and encourage more competition

No Change.

10 TRENDS

72 Hrs. non volatile graphical/tabular trends with zoom

facility and separate dedicated trend for storing min 200

NIBP readings

24 Hrs. non volatile graphical/tabular trends.

JUSTIFICATION:- The point in the specifications is company specific and restricts

many reputed vendors to

No Change.

11. RECORDER

Inbuilt dual channel thermal array recorder Please delete this point

JUSTIFICATION:- Since, the requirement is for 04 monitors with central station and

central station will have its own printer /recorder having additional inbuilt recorders

Can be removed.

13 ACCESSORIES

NIL Please include 02 cables for invasive pressure monitoring with 02 nos. disposable

transducer with each monitor

JUSTIFICATION:- This is as per our suggestion towards point no.2 of your

No Change.

REQ1UEST FOR BUYING MONITORING

SYSTEMS WITH UPGRADABLE PLATFORM FOR

ELECTRONIC CHARTING AND e-ICU.

NIL The monitoring system should be upgradable to a proven a proven integrated

integrated charting solution with a capability of remote monitoring the ICU.

JUSTIFICATION:- With the help of charting solution, flowsheets

No Change.

1. A2. High Definition Surgical vido camera system JUSTIFICATION:- Please make "Camera Head should be fully Autoclavable". This

condition makes the tender specificaiton as Closed specification favouring only couple

of manufacturers.

Autoclavable is prefferd.

2. A6. USB-3Nos JUSTIFICATION:- USB 3 nos as optional": This condition makes the tender

specification as Closed specification favouring only couple of manufacturers,

2 to 3 nos. USB is accepted.

3. LED Light Source JUSTIFICATION:-Optional Halogen Light Sources as against this becomes closed

specification.

only LED source.

4. CE & FDA Approved JUSTIFICATION:- The tender conditon says CE & FDA approved where as it should

read as FE and/or FDA approved as one approval is sufficient for the quality.


A High Defination surgical video camera -3ccd Pl delete points - 1, 2, 4, 5, 6 and 8 for the camera product

JUSTIFICATION:- These points belongs to a single specific company

And most of the branded companies do not have these points in their products

1.video recording and still image capture

2.head should be autoclave

4.USB / network storage and streaming

captures

5 video recording and still image capture

6 USB -3nos

Ethernet -1no.

8 The system should offer a remote login

via internet IP enabled

1. No change.

2. Autoclavable is prefferd.

4. No change.

5. No change.

6. 2 to 3 nos. USB is

accepted.

Ethernet removed.

8. Removed.

E Insufflator


Central Work

Station

USFDA / CE, IEC 60601-1 JUSTIFICATION:- EC-Certificate, ISO13485, IEC 60601-1, AMMI EC-13, AMMI

SP10, ISO 9919

.Independently validated through simulators & results tested against industry

benchmarks

.Providing high levels of safety & accurate results


Central Work

Station

35 E-185 M/s. Arnit

Meditech

laparoscopy System

with Instruments

34 E-185 M/s. Esskay

Surgicals

Laproscopy

Instrumnet

No Change.

Sr.

No

Tender

No.


1 Flow rate -> 15 lit/min Should be 40lit/min

JUSTIFICATION:- Usefull for Obesity patients also

No change.

G instruments for Laparoscopy

CE and USFDA approved It should be CE or USFDA

JUSTIFICATION:- CE is for European Make equipments And USFDA is for

American Make equipments.

Request - Pl make the changes in the specifications so that more companies should

participate in the concerned tender.


36 E-185 M/s. Healthware

Pvt Ltd.

Laproscopy

System with

Instruments

LED Light Source LED Light Source

JUSTIFICATION:- It should be written as LED/Xenon Surgeons still prefers

Xenon Light source. For Advance surgical procedures Xenon Light source is

preferred. This system is globally accepted.

only LED source.

37 telescope

Working length – 330 mm

telescope

JUSTIFICATION:- It should be 300-330mm. This is specifically for one company.

Needs to be in the range. working length 330mm.

No change.

A.High definition surgical video camera system – 3

CCD

1.It should give full HD output of 1920x1080

progressive it should have 2 Buttons on camera head for

4 programmable functions, such as video recording, still

image capture. white balance Enhancement etc.

1. To be changed to 1280 x 1024p or 1920x1080p. No change.

2. Camera head should be fully Autoclavable. 2. Not all companies have this, to be elimenated from Technical Specifications, or else

only 2 companies can compete, making for an unfair enviornment.

Autoclavable is prefferd.

6.It should have following digital outputs----

DVI-D :- 1 no, USB:- 3 nos, ETHERNET:- 1 no

6. This is specifica to only one company technically & unfair to others. Instead we

suggest having Digital output-2nos. Minimum.

2 to 3 nos. USB is accepted.

8. The system should offer a remote login via internet IP

enabled.

8.This is specifica to only one company. Should be removed. Removed this specification.

D. Telescope (Direction of view – 0 degree, 30

degree )

5.Field of view – 75 degree 5. Field of view should be as per date 105 degree. Field of view 75 to 105

degree

6. High speed – III optics for high resolution 6. Such a terminology doesn’t exist with any reputed International major Endoscope

manufacturer, it is misleading & falsfield claim by one particular company, making

the tender one sided. Should be removed.

Removed this specification.

9. Sapphire tips at the distal and proximal end. 9.This is from a single vendor & not applicable to Industry Standards. Should be

removed.


10.Nitrogen filled optical system to avoid interior

condensation.

10. This is falsfield technical specification to suit one individual company. Rather

simple physics states that Nitrogen is a cold inert gas, when it shall come in contact

with any warm outer surface condensation will occur. How does it help? Kindly

remove this.


35 E-185 M/s. Arnit

Meditech

laparoscopy System

with Instruments

38 Laproscopy System

with Instruments

E-185 M/s. MIDAS

ASSOCIATES

Sr.

No

Tender

No.


11. Triple tube design for higher stability 11. This is too technical & impossible to prove. No Internationally reputed company,

whether Karl Storz, Richard Wolf, Stryker or Olympus states this. Hence kindly

remove.


F.LED Light sources

6.Digital display of lamp hour meter in front panel. 6. This is present in Xenon light source & no LED, hence kindly remove. This point for xenon light

only, so removed this

specification.

9. Fiber Optic Cable – Autoclavable, Waterproof,

resistant to chemical solution, compatible with light

source - 02 Nos.

Length:- 250cm to 300cm.

9. No diameter is mentioned, cost varies on this,kindly mention diameter. Our

suggestion is 5mm Fibreoptic bundle dia.

Diameter is 5 to 10mm.

G.Instruments for laparoscopy As per observation, Technical specification as per date stating: PEEK material, Three

way take apart, Stem flushing for hygiene & maintenance is not mentioned for the

forceps. Again to standardize number of players length should mentioned be 33-

36cms for forceps.

No change.

10.Metzenbaum scissors lengths 36 cm, size 10mm 10. This might be an error, size should be 5mm. Metzenbaum scissors lengths

36 cm, size 5mm.

16. Port closure needle store type x 1 no 16. This is company specified name & unfair to others. " Storz type" should be

removed.

Port closure needle.

23.Should provide suitable trolley for instrument- 01No. 23. Do you mean Endoscopy Trolley? Again this would be local, So please mention

that.

Laproscopy Trolly for

laproscope and monitor.

24. Should provide Formalin Chamber - 01 No. 24. This is a local item, please state that. Any Make is considered.

25. S.S. Tray for hand instruments - 02Nos. 25.Kindly specify in detail the requirment. For Cleaning & laying down

Instruments

27.It should have an international standard safety

requirement. CE certified & USFDA approved.

27. Are all the products being asked for to be having CE & US FDA certification?

Kindly confirm


39 E-186 M/s. Rattan Sales

Corp.

deep freezer -80

degree

USFDA & CE with the rising prices of dollar and with USFDA only foreign manufacturers would be

able to participate and our local n indigenous companies would be left out. USFDA

OR CE instead of USFDA & CE


approved

40 E-186 M/s. Gunjan

Surgical &

Scientific Co.

,-80 degree cl.

Refrigerator (Deep

freezer-80 degree

cl)

Should be CE & US FDA approved JUSTIFICATION:- It should be CE or US FDA so more number of bidders can be

participate


approved

41 E-186 M/s.ESCO

BIOTECH PVT.

LTD.,

,-80 degree cl.

Refrigerator (Deep

freezer-80 degree

cl)

,-70 to -90 Degree Centigrade ,-50 to -86 Degree Centigrade

JUSTIFICATION:- 80 Degree Centigrade is required for such applications.

1) Very low power Consumption compared to our competitors

2) Fast cooling down time

3) Fast recovery of temperature after opening of the door

4) 2 years warranty on the whole system

No change.

38 Laproscopy System

with Instruments

E-185 M/s. MIDAS

ASSOCIATES

Sr.

No

Tender

No.


1) Micropipette- 50ul variable Vol. Volume [ul]: 5.0 to 50.0

JUSTIFICATION:- Most commonly use is 10-100 ul. In other size of Micropipette

you have mentioned CE mark. Suggestion-it should also have CE mark.

Volume [ul]: 5 to 50 CE

mark

2) Micropipette- 200ul variable Vol. Volume [ul]: 50 to 200

JUSTIFICATION:- It should be 20-200 ul Suggestion - it should also have CE mark.

Volume [ul]: 50 to 200 CE

mark

3) Micropipette- 100ul variable Vol. Volume [ul]: 200 to 1000

JUSTIFICATION:- It should be 100-1000 ul Suggestion - it should also have CE

mark.

Volume [ul]: 100 to 1000

with CE mark

4) Micropipette- 1000ul variable Vol. Volume Range: Multichannel pipette (8 channels) 30-300 ul

JUSTIFICATION:- In heading you have mentioned 1000 ul Variable volume. Please

clarify.

Volume Range: Multichannel

pipette (8 channels) 30-300

ul


Corp.

cryo bath USFDA & CE with the rising prices of dollar and with USFDA only foreign manufacturers would be



USFDA or CE approved

44 E-187 M/S. Fine Care

Biosystems – India

Multichannel Pipette 30-300 ul Multi channel pipette Safe-Cone Filters to prevent contamination and damage of pipette

JUSTIFICATION:- is not required. This specs increases the initial cost of product

and also operating cost of pipette as it is expected to change filter minimum once a

day depending upon usage of pipette. This filters are not available in open market and

user is forced to purchase from one company without any check on pricing. Instead of

such spec, exactly same purpose can be served by filter tips. They are economical and

marked by various companies. So the spec # 9 should read “Adaptable to wide type of

tips including filter tips”

Adaptable to wide type of

tips including filter tips

45 E-187 M/S. Sun Medical

Systems

Multichannel Pipette Multichannel Pipette – variable Vol. (30-300μl). Safe Cone Filter to prevent contamination and damage of pipette

JUSTIFICATION:- Safe-Cone Filters to prevent contamination and damage of

pipette” is not required. This specs increases the initial cost of product and also

operating cost of pipette as it is expected to change filter minimum once a day

depending upon usage of pipette. This filters are not available in open market and user

is forced to purchase from one company without any check on pricing. Instead of such

spec, exactly same purpose can be served by filter tips. They are economical and

marked by various companies. So the spec # 9 should read as “Adaptable to wide type

of tips including filter tips”

Adaptable to wide type of

tips including filter tips


Corp.

blood storage

cabinet

USFDA & CE with the rising prices of dollar and with USFDA only foreign manufacturers would be



USFDA or CE approved

3.Based on optical principle, LED with 450 nm Based on Electro magentic/ Viscocity/ Optical/ Immunoturbidmetric/LED (Optical &

LED are old outdated technology, They are china based & have problem with

Lipemic/Turbid/Hemoloysed/High Bilirubin Based Sample.

Based on Electro magentic/

Viscocity/ Optical/

Immunoturbidmetric/LED

with 450 nm or MORE

47 E-188 M/s.Suyog

Diagnostic

Coagulometer

42 E-187 M/s. Triton

Technologies

Instrument &

Equipments

Sr.

No

Tender

No.


4.Should have integrated incubation block 24 pre-

warming positions, 4 measuring positions

4. Should have 12 to 24 prewarming position, 4 measuring position at 37degree

Celsius. ( Many competitors can quote. The original specification was

INSTRUMENT SPECIFIC no other company can quote.)

Should have 12 to 24

prewarming position, 4

measuring position at

37degree Celsius.

9.Printer should be attached to the computer. It should have inbuilt Printer. And should have option to connect with RS 232

interface. (As these are stand alone models so there is no separate computer or

exteranl printer provided it will add cost to instrument.)

Printer should be attached to

the computer or It should

have inbuilt Printer.

12. System should be open so that any reagent can be

used

System manufacture should have their own reagent compatible on the system. & also

open for other reagent from any competitor.( Should be useful if government in

following any accrediation program such as CAP. NABL or ISO.

No change.

13.Should be CE & USFDA Approved Should have CE/US FDA/ISO approvals ( As all the bodies are recommended) 13.Should be CE or USFDA

or ISO Approved

14. Equipment with standard accessories reagents

for at least 500 blood samples and standards for

calibration.

Equipment should be provided with standard accessories for 500 tests anf reagent for

at least 50 blood samples & standard for calibration for Factor 8 & Fibrinogen. ( This

will reduce down basic cost of equipment. Reagent have shelf life. There is no

mention of which test parameters required.)

Equipment with standard

accessories reagents for at

least 50 blood samples ,

controls N+P and

calibrator.and standards for

calibration for Factor 8 &

Fibrinogen. Should

separately quote prices for

Fibrinogen & factor 8

Pg. 9, Sr.16, Line1 - Sample

Sample will be called for demonstration within a week

from

responsive bidders after evaluation of Envelop No.1.

Since the tests are critical and expensive, with WET demonstration of the technically

qualified renderers at the time of demonstration with experts opinion with running the

sample on all the approved instruments with running calibration and quality control

for Factor VIII and Fibrinogen tests. ( Since the equipments is for Quality Control

Check at Blood Banks, this evaluation will help in getting which would be functional

for long run and user will be benefited.)

No change.

Pg. 14, Sr. 18, Line2.

The goods should be delivered within 45 (Forty Five)

days from the date of receipt of supply

order to the consignee.

Delivery period 90 days (As the consignee list is all over Maharashtra.) No change.

SR No-4 COAGULOMETER

should be Microprocessor controlled Same, no Change required

Semi-automated with at least 4 channels optics Same, no Change required

Based on optical principle, LED with 450 nm Based on optical principle, LED with 450 nm or MORE

JUSTIFICATION:- Since at 450 nm there is interference of Hemolysis, Ictericity and

lipeamic samples.


Viscocity/ Optical/


with 450 nm or MORE

49 E-188 M/s. Transasia

Biomedicals Ltd

Sr no. 4

COAGULOMETER

47 E-188 M/s.Suyog

Diagnostic

Coagulometer

Sr.

No

Tender

No.


should have integrated incubation block of 4 or more

pre-warming positions, As combination of 4 measurnig

positions.

should have integrated incubation block of 4 or more pre-warming positions, As

combination of 4 measurnig positions and 24 incubation block for pre warming seems

irrational combination and from single specific company.

JUSTIFICATION:- Suggested that if no. of channels are 4 nos., then incubation

positions should be 4 or more.




37degree Celsius.

Suitable for PT, ap TT, fibrinogen, Thrombin time,

factors II, V, VII, VIII, IX, X, XI, XII, Fletcher, AT III,

Protein C and Protein S

Same, no Change required

Results can be represented in seconds,% activity, ratio,

INR, g/L, mg/I

Result can be represented in second, % activity, ratio, INR,g/L, mg/dI

JUSTIFICATION:- There is a typographic error mg/L

Results can be represented in

seconds, % activity, ratio,

INR, g/L , mg/dl

Should be able to store specific test parameters in the

systems


Should have LCD Display Same, no Change required

Printer should be attached to the computer Printer should be internal or external

JUSTIFICATION:- There is no mention of computer anywhere in the specs.

Moreover, this system does not run with a computer.

Printer should be attached to

the computer or It should

have inbuilt Printer.

should generate the standard curve for factor assays

automatically


A suitable UPS with 20 minutes backup should be

provided with the system


|Please allow outsourcing for UPS as none of the equipment manufacturers have UPS

manufacturing facilities.

System should be open so that any reagent can be used. same, no change required.

Should be CE & USFDA approved Should be CE & USFDA approved

JUSTIFICATION:- As agreed in the meeting.

Should be CE or USFDA

approved

Equipment with standard accessories reagents for at

least 500 blood samples, standards for calibarators

Equipment with standard accessories- cuvetters, Fibrinogen and Factor VIII, APTT,

Calcl2 reagents, OV Buffer for at least 50 blood samples, controls N+P and calibrator.

JUSTIFICATION:- This makes the specification specific for blood bank use. Else

there is no clarity on the reagents to be supplied, if all reagents are supplied for 500

tests it will be at least 6 times cost of equipment, and would be of no use to the blood

bank.

Equipment with standard

accessories reagents for at

least 50 blood samples,

controls N+P and calibrator.

and standards for calibration

for Factor 8 & Fibrinogen.

Should separately quote

prices for Factor 8 &

Fibrinogen.

Warranty Period 2 Years and AMC 3 Years Same. No change required Please see Note.

Uptime of equipment should be 98% and downtime is

less than 2% Service time for Mumbai in 4 hours and

out of Mumbai 24 hours.

Same. No change required


Biomedicals Ltd

Sr no. 4

COAGULOMETER

Sr.

No

Tender

No.


Sr No-4 COAGULOMETER Should Be Microprocessor controlled

Same, no change required

Semi -automated with at least 4 channels optics Same, no change required

Based on optical principle, LED with 450 nm Based on optical principle, LED with 450 nm OR MORE

JUSTIFICATION:- since at 450 nm there is interference of Hemolysis, Ictericity and

lipeamic samples


Viscocity/ Optical/


with 450 nm or MORE

Should have integrated incubation block 24 pre-

warming positions, 4 measuring positions

should have integrated incubation block of 4 or more pre-warming positions, As

combination of 4 measuring positions and 24 incubation block for pre warming seems

irrational combination and from single specific company.

JUSTIFICATION:- Suggested that If no. of channels are 4 nos., then incubation

positions should be 4 or more.




37degree Celsius.

Suitable for PT, apTT, fibrinogen, Thrombin time,

factors II, V, VII, VIII, IX, X, XI, XII, Fletcher, AT III,

Protein C and Protein S


Results can be represented in seconds, % activity, ratio,

INR, g/L , mg/l

Results can be represented in seconds, % activity, ratio, INR, g/L , mg/dl

JUSTIFICATION:- There is a typographic error mg/L

Results can be represented in

seconds, % activity, ratio,

INR, g/L , mg/dl

Should be able to store specific test parameters in the

system


Should have LCD display Same, no change required

Printer should be attached to the computer Printer should be internal or external

JUSTIFICATION:- There is no mention of computer anywhere in the specs.

Moreover, this system does not run with a computer

Should generate the standard curve for factor assays

automatically


A suitable UPS with 20 minutes backup should be

provided with the system


JUSTIFICATION:- Please allow outsourcing for UPS as none of the equipment

anufacturers have UPS manufacturing facilities.

System should be open so that any reagent can be used Same, no change required

Should be CE & USFDA approved Should be CE / USFDA approved

JUSTIFICATION:- As agreed In the meeting

Equipment with standard accessories reagents for at

least 500 blood samples,standards for calibrators

Equipment with standard accessories -cuvettes, Fibrinogen and Factor VIII , APTT ,

Calcl2 reagents, OV Buffer for at least 50 blood samples,controls N + P and

calibrator

JUSTIFICATION:- This makes the specification specific for blood bank use.

Else there is no clarity on the reagents to be supplied, if all reagents are supplied

for 500 tests it will be at least 6 times cost of equipment, and would be of no use

to the blood bank


Biomedicals Ltd

COAGULOMETER

Sr.

No

Tender

No.


Warranty Period 2 Years and AMC 3 Years Same, no change required Please see Note.

Uptime of equipment should be 98% and downtime is

less than 2% Service time for Mumbai in 4 hours and

out of Mumbai 24 hours


Fully Automated ELISA reader

General specifications: System should include sample

predilution , dispensing reagents, multipippetting, plate

incubation, plate washing, plate shaking, plate reading

and data management with QC

Same, no change required.

Should be able to perform Elisa test for HIV 1&2,

HBsAg, HCV, VDRL and MP

Should be able to perform Elisa test for HIV 1&2, HBsAg, HCV, Syphilis (VDRL)

and Malaria.

JUSTIFICATION:- Clarification needed in the specs

Should be able to perform

Elisa test for HIV 1&2,

HBsAg, HCV, Syphilis and

Malaria.

Running mode: Batch wise continuous loading Running mode: Batch wise

JUSTIFICATION:- Elisa tests are batch wise tests and continuous loading in

batchwise tests have no meaning

Running mode: Batch wise

Should have robotic arm (1-2) , rotatable upto 270 for

plate transportation

Should have robotic arm (1-2 , with plate transportation

JUSTIFICATION:- Rotatable 270 deg, is a closed specification

Should have robotic arm (1-

2), rotatable for plate

transportation

Parallel sample pipetting for high speed performance Same, no change required.

Lot recording and control Same, no change required.

Full data processing & evaluation with integrated QC

data management


Integrated liquid level detection, reagent specific liquid

handling


Liquid control monitoring system for liquids , waste &

reagents


System should be open for use with any Elisa kit Same, no change required.

Should be CE & USFDA approved Should be CE / USFDA approved

JUSTIFICATION:- As discussed in the meeting

Should be CE / USFDA

approved

Vendor must supply one computer & printer, with UPS

along with the instrument



Biomedicals Ltd

COAGULOMETER

51 M/s. Transasia

Biomedicals Ltd

Fully Automated

ELISA reader

Sr.

No

Tender

No.


Vendor must supply All required containers like Buffer

bottles, reagent containers etc.


Safety features Same,no change required

Liquid detection Same,no change required

Clot detection Same,no change required

Color monitoring clock Same,no change required

Lot management Same,no change required

Positive barcode identification of all labware ( samples,

microplate, reagents, controls etc)

Positive barcode identification of all labware ( samples)

JUSTIFICATION:- NACO supplies do not have barcoded reagents and micoplates. It

makes the system closed and conflict with spec 1.09

NO Change.

Equipment built in software to manage multiple Elisa Same, no change required.

RS232 connectivity & data sharing ability with

software


Integrated with software which converts data in ASTM

or ASCII format & communicates with other software


Integrated Quality Control ( Levey Jennings Chart)

should be operated


Technical specifications

Plate Capacity- 4 plates upgradable to 6 plates Plate Capacity- 4 plates OR Plate Capacity - 4 plates with 2 plates equivalent elisa

processor as standby

JUSTIFICATION:- There is no system upgradable to 6 plates. Moreover all other

specs will change to 6 plates system.Clarification needed in specifications.

Plate Capacity- 4 plates.

Sample capacity: 120-180 samples tube position having

continuous loading

Sample capacity: 120-180 samples tube position .Suggested to make minimum 100

Samples position

JUSTIFICATION:- Batch systems have no use of continuous loading

Sample capacity: 100-180

samples tube position having

continuous loading

51 M/s. Transasia

Biomedicals Ltd

Fully Automated

ELISA reader

Sr.

No

Tender

No.


Pipetting system: a) Pipetting Channels-2/4 pipetting

Channels ( washable or disposable tips) b) volume

range: 10-1000 ul c) Needle size: 1000ul, d) Needle

wash must be present in the system for complete wash

of needles( inside & outside) e) Reagent capacity-

adequate to conduct 4 to 5 elisa test simultaneously f)

Precision : ( at 10 ul)< 5 % Precision (at 100ul )< 2.5%

Pipetting system: a) Pipetting probe-1 ( washable or disposable tips) b) volume

range: 10-1000 ul c) Needle size: 1000ul, d) Needle wash must be present in the

system for complete wash of needles( inside & outside) e) Reagent capacity- adequate

to conduct 4 to 5 elisa test simultaneously f) Precision : ( at 10 ul)< 5 % Precision (at

100ul )< 2.5%

JUSTIFICATION:-Needles are outdated, robotic probes are the latest

Pipetting system: a) Pipetting

probe-1 ( washable or

disposable tips) b) volume

range: 10-1000 ul c) Needle

size: 1000ul, d) Needle wash

must be present in the system

for complete wash of

needles( inside & outside) e)

Reagent capacity- adequate

to conduct 4 to 5 elisa test

simultaneously f) Precision :

( at 10 ul)< 5 % Precision (at

100ul )< 2.5%

Incubator: Ambient & heated module capacity- 4 each Same, no change required.

Micro plate washer: should have 8 channels for

aspiration. 8 channels for dispensing 1-8 wash cycles.

Wash solution- container with level detector, multi

reagent washer module, Should have dispensing

accuracy residual volume < 5 ul per well. Waste bottle

should have level sensor.

Same no change required

Microplate reader : a) 8 measurement channel b)

wavelength range- 400-800 nm & must have 405,

450,492 & 620 nm filter c) Accuracy better than +-

10% d) Resolution 0.001-0.100 c) built in shaking with

programmable speed & time f) measuremnt mode:

single & dual wavelength reading ( preferably 450 &

620 nm)

Same no change required

Warranty Period 2 Years nd AMC 3 years: Uptime of

equipment should be 98% and its down time is less than

2 %. Service time for Mumbai 4 hours and out of

Mumbai 24 hours

Same no change required Please see Note.

Sr No-5 SEMI AUTO ANALYSER52 M/s. Transasia

Biomedicals Ltd

Sr No-5 SEMI

AUTO ANALYSER

51 M/s. Transasia

Biomedicals Ltd

Fully Automated

ELISA reader

Sr.

No

Tender

No.


It should Be Microprocessor controlled,programmable

semi auto analyser to perform routine biochemistry

tests(including end point,fixed time,bi-chromatic &

kinetic assays),enzyme immunoassays (with

multistandard curve calibration & memorization ) etc.


It should offer a minimum of 150 open user definable

chemistry parameters with 1000 test patient results

storage facility.


JUSTIFICATION:- Memory storage necessary for follow up patients to retrieve data.

It should have a peltier controlled reading block and

aflow cell volume of 33uL with temperature

programmable for 25,30 & 37 C .


It should not require aspiration volume more than200uL Same, no change required.

It should have closed or open vial sample analysis

system

Not applicable to Semi Auto Analyser

JUSTIFICATION:- to be deleted as it is applicable in cell counter

No Change.

Should offer built in quality control system Same, no change required.

It should have facility for automatic zero setting and

repeat measurement by read key.


It should be able to perform monochromatic and

bichromatic measurements.


Flow cell with peristaltic pump should be part of main

unit.


It should have 6-8 narrow band static interferance filter

( range minimum 340-700)


The software should be user friendly with LCD display

and built in full thermal printer with connectivity to

external printer ,direct keyboard facility.


It Should have facility to store reagent blank O.D and

two level QC memory should be available with

photometric range from 0 to 2.5 O D .


52 M/s. Transasia

Biomedicals Ltd

Sr No-5 SEMI

AUTO ANALYSER

Sr.

No

Tender

No.


The software should be user friendly and guide the

programmer step by step.It shoulld have access

keys/touchscreen to select parameter directly and

alphanumeric patient ID.


Should have capacity to store at least 200 numeric

patient results


The manufacturer/supplier should have full fledged

service force and good installation base for the quoted

equipment


It should be CE or US FDA approved. Same, no change required


Should provide two years comprehensive warranty for

the quoted model and also quote AMC for five years

seperately Company Should provide technical support

,required spare parts and comnsumables for five years

after warranty period.

Same, no change required. Please see Note.

Demonstration Compulsory Same, no change required.

Should provide training to the end users Same, no change required.

Should provide operitating and service manual Same, no change required.

Power supply:- 230V +- 15% 50 Hz _+ 3% Same, no change required.

Tropicalisation :1.Operating room temp upto 40*C

2. Storage room temp upto 60* C 3.Relative humidity

upto 90% non condensing


Should provide System Compatible UPS preferably sine

wave based with duration of four hours

Semi auto analyser manufacturers do not manufacture UPS ,it is outsourced,

JUSTIFICATION:- If the capacity for back up is higher ,then a separate tender maybe

called so that reputed UPS manufacturers can participate

Should provide System

Compatible UPS preferably

sine wave based with

duration of Two hours

Should be CE & US FDA approved point No 16 ,repeated



approved

Warranty period 2 years and AMC 3 years Point No 17 ,repeated

JUSTIFICATION:- Clarification in specs needed

Please see Note.

Uptime of the equipment should be 98% and down time

is less than 2% service time for mumbai in 4 hours and



52 M/s. Transasia

Biomedicals Ltd

Sr No-5 SEMI

AUTO ANALYSER

Sr.

No

Tender

No.


General specification: System should include sample

predilution, dispensing reagents, multipippetting, plate

incubation, plate washing, plate shaking, plate reading

and data management with QC


Should be able to perform Elisa test for HIV 1 &2,

HBsAg,HCA,VDRL and MP

Should be able to perform Elisa test for HIV 1 &2, HBsAg,HCA, Syphilis (VDRL)

and Malaria.

JUSTIFICATION:- Clarification needed in the specs

Should be able to perform

Elisa test for HIV 1&2,

HBsAg, HCV, Syphilis and

Malaria.

Running mode: Batch wise continuous loading Running mode: Batch wise

JUSTIFICATION:- Ekisa tests are batch wise tests and continuous loading in

batchwise tests have no meaning

Should have robotic arm (1-2, rotatable upto 270 for

plate transportation

should have robotic arm (1-2, with plate transportation

Rotatable 270 deg, is a closed specification

Parsllel sample pipetting for high speed performance Same. No change required

Lot recording and Control Same. No change required

Full data processing & evaluation with integrated QC Same. No change requiredIntegrated liquid level detection, reagent specific liquid

handling.


Liquid Control monitoring system for liquids, waste &

reagents


System should be open for use with any Elisa kit Same. No change required

should be CE & USFDA approved Should be CE / USFDA approved

JUSTIFICATION:- As discussed in the meeting

Vendor must supply All required containers like Buffer

bottles, reagent containers etc.


Safety features Same. No change required

Liquid detection Same. No change required

Clot detection Same. No change required

Color monitoring clock Same. No change required

Lot management Same. No change required

Positive barcode identification of all labware (samples,

microplate, reagents, conrols etc)

Positive barcode identification of all labware (samples)

JUSTIFICATION:- NACO supplies do not have barcoded reagents and micoplates. It

makes the systme closed and conflict with spec 1.09

Equipment built in software to mange multiple Elisa Same. No change required


Biomedicals Ltd

Fully Automated

ELISA reader

Sr.

No

Tender

No.


RS232 connectivity & data sharing ability with

software


Integrated with software which converts data in ASTM

or ASCII format & communicates with other software


Integrated Quality Control (Levey Jennings Chart)

should be operated


Plate Capacity- 4 plates upgradable to 6 plates Plate Capacity -4 plates Or Plate Capacity-4plates with 2 plates equivalent elisa

processor as standby

JUSTIFICATION:- There is no system upgradable to 6 plates. Moreover all other

specs will change to 6 lates systen. Clarification needed in specifications.

Sample capacity:120-180 samples tube position having

continuous loading

Sample capacity: 120-180 samples tube position. Suggested to make minimum 100

Samples position

JUSTIFICATION:- Batch systems have no use of continuous loading.

pipetting system: a) Pipetting Channels 2/4 pipetting

Channels (washable or disposable tips) b) volume

range: 10-1000 ul c) Needle size: 1000ul, d) Needle

wash must be present in the system for complete wash

of needles ( inside & outside) e) Reagent capacity

adequate to conduct 4 to 5 elisa test simultaneously f)

Precision: (at 10 ul) 5% Precision (at 100ul) 2.5%

pipetting system: a) Pipetting Channels 2/4 pipetting Channels (washable or

disposable tips) b) volume range: 10-1000 ul c) Needle size: 1000ul, d) Needle wash

must be present in the system for complete wash of needles ( inside & outside) e)

Reagent capacity adequate to conduct 4 to 5 elisa test simultaneously f) Precision: (at

10 ul) 5% Precision (at 100ul) 2.5%

JUSTIFICATION:- Needles are outdated, robotic probes are the latest

Incubator: Ambient & heated module capacity-4 each Same. No change required

Micro plate washer: should have 8 channels for

aspiration. 8 channels for dispensing 1-8 wash cycles.

Wash solution- container with level detector, multi

reagent washer module, Should have dispensing

accuracy residual volume 5 ul per well. Waste bottle

should have level sensor.


Microplate reader: a) 8 measurement channel b)

wavelength range-400-800 nm & must have 405, 450,

492 & 620 nm filter c) Accuracy better than +-10% d)

Resolution 0.001-0.100c) built in shaking with

programmable speed & time f) measurement mode:

single & dual wavelength reading (preferably 450 &

620 nm)



Biomedicals Ltd

Fully Automated

ELISA reader

Sr.

No

Tender

No.


Warranty Period 2 Years nd AMC 3 years: Uptime of

equipment should be 98% and its down time is less than

2% Service time for Mumbai 4 hours and out of

Mumbai 24 hours

Same. No change required Please see Note.

General Specifications:- General specifications:-

system should include sample pre

dilution, dispensing reagents, multi pipetting, plate

incubation,

plate washing, plate shaking, plate reading & data

management

with Q.C.

JUSTIFICATION:- 1. Should have multiple options for sample dilution, Microplate,

tube, intip dilution offers flexibility.

2. Direct Loading of Kit reagent bottles into the system to avoid reagent

contamination and reduce cost.

3. Air pressure monitoring for all sample and reagent pipetting to ensure accuracy and

safety.

No change

CE & US FDA Should be CE or US FDA Should be CE or US FDA

55 E-189 M/s. Bio-Rad

Laboratories Pvt.:td

Blood group & cross

match

1. Company should provide single antigen card for antigen negative blood.

2. Company should provide cards for details work up of Positive DAT.

3. Company should provide asian cell panel for antibody screening.

4. Company shuld provide quality control kit for Cross Match, Antibody Screening,

Grouping.

5. Company should provide different cards for patient DVI- and donor DVI+

Vendor should provide

microplate as well as gel

card. (System compatible).

Vendor should sperately

quote microplate as well as

price of various gel cards.

1. Company should provide

single antigen card for

antigen negative blood.


cards for details work up of

Positive DAT.


asian cell panel for antibody

screening.

4. Company shuld provide

quality control kit for Cross

Match, Antibody Screening,

Grouping.


different cards for patient

DVI- and donor DVI+

Specimen Slide throughput of atleast 200

slides/hourupto 600 slides per hour

Specifications through put should be atleast 400 to 600 slides per hour

Justification:- There is huge price difference between 200 throughput machine and

600 throughput systems.

Reagent stations, Slide rack as per i tender specifications does not fit in 200 through

put system.

atleast 200slides per hour.E-190 &

191

M/s. Trivitron

Health Care Pvt

Ltd.

190-Automated

Slide Stainer & 191-

Semi Auto Analyzer.


Biomedicals Ltd

Fully Automated

ELISA reader

56

54 E-189 M/s. Bio-Rad

Laboratories Pvt.:td

Elisa Processor

Sr.

No

Tender

No.


Should be CE & US FDA Approved Should be CE OR US FDA Approved

JUSTIFICATION:- CE has equivalent criteria's of FDA. But CE is applicable to all

countries and US FDA is applicable to US & European

countries only.

Should be CE OR US FDA

Approved

Warranty Period 2 years and AMC 3 years Warranty Period 2 years

JUSTIFICATION:- There is confusion between point no 21and 27, were in it is

normal practice of DHS to provide warranty of 2 years and freeze prices of AMC for

next 5 years. AMC for 3 years should be removed from point no 27.

Please see Note.

It Should have facility for automatic Zero setting and

repeat measurement by read key

Specifications Should have facility for automatic Zero setting.

JUSTIFICATION:- Repeat Measurement by direct key can

gives false results if repeat key is used during kinetic tests. During kinetic tests the

reaction is over by end of the time

period and by pressing repeat key as there is no reaction taking place hence will give

WRONG results.

No change

Warranty Period 2 years and AMC 3 years Warranty Period 2 years.

There is confusion between point no 21and 27, were in it is normal practice of

DHS to provide warranty of 2 years and freeze prices of AMC for next 5 years.

AMC for 3 years should be removed from point no 25.

Please see Note.

It shoule offer a minimum of 150 open user definable

chemistry parameters with 1000 test patient results

storage facility

JUSTIFICATION:- Memory Storage necessary for follow up patients to retrieve data. No Change.

Should provide System Compatible UPS preferable sine

wave based with duration of four hours

Semi auto analyser manufacuturers do not manufacture UPS, it is outsource,

JUSTIFICATION:- If the capacity for back up is higher, then a separate tender maybe

called so that reputed UPS manufacturers can participate.

Should provide System

Compatible UPS preferable

sine wave based with

duration of Two hours

Should be CE & US FDA approved Justification:- As agreed in the meeting Should be CE or US FDA

approved

Warranty period 2 years and AMC 3 years Justification:- Clarification in specs needed. Please see Note.

Eleganlty designed & Fabricated Water Bath with Lid

and Thermometer stand

JUSTIFICATION:-As you have asked for microprocessor based digital one. So it

does not require thermometer.

Thermometer stand is to be deleted.

No Change

Outer wall: Made of Mild Steel duly powder coated

after surface treatment.

JUSTIFICATION:-It should be fully Stainless steel outer as well as inner because it

is always filled with water & being S.S. Construction it will have rushed free

operation.

No Change

Inner Chamber: It is rectangular in construction & is

made of SEAMLESS (Mild steel stainless sheet

polished bright)

JUSTIFICATION:-nner chamber also should be S.S. for rushed free operation. It is

also recommended to have SEAMLESS inner chamber for leak proof operation. As

mentioned in specification, mild steel stainless sheet does not exist.

Inner chamber also should be

S.S. And SEAMLESS

E-190 &

191

M/s. Trivitron

Health Care Pvt

Ltd.

190-Automated

Slide Stainer & 191-

Semi Auto Analyzer.


Biomedicals Ltd.

Semi Auto Anayser


Surgical &

Scientific Co.

Water Bath

56

Sr.

No

Tender

No.


Chamber Size (mm): 240(L)X 150(W)X 50(D) approx. JUSTIFICATION:-Chamber Size should be approximate (270 mm x 130mm x 120

mm) +- 10mm Depth Should be minimum at least 120 mm so that test tube rack can

be immersed in water. This size is regular size for serological water bath.

Dimensions are approximate

.No Cahnge

Should be CE & USFDA approved JUSTIFICATION:- It should be CE or US FDA approved Manufacturer should be

ISO Company.

should be CE or US FDA

approved

Elegdniiy designed & Fdbricdied Woier Both with Lid

and Thermomeier slanci.

JUSTIFICATION:- Thermome'rer is nci required as H is a microprocessor based

digilal baih 8. it will direcl readoul lor lemperalure on LED display.

No Cahnge

Outer wall : Made of Mild Steel duly powderCooled

aiier surface ireairnen'f.

Wafer bath is always filled with waler l. hence it is essenlial lo have compiere

Stainless Sleel conslruclion lor rust-free operallon.

No Change

lnner Chamber: ll ís reclangular in construction & is

made of seamless (Mild steel stainless sheet polished

bright)

it is recommended to have seamless inner chamber for leak proof operation as water

bath is always filled with water & hence it is essential to have complete stainless steel

construciton for rust-free operation.

Inner chamber also should be

S.S. And SEAMLESS

serological Water

Bath


Surgical &

Scientific Co.

Water Bath

59 E-191 M/s.MEDICA

INSTRUMENT

MFG CO.

Sr.

No

Tender

No.


Heating Element: Embedded heater element plate It is recommended to use immersion type tubular heater for faster heat transfer. No Change

Temperature Controller: Micro Processor Based Digital. Micro-processor based temperature controller with LED display. No Change

Chamber Size (mm): 240(L)X150(W)X50(D) approx. Length should be: 250 +- 10mm, width should be: 130+-10mm, Depth should be

atleast 120 mm so that test tube racks can be property immersed in water. Running

Regular Bath Size available in market is : 250X130X120mm

Dimensions are approximate

.No Cahnge

Should be CE & USFDA approved It should be CE or USFDA approved. Manufacturer should be ISO 13485 certifited . should be CE or USFDA

approved.

3. Inner Chamber: It is rectangular in construction & is

made of seamless (Mild steel stainless sheet polished

bright)

JUSTIFICATION:- Inner chamber should be stainless still rathar than mild steel

couters.

No Change

6. Heating Element: Embedded heater element plate. SS tabular heater instead of Plate No Change

9.Chamber Size(mm): 240(L)X 150(W)X 50(D)

approx.

Size 240 X 150 X 100 mm fine requested Dimensions are approximate

.No Cahnge

Should be CE & USFDA approved We request you to remove as there are many more manufacturers are available with

count from Pg.1 (Elegantly designed & Fabricated Water Bath with Lid and

Thermometer stand.)

should be CE or USFDA

approved.

12. Uptime of equipment should be 98% and down time

is less than 2% Service time for Mumbai in 4 hours and


Service time for Mumbai - One days

out of Mumbai- Three days

Service time for Mumbai - 12

Hrs

Out of Mumbai- Three days

61 E-191 M/s. Thermolab Water Bath Diamension Thermometer stand & up time & down

time of the water bath.

1. Diamension of the Water bath. (Internal & External) in L X W X D.

. As depth is mentioned as 50 mm

2. Thermometer Stand

3. Uptime & downtime of the Instrument

No Change

Note :-

Please refer Tender documents of Tender No.E-183 to E-191 Point No. 22.2 As per G.R. dated – 1st February, 2013

Annual maintenance Contract & CMC Should read as follows :-

(a) The tenderer will have to agree to enter into comprehensive maintenance contract (CMC) @ 5% of the ordered value of the equipment for the period of 5 years after completion of Warrantee Period.

(b) Tenderer will have to agree for Annual Maintenance Contract (AMC) @ 0.5% in Mumbai and 1% in other area after completion of CMC period.

(c) The Supplier will have to submit the Bank Guarantee from Nationalized/Scheduled Bank for the amount of AMC/CMC value. In case of non-compliance of AMC/CMC obligations, the tenderer will be liable to pay a penalty as

appropriate including blacklisting. Such Penalty shall be recovered from the amount of Bank Guarantee submitted.

(d) Payment for AMC/CMC on yearly basis will be made by the end user at the end of year after satisfactory performance report.

Last Date of Sale & Preparation of Bid is Extended up to 05.10.2013 up to 13.00 Hrs.

Closing of Bid is 05.10.2013 at 13.01 Hrs to 17.00 Hrs .

Date of Bid Submission is 05.10.2013 at 17.01 Hrs to 9.10.13 up to 14.00 Hrs .

Opening of Bid is 9.10.13 at 14.01 Hrs to 17.30 Hrs.

Jt. Director of Health Services,

( Procurement Cell ) Mumbai

serological Water

Bath

60 E-191 M/s. Smita

Scientific

Water Bath

59 E-191 M/s.MEDICA

INSTRUMENT

MFG CO.

Sr.

No

Tender

No.


Sr.

No

Tender

No.


.

pre-bid minutes e-tender no. 183 to e-191 ( meeting...

Documents