amendment to prebid meeting held on dt. 16.03.2019 …osmcl.nic.in/sites/default/files/prebid...

49
Page 1 of 49 AMENDMENT TO PREBID MEETING HELD ON DT. 16.03.2019 OF THE TENDER FOR SUPPLY & INSTALLATION OF CARDIOLOGY, RADIOLOGY & ANESTHESIA EQUIPMENT’S AT CARDIAC CARE HOSPITAL, JHARSUGUDA AND AT SCBMCH-CUTTACK Bid Ref. No.: OSMCL/2018-19/CARDIAC CARE/31 Total No. of prospective bidders/ representatives present in the pre-bid meeting are Twenty Five (25). The amendment to technical specification of the tender items and techno-commercial points is attached at Annexure-A and Annexure-B. Annexure-A AMENDMENT TO TECHNICAL SPECIFICATION Queries raised and received from the prospective bidders Original Technical Specification Clarifications/ Amendments in response to the queries. ITEM NO.1 (CATH LAB) AND ITEM NO.2 (CATH LAB (for SCB)) Under Operational Requirement, The requirement of 3D Rotational Angiography and area of application may be specified. Or Requested to delete this point. Under Operational Requirement, 3D Rotational Angiography should be available. Amended The requirement of “3D Rotational Angiography” is deleted from the specification. Pg.58 &63 1. Gantry (Pt.no.1): Celling/ floor mounted gantry providing full body coverage without repositioning of patient. Gantry must have 3 working position for easy operation Celling /Floor mounted gantry providing full body coverage without repositioning of patient. Gantry must have 0, 90, -90deg working position for easy operation from 3 sides of the patient Amended Celling/ floor mounted gantry providing full body coverage without repositioning of patient. Gantry must have 3 working position for easy operation. Pg.58&63 1. Gantry (Pt.no.2): Facility for motorized positioning/ rotation of stand may be either from the ceiling or from floor pivot. Or The point may be deleted. Or Generalize as movement should be manual with electromagnetic locking mechanism. Facility for motorized positioning/rotation of stand from the ceiling pivot by +/-90 degrees for improved workflow Amended Facility for motorized positioning/rotation of stand from the ceiling or floor pivot by +/-90 degrees for improved workflow. Pg.58&63 1. Gantry (Pt.no.2): Patient access must be possible from either left or right side. 15 deg. /sec or higher rotation speed with non-contact sensing mechanism. Or Patient access must be possible from either left or right side. 25 deg. /sec or Patient access must be possible from either left or right side. 25 deg. /sec or higher rotation speed with non-contact sensing mechanism. Amended Patient access must be possible from either left or right side. 25 deg. /sec or higher rotation speed with non-contact sensing mechanism or collision protection switches.

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Page 1: AMENDMENT TO PREBID MEETING HELD ON DT. 16.03.2019 …osmcl.nic.in/sites/default/files/Prebid Amendment...page 1 of 49 amendment to prebid meeting held on dt. 16.03.2019 of the tender

Page 1 of 49

AMENDMENT TO PREBID MEETING HELD ON DT. 16.03.2019 OF THE TENDER FOR SUPPLY & INSTALLATION OF CARDIOLOGY, RADIOLOGY & ANESTHESIA EQUIPMENT’S AT CARDIAC CARE HOSPITAL, JHARSUGUDA AND AT SCBMCH-CUTTACK Bid Ref. No.: OSMCL/2018-19/CARDIAC CARE/31

• Total No. of prospective bidders/ representatives present in the pre-bid meeting are Twenty Five (25).

• The amendment to technical specification of the tender items and techno-commercial points is attached at

Annexure-A and Annexure-B.

Annexure-A

AMENDMENT TO TECHNICAL SPECIFICATION

Queries raised and received from

the prospective bidders

Original Technical

Specification

Clarifications/

Amendments in response

to the queries.

ITEM NO.1 (CATH LAB) AND ITEM NO.2 (CATH LAB (for SCB))

Under Operational Requirement,

The requirement of 3D Rotational

Angiography and area of application

may be specified.

Or

Requested to delete this point.

Under Operational Requirement,

3D Rotational Angiography should

be available.

Amended

The requirement of “3D

Rotational Angiography” is

deleted from the

specification.

Pg.58 &63 1. Gantry (Pt.no.1):

Celling/ floor mounted gantry providing

full body coverage without repositioning

of patient. Gantry must have 3 working

position for easy operation

Celling /Floor mounted gantry

providing full body coverage

without repositioning of patient.

Gantry must have 0, 90, -90deg

working position for easy

operation from 3 sides of the

patient

Amended

Celling/ floor mounted gantry

providing full body coverage

without repositioning of

patient. Gantry must have 3

working position for easy

operation.

Pg.58&63 1. Gantry (Pt.no.2):

Facility for motorized positioning/

rotation of stand may be either from

the ceiling or from floor pivot.

Or

The point may be deleted.

Or

Generalize as movement should be

manual with electromagnetic locking

mechanism.

Facility for motorized

positioning/rotation of stand from

the ceiling pivot by +/-90 degrees

for improved workflow

Amended

Facility for motorized

positioning/rotation of stand

from the ceiling or floor pivot

by +/-90 degrees for

improved workflow.

Pg.58&63 1. Gantry (Pt.no.2):

Patient access must be possible from

either left or right side. 15 deg. /sec or

higher rotation speed with non-contact

sensing mechanism.

Or

Patient access must be possible from

either left or right side. 25 deg. /sec or

Patient access must be possible

from either left or right side. 25

deg. /sec or higher rotation speed

with non-contact sensing

mechanism.

Amended

Patient access must be

possible from either left or

right side. 25 deg. /sec or

higher rotation speed with

non-contact sensing

mechanism or collision

protection switches.

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higher rotation speed with non-contact

sensing mechanism or collision

protection switches.

Pg.59&63 1.Gantry (Pt.no.2):

Gantry rotation (Cranial-to-caudal)

angulation cannot be +/- 120 deg. and

+/- 90 deg. respectively.

Or

LAO/RAO +/-120 deg. and Cranial to

caudal+/- 45deg

Rotational angle +90 degree and -90

degree and orbital angle +45 degree

and -45 degree

Or

Rotational angle: RAO120 to LAO 120,

Sliding Angle: CRA 50 to CAU 90

Gantry rotation (Cranial-to-

caudal) angulation +/- 120 deg.

and +/- 90 deg. respectively.

Amended

Gantry rotation (Cranial-to-

caudal) angulation should be

+/- 45 deg. and LAO and

RAO should be +/- 120 deg.

and +/- 90deg. respectively.

Pg.59&63 1.Gantry (Pt.no.4):

The throat depth of the gantry should

be 90cm or more.

The throat depth of the gantry

must be 100cm or more for better

groin access.

Amended

The throat depth of the

gantry should be 90cm or

more.

Pg.59&64 2.Table (Pt.no.6):

Extendable arm rest both sides and

Elbow guard. Motorized up/down, free

floating 4way table top, least radiation

attenuation, at least 250 kg. instead of

200Kg. + at least 100kgs of additional

weight for resuscitation in the metal

free overhang area without having to

retract the table back on its base.

Extendable arm rest both sides

and Elbow guard. Motorized

up/down, free floating 4way table

top, least radiation attenuation, at

least 200 kg + at least 100kgs of

additional weight for resuscitation

in the metal free overhang area

without having to retract the

table back on its base.

No Change

Pg.59&64 2.Table (Pt.no.8):

Table tilting movement may be deleted.

At least +/- 15degree tilt must be

possible. No Change

Pg.59&64 2.Table (Pt.no.9):

Motorized longitudinal imaging

coverage should be 120cm or more

Motorized longitudinal travel

120cm or more.

No Change

Pg.59&64 2.Table (Pt.no.10):

Transverse Travel +/-14 cm or more

Manual transverse travel +/-

17.5cm or more.

Amended

Manual transverse travel +/-

14cm or more.

Pg.59&64 2.Table (Pt.no.10):

Accessories with table and

mattress:

Remove or make it optional

Accessories with table and

mattress:

Peripheral filter set

Amended

Peripheral filter set or any

equivalent technique for

same purpose should be

available.

Pg.59&64 3.Detector (Pt.no.1):

Detector size may be 30x30cm instead

of 30x40cm detector.

Or

A 30 x 40cm rectangular detector

that can be rotated by 90 degrees

for better flexibility and projection

angles depending upon area of

No change

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20 X 20 cm or more square digital flat

panel detector for all projections

depending on area of interest.

interest.

Pg.59&64 3.Detector (Pt.no.2):

The digital output of the flat detector

may be is 2k x 2k image matrix instead

of 2k x 2.5k at 16 bits instead of 14bit

depth.

14bit (Toshiba)

Or

Flat Detector of latest generation, the

digital output of the flat detector must

be is 1k x 1k image matrix at 14 bits

depth for the largest mode

Or

Flat Detector of latest generation, the

digital output of the flat detector must

be is 2k x 2.5k image matrix at 16 bits

depth for the largest mode.

Flat Detector of latest generation,

the digital output of the flat

detector must be is 2k x 2.5k

image matrix at 14 bits depth for

the largest mode.

Amended

Flat detector of latest

generation, the digital output

of the flat detector must be is

2k x 2k image matrix at 16

bits depth for the largest

mode.

Pg.59&64 3.Detector (Pt.no.3):

System must have at least 4 imaging

modes.

System must have at least six

imaging modes. No change

Pg.60&64 3.Detector (Pt.no.5):

Minimum pixel pitch may be of at least

194 x 194 microns or lower instead of

160 micron or lower.

Or

Pixel size should be 200 microns or less.

Or

Min. pixel pitch of at least 194

(microns) or lower for better resolution.

Min. pixel pitch of at least 160

(microns) or lower for better

resolution.

No change

Pg.60&64 4.Image Processing &

Storage (Pt.no.5):

System must have a fully digital 1K

image processing for improved detailed

visualization of small structures

Or

System must have a fully digital 1K

image processing for improved detailed

visualization of small structures. System

must have storage capability of at least

1,00,000 images at matrix size of 1024

x 1024.

System must have a fully digital

2K image processing for improved

detailed visualization of small

structures.

Amended

System must have a fully

digital 1K or 2K image

processing for improved

detailed visualization of small

structures.

Pg.60&65 5. X-ray Generator:

Pulsed X-ray for (subtracted) acquisition

up to 30 frames/sec. for vascular

applications.

Pulsed X-ray for (subtracted)

acquisition up to 6 frames/sec. for

vascular applications.

No Change

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Pg.60&65 6. Tube (Pt.no.1):

A noise-free, water/oil cooled, dual

focus rotating anode x-ray tube with

spiral groove bearing technology and

fluid lubricant/ closed loop water chiller

for faster cooling must be provided.

A noise-free, oil cooled, dual

focus rotating anode x-ray tube

with spiral groove bearing

technology and fluid lubricant for

faster cooling must be provided.

No Change

Pg.60&65 6. Tube

Tube power should be 80KW or more. Additional point for X-ray tube. No Change

Pg.60&65 6. Tube (Pt.no.2):

Minimum Anode Heat Capacity may be

3.5 MHU or more instead of 2.4 MHU or

more

Or

5MHU or more

Or 3MHU or more

Minimum Anode Heat Capacity:

2.4 MHU or more

Amended

Minimum Anode Heat

Capacity: 3 MHU or more

Pg.60&65 6. Tube (Pt.no.3):

Cooling rate or Anode Heat Dissipation

of x-ray tube should be 900 kHU/min or

more

Or

Cooling rate or Anode Heat Dissipation

of x-ray tube must be 460 kHU/min or

more.

Cooling rate or Anode Heat

Dissipation of x-ray tube must be

more 500 kHU.

Amended

Cooling rate or Anode heat

dissipation of x-ray tube must

be 500 kHU or more.

Pg.60&65 6. Tube (Pt.no.4):

X-ray tube may have primary or

secondary grid switching.

Or

X-ray tube must have secondary/ inbuilt

grid switching.

X-ray tube must have secondary

grid switching.

Amended

X-ray tube should have

primary or secondary grid

switching or inbuilt grid

switching.

Pg.60&65 6. Tube (Pt.no.5):

Deliverable power may be 3000W on

continuous fluoro power instead of

3200W.

Or

System must be capable of delivering

minimum 2200W continuous fluoro

power.

System must be capable of

delivering minimum 3200W

continuous fluoro power.

Amended

System should be capable of

delivering minimum 2200W

continuous fluoro power.

Pg.60&65 6. Tube (Pt.no.6):

Additional beam filtration of at least 1.0

mm Al/Cu equivalent.

Different filter sizes and types to be

freely selectable at the table side for

any patient weight for maximum

radiation safety to staff and patients.

Additional beam filtration of at

least 1.0 mm Cu equivalent.

Different filter sizes and types to

be freely selectable at the table

side for any patient weight for

maximum radiation safety to staff

and patients.

Amended

Additional beam filtration of

at least 1.0 mm Al/Cu

equivalent.

Different filter sizes and types

to be freely selectable at the

table side for any patient

weight for maximum

radiation safety to staff and

patients.

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Pg.60&65 6. Tube (Pt.no.10):

The point should be deleted.

Parallel display of live and

roadmap image for optimal guide-

wire navigation.

No Change

Pg.61&66 7. Image Display

Monitors (Pt.no.1):

Four/Six LCD/TFT flat 19 inch may be

supplied instead of Two monitors/

System should have 55inch or more

large monitor to display live image,

reference & hemodynamic

Or

Two backup monitors for live and

reference

Two LCD/TFT flat 19inch

Monochrome Monitors with wide -

viewing angle, high luminance,

high contrast, flicker free,

distortion-free: one for live image

& one for reference.

Amended

Four/Six LCD/TFT flat 19inch

monochrome monitors with

wide -viewing angle, high

luminance, high contrast,

flicker free, distortion-free:

one for live image & one for

reference.

Pg.62&67 Accessories (Pt.no.8):

The point “Radiation protection Visor

X4” may be clarified.

Radiation protection Visor X4

Amended

The point “Radiation

protection Visor X4” should

be understood as Lead

goggles for vision protection.

Pg.58&67 Operational

Requirement (Pt.no.17):

Lead-free aprons may be asked.

Lead aprons: 6nos. should be

supplied.

Amended

Lead-free aprons: 6nos.

should be supplied.

Pg. 61&66 Quantification Software

Suggestion to add: The system should

have stent Enhancement software with

fade and fade out and it should be

operated in the control room.

Additional specification to

Quantification Software

Amended

The system should have

stent enhancement software

with fade and fade out and it

should be operated in the

control room.

Pg. 61&66 Quantification Software

Suggestion to add: FFR License

Additional specification to

Quantification Software

Amended

The system should have FFR

license.

Pg. 61&66 Image Display Monitors

(Pt. no.4):

Monitors brightness should be at least

800 cd/m2 instead of 600 cd/m2.

Monitors brightness should be at

least 600 cd/m2

Amended

Monitors brightness should

be at least 600 cd/m2 or

more.

ITEM NO.3 (IABP- INTRA AORTIC BALLOON PUMP)

Pg.70 System Configuration

(Pt.no.4.3):

Intra Aortic Balloon Catheter for adults,

Size 34cc may be amended to

30cc/34cc- 4nos., Size: 40cc - Qty: 6

Nos. Reusable Invasive Blood pressure

transducer system with pressure flush

device system. Qty: 2 Nos.

Intra Aortic Balloon Catheter for

Adults, Size: 34cc - Qty: 4 Nos,

Size: 40cc - Qty: 6 Nos. Reusable

Invasive Blood pressure

transducer system with pressure

flush device system. Qty: 2 Nos.

Amended

Intra Aortic Balloon Catheter

for Adults, Size: 30cc/34cc -

Qty: 4 Nos, Size: 40cc - Qty:

6 Nos. Reusable Invasive

Blood pressure transducer

system with pressure flush

device system. Qty: 2 Nos.

ITEM NO.4 (3D ECHO MACHINE WITH TEE)

Pg.72 Technical Specification

(Point. No 6)

The clause should be removed as it will

System should be capable of

supporting LIVE 3D matrix

No Change

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restrict participation. transducer capable of supporting

up-to 2000 elements for

exceptional LIVE 3D image quality

on the matrix array transducer.

Pg.72 Technical Specification

(Point. No.9)

The clause should be removed as it is

vendor specific.

System should offer LIVE X –

Plane imaging with manipulation

of orthogonal plane-lateral,

elevation and rotation should be

possible. Elevation beam steering

should be possible so that ideal

en-face views for measurements

can be obtained without moving

the transducer.

No Change

Pg.72 Technical Specification

(Point. No.17)

The clause should be removed as it is

vendor specific.

Based strain like VVI, AFT and

TMQ should be offered. These

should be offered both OFF-LINE

as well as online.

No Change

Pg.72 Technical Specification

(Point. No 20)

Should have great ergonomic design

with dual touch control panel of

minimum size 10-11 inches, which is

comfortable and convenient to avoid

user muscle strain & stress injuries.

System should have a 21-inches high

resolution flat panel medical grade

display monitor with nearly infinite

position adjustment

Or

System should have a 22 -inch high

resolution flat panel medical grade

display monitor with nearly infinite

position adjustment.

Should have great ergonomic

design, with dual touch control

panel of minimum size-10-11

inches, which is comfortable and

convenient to avoid user muscle

strain & stress injuries. System

should have a 24-inch high

resolution flat panel medical

grade display monitor with nearly

infinite position adjustment

Amended

Should have great ergonomic

design, with dual touch

control panel of minimum

size 10 to 11 inches, which is

comfortable and convenient

to avoid user muscle strain &

stress injuries.

System should have atleast

21inch or more high-

resolution flat panel medical

grade display monitor with

nearly infinite position

adjustment.

Pg.72 Technical Specification

(Pt.no.26):

Hard disk capacity of 5TB may not be

available.

System should have storage

facility of images, loops in the

hard disk drive of 5 TB or more.

System should be able to transfer

Images & clips to CD& DVD

media.

Amended

System should have storage

facility of images, loops in the

hard disk drive of 1 TB or

more System should be able

to transfer Images & clips to

CD & DVD media.

Pg.72 Technical Specification

(Pt.no.26.e):

Should have 2D Convex Probe

Convex Array Matrix Transducer

for adult LIVE 3D with frequency

ranging from 1-5 MHz.

No Change

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ITEM NO.5 (ULTRASOUND MACHINE WITH COLOR DOPPLER)

Pg.74 Product Quality Standard:

Both the machine and the real time

shear wave electrography should be

USA FDA certified.

Should be USFDA and European

CE approved product.

Amended

The whole system along with

probes should be USFDA and

European CE approved.

Pg.74 Technical Specification (Pt.

no.3):

Digital processing channels should be

more than 4,00,000

The system should have 60,000

or more digital processing

channels.

No Change

Pg.74 Technical Specification (Pt.

no.7):

The system should have a frame rate

on receive of over 2500 frames per

second or more

The system should have a frame

rate on receive of over 5000

frames per second or more.

No Change

System should have fusion and

navigation software as a standard part

of configuration or upgradation should

be available.

Additional point to specification No Change

Pg.75 Technical Specification (Pt.

no. 19, bullet pt.1):

Should have real time shear wave

elastography mode capable of

performing Real time Shear Wave tissue

elastography imaging with convex and

linear probe.

The real time shear wave

elastography mode should be

capable of performing;

Real time Shear Wave tissue

elastography imaging with

convex, linear, 3D, micro convex

and endocavity transducers.

Amended

Should have shear wave

elastography mode capable

of performing Real time

Shear Wave tissue

elastography imaging on

convex and linear probe.

Pg.75 Technical Specification (Pt.

no. 19, bullet pt.5):

User adjustable elasticity-box size with

a Display Depth should be 0 to 8cm or

more instead of 0 - 12cm.

Should be User adjustable

elasticity-box size with a Display

Depth: 0 - 12cm

Amended

Should be user adjustable

elasticity-box size with a

display depth: 0 to 8cm or

more.

Pg.75 Technical Specification (Pt.

no. 19, bullet pt.6):

Point need to be deleted

Elastography Quantification

should be available with pixel

accurate absolute or discreet

Elasticity values on all

transducers.

Amended

The feature of elastography

quantification should be

available with pixel accurate

absolute or discrete elasticity

values.

Pg.75 Technical Specification (Pt.

no. 27, bullet pt.6):

Convex transducer should be single

crystal type.

All the transducers are of single

crystal type.

No Change

Convex and linear transducer

should be single crystal type.

Following features should be

added

• Elastography on Convex Probe &

Linear Probe

• System should have 4 active probe

ports

Additional point to specification

Amended

System should have atleast 4

active ports.

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ITEM NO.6 (PORTABLE ECHO)

Pg.77 Technical Specification (Pt.

no. 3):

System weight should be maximum

7.5kg. or less with the internal battery.

The system should be very light

with maximum of 6.5 kgs.

Amended

The system should be very

light with maximum of 7.5

kg. or less with internal

battery but without the probe

attached.

Pg.77 Technical Specification (Pt.

no. 5):

Display size may be 15inch or more

instead of 17inch.

System must have minimum 17

inch high resolution integrated

flat panel display monitor with

minimum monitor resolution of

1050 x 1040.

Amended

System must have minimum

15 inch or more high

resolution integrated flat

panel display monitor with

minimum monitor resolution

of 1050 x 1040.

Display size may be 14inch or more

instead of 17inch.

Pg.77 Technical Specification (Pt.

no. 5):

System must be offered with 2D M-

mode, color M-mode, anatomical M-

mode, color flow, pulse wave doppler,

continuous wave Doppler and

directional color power Doppler

System Must be offered with 3D

M-mode, color M-mode,

anatomical M-mode, color flow,

pulse wave Doppler, continuous

wave Doppler and directional

color power Doppler

Amended

System must be offered with

2D M-mode, color M-mode,

anatomical M-mode, color

flow, pulse wave Doppler,

continuous wave Doppler and

directional color power

doppler and tissue doppler

imaging.

Pg.77 Technical Specification (Pt.

no. 14):

3D frame is not applicable for such

system.

System must be offered with 3D

frame rate of at least 750

frames/second. Acquisition frame

rate should be clearly mentioned

in the technical quote.

Amended

System must be offered with

2D frame rate of at least 750

frames/second. Acquisition

frame rate should be clearly

mentioned in the technical

quote.

Pg.78 Technical Specification (last

point)

Requirement of TEE probes may be

clearly specified.

Should be compatible with TEE

probes supplied with the main

machine

Amended

Should be compatible with

TEE probes supplied with the

main machine and separate

TEE probe should also be

quoted and supplied. The

cost of the TEE probe shall

have to be quoted in

separate price bid format in

pdf file (Format-B) as unit

price breakup quoted in the

excel BoQ file.

ITEM NO.7 (PORTABLE COLOR DOPPLER ULTRASOUND MACHINE)

Pg.78 Technical Specification (Pt.

no. 11)

Flat LCD/TFT monitor of at least 14” or

more with flicker free image

Flat LCD/TFT monitor of at least

17inch with flicker free image. No Change

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Pg.79 Technical Specification (Pt.

no. 11)

Battery capacity may be at least 30

minutes or more instead of 2hours.

On-board storage of at least

10,000 images, USB port for

connectivity to computer. Should

be able to operate both on AC

and battery. Battery pack should

be self-recharging and should last

at least for 2 hours when fully

charged.

Amended

On-board storage of at least

10,000 images, USB port for

connectivity to computer.

Should be able to operate

both on AC and battery.

Battery pack should be self-

recharging and should last at

least for 30 minutes or more

when fully charged.

Pg.79 Technical Specification (Pt.

no. 13)

Weight of the system may be specified

as mentioned in other portable item.

Additional point to specification

Amended

The system should be very

light with maximum of 7.5

kg. or less with internal

battery but without the

probes attached.

ITEM NO.8 (DIRECT DIGITAL FLAT PANEL FLUOROSCOPY & RADIOGRAPHY SYSTEM)

Pg.79 Technical Specification

Product Quality Standard:

Product may be USFDA and European

CE approved.

Should be USFDA/European

CE/BIS approved product. No Change

Pg.79 Technical Specification

Product Quality Standard:

The model should have AERB type

approved /NOC

The model should have AERB

type approved No Change

Pg.80 Technical Specification

All major components should be of

reputed make as most of the x-ray

equipment companies do not

manufacturer x-ray tube and detectors.

The most important factor is

compatibility of x-ray tube and detector

with the x-ray generator and carefully

managed exposure interlocks to avoid

any type of damage to the tube in case

of over load temperature and exposure

factors. Hence the point may be

deleted.

Or

Generator, Tube and flat panel

detector, out of three components, two

components should be from the main

manufacture

Generator & flat panel detector

should be from the main

manufacturer. In order to ensure

the quality of the equipment

Amended and Clarified as

The point “Generator & flat

panel detector should be

from the main manufacturer

in order to ensure the quality

of the equipment” is deleted

from the specification.

However, all the major

components of the system

such as generator, flat panel

detector, X-ray tube, Table,

Console, Control panel should

be clearly mentioned in the

AERB or CE certificate.

Relevant document should be

produced in the technical bid.

Pg.80 1.Table (Pt.no.1):

Floor mounted adjustable height table

with sliding table instead of floating top

of carbon fibre, scratch resistant

Floor mounted adjustable height

table with floating table top of

carbon fibre or equivalent suitable

scratch resistant surface

No Change

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surface should be provided.

Or

Height adjustment table may not be

required.

Pg.80 1.Table (Pt.no.5):

The typographical error may be

corrected as Motor Driven +90/- 45

degree or more table tilt along with

digital angle display.

Or

May be corrected as Motor Driven

+90/- 20 degree or more table tilt along

with digital angle display.

Or

May be corrected as Motor Driven

+90/- 90 degree or more table tilt along

with digital angle display.

Or

May be corrected as Motor Driven

+90/- 30 degree or more table tilt along

with digital angle display.

Motor Driven +900/- 450 degree

or more table tilt along with

digital angle display

Amended

Motor Driven +90/-20 degree

or more table tilt along with

digital angle display.

Pls specify the requirement of the

pressure injector with specification.

Injector interface (Additional

requirement to specification)

Amended

Pressure injector should be

provided with the system.

Pg.80 1.Table (Pt.no.1):

Single Digital flat panel Detector of size

35 x 43cm or more, made of

amorphous silicon with CSI scintillator.

Single Digital flat panel Detector

of size 43 x 43cm or more, made

of amorphous silicon with CSI

scintillator.

Amended

Single digital flat panel

Detector of size 35 x 43cm or

more made of amorphous

silicon with CSI scintillator.

Pg.80 1.Table (Pt.no.2):

Image Matrix 2688x2208 or better

Image Matrix 2800x2800 or

better

Amended

Image Matrix 2688x2208 or

better.

Pg.80 1.Table (Pt.no.8):

Patient Load: 200kg or more Patient Load: 160kg or more No Change

Pg.80 2.Digital Detector (Pt.no.3):

DQE >65% at may be 0.05lp/mm

instead of 0lp/mm.

Or

DQE>55 % at 0lp/mm

DQE>65 % at 0lp/mm

Amended

DQE >65% at should be

0.05lp/mm.

Pg.80 2.Digital Detector (Pt.no.5):

Digitization depth should be 16 bit

instead of 14bit.

Or

Digitization depth 12 bits or more

Digitization depth 14 bits or more No Change

Pg.80 2.Digital Detector (Pt.no.6):

Pixel size should be 160 micron or less.

Pixel size should be 150 micron or

less.

No Change

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Pg. 81 3.Monitors

Medical display should be 19”/21” LCD

for high –contrast (1.0/2.0 mega pixel)

Or

Display size may be 19inch or more

instead of 24inch.

Or

Medical grade 19” or more LCD

(1.0Mega pixel)

Medical grade 24” HD (2.0Mega

pixel)

Amended

Medical display should be

atleast 19inch or more LCD

for high contrast resolution of

minimum 1.0 mega pixel or

more.

Pg. 81 4.X-ray Generator Pt.1:

Radiography: mA range should be up to

1000mA.

mA Range: 10-1000mA

Amended

Radiography: mA range

should be up to 1000mA.

Pg. 81 4.X-ray Generator Pt.2:

The point may be deleted.

Touch screen operation for

multiprogramming. User defined

programs.

Amended

The point “Touch screen

operation for multi-

programming. User defined

programs” is deleted.

Pg. 81 4.X-ray Generator Pt.2:

Fluoroscopy: mA range: up to 20mA for

better fluoroscopy

mA range:0.5 to 5mA or better No Change

Pg. 81 4.X-ray Generator Pt.2:

Fluoroscopy

k v Range 50-125 kv or better

m A Range: 0.3 to 4mA or better

Fluoroscopy

(i) kv Range 40-110 kv or better

(ii) mA Range: 0.5 to 5mA or

better

No Change

Pg. 81 5.X-ray Tube (Pt.no.1)

One number dual focus x-ray tube

mounted on table stand with rotating

anode with 9000-10000rpm should be

provided.

Or

One number single couch mounted

Dual Focus X-ray tube with rotating

anode with 9000 rpm or more.

Or

X-ray tube for fluoroscopy should be

mounted in an over couch as all the

fluoroscopy system come with mounted

over couch

One number ceiling suspended

/Floor Mounted Dual Focus X-ray

tube with rotating anode with

9000 rpm or more

Amended

One number ceiling

suspended or Floor Mounted

or Couch mounted dual focus

X-ray tube with rotating

anode with 9000 rpm or

more.

Pg. 81 5.X-ray Tube (Pt.no.5)

Longitudinal movement 95cm or more

instead of 100cm or more.

Or

Longitudinal movement of tube across

the patient must be 90 cm or more.

Longitudinal movement of tube

across the patient must be 100

cm or more.

Amended

Longitudinal movement 90cm

or more.

Pg. 82 6.Direct Digital Imaging

System (Pt.no.1)

Field of view of at least 17inchX 14 inch

or more

Field of view of at least 40cms or

more No Change

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Pg. 82 6.Direct Digital Imaging

System (Pt.no.6)

Pulse fluoroscopy should be provided

with variable frame rate selection.

Additional point to specification No Change

Pg. 82 6.Direct Digital Imaging

System (Pt.no.7)

Trans lateral radiography may be

deleted.

Or

Vertical Bucky stand to perform

radiography may be added.

Provision for trans lateral

radiography should be available.

Amended

The point “Trans lateral

radiography” is deleted.

Pg. 82 7. Control Console, Image

Processing, Image display, Image

storage system and Transmission

Pt.5

System should have on line dosimeter

on the console to display actual

radiation dose or display on small

console.

System should have on line

dosimeter on the console to

display actual radiation dose.

Amended

System should have on line

dosimeter on the console to

display actual radiation dose

or display on small console.

Pg. 82 7. Control Console, Image

Processing, Image display, Image

storage system and Transmission

Pt.6

The feature may be optional feature.

Fully loaded Digital Subtraction

Angiography with all features.

Amended

The point” Fully loaded

Digital Subtraction

Angiography with all

features” is not mandatory.

Pg. 82 7. Control Console, Image

Processing, Image display, Image

storage system and Transmission

Pt.9

Multiple image display of 9 on 1 format.

Multiple image display of 16

images and 4 images.

Amended

Multiple image display of 9 or

more in one format.

Pg. 82 7. Control Console, Image

Processing, Image display, Image

storage system and Transmission

Pt.13

The point may be deleted.

Storage of fluoroscopic images

Amended

Storage of fluoroscopic

images is not mandatory.

Past performance in India/ Worldwide

should be allowed. In India Only No Change

ITEM NO.9 (FIXED X-RAY WITH MOTORIZED TABLE (600mA HIGH Frequency)

Pg.83 Product Quality Standard

Should be USFDA & European CE

approved model.

Or

Should be European CE / USFDA

approved model.

Should be USFDA/European CE/

BIS approved product No change

Pg.83 1. Generator (Pt. no.a)

Generator frequency may be 100kHz

instead of 200MHz or more.

Or

Generator should be high

frequency (200 MHz or more) for

constant output.

Amended

Generator should be high

frequency 100KHz or more

for constant output.

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Generator frequency may be 40Khz or

more.

Pg.83 1. Generator (Pt. no.f)

It should have automatic exposure

control device. Exposure time= 0.001

sec to less than 7second

It should have automatic

exposure control device exposure

time= 0.1 sec to less than

5second

Amended

It should have automatic

exposure control device.

Exposure time should be 0.1

sec to less than 7second.

Pg.84 2. X-ray Tube (Pt. no.e)

Tube with anode heat storage capacity

600 KHU or more instead of 300KHU or

more.

Tube with anode heat storage

capacity 300 KHU or more. No Change

ITEM NO.10 (C-ARM IMAGE INTENSIFIER)

Pg.85 1-X-ray Generator (Pt. no.2)

Power output may be 2.5KW or more.

Or

Power output: 3.5KW or more.

Power output: 6.0 KW or more

Amended

Power output: 2.5 KW or

more

Pg.85 2-Control (Pt. no.8)

mAs range should be 0.1 to 100mAs or

higher instead of 0.1 to 300mAs.

Or

Radio timer:0.1 to 200mAs in 20 steps

In built radio timer that enables

to select mAS from 0.1 to 300 in

25steps for radiography.

Amended

In built radio timer that

enables to select mAS from

0.1 to 200mAs or more in

20steps or more for

radiography.

Pg.85 2-Control (Pt. no.6)

Request for 25mA or more Radiography mA: 80mA or more No Change

Pg.85 3.X-ray Tube (Pt. no.1)

Anode type may be Stationary Anode

instead of rotating anode.

Rotating Anode

Amended

Anode should be stationary

or rotating type.

Pg.85 3.X-ray Tube (Pt. no.2)

Small Focal Spot:0.6mm and Large

focal spot: 1.0mm & heat storage

capacity:80KHU

Or

Small Focal Spot:0.6mm and Large

focal spot: 1.6mm. Anode heat storage

capacity:56KHU or more and tube

housing capacity: 1100KHU or more

Small focal spot:0.3mm (max.

Power:5kw) Large focal

spot:0.6mm (Max power :17KW)

Anode heat storage capacity

:250KHU or more

Amended

Small Focal Spot:0.6mm or

less and Large focal spot:

1.0mm or more. Anode heat

storage capacity: 56KHU or

more

Pg.86 4. CCD Camera

High resolution compact CCD camera

½‖ size. Total pixels: 1280(H) X

1024(V) should be there.

High resolution compact CCD

camera ½ inch size. Total pixels:

752(H) X 582(V) should be there.

No Change

Pg.86 5. Monitor

Monitor:27” or more with split screen

along with trolley

Two nos. 21” high resolution

monitors along with a trolley

Amended

Should have two nos. 21inch

or more high resolution

monitors or single monitor of

27inch or more with split

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screen provided along with a

trolley.

Pg.86 8. C-Arm Mobile Stand

Horizontal Travel 200mm. Horizontal Travel 210±10 mm No Change

Pg.86 9. Digital Image Memory

Systems:

Temp & Permanent storage up to

200images

Digital Image Memory Systems:

Temp & Permanent storage up to

100 frames

Amended

Temporary and Permanent

storage of 200 images or

more.

Pg.87 12. Quality Standard

Should be USFDA and European CE/BIS

approved product.

Should be USFDA/European

CE/BIS approved product. No Change

ITEM NO.12 (PORTABLE MOBILE X-RAY)

Pg.89 12. Pt.3

It should have powerful and rugged 4.0

kW high frequency (100KHz or more)

generators easy to plug to a standard

outlet 15AmP.

It should have powerful and

rugged 4.0 kW high frequency

generators easy to plug to a

standard outlet 15AmP.

No Change

Pg.90 Fixed Anode Tube

Focuses: 1.8mm or less Focuses: 0,6& 1,5 mm

Amended

Focuses: 1.8mm or less

Pg.90 Fixed Anode Tube

Exposure time: 10 ms to 5 s Exposure time: rom 1 ms to 10 s

Amended

Exposure time: 10ms to 5

sec. or more.

Pg.90 Fixed Anode Tube

The line has been repeated. May be

deleted.

Focal spot not more than 1mm.

Amended

The line “Focal spot not more

than 1mm” is deleted.

Pg.90 Product & Manufacturer

Quality Standards:

Should be USFDA and European CE/BIS

approved product.

Should be USFDA/ European

CE/BIS approved product. No Change

ITEM NO.13 (ANAESTHESIA WORKSTATION)

Pg.91 1. Gas Management

The system should be having an

integrated/modular Anaesthesia gas

module to measure inspired & expired

values of O2, N2O and all agents with

MAC value and should also display

these parameters with the CO2

waveform on the display of the

Anaesthesia Workstation.

Additional point to specification

Amended

The system should have an

integrated/modular

anaesthesia gas module to

measure inspired & expired

values of O2, Air or N2O and

all agents with MAC value

and should also display these

parameters with the CO2

waveform on the display of

the Anaesthesia Workstation.

Pg.91 1. Gas Management Pt.No.5

Electronic /mechanical Gas mixing

measurement and display od accurate

Electronic Gas Mixing

measurement and display for

accurate gas flows and mixing

No Change

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gas flow and mixing

Pg.91 1. Gas Management

Pt.No.11

The point should be deleted.

Should have decision support tool

for optimizing FGF No Change

Pg.91 1. Gas Management

Pt.No.14

Should be supplied from OEM of the

item.

Reusable adult and paediatric

autoclavable silicone circuit -

02nos. for each

No Change

Pg.91 1. Gas Management

Pt.No.19

Total agent consumption in ml should

be measured and displayed on the

screen.

Total agent consumption in ml

should be measured & displayed

on the screen, with a log of at

least 3 cases

No Change

Pg.91 1. Gas Management

Pt.No.21

Pause gas Flow (Preferable) – turns off

all gases for one minute during

intubation or suctioning / cardiac

bypass mode

Pause gas Flow (Preferable) –

turns off all gases for one minute

during intubation or suctioning

Amended

Pause gas flow: turns off all

gases for one minute during

intubation or suctioning or

cardiac bypass mode

Pg.91 1. Gas Management

Pt.No.19 to 21

The three points should be deleted.

• Total gas consumption for 02,

N20 or Air, to be measured and

displayed on the display screen

• Total Agent consumption in ml

should be measured and

displayed on the screen, with a

log of at-least 3 cases.

• Pause Gas flow (preferable)-

turns off all gases for one minute

during intubation or suctioning

(optional)

No Change

Pg.92 2. Vaporizer:

Vaporizer should be USFDA approved. Additional point to specification

Amended

The vaporiser being an

integrated part of the

anaesthesia system should

also have USFDA approval.

Pg.92 2. Vaporizer Pt.no.7:

Vaporizer should have extended

delivery range of 0-5vol%

Vaporizer should have extended

delivery range of 0-6vol%

Amended

Vaporizer should have

extended delivery range of 0

to 5vol.%

Pg.92 3. Breathing system Pt.no.2:

Total circuit volume shall not exceed 3L

in case of pneumatic driven system.

Total circuit volume shall not

exceed 2.7 L, including absorber

volume.

Amended

Total circuit volume shall not

exceed 3L in case of

pneumatic driven system.

Pg.92 3. Breathing system Pt.no.8:

Components coming in contact with

patient gas shall be disposable or

Components coming in contact

with patient gas shall be

Amended

Components coming in

contact with patient gas shall

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autoclavable except for ventilator part

including flow sensors. Ventilator with

flow sensor should be autoclavable.

disposable or autoclavable.

be disposable except flow

sensors.

Pg.92 3. Breathing system Pt.no.9:

FIO2 monitoring should be available &

should be paramagnetic.

FIO2 monitoring should be

available. No Change

Pg.92 3. Breathing system

The CO2 absorber should have bypass

facility.

Additional point No Change

Pg.92 4. Ventilation Pt.no. 1:

The workstation should have integrated

anaesthesia ventilator system and

screen size (TFT/LCD) of 15 inches

Or

The workstation should have integrated

anaesthesia ventilator system and

touch screen display of screen size

(TFT/LCD of 10” or more

Or

The workstation should have integrated

Anaesthesia Ventilator system and

screen size (TFT/LCD) of 15" with

touchscreen interface.

The workstation should have

integrated anaesthesia ventilator

system and screen size (TFT/LCD)

of 7 inches

Amended

The workstation should have

integrated anaesthesia

ventilator system and screen

size (TFT/LCD) of 10 inches

or more.

Pg.92 4. Ventilation Pt.no. 3:

Visible bellows for visual indication of

leak in the system or electronic alarm

for leakage in system to be displayed.

Visible bellows for visual

indication of leak in the systems

Amended

Visible bellows for visual

indication of leak in the

system or electronic alarm for

leakage in system to be

displayed.

Pg.92 4. Ventilation Pt.no. 4:

Delete dual mode and add SIMV/PS

Dual mode PCV, VCV and PS

needed for difficult lung

ventilation, Obese patient

laparoscopy, breathing heart and

neonatal

Amended

PCV, VCV and PS should

available for difficult lung

ventilation, obese patient

laparoscopy, breathing heart

and neonatal.

Pg.92 4. Ventilation Pt.no. 7:

Delete apnea back up

SIMV and pressure support

ventilation with apnea backup

ventilation should be offered

Amended

SIMV and pressure support

ventilation should be offered.

Pg.92 4. Ventilation Pt.no. 10:

The point should be deleted.

Or

The point should be retained.

Compliance measurement and

trending (Preferable): Measures

and displays the patients

compliance to offer an view of the

patient lung condition (lung

spirometry including PV and FV

loops)

Amended

Should have facility to

measure and display the

patient compliance for view

of the patient lung condition.

Pg.92 4. Ventilation Pt.no. 11:

Please remove the complete point from

the existing technical specification

Vital capacity & cycling

procedures (preferable): to

automate the procedure for

Amended

Should have lung recruitment

tool for optimal peep setting.

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Or

The point should be retained.

optimal peep setting to recruit the

lungs.

Pg.92 4. Ventilation Pt.no. 12:

Tidal volume: 20ml to 1400ml

Tidal volume: 20ml to 1500ml in

VCV, TV=minimum in PCV mode

Amended

Tidal volume should be 20ml

to 1400ml. or more in VCV,

TV=minimum in PCV mode

Pg.92 4. Ventilation Pt.no. 14:

Electronic PEEP: off 0-20 cmH2O

Electronic PEEP: Off ,4 to 20cms

H2O No Change

Pg.92 4. Ventilation Pt.no. 15:

Settable I:E ratio pause, Trigger (0.5-

10L/min). Insp pressure from 5 up to

50 cms H2O

Settable I:E ratio pause, Trigger

(0.2-10L/min). Insp. pressure

from 5 up to 50 cms H2O

Amended

Settable I:E ratio pause,

Trigger (0.5 to 10L/min).

Insp pressure from 5 up to

50 cms H2O.

Pg.92 4.Ventilation Pt.no. 23:

Machine should have mounting

capability of one O2 and one N2O pin-

index cylinder.

Machine should have mounting

capability of two O2 and two

N2O pin-index cylinder

Amended

Machine should have

mounting capability of two O2

and one N2O pin-index

cylinder.

Pg.94 5.Display Pt.no. 1:

12”colour display with USFDA

certification

Or

Around 15" Color TFT Touchscreen

Display with high visibility and highly

visible alarm light mounted on the

Anaesthesia Workstation

Around 15" Color TFT Display

with high visibility and highly

visible alarm light mounted on the

Anaesthesia Workstation.

Amended

Should have 12" or more

color TFT Display with high

visibility and highly visible

alarm light mounted on the

Anaesthesia Workstation.

Pg.94 5.Display Pt.no. 5:

Battery backup 3hrs.instead of 2hrs.

Should have an individual battery

backup minimum of 2hrs. No Change

Pg.94 5. Display Pt.no. 8:

Basic Patient side module for Measuring

Parameters like 5 lead ECG, NIBP, low

perfusion SPO2, RESP, 2xIBP, 2xTemp.

Additional modules to measure

parameters like level of Depth of

Anesthesia monitoring and NM

monitoring. EtCo2(side stream) with

Anesthesia Gas monitoring should be

offered as an option as the Anesthesia

Gas Module is to be supplied with

Anesthesia Workstation

Basic Patient side module for

Measuring Parameters like 5 lead

ECG, NIBP, SPO2,RESP,2xIBP,

2xTemp,EtCo2(side stream),

Anesthesia Gas monitoring, Level

of Depth of Anesthesia monitoring

and NM monitoring

Amended

Basic Patient side module

should be supplied for

measuring parameters like 5

lead ECG, NIBP, low

perfusion SPO2, RESP, 2xIBP,

2xTemp.

Should have additional

module for EtCO2(side

stream/main stream),

Anesthesia Gas monitoring,

Level of Depth of Anesthesia

monitoring and NM

monitoring.

Pg.94 Accessories Pt.no.1

Lead ECG Cable with diathermy

protection (2 Nos.)

Standard use for ECG (2 in no.)

No Change

Pg.94 Accessories Pt.no.6

NM monitoring cables recording option

EtCO2-10 filter assemblies and 10

tubing for anaesthesia gas

Amended

EtCO2-10 filter assemblies

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for printing up to 3 waveforms instead

of 4 waveforms and alphanumeric data,

and trends etc.

monitoring, depth of anaesthesia

monitoring (with 25 disposable

leads), NM monitoring cables,

recording option for printing up to

4 waveforms and alphanumeric

data, and trends etc.

and 10 tubing for anaesthesia

gas monitoring, depth of

anaesthesia monitoring (with

25 disposable leads), NM

monitoring cables, recording

option for printing of

minimum 3 waveforms and

alphanumeric data, and

trends etc.

Pg.94 Breaking Mechanism

The system should have a central

locking system.

Front caster wheel should have a

braking mechanism

Amended

The system should have a

central locking system.

Pg.95 Upgrades

The point should be deleted.

Facility of automatic electronic

charting solution with data

archival facility for patient

monitor and ventilator data. It

should be single centralized

server based for multiple beds

upgrade

Amended

The point “Facility of

automatic electronic charting

solution with data archival

facility for patient monitor

and ventilator data. It should

be single centralized server

based for multiple beds

upgrade” is deleted.

Pg.95 Quality standards

The anaesthesia Workstation \model

should be European CE approved and

patient monitor model should be both

USFDA and European CE approved

The anaesthesia Workstation and

patient monitor should USFDA

and European CE approved

No Change

Pg.95 Technical Specification (Pt.

no.-8 Up gradation)

The requirement of mentioned up

gradation should be clearly specified as

optional has been written.

Or

1.Mainstream/Side Stream/Mico Stream

EtCO2 monitoring should be possible.

3. Cardiac Output module for

measuring the cardiac output using the

thermo-dilution technique with total

four Invasive pressure channels in the

monitor.

5. SvO2/ScVO2 monitoring or similar

software with Calibration kit.

6. Facility for Mainstream/

Sidestream/Micro stream EtCO2 with

dedicated accessories for Adult,

Paediatric& Neonates (25 each) for

Sidestream and microstream and

atleast 5 reusable airway adapter each

for adult & for paediatric/neonatal

1. Mainstream EtCO2 monitoring

should be possible

2. EEG-minimum 4 channels with

display of spectra

3. Cardiac Output module for

measuring the cardiac output

using the thermo-dilution

technique with four Invasive

pressure channels

4. Module for monitoring Cardiac

Output

5. Facility for monitoring

transcutaneous O2 /CO2 and

ScVO2 monitoring or similar

software with Calibration kit

6. Facility for Micro stream EtCo2

with dedicated accessories for

Adult, Paediatric& Neonates

(25 each)

7. Facility of automatic electronic

charting solution with data

archival facility for patient

Amended

The patient monitor should

have facility for following

parameters and shall have to

be quoted accordingly.

1. EEG-minimum 4 channels

with display of spectra

2. Cardiac Output module or

provided with separate

standalone Cardiac Output

monitor for measuring the

cardiac output using the

thermo-dilution technique

with four invasive

pressure channels or

3. Facility for monitoring

transcutaneous O2 /CO2

and ScVO2 monitoring or

similar software with

Calibration kit.

4. Accessories for

Sidestream EtCo2 for

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patients. monitor and ventilator data. It

should be single centralized

server based for multiple beds

upgrade.

Adult, Paediatric (25 each)

ITEM NO.14 (MULTI PARA PATIENT MONITOR)

Quality Standard:

USFDA/CE approved by notified body

USFDA and European CE

approved No Change

Pg.95 Technical Specification (Pt.

no.-A Basic Monitor)

Monitor module for ECG, HR, RR, SPO2

and NIBP, IBP (Combined or separate

or integrated) and EtCO2, AGM and CO-

modular type with capability of

accepting atleast 2 modules.

Or

Monitor should be modular type, with

capability of accepting at least 4

modules/ smart module/Flexi port.

Or

All parameters should be

interchangeable between the monitors

without help of any service engineer.

Monitor should be modular type,

with capability of accepting at

least 4 modules.

Amended

Should be a modular monitor

with module for ECG, HR, RR,

SPO2 and NIBP (Combined or

separate or integrated) and

separate individual module

for 2 IBP, EtCO2, AGM and

Cardiac Output of modular

type with capability of

accepting atleast 4 modules.

All modules should be

interchangeable.

Pg.95 Technical Specification (Pt.

no.-A Basic Monitor Pt.2)

Display size may be atleast 15inch or

more instead of 12inch.

Or

Should have a minimum 12 inch TFT

color touch display screen or more

Should have a minimum 12 inch

TFT color display screen or more.

Amended

It should have a minimum 12

inch or more TFT color touch

display screen.

Pg.96 Technical Specification (Pt.

no.-A Basic Monitor Pt.7)

Should be capable of numerically

displaying information of all parameters

for which waveforms are being

displayed as well as displaying numeric

values of all additional modules

attached.

Should be capable of numerically

displaying information of all

parameters for which waveforms

are being displayed as well as

displaying numeric values of

additional parameters if more

than 4 modules are being used at

a time.

Amended

Should be capable of

numerically displaying

information of all parameters

for which waveforms are

being displayed as well as

displaying numeric values of

all additional modules

attached.

Pg.96 A. Basic Monitor Pt. no.3

Should be capable of displaying 120

hour trends for the monitored

parameters

Should be capable of displaying

24 hour trends for the monitored

parameters

Amended:

Should be capable of

displaying 72hour trends for

the monitored parameters.

Pg.96 A. Basic Monitor Pt. no.6

Should be able to display at least 10

waveforms or more with facility of over

lapping pressure waveform

Should be able to display at least

6 wave forms with facility of

overlapping pressure waveforms

No Change

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Pg.96 A. Basic Monitor Pt. no.8

Should have DICOM & HL7 facility

Should have DICOM facility and

connectivity to computer local

area network (LAN)(preferable)

Amended

Should have DICOM or HL7

facility and connectivity to

computer local area network.

Pg.96 B. Modules Pt. no.1)

ECG, Respiration SPO2, NIBP & Dual

Temp should be in a single module for

space saving

Or

Should be supplied with individual each

parameter module or smart flexi port

module to connect any parameter.

It should be possible for each

monitor accept modules

1.ECG+ Respiration: One

2.Oxygen saturation (pulse

Oxymeter/SpO2: One

3.Non-Invasive Blood Pressure

(NIBP): One

Temperature: Two

Amended

Should be a modular monitor

with module for ECG, HR, RR,

SPO2 and NIBP (Combined or

separate or integrated) and

separate individual module

for 2 IBP, EtCO2, AGM and

Cardiac Output of modular

type with capability of

accepting atleast 4 modules.

All modules should be

interchangeable.

Pg.96 Technical Specification (Pt.

no.-B Modules)

Under Oxygen saturation for pulse

Oxymeter, low perfusion and motion

condition functionality should be

mentioned.

Oxygen saturation (Pulse

Oxymeter/SpO2): One

Amended

Oxygen saturation (Pulse

Oxymeter/ SpO2): One

Should operate under low

perfusion and motion

tolerance condition and

should have either MASIMO

SET or NELLCOR OXIMAX

technology in the probe as

well as monitor.

Pg.96 B. Modules Pt. no.7

EtCO2 may be either side stream or

main stream or micro stream.

End-tidal CO2 monitoring (EtCO2)

Main stream: One

Amended

End-tidal CO2 monitoring

(EtCO2) Mainstream/ Side

stream: One

Pg.97 E. Pulse Oxymeter Pt. no.1

Should display plethysmograph and

Spo2 values with perfusion index also

Should display plethysmograph

and SpO2 values

Amended

Should display

plethysmograph and SpO2

values with perfusion index.

Pg.97 E. Pulse Oxymeter Pt. no.5

Adult & paediatric SpO2 Probes Adult or paediatric SpO2 Probes

Amended

Reusable adult or paediatric

probes (finger probes-2 nos.

and multisite-2 nos.) as

required should be provided

with each monitor

Pg.97 H. Cardiac Output Pt. no.1

May have Cardiac output monitoring:

one instead of Continuous cardiac

output monitoring: one

Or

Cardiac output of thermodilution

method may be allowed.

Continuous cardiac output

monitoring: one No Change

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Pg.97 J. End-tidal CO2 Pt. no.4

The point may be deleted.

Sampling tubes:10nos to be

provided with each module No Change

Pg.97 K. Printer Pt. no.1

Built in thermal printer should be

provided which should be able to print

data from monitor.

Single central printer should be

provided which should be able to

print data from selected monitor

Amended

Printing facility is not

required.

Pg.97 K. Printer Pt. no.3

Should be able to print real-time or

saved output of 2 channels.

Should be able to print real-time

or saved output of 3 channels

e.g. ECG and 2 invasive

pressures.

Amended

Printing facility is not

required.

Pg.98 L. AGM Module

AGM module: CO2:0-99mmHg instead

of 0 to 100mmHg.

CO2:0-100mmHg

Amended

AGM module: CO2: 0 to

99mmHg

Additional Specification: Monitor

should be upgradable to have

spirometer, non-invasive haemoglobin

and ScVo2 through interchangeable

modules.

Manufacturer should be capable to

upgrade ICU monitoring system to an

USFDA approved integrated clinical

information system with automated

charting of same make

Additional point to specification No Change

ITEM NO.15 (MULTI PARAMETER MONITOR WITH CENTRAL WORKSTATION)

Pg.99 A. Basic Monitor Pt. no.1

Monitor should be modular type with

capability of accepting at least 4

modules/ smart module

Or

All the modules of all parameters

should be interchangeable.

Or

Monitor should be modular type with

capability of accepting atleast 3

modules

Or

Monitor module for ECG, HR, RR, SPO2

and NIBP, IBP (Combined or separate

or integrated) and EtCO2 module with

Central workstation having capability of

atleast 2 modules.

Monitor should be modular type

with capability of accepting

atleast 4 modules

Amended

Should be a modular monitor

with module for ECG, HR, RR,

SPO2 and NIBP (Combined or

separate or integrated) and

separate individual module

for 2 IBP, EtCO2 and Cardiac

Output of modular type with

capability of accepting atleast

4 modules. All modules

should be interchangeable.

Pg.99 A. Basic Monitor Pt. no.2

It should have a minimum 17inch TFT

touch screen color Display screen or

more

Or

Should have a minimum 12inch TFT

It should have a minimum 12inch

TFT color display screen or more

Amended

Should have a minimum

12inch or more touch screen

color display screen.

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touch screen color display screen or

more

Pg.99 A. Basic Monitor Pt. no.3

Should be capable of displaying 120

hours trends for the monitored

parameters

Or

Should be capable of displaying

72hours trends with full disclosure for

the monitored parameters

Should be capable of displaying

24hour trends for the monitored

parameters

Amended

Should be capable of

displaying 72hour trends for

the monitored parameters

Pg.99 A. Basic Monitor Pt. no.6

Should be able to display at least 10

waveforms or more with facility of over

lapping pressure waveform

Or

Should be able to display at least 6

wave forms.

Should be able to display at least

6 wave forms with facility of

overlapping pressure waveforms

No Change

Pg.99 A. Basic Monitor Pt. no.7

Should be capable of numerically

displaying information of all parameters

for which waveforms are being

displayed, as well as displaying numeric

values of additional parameters if more

than 2 modules are being used at a

time.

Should be capable of numerically

displaying information of all

parameters for which waveforms

are being displayed, as well as

displaying numeric values of

additional parameters if more

than 4 modules are being used at

a time.

No Change

Pg.99 A. Basic Monitor Pt. no.8

Should have DICOM & HL7 facility

Or

Should have connectivity to computer

local area network (LAN) (preferable)

Should have DICOM facility and

connectivity to computer local

area network (LAN) (preferable)

Amended

Should have DICOM or HL7

facility and connectivity to

computer local area network.

Pg.99 B. Modules

It should be supply with individual each

parameter module or smart flexi port

module to connect any parameter

Modules: It should be possible for

each monitor to accept modules

No Change

Pg.99 B. Modules

ECG, Respiration SPo2, NIBP & Dual

Temp should be in a single module for

space saving

It should be possible for each

monitor accept modules

1.ECG+ Respiration: one

2.Oxygen saturation (pulse

Oxymeter/Spo2:one

3.Non-Invasive Blood Pressure

(NIBP):one

Temperature: Two

Amended

Should be a modular monitor

with module for ECG, HR, RR,

SPO2 and NIBP (Combined or

separate or integrated) and

separate individual module

for 2 IBP, EtCO2 and Cardiac

Output of modular type with

capability of accepting atleast

4 modules. All modules

should be interchangeable.

Pg.99 B. Modules pt. no. 6

Continuous /Thermo dilution Cardiac

Continuous Cardiac output

monitoring: One No Change

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output monitoring: One

Pg.100 E. Pulse Oxymeter Pt.no.1

Should display plethysmograph and

SpO2 values with perfusion index also

Should display plethysmograph

and Spo2 values

No Change

Should display

plethysmograph and SpO2

values with perfusion index.

Pg.100 E. Pulse Oxymeter Pt. no.5

Adult & paediatric SpO2 Probes Adult or paediatric SpO2 Probes

Amended

Reusable adult or paediatric

probes (finger probes-2 nos.

multisite-2 nos.) as required

should be provided with each

monitor.

Pg.101 J. End-Tidal CO2 Pt. no.1:

Side stream Monitoring of EtCO2 may

be allowed.

Or

Microstream may be asked.

Main stream Monitoring of CO2

Amended

End-tidal CO2 monitoring

(EtCO2) Mainstream/ Side

stream: One

Pg.101 J. End-Tidal CO2 Pt. no.2:

Display of pCO2 (mm Hg) and

concentration (%) may not be required.

End tidal CO2: Display of pCO2

(mmHg) and concentration (%)

Amended

The point “End tidal CO2:

Display of pCO2 (mmHg) and

concentration (%)” is

deleted.

Pg.101 J. End-tidal CO2 Pt. no.4

The point may be deleted.

Sampling tubes:10nos to be

provided with each module No Change

Pt.102 Central Monitoring Work

station- Product Quality Standard:

USFDA/CE approved by notified body

Or

Central Monitoring System (Japan) FDA

and CE approved

Or

Should be USFDA approved model.

USFDA and European CE

approved No Change

Pt.102 Central Monitoring Work

station:

Central Station Monitor of minimum 19

inch or more LED to be provided with

one laser printer and one minimum 19

inch slave monitor. All the monitors

should be connected via wired /

wireless. One CNS should be able to

connect up to 16 monitors.

Central Station Monitor of

minimum 21inch LED to be

provided with one laser printer

and one minimum 21inch slave

monitor. All the monitors should

be connected via wired / wireless.

One CNS should be able to

connect up to 30 monitors.

No Change

Pt.102 Central Monitoring Work

station:

Monitor should have the facility to

communicate bed to bed and bed to

Central without having a wired /

wireless network and the same shall

Monitor should have the facility to

communicate bed to bed and bed

to Central without having a wired

network and the same shall

provide the capability to control

and interact with remotely –

Amended

Monitor should have the

facility to communicate bed

to bed and bed to Central

with wired or wireless

network and the same shall

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provide the capability to control and

interact with remotely – viewed

parameters to maximize efficiency

viewed parameters to maximize

efficiency

provide the capability to

control and interact with

remotely viewed parameters

to maximize efficiency.

Pg.102 Central Monitoring

Workstation Pt. no.1

CNS should able to connect up to 16

monitors instead of 30 monitors.

One CNS should be able to

connect up to 30 monitors.

Amended

One CNS should be able to

connect up to 16 monitors.

Pg.102 Central Monitoring

Workstation Pt. no.6

Trend storage of CNS should be for

atleast 72hrs. instead of 24hrs.

Or

CNC should have 150 hr. stored patient

data monitoring –trends (pre & post

discharge both)

CNC should have 150 hr. event review

facility

CNS should offer wave review with 150

hr. full disclosure

CNS should have 24 hr stored

patient data monitoring – trends

Amended

CNS should have atleast 72

hrs. or more stored patient

data monitoring trends.

ITEM NO.16 (VENTILATOR)

Under Quality standard

The model should be US FDA or

European CE approved

Or

Should retain USFDA and European CE

approved.

The model should be US FDA and

European CE approved No change

Pg.103 Technical Specification (Pt.

no.2)

Microprocessor Controlled suitable for

Neonate to Adult ventilation

Microprocessor Controlled suitable

for paediatric to Adult ventilation

Amended

Microprocessor controlled

suitable for infant to Adult

ventilation.

Pg.103 Technical Specification (Pt.

no.4)

Should have built in touch color screen

TFT display of minimum 10” or more for

display of waveforms and monitored

value.

Or

Screen should be 15 inch or more for

display of waveforms and monitored

value.

Should have built in touch color

screen TFT display of minimum

12” or more for display of

waveforms and monitored value

No change

Pg.103 Technical Specification (Pt.

no.5)

EtCO2 facility may be integrated instead

of inbuilt in the ventilator.

Should have inbuilt facility to

upgrade with EtcO2. No Change

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Pg.103 Technical Specification (Pt.

no.7)

Should have automatic compliance and

leakage compensation for circuit up to

100L/Min

Automatic compliance and

leakage compensation circuit No Change

Pg.103 Technical Specification (Pt.

no.9(a)

Tidal volume should be minimum of

50ml to 2000ml.

Or

2ml Tidal Volume onwards to cover

entire range

Or

Tidal Volume:5ml to 2000ml

Tidal volume (Minimum at least

20ml, Maximum up to 2000ml) No Change

Pg.103 Technical Specification (Pt.

no.9 .b)

Inspiratory pressure (up to 60cm of

H2O or more

Or

Inspiratory pressure :0-100cmH2o for

efficient ventilation

Inspiratory pressure (up to 80cm

of H2O or more

No Change

Pg.103 Technical Specification (Pt.

no.9.c)

Respiratory should be 5 to150bpm

Respiratory should be 1-80 bpm

Amended

Respiratory should be 5 to 80

bpm

Pg.103 Technical Specification (Pt.

no.9 (i)

Pressure or Flow Trigger

Pressure and Flow Trigger No Change

Pg.103 Technical Specification (Pt.

no.9 (j)

Inspiratory flow up to 210lpm

Inspiratory flow upto 180lpm No Change

Pg.103 Technical Specification (Pt.

no.9 (l)

Volume trap may be included.

Occlusion pressure No Change

Pg.104 Technical Specification (Pt.

no.10)

The lung recruitment or lungs

protection tools software may be asked.

Additional feature

Amended

The advanced modes and

lung recruitment or lungs

protection tools software

should be provided.

Pg.104 Technical Specification (Pt.

no.11)

Request to add –ATC should be

available as a weaning parameter

Or

Newer modes like lungs protective

modes: PRVC. APRV,

Bilevel/BiVent/DuoPAP

Waning modes: Volume

Should have facility for invasive

and non-invasive ventilation No Change

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support/Spontaneous breathing

trial/NAVA

Closed loop ventilations: ASV/Smartcare

PS/BiLevel-VG/Automode

Pg.104 Technical Specification (Pt.

no.11(h))

Dedicated NIV mode should be

available.

Non-invasive ventilation in all

modes (BIPAP, CPAP) No Change

Pg.104 Technical Specification (Pt.

no.11(j))

Request to add inverse ratio ventilation

/APRV

Inverse ratio ventilation

Amended

Inverse ratio ventilation/

APRV (Airway pressure

release ventilation)

Pg.104 Technical Specification (Pt.

no.12)

Should have built in safety alarms for

Airway Pressure High & Low, Minute

Volume High & Low ,Power Failure, Low

Oxygen ,High respiratory Rate, Air

Source in – operable/Low pressure

Should have built in safety alarms

for Airway Pressure High & Low,

Minute Volume High & Low

,Power Failure, Low Oxygen ,High

respiratory Rate, Air Source in –

operable

No Change

Pg.104 Technical Specification (Pt.

no.13)

Inbuilt exhalation filter may be deleted

and detachable autoclavable expiratory

block may be added.

Or

Atleast 100 disposable exhalation filters

should be provided.

Should have inbuilt exhalation

filter

Amended

Should have inbuilt

exhalation filter or detachable

autoclavable expiratory block.

In case of exhalation filter,

100 pcs. Should be supplied

with the system.

Pg.104 Technical Specification (Pt.

no.14)

Turbine system may be allowed.

Or

The ventilator should be inbuilt turbine

driven with peak flow of 260L/Min or

more

Or

Ventilator should be Compressor

/Turbine driven and from the same

manufacturer

Or

Ventilator should be compressor driven.

Ventilator should be compressor

driven and should be of same

manufacturer

No Change

Pg.104 Technical Specification (Pt.

no.16-For humidifier)

USFDA/CE approved by notified body

USFDA and European CE

approved No Change

Pg.104 Technical Specification (Pt.

no.16-For humidifier)

Humidifier should be supplied with

proximal sensor & its warranty should

be cover up to warranty period of

Additional point to specification

Amended

Humidifier should be supplied

with proximal sensor & its

warranty should be cover up

to warranty period of

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ventilator ventilator.

It should be from OEM Hinged arm holder for holding the

circuit No Change

Pg.104 Technical Specification (Pt.

no.17)

Inbuilt nebulizer for better synchrony

with particle size less than 3 micron.

Or

Nebulization assembly compatible with

ventilator and circuit, inspiration

synchronised and particle size less than

0.3micron.

Nebulization Technology should be

ultrasonic or vibrating mesh. The

nebulizer should also have USFDA & CE

quality certificate

Nebulization assembly compatible

with ventilator and circuit

,inspiration synchronized and

particle size less than 5 micron

No Change

Pg.105 Technical Specification (Pt.

no.20)

Expiratory cassette or valve unit life

should be more than warranty period of

the machine

Expiratory unit life should be

more than 3years

Amended

Expiratory cassette or valve

unit, flow sensors and

oxygen sensors should be

covered under warranty of

the system and must be

replaced free of cost within

the warranty period.

Pg.105 Technical Specification (Pt.

no.21)

Data storage facility for at least 7days

or more

Or

Data storage facility minimum 72 hrs.

Data storage facility for at least

24hrs or more

Amended

The trend data should be

available for atleast 48 hours.

Pg.105 Technical Specification (Pt.

no.22)

Internal battery: 4-6 hours of battery

can be helpful anytime & is available

(including inbuilt air source.

Internal rechargeable battery at

least 60 min backup. No Change

Pg.105 Technical Specification (Pt.

no.23)

Flow sensors and oxygen sensors if

required during the warranty period,

company will be supplied free of cost as

& when required.

Should have flow sensors and

oxygen sensors having long life

and the company shall specify the

lifecycle and the cost of the flow

sensors and oxygen sensors at

the time of quoting the tender

Amended

Flow sensors and oxygen

sensors shall be supplied free

of cost by the supplier during

the warranty period.

Pg.105 Technical Specification (Pt.

no.24.b)

It should be from OEM

• Non-invasive ventilator masks

reusable for adult (3 sizes) and

paediatric according to age 4 sets

each

• HME filter-50nos.

Amended

The following items should

be from OEM with having

product catalogue number

• Non-invasive ventilator masks

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• Disposable circuit-50no. reusable for adult (3 sizes)

and paediatric according to

age 4 sets each

• HME filter-50nos.

Disposable circuit-50no.

Additional Specification

Automatic Rise time: Automatic rise

time setting avoids pressure overshoots

follows patient breathing pattern and

adjusting rise time automatically. This

features is now available in addition to

conventional annual rise time setting.

So clinicians has a choice to manual rise

time or auto rise time

Additional point to specification No Change

Additional Specification

Automatic exhalation sensitivity. In

addition to conventional manual

exhalation trigger sensitivity now

automatic expiratory trigger sensitivity

is available. It allows better

synchronization as ventilator adjust

automatically exhalation sensitivity

based on patient breathing pattern for

spontaneously breathing patient. So

clinician has a choice to choose from

manual exhalation or automatic

exhalation trigger sensitivity.

Additional point to specification No Change

Additional Specification

Automatic leakage compensation upto

100L/min (compared to 40l/min or

60l/min)

For success of non-invasive ventilation

Automatic leakage compensation of

upto 100L/min or more peak, flow rate

above 200L/min & Automation of Rise

Time & Exhalation sensitivity are

important criterion .We strongly

recommend higher leakage

compensation upto 100L /min which

will impact success of non invasive

ventilation.

Additional point to specification No Change

Additional Specification

High Flow oxygen Therapy: Is widely

used now and is available with most

ventilator manufacturer. Possibly to

nebulization through high flow is also

available

Additional point to specification No Change

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Additional Specification

Lung Recruitment Tool: Automatic LRT

is now available & is extremely useful

for ATDS patient

Additional point to specification No Change

ITEM NO.17 (TRANSPORT VENTILATOR)

Under Quality standard

The model should be US FDA or

European CE approved

The model should be US FDA and

European CE approved No change

Pg.105 Technical Specification

Under product quality standard, shock

proof and vibration proof certificate

should be asked for the product.

Additional point

Amended

Test reports towards shock

proof and vibration proof of

the quoted model from

accredited testing laboratory

should be furnished in the

technical bid.

Pg.105 Product Quality Standard:

The USFDA approval should specify the

ventilator model for both intra hospital

and inter /pre hospital transport

purpose for both paediatric and adult

patient with invasive as well as non-

invasive ventilation modes under

indication of use. Devices with only

generic classification as portable

/transport would be summarily rejected.

Should be USFDA and European

CE approved model. CE certificate

must be furnished by notified

agency

Amended

The model should be certified

or approved as a transport

ventilator for both paediatric

and adult patients and it

should be approved for both

intra hospital and inter /pre

hospital transport purpose

and should support for air

ambulance use.

Pg.105 Technical Specification Pt.

no. 1

Mountable transport ventilator suitable

for neonatal to adult patient

Mountable transport ventilator

suitable for paediatric to adult

patients

No Change

Pg.105 Technical Specification Pt.

no. 3

Microprocessor/ Pneumatic controlled

Microprocessor controlled No Change

Pg.105 Technical Specification Pt.

no. 4

Delete PRVC and BiPAP and request to

add CPR mode and NIV

Or

Should have following modes of

ventilation: Assist control (pressure

controlled and volume controlled) CMV,

PS, SIMV and CPAP in both Invasive

and Non-Invasive type of ventilation

Or

CPAP can be eliminated.

Should have following modes of

ventilation: Assist control

(pressure controlled and volume

controlled) CMV, PS, SIMV and

CPAP, PRVC (CMV & SIMV)

No Change

Pg.105 Technical Specification Pt.

no. 5

Display 4”or more or 6” or more

Display 8” or more

Amended

Should have inbuilt user

interface display should be 6

inch or more.

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Pg.105 Technical Specification Pt.

no. 9

Tidal volume 50 to 2500ml.

Or

Tidal Volume 5ml -2000ml.

Or

Tidal volume range 50 to 1500 ml

Tidal volume range 30 to 1500 ml No Change

Pg.105 Technical Specification Pt.

no. 9

PEEP 0 to 20cm water

PEEP 0 to 30cm of water Amended

PEEP 0 to 20cm water

Pg.105 Technical Specification Pt.

no. 10

FiO2 setting range between 21% to

100% should be seamlessly selectable

at any value as per the application

requirement.

Any fixed setting between 21% to

100% wont be acceptable.

If the device is expected to work on low

pressure oxygen source like oxygen

concentrators or flow meters then

please specifically mention that the

device should provide oxygen

enrichment on both low (up to 10psi

like flow meter/ oxygen concentrator)/

high –pressure (40 to 60 psi) oxygen

supply source.

FiO2 setting range between 21%

to 100 % setting 100% FiO2

should be mandatory

Amended

FiO2 setting range between

21% to 100% should be

seamlessly selectable at any

value as per the application

requirement.

Any fixed setting between

21% to 100% shall not be

acceptable.

Pg.106 Technical Specification Pt.

no. 11(ii)

Flow triggers 3-15L/min

Flow triggers 1-10L/min No Change

Pg.106 Technical Specification Pt.

no. 12

Both flow and pressure trigger

Trigger sensitivity -Flow Amended

Both flow & Pressure Trigger

Pg.106 Technical Specification Pt.

no. 2.4

USB and Bluetooth connectivity

Software and /or standard of

communication (where ever

required)

No Change

Pg.106 Technical Specification Pt.

no. 4.2

Battery backup minimum 6hours

Should be both main and battery

operated with minimum battery

backup of 4 hrs.

No Change

Pg.106 Technical Specification Pt.

no. 5 (Accessories)

All from OEM

Pole mounting bracket

Adult test lung

Infant test lung

Amended

The following accessories/

consumables should be from

manufacturer approved OEM

supplier having product

catalogue number. Such as

Pole mounting bracket, Adult

test lung, Infant test lung.

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ITEM NO.18 (MULTIPARA MONITOR)

Pg.106 Quality Standard

USFDA/CE approved by notified body

USFDA and European CE

approved No Change

Pg.107 A)Basic Monitor Pt. no. 1

Monitor should be modular type, with

capability of accepting at least 4

modules. All parameters should be

interchangeable between the monitors

without help of any service engineer

Or

Monitor should be modular type with

capability of accepting atleast 3

modules instead of 4 modules.

Monitor should be modular type

with capability of accepting

atleast 4 modules

Amended

Should be a modular monitor

with module for ECG, HR, RR,

SPO2 and NIBP (Combined or

separate or integrated) and

separate individual module

for 2 IBP, EtCO2 and Cardiac

Output of modular type with

capability of accepting atleast

4 modules. All modules

should be interchangeable.

Pg.107 A)Basic Monitor Pt. no. 2

It should have a minimum 17 inch TFT

touch screen color Display screen or

more

It should have a minimum 12 inch

TFT touch screen color Display

screen or more

No Change

Pg.107 A)Basic Monitor Pt. no. 3

Should be capable of displaying 120

hour trends for the monitored

parameters

Or

96-hours graphic and tabular trends of

all parameters

Should be capable of displaying

24 hours trends for the monitored

parameters

Amended

Should be capable of

displaying minimum 72hour

trends for the monitored

parameters.

Pg.107 A)Basic Monitor Pt. no. 8

Should have connectivity to computer

local area network (LAN) - (preferable).

Should have DICOM facility and

connectivity to computer local

area network (LAN) -

(preferable).

No Change

Pg.107 B)Modules Pt. no. 3

ECG, Respiration, SPO2,NIBP & Dual

Temp should be in a single module for

space saving

It should be possible for each

monitor accept modules

1.ECG+ Respiration: one

2.Oxygen saturation (pulse

Oxymeter/Spo2:one

3.Non-Invasive Blood Pressure

(NIBP):one

Temperature: Two

No Change

Pg.107 B)Modules Pt. no. 6

Continuous /Thermo dilution Cardiac

output monitoring: One

Continuous Cardiac output

monitoring: One No Change

Pg.107 B)Modules Pt. no. 7

Microstream may be allowed.

Or

Sidestream EtCO2 should be allowed.

End-tidal CO2 monitoring (EtCO2)

Main stream: One

Amended

End-tidal CO2 monitoring

(EtCO2) should be main

stream/ sidestream: One

Pg.108 E)Pulse Oxymeter Pt. no. 7

Oxygen saturation Masimo SET with PVI

It should be capable of measuring

SPO2 in low perfusion status and

motion tolerance certification in

No Change

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this regard is to be attached.

Pg.108 H)Cardiac Output Pt. no. 1

Cardiac output monitoring: one

Or

Continuous /Thermo dilution Cardiac

output monitoring

Continuous cardiac output

monitoring: one No Change

Pg.110 K)Printer Pt. no. 1

Built in thermal printer should be

provided which should be able to print

data from monitor

Single central printer should be

provided which should be able to

print data from selected monitor

Amended

Printing facility not required.

Additional Specification:

Monitor should be upgradable to have

spirometry, non-invasive haemoglobin

and ScVo2 through interchangeable

modules

Manufacturer should be capable to

upgrade ICU monitoring system to an

USFDA approved integrated clinical

information system with automated

charting of same make

Additional point to specification No Change

19.MULTIPARA METER MONITOR (ECG, HR, RR, SPO2 AND NIBP)

Pg.110 Technical Specification

(Quality Standard)

USFDA/CE approved by notified body

USFDA and European CE

approved No Change

Pg.110 Technical Specification

Should be upgradable to ETCO2,IBP and

should be in form of external modules

which can be replaced easily

Standard Parameter No Change

Pg.110 Technical Specification

ECG:

Should have following software’s

ST Mapping, QT analysis, HRV analysis

Additional point to specification No Change

Pg.110 Technical Specification

SpO2:

From MASIMO

Or

MASIMO with PVI

Spo2 technology

Amended

SpO2 technology should work

and measure on low

perfusion condition and

motion tolerance.

Pg.110 Technical Specification

SpO2:

Should have storage facility of trends

on USB

72 hours graphic and tabular

trends of all parameter No Change

Pg.111 Technical Specification

Pulse Rate:

15” color LCD/TFT

Or

12inch colour touch LCD with high-

12inch colour LCD with high-

resolution displays patient

parameter.

Amended

Should have 12inch colour

touch LCD with high-

resolution displays patient

parameter.

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resolution displays patient parameter.

Additional: Monitor should be

upgradable to ETCO2, Minimal invasive

continuous cardiac output and 3IBP

through interchangeable modules

Manufacturer should be capable to

upgrade ICU monitoring system to an

USFDA approved integrated clinical

information system with automated

charting of same make

Additional point to specification No Change

ITEM NO.20 (DEFIBRILLATOR WITH & WITHOUT PACE MAKER)

Pg.111 Product Quality Standard:

The model should be US FDA or

European CE approved model. CE

certificate must be furnished by notified

agency

Should be USFDA and European

CE approved model certificate

must be furnished by notified

agency

No change

Pg.111 Technical Characteristics

Pt. no.1:

Biphasic waveform with 200Joules

Truncated dual phase exponential

wave form with charge of 1 to

360joules with operating

instructions on the panel of bi-

phasic defibrillator monitor or any

other energy configuration

desired by the user

No Change

Pg.111 Technical Characteristics

Pt. no.2:

With the equipment powered by electric

grid or even powered by the new

battery (and fully charged) its charge

time of up to 6 seconds to reach

maximum energy.

With the equipment powered by

electric grid or even powered by

the new battery (and fully

charged) its charge time from

maximum energy of up to 5

seconds for 200 joules or up to 6

seconds or 360 joules.

No Change

Pg.111 Technical Characteristics

Pt. no.10:

Capacity to perform minimum 100

discharges of 360 Joules with full load

(new battery fully charged)

Or

Should perform atleast 100 discharges

Capacity to perform minimum 220

discharges with full load (new

battery fully charged)

Amended

Should have capacity to

perform minimum 100

discharges with full load on

fully charged battery.

Pg.112 Technical Characteristics

Pt. no.11:

More details may be given.

External reserve batteries with

internal charger (Optional)

Amended

External reserve batteries

with internal charger not

mandatory.

Pg.112 Technical Characteristics

Pt. no.13:

Up to 1000 event memory and Up to for

24 hours consecutive ECG Waveform

Or

Event memory including curve,

date and hour, of approximately

250 MB that corresponds to over

100 hours of continuous

recording.

Amended

Event memory including

curve, date and hour of

atleast 100 events or up to

24 hours.

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100event memory including curve date

and hour

Pg.112 Technical Characteristics

Pt. no.17:

The communication should be done

with help of USB

Or

The point should be deleted.

Enable communication with micro

computer through connection for

memory data visualization

Amended

Communication facility should

be available through USB or

internal memory.

Pg.112 Technical Characteristics

Pt. no.22:

The above points may be removed.

When BIPHASIC DEFIBRILLATOR

is configured in automatic mode,

the change energy follows a

trigger of 150J and 200J.

No Change

Pg.112 Technical Characteristics

Pt. no.24:

Impedance detection in the 20 ohm to

200Ohm range for the triggering

Impedance detection in the 25

ohm to 500Ohm range for the

triggering

Amended

Impedance detection in the

25 ohm to 200Ohm range for

the triggering

Pg.112 Technical Characteristics

Pt. no.25,26,27:

The above points may be removed.

Software for drug calculation

Software for ventilation/

incubation mode

ST segment and arrhythmia

analysis

Telemetry software

Amended

The following points, such as

• Software for drug calculation

• Software for ventilation/

incubation mode

• ST segment and arrhythmia

analysis

• Telemetry software

is deleted from the

specification.

Pg.112 Technical Characteristics

Pt. no.29:

Memory data card for recording up to

for 24 hours Consecutive ECG

Waveform

Memory data card of 250MB that

correspond to over 100 hours of

continuous recording.

Amended

Memory data card for

recording up to for 24 hours

Consecutive ECG Waveform

should be available.

Pg.112 Technical Characteristics

Under Point ECG Characteristic,

Pt.2

12 derivations with 10 –lead ECG Cable

12 derivations for 5 way ECG

cable

Amended

12 derivations for 5 or 10

lead ECG cable.

Pg.112 Technical Characteristics

Under Point ECG Characteristic,

Pt.4

Cardiac Frequency : Any frequency

reading frequency from 10 to 150 rpm

with numerical presentation

Cardiac Frequency: Any frequency

reading frequency from 10 to 350

rpm with numerical presentation

Amended

Cardiac Frequency: Any

frequency reading frequency

from 10 to 150 Hz with

numerical presentation.

ITEM NO.21 (VIDEO BRONCHOSCOPE WITH PROCESSOR)

Page No 113 point A2

Distal End diameter maximum 0f

6.4mm

Distal End diameter maximum of

6mm or less

Amended

Distal End diameter

maximum 0f 6.4mm

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Page No 113 point A3

Insertion tube diameter of 6.4 mm or

less

Insertion tube diameter of 6mm

or less

Amended:

Insertion tube diameter of

6.4 mm or less

Page No 113 point A6

Should have 180 degree upward and

120 degree down ward deflection or

better

Should have 180 degree upward

and 120 degree down ward

deflection

No change

Page No 114 point A10

It should have xenon light source

It should have portable self-

illuminating white LED light

source light source

Amended

It should have LED/Xenon

light source

Page No 114 point C2.

HD processor system should have

xenon light source

HD processor system with 16: 9

aspect ratio with inbuilt LED light

sources

Amended

HD processor system with

16: 9 aspect ratios with

LED/Xenon light sources

Page No 114 point C7.

This should be removed as

recommended amendment is for xenon

light source

LED as a source of lamp with a

minimum color temperature of

5000K and minimum lamp life

hour 20000

Amended

LED/Xenon as a source of

lamp with a minimum color

temperature of 5000K

Page No 114 point C12

HDTV should be removed Video signal :

standards output :RGB, y/C composite

,DVI

Video signal: standards output:

HDTV: RGB, y/C composite ,DVI

Amended

Video signal: standards

output: RGB, y/C composite,

DVI

ITEM NO.22 (FLASH STERILIZER)

Page No 115 Quality Standards

Should be USFDA /CE (European origin)

approved product.

Should be USFDA and CE

(notified) approved product.

Amended

Should be USFDA or CE

(issued by notified European

agency) approved product.

Page No 115 Quality Standards

The IEC 60601 may be removed.

IEC 60601(or equivalent BIS

standard) No Change

Page No 115 Quality Standards

The EMC standard may be removed.

EMC for electro medical

equipment :61326-1

Amended

EMC for electro medical

equipment :61326-1 is not

mandatory.

Page No 116 Technical

Specification Pt.no.6:

The sterilization chamber /jacket and

steam generator should be made of

high quality stainless steel of 304L

/316L grades

The sterilization chamber, jacket

and steam generator should be

made of high quality stainless

steel of 316L grades

Amended

The sterilization chamber,

jacket and steam generator

should be made of high

quality stainless steel of 316

or 316L grades.

Page No 116 Technical

Specification Pt.no.7:

If required, should have an integrated

water purification system.

It should have an integrated

water purification system.

Amended

System should be provided

with integrated or separate

water purification system of

suitable capacity required for

one cycle of the sterilisation.

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Page No 116 Technical

Specification Pt.no.10:

The system should have safety features

for overheating of chamber / jacket

operation of the steam generator

without water

The system should have safety

features for overheating of

chamber, jacket operation of the

steam generator without water

Amended

The system should have

safety features for

overheating of chamber /

jacket operation of the steam

generator without water.

ITEM NO.23 (ETO MACHINE)

Page No 116 Technical

Specification Pt.no.1:

The depth of the sterilizer should be 60

inches instead of 36 inches. As the

catheters and long in some cases

Chamber size:16” x 16”x 36” No Change

Page No 116 Technical

Specification Pt.no.1:

Chamber material made of aluminium

sheet as it is better conductor than

stainless steel

Or

The Chamber should be Single /Double

walled made of suitable Material

(S.S.316L) which is Resistant to

corrosion and gas

Chamber should be double walled

made of SS316 grade.

Amended

The chamber should be

double walled made of

suitable material (SS 316 or

SS 316L) which is resistant to

corrosion and gas.

Page No 117 Technical

Specification Pt.no.4:

Better uniformity of temperature

heating should be done by hot water

circulating system.

There should be provision of

heating the chamber either with

strip air heater or hot water

circulated through a coil around

the chamber to maintain the

chamber temperature around 30

to 55 degree centigrade.

No Change

Page No 117 Technical

Specification Pt.no.8:

The sterilizer shall be provided with

suitable vacuum pump and gas trap (if

required) to separate and evacuate the

gas.

The sterilizer shall be provided

with suitable vacuum pump and

gas trap to separate and evacuate

the gas.

Amended

The sterilizer shall be

provided with either suitable

vacuum pump or gas trap to

separate and evacuate the

Gas or be provided with

exhaust pipeline system to

the atleast 25ft. above of the

system.

Page No 117 Technical

Specification Pt.no.9:

Vacuum pump should be diaphragm

only

Vacuum pump should be

diaphragm /water ring type No Change

Page No 117 Technical

Specification Pt.no.10.D:

Delete the point i.e. There should be

inbuilt gas catalytic converter for the

exhausted ETO gas.

There should be inbuilt gas

catalytic converter for the

exhausted ETO gas.

Amended

The point “There should be

inbuilt gas catalytic converter

for the exhausted ETO gas” is

deleted.

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Page No 117 Technical

Specification Pt.no.10.E(c):

Cartridge Puncturing /gas purging

should be automatic

Cartridge Puncturing /gas purging

depending on the cycle selected.

Amended

Cartridge puncturing or gas

purging should be automatic

depending on the cycle

selected.

Page No 117 Technical

Specification Pt.no.17:

Should be USFDA/CE certified.

Should Be USFDA And European

CE Certified. (Or equivalent)

Amended

Should be USFDA or CE

(issued by notified European

agency) approved product.

ITEM NO.24 (INSTRUMENT WASHER DISINFECTOR WITH TROLLEY)

Page No 119 2. Technical

Characteristics Pt.no.2.1:

The chamber should be single /double

walled made of suitable material

(s.s316L) which is resistant to corrosion

and gas

Double wall construction with

high quality insulation.

Amended

Should be double wall

construction with high quality

insulation and made of

suitable material (SS 316/SS

316L) resistant to corrosion

and gas.

Page No 120 3. Physical

Characteristics Pt.no.3.3:

The size mentioned in 50 to 60 liters

which is very small for CSSD

department. It should be from 300 to

500 liters.

The size mentioned in 50 to 60

liters No Change

Battery backup for display system by

UPS Additional point to specification No Change

ITEM NO.25(HORIZONTAL AUTOCLAVE)

Page No 122 2. Technical

Characteristics Pt.no.5:

It should have celling with only silicone

long lasting and durable gasket

Sealed with Neoprene/ Silicone

long-lasting and durable gasket.

Amended

Sealed silicone long-lasting

and durable gasket.

Battery with UPS is again advisable for

display system Additional point to specification No Change

Page No 122 4. Energy Source

Pt.no.4.7:

Power consumption 18KW

Power consumption: 18- 20kW No Change

ITEM NO.26(ULTRASOINC CLEANER)

Page No 125 Technical

Specification Pt.no. (v):

The capacity should not be less than 20

liters.

Should have a tank capacity of

minimum 10 L.

No change

ITEM NO.28(ABG MCHINE WITH ELECTROLYTE (CATRIDGE BASED)

Page No 126 Technical

Specification Pt.no. 7:

Should calculate analyte Hct.

Should measure analyte Hct. No Change

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Page No 126 Technical

Specification Pt.no. 8:

Should measure analyte tHb.

Should calculate analyte tHb.

Amended

Should be under measured

analyte for tHb.

Page No 126 Technical

Specification Pt.no. 9:

The point should calculate analyte

glucose may be deleted.

Should calculate analyte Glucose.

Amended

Glucose should be under

measured parameters.

Page No 126 Technical

Specification Pt.no. 10:

Should measure lactate

Should calculate lactate

Amended

Lactate should be under

measured parameters.

Page No 126 Technical

Specification Pt.no. 11:

Should measure Cl-.

Or

The point should calculate analyte Cl-

may be deleted.

Should calculate Cl-

Amended

Cl- parameter should be

under measured parameters.

Page No 126 Technical

Specification Pt.no. 13:

Software includes printouts of Levey –

Jenning /Static graph charts for quality

Software includes printouts of

Levey-jenning Charts for quality

Amended

Software includes printouts of

Levey –Jenning /Static graph

charts for quality.

Page No 126 Technical

Specification Pt.no. 14:

Method to recalibrate in current

environment not OEM factory calibrated

/Auto save current calibration, Auto

aspiration sample ,backlit display with

easy viewing in all ambient light levels

cartridges –combination of various

tests: Single cartridge/multiple test

cartridges

Method of recalibration /Save

current calibration, set sample

size Backlit display with easy

viewing in all display with easy

viewing in all ambient light levels

cartridges combination of various

tests: single cartridge

Amended

Should be single cartridge or

multiple use test cartridges.

However the test parameters

of the cartridges should be

specified in the technical bid.

Additional Point

All test should come simultaneously in a

single test.

Additional point to specification

Amended

All the test parameters

should available in single or

multiple cartridges.

Cartridges for 100 numbers

of blood samples should be

supplied free of cost with the

machine. However, cost of

each type of cartridge for

all parameters for 1000

tests shall have to be

quoted in separate pdf

file which shall be taken

into account of evaluation

and shall be valid during

the warranty period.

ITEM NO.32 (TREADMILL STRESS TESTING)

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Review of procurement from the rate

contract

Extra request to procure from

rate contract. Not Accepted

Page No 131 Technical

Specification ECG module:

The analysis frequency should be at

least 8000Hz

Post Test Raw ECG /medians

ECG analysis frequency:500Hz

Re analysis: Post-test medians

measurements from E,J and Post-

J point selection

Amended

ECG analysis

frequency:8000Hz

Re analysis: Post-test

medians measurements from

E, J and Post-J point

selection.

Page No 131 Technical

Specification

ECG Acquisition should be 12 & 16 Lead

& ECG analysis should be available for

12 & 16 analysis

Vector cardiograph (15 lead)

Amended

ECG Acquisition should be 12

& 15/16 Lead & ECG analysis

should be available for 12 &

15/16 analysis.

Page No 131 Technical

Specification Data acquisition:

Sampling rate should be @8000Hz

Sampling rate @4000Hz No Change

The report should be stored in non-

proprietary pdf format and should work

available windows operating system

Complete ECG record and test

results PDF export of final reports

with auto naming protocols also

from Microsoft word and excel

XML export of specified data

network server with editing

workstations \windows XP

operating system

Amended

The ECG record and test

reports should be exported to

PDF format and should be

read in any computer system.

Page No 132 Technical

Specification Display:

Display size should be 22” or more

Monitored leads :3,6,12 &r 15

Displayed Leads: 3,6,12 & 15

Display size :19” or more

Monitored leads :3,6,12 or 15

Displayed Leads: 3,6,12 or 15

No Change

Page No 132 Technical

Specification Display:

Display format: 3rythm ,3rhythm +

medians /raw, 3rhythm + trends,6

rhythm,4 X 2.5 +1 rhythm,2x6

Display format: 3rythm ,3rhythm

+ medians, 3rhythm + trends,6

rhythm,4 X 2.5 +1 rhythm,2x6

No Change

Blood pressure measurement unit and

spo2 unit to be supplied as standard

Vital signs display: Heart rate,

target heart rate ,blood pressure

,exercise clock, stage clock ,phase

clock, protocol ,speed and grade

watts ,METS RRP and spo2

No Change

PrinterLeads:3,6,12 & 15 leads as

standard, NEHB, Cabrera configurable)

PrinterLeads:3,6,12 or 15 leads as

standard, NEHB, Cabrera

configurable)

Amended

PrinterLeads:3,6,12 & 15

leads as standard, NEHB,

Cabrera configurable.

Should be as per manufacturer Height: 148 cm (58 in) with no

monitor installed (LCD display

Amended

Should be as per standard

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rotates vertical and horizontal for

optimum viewing

Width :62 cm (24 in) with paper

tray removed

Depth:75cm (30 in)

Weight:68kg without motor

manufacturing design.

Serial ports are old technology and

hence should be removed

Serial ports :6, Com-1-2, COM A-

D, Treadmill, BP, Ergo meter

Spo2

Amended

The serial ports are removed.

ITEM NO.33 (ECG MACHINE)

Page No 134 Technical

Specification

Should have real time display of ECG

wave forms

Should have real time display of

ECG wave forms with signal

quality indication for each lead

Amended

Should have real time display

of ECG wave forms.

Page No 135 Quality standards:

Should be USFDA or European CE

approved product.

Should be USFDA and European

CE approved product. No change

Page No 134 Technical

Specification

Screen size 3” TFT colour HD touch

screen

Should display ECG on LCD/TFT

Display with screen size minimum

5 inch or more.

No change

Page No 135 Technical

Specification Power backup:

up to 8hours at 25mm/h

Additional point to specification

Amendment:

Should have battery back-up

for atleast 2hours at speed of

25mm/hr.

ITEM NO.34 (INFUSION PUMP (VOLUMETRIC))

Page No 135 Product quality

standard

Under product quality standard, the

product should be USFDA or European

CE certified.

Should be USFDA and European

CE approved model.

Amended

Model should be USFDA or

European notified CE

certified.

Page No 135 Technical

Specification Pt. no.1

Screen Size minimum 3inch

monochrome LCD screen/ 4” colour

Or

Large color display. TFT display leads to

specific product

Screen size minimum 4inch TFT

colour HD touch screen

Amended

Screen size should be of 4

inch diagonally colour screen.

Touch screen is not

mandatory.

Page No 135 Technical

Specification Pt. no.2

Operating system: Self-test system

Operating system: System self-

guidance

Amended

The system should have self-

test facility.

Page No 135 Technical

Specification Pt. no.3

Accuracy: ±5%

Or

Accuracy of the pump should be for all

flow rates. Please omit flow rate

Accuracy:>1ml. /hr. ±5%

Amended

Accuracy should of ±5% or

better for all flow rate.

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restriction of >1ml/hr.

Page No 135 Technical

Specification Pt. no.4

VTBI /Pre-Set Volume :0 to 9999ml

minimum step is 0.1ml.

Or

0.1-99.99ml increment of 0.01ml.

100.0- 999.0 ml in increment of 0.1ml.

1000-9999ml in increment of 1ml.

VTBI /Pre-Set Volume :0-9999ml

minimum step is 0.01ml

Amended

VTBI /Pre-Set Volume :0 to

9999ml. minimum step is

0.1ml

Page No 135 Technical

Specification Pt. no.5

Total volume infused: 01-9999.99ml

minimum step is 0.1ml

Total volume infused :0.01-

9999.99ml minimum step is

0.01ml

Amended

Total volume infused: 0.1-

9999.99ml minimum step is

0.1ml.

Page No 135 Technical

Specification Pt. no.7

Rate range: 0.1ml/hr to 200ml/hr.

Or

Rate range from 0.1-1200ml/hr.

Rate range 0.01 ml-1200ml/hr

Amended

Should have flow rate range

of 0.1ml./hr. to 1000ml./hr.

or higher.

Page No 135 Technical

Specification Pt. no.10

Infusion mode: 4modes (ml/h: body

weight Micromode, Sequential Mode for

TPN therapy)

Infusion mode:3modes (ml/h:

body weight Micro mode No Change

Page No 135 Technical

Specification Pt. no.11

Infusion rate :20-drops specification

infusion apparatus :0.1 ml/hr to

2000ml/hr. ,60 drops specification

infusion apparatus :0.1 ml.hr to

2000ml/hr.

Infusion rate :20-drops

specification infusion apparatus

:0.01 ml/hr to 1200ml.h ,60 drops

specification infusion apparatus

:0.1 ml.hr to 400ml/hr

Amended

Infusion rate: 60 drops with

flow rate of 0.1 ml/hr to

1000ml/hr.

Page No 135 Technical

Specification Pt. no.16

KVO Rate : Delivery rate >10ml/hr KVO

rate 3ml/h <10ml/hr

KVO rate 1ml/h <1ml/hr

KVO rate default setting 0.1ml/hr.

KVO rate: 0.1 -5.0 ml /h

adjustable default value 1ml/H No Change

Page No 135 Technical

Specification Pt. no.17

Bolus: Auto bolus @ 0.1 -2000ml/hr

with every 0.5ml beep add to the

specification

Bolus: manual and programable

,VTBI 0.1-50ml No Change

Drug Library: Support up to 200

Or

Drug Library: 1500 drugs including all

parameters in drug library upt to 10

users defined drug categories

Drug library: Support 30 drugs

Amended

Should have drug library of

atleast 200 drugs with option

for user defined drug

categories.

History Records: >3000 last history History Records: >5000 last Amended

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entries

100 events for system diagnostics.

history entries

History Records: atleast 3000

last history entries

Password protected: supported to be

deleted. Password protected: supported

Amended

Password protected is not

mandatory.

15 kinds of alarm: please elaborate 15 kinds of alarm Amended

Should have alarm facility.

Power supply :9hr at 25ml.hr.: please

elaborate

or

4hours at 100ml/hr with battery

capacity display in h and min

Power supply :9hr at 25ml.h

Amended

Should have battery backup

for atleast 4 hours at flow

rate of 25ml/.hr.

Battery charging Time: ON or \off

status

Battery charging Time: 5hrs

under OFF status

Amended

The point “Battery charging

Time: 5hrs under OFF status”

is deleted.

Other functions: nurse call, RS 232 and

\data export/ Other functions: nurse

call, RS232 and \data export

Other functions: nurse call, RS

232 and \data export & WIFI

SUPPORTED

Amended

The feature of nurse call, RS

232 and \data export & wifi

supported is not mandatory.

ITEM NO.35 (SYRINGE INFUSION PUMP)

Page No 136 Product quality

standard:

The product should be USFDA or

European CE certified.

Should be USFDA and European

CE approved model.

Amended

Should be USFDA or

European notified CE certified

model.

Page No 136 Product quality

standard:

Electrical safety confirms to standards

for electrical safety IEC-60601-1,Class I.

Electrical safety confirms to

standards for electrical safety IEC

60601-1,Class II”

Amended

Electrical safety confirms to

standards for electrical safety

IEC 60601-1 for Class -I and

IEC 60601-2-24.

Pg.136 Technical Specification

(Pt.no.1)

Flow rate Range:0.1 to 200ml/hr

(depending on the syringe capacity –up

to 2000ml/hr,

Or

(up to 1200ml/hr)

or

Flow rate range: 0.01 to 999.9 ml/hr.

Flow rate Range:0.1- 200ml/hr

(depending on the syringe

capacity –up to 1200ml/hr

Amended

Flow rate Range:0.1 to

200ml./hr. with maximum up

to 999.9ml/hr. or more

depending on syringe

capacity.

Pg.136 Technical Specification

(Pt.no.2)

Flow rate accuracy: ≤±2%

Flow rate accuracy: ±1% on

machine, ±2% on syringe

Amended

Flow rate accuracy: ±2% or

better with syringe.

Pg.136 Technical Specification

(Pt.no.3)

Syringe capacity of 5ml. may be added.

Syringe capacities: 10, 20, 30/35,

50/60 CC.

Amended

Syringe capacities: 5ml,

10ml. ,20ml., 30/35ml.,

50/60ml.

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Pg.136 Technical Specification

(Pt.no.9)

Auto bolus @ 0.1 -2000ml/hr. with

every 0.5ml beep right next to the

above point of the specification

Or

Delivery rate: 1-1,800ml/hr. max, Bolus

volume 99.99ml Bolus on demand

Bolus with volume /dose

Pre- selection Bolus over time (1min-24

hr.)

Manual bolus Rate 50-1200ml/hr.

(50ml/hr. increment)

Amended

System should have

automatic bolus infusion

facility.

Pg.136 Technical Specification

(Pt.no.10)

Drug library: up to 200 drug name ,add

or delete drugs available in user –

defined drug list.

Or

Drug name display: Drug library with

multiple care area profiles and up to

2000 drug protocol for display during

infusion

Or

1500 drugs can be included.

Drug library: Initial list of 50

agents adjustable with Vigilant

the IV medication Safety

.Adjustment of the dilution

,authorized infusion modes

,default infusion modes flow rate

and limits in ml/hr.

Amended

Should have drug library of at

least 200 drugs or more with

option for user defined drug

categories.

Pg.136 Technical Specification

(Pt.no.11)

Pressure Modes: Dynamic pressure

system with real time pressure with

three or five stage with minimum of 75

mmHg to maximum of 900mmHg.

Or

Pressure setting should be from 50-

1000mmhg in 11 levels of pressure

settings for more precise detection of

occlusion

Or

9 levels from 0.1 bar to 1.2 bar (75

mmHg to 900 mm HG)

Pressure modes: 2 modes

available: variable or 3 pre-set

levels –From 100 to 900 mmHg

,50 mmHg increment

No Change

Pg.136 Technical Specification

(Pt.no.12)

DPS: The Dynamic pressure system

(DPS) warns of pressure variations. A

risk of obstruction or a pressure drop

alarm can be anticipated.

Or

The Dynamic pressure system: DPS –

warns of pressure variations with upper

and lower threshold setting. A risk of

obstruction or a possible leak in the

The Dynamic pressure system

(DPS) warns of pressure

variations. A risk of obstruction or

a possible leak in the infusion line

can thus be anticipated

Amended

The point “DPS: The Dynamic

Pressure System - DPS -

warns of pressure variations.

A risk of obstruction or a

possible leak in the infusion

line can thus be anticipated”

is deleted.

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infusion line can thus be anticipated.

Or

Please remove the dynamic pressure

system.

Pg.137 Technical Specification

Pt.14

Battery capacity should be

4hrs/6hr/10hrs. or more instead of

10hrs. at 5ml./hr.

Or

The point may be removed.

Battery capacity minimum: 10

hours at 5 ml/hr.

Amended

Should have battery capacity

of minimum 4 hours at 5

ml/hr.

Pg.137 Technical Specification

Power Supply:

External power 9V DC by a converter is

not required as 5hrs.battery backup of

5hrs.

Power supply:

100 – 240 Vac / 15 VA, external

power 9 Vdc by a converter

Amended

Power supply: 100 to 240

Vac / 15 VA, external power

9V DC by a converter is not

mandatory.

Additional Points:

Ambulance Usage compatibility EN

1789 Water /Dust –proof IP34

Light weight, LCD Display Size 3.0inch

or better visibility.

Volume collection Function: Assist

infused volume record through

automatically volume Calculation with

Four modes:24 Total, Current total,

Time (certain Period)Timing

Volume(Timing interval)

Additional point to specification No Change

The pump should have inbuilt RS 232

port to enable the same to connect to

PDMS/HIS ,if required

Additional point to specification No Change

The pump should have inbuilt drug

dose calculator software and at least 10

levels of occlusion alarm setting

Additional point to specification No Change

Vigilant is proprietary name of a specific

manufacturer. please mention generic

name of software i.e drug error

reduction software and minimum 2000

drug should be configured for better

clinical use

Drug library: Initial drug list of 50

agents adjustable with vigilant

the IV medication safety solution

Adjustment of the dilution

authorized infusion modes,

default infusion modes, flow rate

and bolus limits in ml/hr

Amended

Vigilant/any drug error

reduction software should be

available.

Additional point:

Visibility from 80 degree and

stackability of minimum 3 pumps

Additional point to specification No Change

ITEM NO 36 (PATIENT WARMER)

Pg.137 Technical Specification Pt.2

System should be compatible for

paediatric, infant and adult

Should have Air flow setting for

Adult, Paediatric and infant

patient in same machine

Amended

Should be compatible for

adult, paediatric and infant

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patient.

Pg.137 Technical Specification Pt.7

Should have variable Temp. range

from Ambient to 42degree C,±2°Max

Should have variable Temp.

range: Ambient to 42degree

C,±1.5°Max

Amended

Should have variable temp.

range from ambient to

42degree C with ±2°max.

Pg.137 Technical Specification

Pt.10

The blanket should be made of

materials polyethylene film inner layer

and non-woven outer layers or of

similar standard which should be

washable and can be reused

/compatible disposable should be

provided as ours is disposable and

recommended for disposable to avoid

cross contamination

The blanket should be made of

materials polyethylene film inner

layer and non-woven outer layers

or of similar standard which

should be washable and can be

reused.

No change

Pg.137 Technical Specification

Pt.12

The point may be deleted.

Should be compatible during the

use of with blood /Fluid warming No change

Pg.137 Quality Standard

Should be USFDA or CE approved.

Should have safety certificate

from a competent authority CE

(notified) and USFDA (US)

approved.

Amended

Should be USFDA or

European notified CE

approved model.

ITEM NO. 37 (BLOOD/FLUID WARMER)

Pg.138 Quality Standard

Should be USFDA or CE approved.

Should be US FDA and CE

(Notified body) approved model.

Amended

Should be USFDA or

European notified CE

approved model.

Pg.138 Quality Standard

Manufacturer should have ISO9001 or

ISO13485.

Manufacturer should be ISO 9001

& ISO 13485 certified for quality

standards.

Amended

Manufacturer should be ISO

13485 certified for quality

standards.

Pg.138 Quality Standard

The IEC 60601-2-24 should be deleted.

Certified for meting IEC 60601-2-

24: Particular requirements for

the safety of infusion pumps and

controllers.

Amended

Product should meet IEC

60601 standard for general

safety.

Pg.138 Technical Specification Pt.4

Typographical error in temperature.

Temperature should be

maintained at 400C±20C with

accuracy of 10C.

Amended

Temperature should be

maintained at 400C±20C with

accuracy of 10C.

Pg.138 Technical Specification Pt.5

Flow rate of 50-2000ml/hr.

Or

It should be safely and effectively

warms fluids with flow rate minimum

10000ml/hr.

It should be safely and effectively

warms fluids with flow rate of 50

to 2000ml/hr.

No Change

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Pg.138 Technical Specification Pt.6

It should be quickly reacts through auto

sensor technology in flow rates

It should be quickly reacts to

changes in flow rate No Change

Pg.138 Technical Specification Pt.7

No disposable set should be asked. Disposable warming set No Change

Should supply a pack of 50 nos. of

consumable tubes /cartridges with the

machine. Cost of 50 nos. of tubes

/plates should be quoted separately in

the financial bid for price evaluation

Should supply a pack of 50 nos.

of consumables tubes/ cartridges

with the machine. Cost of 50 nos.

of tubes /plates should be quoted

separately in the financial bid for

price evaluation.

Amended

Should supply a pack of 50

nos. of consumables tubes/

cartridges/plate with the

machine. Cost of 50 nos. of

tubes /plates/cartridges

should be quoted separately

in the financial bid for price

evaluation.

Single/ dual bag connection facility Dual bag connection facility

Amended

Should have Single or dual

bag connection facility.

Auto/Touch buttons for control Touch buttons for control

Amended

Should have switch or touch

buttons for control.

ITEM NO.39 (PULSE OXYMETER)

Pg.140 Technical Specification Pt.1

LCD display (minimum 3.4”) large

digital display of Spo2.pulse rate and

plethysmogram

LCD display (minimum 4”) large

digital display of SpO2, pulse rate

and plethysmogram

No Change

Pg.140 Technical Specification Pt.5

Compact, portable and easy to set up

with minimum 4Hrs battery backup

Compact, portable and easy to

set up with minimum 4Hrs battery

backup with battery level

indicator

No Change

Pg.141 Quality Standard

USFDA or CE approved

Should have European CE mark

and US FDA approved. No change

ITEM NO.42 (AMBULATORY BLOOD PRESSURE MONITOR)

Measurement method of Asculatory

may be allowed.

Measurement method:

Oscillometric

Amended

Measurement method:

Oscillometric or Asculatory

Equivalent system for data output may

be asked. Data Output RS-232C (Direct)

Amended

Data Output RS 232C

(Direct)/equivalent

USFDA & CE approved USFDA or CE approved Product No Change

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Annexure-B

Sl. Queries raised by the prospective bidders

Original Specifications

Clarifications /Amendments of

specification in response to the queries

1 Regarding BG Validity of EMD

Section-III 3.1.3: Bid Details

Note: The EMD may be furnished

in the shape of DD / BG (in shape

of one or multiple DD/BG & the

details of DD (s) / BG (s) are to

be furnished in Format T3). In

case of BG (s), it must be

submitted in the required format

at Annexure V, which is / are to

be valid till 31.01.2019.

Amended

The EMD may be furnished in

the shape of DD / BG (in

shape of one or multiple DD /

BG & the details of DD (s) / BG

(s) are to be furnished in

Format T3). In case of BG (s),

it must be submitted in the

required format at Annexure V,

which is / are to be valid till

Dt. 31.05.2020.

2

120 days from the date of

technically and commercially

clear order, Establishment of

letter of Credit, or site

readiness whichever is later

Section-V Clause 5.1.1 :

Delivery Period

70 days from date of issuance of

Purchase Order

Amended

90 days from date of issuance

of Purchase Order (For Cath

Lab Only)

and

70 days from date of issuance

of Purchase Order (For other

tendered items)

120 days from the date of

opening of commercially clean

letter of Credit

3

For the item Direct Digital

Flat Panel Fluoroscopy &

Radiography System, It

Should have proof of supply of

at least 100% of the tender

requirement (executed directly

by manufacturer /

Importer/authorized

distributor) of the

equipment(s)/ similar

equipment(s) mentioned in the

schedule of requirement to any

Govt. organization / Corporate

Hospitals / PSU Hospitals / UN

Agencies in India/Worldwide

and purchase order copies in

support of that in last 3

Financial years i.e. 2015-16,

2016-17 & 2017-18 (As per

Format T9– Item-wise).

Section-V Clause 5.2

Prequalification of the

Bidders:

(vi) Should have proof of supply

of at least 100% of the tender

requirement (executed directly by

manufacturer /

Importer/authorized distributor)

of the equipment(s)/ similar

equipment(s) mentioned in the

schedule of requirement to any

Govt. organization / Corporate

Hospitals / PSU Hospitals / UN

Agencies in India and purchase

order copies in support of that in

last 3 Financial years i.e. 2015-

16, 2016-17 & 2017-18 (As per

Format T9– Item-wise).

No Change

4

Bid validity of 120 days from

date of opening of technical

bid. As we have to quote in

INR or allow us to quote in US

Section-VI Clause 6.10.1:

Period of validity of bid

The bid must remain valid for

minimum 180 days (six months)

No Change

Clarified

The bid must remain valid for

minimum 180 days (six

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dollar from the date of opening of

technical bid for the purpose of

bid evaluation / finalization of

rate contract. As this is rate

contract tender, after finalization

of the rate contract, the approved

rates shall be valid for a period of

one year from the date of

approval of the rate contract. A

bid valid for a shorter period shall

be rejected by the Tender Inviting

Authority as non-responsive.

months) from the date of

opening of technical bid for the

purpose of bid evaluation /

finalization of rate contract

and the bidder have to

quote in INR only.

5

100% confirmed LC out of

which 90% to be paid against

dispatch in the site and 10%

after successful installation and

commissioning of the system

Section-VI Clause 6.30.2 :

Payment:

90% of the cost of the equipment

(excluding CMC Cost) + 100%

installation cost if any + 100%

tax shall be paid to the supplier

on receipt of the stock entry

certificate, installation and

demonstration /training of the

item from the consignee.

Amended

90% of the cost of the

equipment (excluding CMC

Cost) + 100% installation cost

if any + 100% tax shall be

paid to the supplier on receipt

of the stock entry certificate,

installation and demonstration

/training of the item from the

consignee. 90% Payment

can be released through

inland irrevocable Letter of

Credit at sight after

fulfilment of contractual

obligation. (For Cath Lab

only)

100% through irrevocable

Letter of Credit payable 90%

against dispatch document &

10% on installation

Payment should be 100% vide

inland Letter of Credit with

80% payable on delivery &

balance 20% within 30 days of

installation

6

Penalty for Liquidated

Damages should be capped

@5%

Section-VI Clause 6.43.5

Liquidated Damages:

If the successful bidder fails to

deliver any or all of the goods

within the time frame(s)

prescribed in the contract, the

Tender Inviting Authority/User

Institution shall, without prejudice

to other rights and remedies

available to the Tender Inviting

Authority/User Institution under

the contract, deduct from the

contract price / purchase order

price as liquidated damages, a

sum equivalent to 1% of the

value of the item to be supplied

per week of delay or part thereof

on delayed supply of item (s)

until actual delivery or

performance subject to a

No Change

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maximum of 4%. Managing

Director, OSMCL reserves the

right to allow an additional penal

period of 4 (four) weeks beyond

the normal penal period (4

weeks) on the written request of

the supplier with the condition

that liquidated damage @ 1.5%

will be charged for each week or

part thereof during the extended

penal period.

N.B:

1. The amendments mentioned above are to be treated as amendments in the general term(s) and

condition(s) and scope of work of the above tender reference. All other terms conditions remain

unchanged.

2. Since any text in the price BOQ can’t be changed in the e-tender portal, the amendments mentioned

above are to be treated as amendments pertaining to price bid/ BOQ (if applicable).

Sd/-

Managing Director

OSMCL