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Annexure-A

Sr. Item Name Qty (Approx.)


No.
1 C-Arm Machine 8
2 CR System 13
3 Multipara Monitor 100
4 Nebulizer 81
5 Syringe Needle Cutter 150
6 Blood Cell Counter 3 Part 10
7 Environmental Decontamination System 24
8 Disinfectant Generation System 15
9 Steam Disinfection System for Decontamination of 15
Surfaces
10 Mortuary Cabinet 2 Body 84
11 Mortuary Cabinet 4 Body 38
12 ECG Machine 97
13 BP Instrument Digital 587
14 Microscope with Digital Display 100X 24
15 Blood storage refrigerator-50 bags 15
16 Blood storage refrigerator- 200 bags 15

C-ARMMACHINE
Sr. No. Description of Technical Specification
1 A) C-Arm Machine:
2 1. IMAGE INSTENSIFIER
a) Image Intensifying Tube: 9 Inches or more, triple field Normal = 9" or more, Zoom
3
facility.
4 b) Nominal Entrance Field Size: 200mm or more.
5 c) Output image diameter: 23 mm or more
6 (d)-CCD Camera: high resolution compact CCD camera ½” size
e) Monitors and Trolley: 2 Nos. 18" or more medical grade monitors along with modular
7
trolley.
8 f) Image Intensifier head safety lock. : To be provided.
9 2. C-ARM MOBILE STAND:
10 a) Rotation: ± 180 Degrees.
11 b) Up/Down movement with Actuator /Motorized: 400mm or more
12 c) Horizontal Travel: 200mm or more
13 d) Arc Orbital Movement: 120 Degrees or more.
14 e) Wig Wag: ± 12.5 Degrees
f) Tube Head: 40 KHz stationary anode tube of focal spot 0.6mm (FLR) and 1.5mm
15
(RAD). It is AERB type approved.
16 g) Min. Voltage: 40 -110kV
17 h) Fluoroscopic mA: 0.1-5 mA or more (normal mode)
18 i) Pulse fluoroscopy mA: 0.1 -3 mA
19 j) Radiographic mAs: 200mAs or more.

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20 3. INVERTOR
a) Mains Voltage: AC/DC converter for H.F. X-Ray Generator (suitable for X-Ray
21
Tube).
22 b) Max. Output power: 3.5 KW or more
23 c) Display for: display for K.V, mAs, mA
24 d) Radiography: Manual and APR
25 e) Technique Selection: Fluoro and radio mode selection.
26 f) Radiographic Timer: An inbuilt radio timer enables to select upto 200 mAs
27 g) Fluoroscopic Timer: Five minutes cumulative timer with buzzer.
28 h) Fluoro mA: Continuously variable.
29 i) Memory 10000 images or more.
30 j) Collimation - Radiation free. IRIS Collimation
31 k) X-ray tube with offered model should be approved with AERB.
32 l) Auto Brightness
33 CMC for 5 years with X-ray tube.
The equipment should be supplied with 06 numbers good quality, light weight lead
34
aprons.
35 Onsite QA as per AERB Guidelines is must.
The equipment should be European CE/BIS certified and AERB approved. The bidder
36
should be ISO 13485 certified.
Addition-Ordering authority shall register them selves with ELORA. If order is placed
37 without registration on ELORA than RC holder is not obligated to supply the machine
and no penalty shall be imposed.
38 Warranty: 3 years
39 CMC: 5 years

CR SYSTEM
(CR SYSTEM-SINGLE PLATE, READER TYPE FOR DIGITAL,
RADIOGRAPHY)
Sr.
No. Description of Technical Specification
Digitizer CR system should have capacity to process 60 or more
1 cassettes per hour of the largest size 14" x 17" size.

Standard work station (Console) coupled with CR image storage


2 capacity at least 2000 images specify the numbers.
3 Other feature of CR system
a Image post processing
b Windows leveling
c Annotation

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d Area of interest Zoom
e Magnification
f Flipping & panning
g Automatic exposure correction
h - Pre view software
I Edge enhancement stepwise
j Contrast/ Brightness adjustment
k Shuttering / ROI Finder
l Application related software like pediatric should be available
m DICOM Print
n DICOM image output to network workstation.
o Grid Pattern removal software & noise compression processing
p - Gray Scale reversal
q Rotation

r - Image preview time 25 to 60 Sec. (For large image)


s System should be fully compliant with DICOM 3
"Dry chemistry camera with Two or more than two film size on line
5 14" x 17", 10"x 12" & 8" x 10".Online film Sizes : At least 2 film size"
"True size printing should be possible from reader console. Automatic
6 exposure correction and facility for manoeuvring reading sensitivity
manually.Multiple object intensity
7 Specification for Dry chemistry camera
Mention Spatial resolution higher level preferable minimum 300
a DPI/PPI or more.
b Mention Gray Scale resolution : More than 12 bits preferable
Mention processing capacity /hour for (14” X 17”) films, it should have
c at least 70 films / Hour.
Cost per film for: Bidders are required to quote the cost per
film without Tax .Taxes as applicable Shall be paid extra.
8 Acceptable film size : 14” X 17”, 10” X 12” & 8” X 10” etc.
a Online film sizes : At least 2 film size or more
b DICOM compatible.

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9 CR workstation should have following feature :
a Multiple image printing with multiple formats.
c Preloaded annotation
d DICOM CD writingfacility.
e Image inverse, image flipping, image magnification, zooming.
f Addition of patient’s photograph on image.
h Image preview
i Image cropping
j Printing multiple patient on one film
k CD writing for multiple patient on one CD
l Should have a hard disk of 80 GB or more for storing image
10 Please provide cassette for CR with PSR Plate (IP)
a 14” X 17” – 1 each

b 10” X 12”- 1 each

c 8” X 10”- 1 each

d one Cassette of each size


e Suitable online UPS more than 30 minutes backup for whole system
1.5 Ton 5 Star split AC with voltage stabilizer should be supplied
with machine with complete installation (Hitachi/O-
11 general/DAIKIN/Mitsubishi).Technical Specification for AC unit:
Additional Requirements for A/C unit:
3 mtr copper piping with superlon insulation for suction line (copper
a pipe of minimum 0.70 mm thickness)
3 mtr copper piping with superlon insulation for Discharge line (copper
b pipe of minimum 0.70mm thickness)
c 3 mtr PVC piping for drain or as required (15 mm dia. flexible type)
3Mts. Indoor – Outdoor unit connecting power cable and required cable
from power socket to stabilizer and from stabilizer to A.C. unit with
d suitable MCB box & power socket top plug.

e Base plate for hanging indoor unit

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f MS Stand for outdoor unit
12 OTHER REQUIREMENTS :
Warranty: Three years on whole system including CR, imaging screens
, cassetts, and camera from date of installation. One year on AC and
a Voltage Stabilizer from date of installation. Five years on AC
compressor from the date of the installation
CMC for the CR Machine : CMC should
be given for three year (on yearly basis) after
warranty period of three years in the price bid format . If CMC price is
b not given it would be
considered free of cost.

c The product should be USFDA/ European CE approved. (valid

documentation should be submitted in technical bid)


The company should submit technical compliance sheet as per
technical specifications mentioning the make & model of quoted item
d in the Technical bid.
f The company should have a local Service centre
g Installation will be done by supplier free of cost.
The Company should submit original catalogue and data sheet (signed
h & stamped) of quoted item at the time of bid submission. Any
declaration/undertaking in this regard shall not be considered

Note : Cost per film should be quoted as follows:-


Size of film Per film cost (In Rupees) Total prices of 10,000 film of each
size(for comparison purpose)
14” X 17”
10” X 12”
8” X 10”

Size of film Per cassette cost (In Rupees) Total prices of 1 cassette of each
size(for comparison purpose)
14” X 17”
10” X 12”
8” X 10”

Above prices shall be taken into consideration while evaluating


the price bid. Above prices shall be added to equipment prices & their

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total price shall be compared. Above prices shall be valid till three years
from the date of signing of contract. Film pack size should not be
greater than 150 films.

Multipara Monitor
S.No. Description of Technical Specification
1 The machine shall have a modular design to allow flexible configuration of the monitored parameters.
It should have inbuilt ” TFT LCD Display with resolution It should have following parameters as standard -

 ECG(5 lead selectable, 12 lead optional)


2  Respiration
 NIBP
 SpO2
The unit should be upgradable to the following parameters (price should be mention in price bid )–

3  Temperature
 Etco2 ( Sidestream)
ECG should have ST analysis and Arrhythmia Analysis (16 types).
4
It should have following Interface -

 VGA Output
 Analog output
5
 Defibrillator synchronization output
 SD Card
 USB
It should have option of Wired/Wireless central station and should support Nurse Call function.
6
It should have Trends review of all parameters for 150h and NIBP measurement storage of 1200 sets.
7
It should support – HL-7 compitability.
8

It should have a Li-ion rechargeable Battery with a backup of upto 4 hours for longer duration.
9

It must have a valid USFDA and CE certificates.


10

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Nebulizer
S.No. Description of Technical Specification
Light Weight ,Portable and Compact- Yes
1
Weight (kg) - 1.5

Weight (kg) not more than - 1.5


2
Storage Temp:- -10 degree C to +50 degree C
3
Air Flow in Liter Per Minute (LPM) - 10
4
Maximum air Flow - 8
5
Machine stops when Tank is empty - Yes
6
Medication capacity - 2
7
Granule Size of medication (micron) - 5
8
Operating Temp/Humidity :- -10 degree C to +50 degree C, 30% to 95% Relative Humidity Max.
9
Machine takes a liquid medication and turns into a aerosol mist via pressurized air automatic mist - Yes
10
Noise level (db) - 58
11
Size of uniform Particle (MMAD), (micron) - 2
12
Technology - Aerosol with piston electro compressor type
13
Maximum Pressure (kPa) - 100
14
Nabulizing Rate - 0.5 ml/minute for 10 LMP
15
Dust Filter - Yes
16
Check Valve - Yes
17
Air tube and Air Filter and kit with mask(child and adult), (minimum 5 nos of air filters along with each
18 equipment) - Yes

Protection against electric shock (High Voltage) 3KV for one minute - yes
19
Power Source - 120V-250V/50 HZ
20
Maximum Power Consumption - 180 Watt
21
Rechargeable battery 12 Volt/150AH Lead Acid SMF Type - No
22
Molded Plug power cord length, ISI Marked (Min) - 2 meter
23

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Battery Backup -
24
Test Report to be shown to Buyer as and when required - Yes
25
Submission of Test Report on Form 39 or from Central Govt./NABL/ILAC accredited Lab at the time of supply for
26 performance test - Yes

Certification : ISO:13485-2016, ISO 14001-2004, OHSAS 18001 acreditation for their manufacturing premises -
27 Yes

Product Certification (BIS/European-CE/US-FDA/CE for the product ) - BIS


28

Syringe Needle cutter


S.No. Description of Technical Specification
1 The cutting blade of the cutter will be made of stainless (IS 6911 of 1992).
The thickness of the blade will not be less than 0.5 mm one side sharpen to cut
2 minimum of 10,000 cuts.
All other metal if used in the hub cutter will be made of galvanized carbon steel
which will withstand rusting even in rough weather with high humidity coastal
3 region for a minimum of five year (IS 277 of 2003 – galvanized steel sheet
specification)
The spring if used in the hub cutter will made of steel wire for mechanical spring (oil
4
harden and tampered steel wire) ISI-4454 of 2001 revision part.
Able to destroy from hub of AD syringe with needles from 18-28 gauge diameter
5 and from 10-25 mm length and fitted with all types of needle fittings, eg. Fixed luer
lock luer ship of snap – on.

BLOOD CELL COUNTER 3 PART


THREE PART HEMATOLOGY CELL COUNTER
S.No. Description of Technical Specification
It should be 3 part fully automatic hematology analyzer able to report& print all 19Parameters: -RBC, WBC,
PLT, Hb, MCV, MCH, MCHC, PCT, MPV, PDW, RDW-SD, RDW-CV LYM % & #, MON % & #, GRAN % & #, with
1 LMG, RBC & PLT HISTOGRAM. Histogram Interpretation booklet of the same company for model quoted
should be provided.

Final technical approval after demonstration.


2
It must be able to report Platelet Concentration.
3
Method- Principal of cell counting by impedance and selective lysing Hb by cyanide free liquid, Photometry.
4

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5 The instrument should have dual chambers for RBC & Platelet, WBC & Hb.
6 It must have floating threshold to separate overlapping of PLT & RBCs.
It should be able to give pathological flags specially indicating Microcytes, Schizocytes, Myelocytes,
7 Metamyelocytes, Lymphoblast, Eosinophilia, NRBCs

Sample Volume should be less than 20ul whole blood.


8
Should have throughput of 60 samples per hour. Use only three reagents Diluent, Lyse and Cleaner with
automated cleaning of sample probe and reagents should be in compact pack size without the limitations of
9
any card system.

It should have single button Start Up and Shut Down facility and should have facility to initiate Start Up
10 manually

It should have special provision to avoid sample carry over.


11
It should be based on Pressure and Syringe / SRV Technology
12
It should have inbuilt printer and facility for external printer should be provided.
13
It should be US-FDA and CE98/79/CE directive ISO certified.
14
The firm should have their own Quality control and Calibrators and extensive quality features.
15
Firm must have engineers in Madhya Pradesh. Service should be provided within 24hrs of breakdown call. List
16 of engineers together with their contact number working in MP only should be given.

Branded 1 KVA UPS with 30 minutes back up should be supplied with equipment. (Microtech/APC/Delta).
17
Quoted model should have user friendly Large Touch Screen for easy operation.
18
Firm should have at least 1000 installations of quoted model in Govt institutions in India. User list must be
19 submitted.

Linearity limit must be for RBC (0-8 x 105/mm3), WBC (0-100x 103/mm3), PLT (0-2200x103/mm3)& Hb(0-26g/dl)
20 & PLT Con. (0-4000x103/mm3).

It should have large measuring range for WBC up to 400fl, RBC up to 300 fl& PLT up to 33fl for better
21 reporting of cells.

It should have large measuring range for WBC up to 400fl, RBC up to 300 fl& PLT up to 33fl for better
22 reporting of cells.

23 It should have USB port/ RS 232 port for data transmission.


Cost of reagents start up, shut down per cycle for 30 sample per day considering 25 days in a month for three
years. Per test cost should be mentioned separately which would be added in the cost of equipment
24 mentioned in BOQ during financial evaluation. Taxes and other levies will be charged as per terms and
condition.

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Cost of controls and calibrator should be given separately in financial bid. It shall be considered along with the
25 cost of equipment.

Three years guarantee to be given with the equipment.


26
CMC will be given @5%+ GST (as applicable) and yearly escalation of 5% of last year’s CMC price. The CMC
may be awarded for five years (On yearly basis) after completion of guarantee period for three years.
27 Either manufacturers or its sole importer in India can quote the tender. Certificate of authorization should be
enclosed.

Free reagents with start-up kit with standard pack size, calibrator and control should be provided on the time
28 of installation along with instrument.

Operational manual and service manual must be provided at time of installation.


29
Installation, Commissioning and training to the staff will be free of cost.
30

Environmental Decontamination System


Sr. Description of Technical
No. Specification
1 System should be designed to kill bacteria, viruses, fungus in the indoor air.
It should also eliminate the volatile organic compounds with the help of dual
2 ACF & photo catalytic filter.
The machine should have multi stage mechanical filtration & a photo
3 catalytic filter
It should have 1-2 curved UV lamps for germicidal activity & photo catalytic
4 activation.
The machine should have multi stage mechanical filtration & a photo
catalytic filter. In filtration module it should have 1 curved UV lamp (Min
12W power) for germicidal activity & photo catalytic activation of Tio2
5 filters& also a UV change indicator based on real time, online, intensity
monitoring. It should use Flash Thermal Energy for continuous
decontamination of air.
6 The flash thermal energy module should be fan free & chemical free system

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It should also have a gas based disinfection module using corona discharge
7 or surface discharge technologies.
The system should be programmed remotely without entering into the
8 air- treatment area.
9 It should be CE certified, Class I Medical Device.
The manufacturer should have ISO 14001-2004, ISO 13485 – 2003, WHO –
10 GMP/ GPP certifications
The machine should be demonstrated in front of the constituted technical
11 committee & the crucial things like: all the features and remote
programming should be shown.
12 It should be CE/ FDA/BIS/ISO13485 approved

Disinfectant Generation System


Sr.
No. Description of Technical Specification

1 Automated MIXED oxidant generation system.


2 System should be an automated, compact & mobile unit. Machine should be
made of nonmetallic (fiber/PVC/Plastic), rust free frame & body.
It should generate a solution which contains Hypochlorous acid and oxidants
3 like Chlorine dioxide, Ozone, Hydrogen Peroxide and Sodium Hypochlorite.
This generated solution should have an oxidant concentration of more than
4 400ppm & a TDS of ≤ 2000ppm.
Automatic dilution and dispensing system should be present for dispensing
5 100ppm, 200ppm and 400ppm readily usable disinfectant solution
eliminating the need of manual dilution.
6 The pH of the solution should be almost neutral (7±1.0).
The machine should have 2 cells for uninterrupted working. It should havea
7 real-time LCD display for current & voltage
It should auto identify errors and display the type of error for easy trouble
8 shooting.

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The machine should have an automatic preventive maintenance cycle for
9 enhanced life of membranes used in water conditioning. The machine
should have automatic descaling of cells.
It should have a generation capacity of 45-55 liter per hour of the final
10 solution. One liter of electrolyte solution should generate 45-55 Ltr. of
solution with > 400 ppm of oxidant concentration.
The machine should be quoted with suitable storage tanks for storing
11 generated disinfectant as per the requirement of the user (Storage tank
volume should be 45-55 Ltr.)
The machine should have been purchased & installed in Govt. hospitals for
12 hospital infection control.
The machine should audit the solution quality in real time. The machine
should stop production & prompt the user for preventive maintenance if the
13 quality isn't up-to the mark & go into a preventive cycle without user
intervention. It should be CE certified, Class I Medical Device.
The manufacturer should have ISO 9001-2008, ISO 13485 - 2003, WHO –
12 GMP/ GPP certifications
The machine should be demonstrated in front of the constituted technical
committee & the crucial parameters like: TDS, pH & oxidants concentration
13 should be demonstrated as per the specs.

. The machine should be quoted along with the consumables (10 packs of 10
14 ltr). This one liter of electrolyte solution should generate 45-55 Ltr. of
solution with >400 ppm of oxidant concentration
Bidder should quote price of Electrolyte concentrate(10 litre/pack ) in price
bid and this price shall be added to the quoted equipment price for price
comparison. The price of consumable shall be fixed for three years
from the date of contract agreement
15 It should be CE / FDA/BIS/ISO13485 approved

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STEAM DISINFECTANT SYSYTEM FOR
DECONTAMINATION OFSURFACES
Sr. Description of Technical Specification
No.
1
System should produce superheated saturated atomized steam at 180±5
degreeCelsius for proper disinfection in shorter time
2 This generated steam should be delivered at low pressure (4 to 6 bar).
3 There should be system in the machine for monitoring the boiler pressure.
4 The machine should have a continuous steam adjustment from 0 to 100
g/min
5 The generated steam should be delivered through a nozzle.
6 The steam should not leave any residual moisture & staining on the treated
Surfaces
7 The machine should use a sanitizing agent to ensure proper cleaning.
8 The mixture of steam & cleaning agent should be safe & can be used in the
presence of human
9 It should be safe enough to use on surfaces & fabrics.
10 It should be CE certified
The machine may be demonstrated in front of the constituted technical
11 committee. Machine should be supplied along with it's consumables (50
ml/bottle of sanitizing agent)
12 It should be CE /FDA/BIS/ISO 13485 approved
13 Warranty 3 Years
14 Training should be provided after Installation

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Mortuary CABINET– 2 Bodies
S.No. Description of Technical Specification
1 Compact size.
SS outer shell. SS Grade 304 inner chamber.
2
No exposed welded joints to prevent rusting.
3
4 Continuous rated working temp. range 0-5 degree C at 35 degree C ambient temperature.
5 Cooling system accessible and serviceable without entering the chamber.
6 Polymer rollers each with double ball bearings in each body chamber for smooth noise free sliding of stretcher.
7 Microprocessor Controlled Temperature indicator cum controller.
High density PUF insulation, mounted on lockable castor wheel. Audio / visual alarm for high/low temperature
8 with stand by compressor.
Approximate size of chamber : LxWxH – 2370 x 700 x 1250 mm. (approximate outer dimensions : L 2600 x B
9 850 x H1400 including wheels). All dimensions with ± 50mm deviation.
10 Power Supply :- Single phase. 220V 50 Hz.
11 Controls :- Digital control unit Mounted on top with backlit LCD display.

12 Quality Certificate- ISO 13485

Mortuary CABINET – 4 Bodies

S.No. Description of Technical Specification


1 Compact size.
SS outer shell. SS Grade 304 inner chamber.
2
No exposed welded joints to prevent rusting.
3
4 Continuous rated working temp. range 0-5 degree C at 35 degree C ambient temperature.
5 Cooling system accessible and serviceable without entering the chamber.
6 Polymer rollers each with double ball bearings in each body chamber for smooth noise free sliding of stretcher.
7 Microprocessor Controlled Temperature indicator cum controller.
High density PUF insulation, mounted on lockable castor wheel. Audio / visual alarm for high/low temperature
8 with stand by compressor.
Approximate size of chamber : LxWxH - 2370x1250x1250 mm. (approximate outer dimensions : L 2600 x
9 B1350 x H1400 including wheels). All dimensions with ± 50mm deviation.
10 Power Supply :- Single phase. 220V 50 Hz.
11 Controls :- Digital control unit Mounted on top with backlit LCD display.
12 Quality Certificate- ISO 13485

ECG Machine

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S.No. Description of Technical Specification
1 Lead Selection
2 Leads 12-lead selection
3 Frequency Response
4 Frequency response : 0.05 Hz to 150 Hz (-3dB)
Should have 5 inch or more LCD/TFT Digital display for display of
5
ECG waveforms
6 Patient Safety
7 Patient leakage current : Less than 10 UA (220V/50Hz)
8 Sensitivity : 5, 10, 20 mm/mV Auto
9 Calibration : I m V push button effective at input amplifier
10 European CE from notified body.
11 Added- ECG storage- 50 ECG or more
12 Added- 100 ECGs on full charged battery
13 Added- Battery type : Li-Ion battery
14 Added- 3 channel printer
Added- Simultaneous 3 channel ECG recording with 12 lead
15
simultaneous acquisition and Arrhythmia Detection
16 Warranty: 3 years Warranty and 5 years CMC

BP INSTRUMENT DIGITAL
(Blood Pressure Apparatus,DIGITAL)
Sr.
No. Description of Technical Specification
1 Measurement method -Electronic
2 Measurement range
a Numerical display Pressure: 0 ~ 300 mmHg
b Pulse: 30 ~ 200 beats / minute
c Pressure bar display Pressure: 20 ~ 280 mmHg
3 Measurement accuracy
a Numerical display Pressure: ±3 mmHg 15
b Pulse: ±5 %

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c Pressure bar display Pressure: ±4 mmHg
4 Power supply- 2 x 1.5 V alkaline batteries (LR6 or AA)
5 Upper arm circumference -23 ~ 33 cm using the medium cuff
6 Number of measurements- Approx. 2000 measurements,
when AA alkaline batteries are used, with pressure value of 180 mmHg at
room temperature of 23°C 8. Classification - Internally powered ME
7 equipment
8 Continuous operation mode EMC IEC 60601-1-2: 2007
Operating conditions +10°C to +40°C / 15%RH to 85 %RH 800 hPa to
9 1060 hPa
10 Storage conditions -15°C to +60°C / 10%RH to 95 %RH
11 Dimensions standard
12 Weight standard
13 USFDA Approved/ CE certificate.

Microscope with Digital Display & having Magnification 100 X


S.No. Description of Technical Specification
Microscope unit must have HD camera & LCD Displaying unit (Monitor) of size between 18 - 26 inches with
1 laptop & software system for particle size and colour auto measurement facility and future upgradable.

HEAD - Universal Infinity Corrected, 30 ͦinclined Seidentop Trinocular viewing head, interpupillarydistance: 50
2 - 76 mm, splitting ratio : 0:100/20:80/100:0 with Digital Display.

Objectives - Infinity plan achromatic objective 100x / 1.25.


3

Frame - Co-axial coarse & fine adjustment, with coarse adjustment stop and tightness adjustment, range:
4 25mm, precision: 0.002mm

Nosepiece - Quadruple Nosepiece


5
Stage - 140mm X 132mm mechanical stage, move range 76mm X 50mm, precision 0.1mm
6
Condenser - N.A. 1.25 Abbe condenser with iris diaphragm
7

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Illumination - Single LED bulb (predetermine filament center), intensity adjustable.
8
Power Backup - Battery/UPS & should be compatible with microscope with 8 hours backup.
9

Power Input - 100V - 240V


10

Blood Bank Refrigerator/ Serology Refrigerated for Blood


Storage Unit (50 Bag Capacity)
1 Clinical purpose ;A refrigerator for storing whole blood or red cell packs in a blood bank.
A refrigerator for storing various reagents and /or patient samples.
2 TECHNICAL CHARACTERISTICS
2a Technical characteristics (specific to this type of device)-Compression type refrigerator
that uses CFC free refrigerant gas.
Construction:Internal: Stainless steel (min. 22g) (S.S. V2 A- 1.4301)
External: Solid outer Corrosion Resistant (at least 1mm thickness), CFC free insulation
Drawers: Roll out type, Stainless steel scratch resistant material, perforated on the bottom for
perfect and homogeneousdistribution of cold air. The separators, if provided in the drawers,
should be such that blood bags are held in a verticalposition with the lable side visible.
Door: Glass door, Automatic closing of the front door below opening angle of 90 deg C and
opening angle limited to 110deg C, Insulation and gasket should be silicon. Polyurethane
insulation should be minimum 80mm thickness. Door openingaudio and visual display alarm.
Temperature Range: 2 deg C to 6 deg C and adjustable with setting accuracy of ±0.1 deg C
with set temperature of 4 deg
C. User parameter settings: set point, high alarm point, low alarm point, buzzer off time, C/F
temperature choice.
Minimum Compressor Starting Voltage: 22% below nominal voltage
Internal Temperature Control: Electronic temperature control, range +2 deg C to +6 deg C
with setting accuracy of ±1deg C whatever the load, Fan air cooling.
External Ambient Temperature: Performs in an ambient temperature of +10 deg C to +40
deg C.
Hold over time: A full load of blood packs at +4 deg C (±1 deg C) takes at least 30 minutes
to rise to above +6 deg C.
Internal temperature hold over time in case of power failure should be at least 1.5 hrs.
Cooling Down Time: A full load of plasma packs at +25 deg C takes a maximum of 13 hrs
for all the packs to reach below+6 deg C
Temperature Monitoring: Digital temperature (LED) display with 0.1 deg C graduation,
Temperature recording device,Microprocessor control for operation with integrated audio
visual temperature alarm function with digital monitoring display.Independent safety
thermostat to avoid negative temperatures. Atleast 2 temperatures sensors: Sensor for
temperaturemonitoring shown on front display, sensor for managing use of compressor.

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Temperature recording device: Visual and audible alarm system indicating unsafe
temperatures. Battery backup foralarm system indicating unsafe temperatures. Seven days
graphic temperature recorder with range of -10 deg C to +20
deg C with supply of free charts for a period of one year. Ideal compressor running time of
27% at room temperature. Doorlocks should be available. Audio and visual alarm for
variation in temperature, Interior lightening, Auto defrosting.
2b Capacity - As required by the blood bank (50 plasma bags of 350/450 mL each)
2c Settings - Manual
2d User's interface - Manual
2e Software and/or standard of communication(where ever required)- Built in

3 PHYSICAL CHARACTERISTI CS
3a Noise (in dBA) Noise factor should not exceed 60 decibels.
4 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ....)
4a Power Requirements input voltage - 220/240V 50Hz
4b Battery operated - NA
4c Tolerance (to variations, shutdowns) - NA
4d Protection - A line voltage corrector of appropriate rating will form part of standard
configuration.
4e Power consumption - NA
4f Other energy supplies – NA

5 ACCESSORIES, SPARE PARTS, CONSUMABLES


5a Accessories & spareparts - Complete with comprehensive set of spare parts and a suitable
capacity voltage stabilizer. The make, rating, model,description, specifications, price,
quantity of each item shall be furnished separately.

6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS


6a. Atmosphere /Ambiance (air conditioning, humidity, dust ...) - Capable of being stored
continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.
Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative
humidity of 15 to 90%.
6b. Additional Requirements - All equipments should specify Design qualifications,
Installation qualifications, Operational qualifications and performance qualifications,
validation and calibration reports should have traceability towards applicable national/
international standards. Performance, efficiency, other factors such as distortion etc. as
applicable be also furnished. Complete construction, details in respect of material
specification, thickness, finish etc. are to be furnished.
6c. User's care, Cleaning, Disinfection & Sterility issues - Complete unit to be easily
washable and sterilizable using both alcohol and chemical disinfectant.

7 STANDARDS AND SAFETY

7a. Product certifications - European CE or US FDA certified

Page 18 of 22
7b. Quality certifications - ISO 13485 certified
7c. Electrical Safety - Equipment meets electrical safety specifications of IEC 60601-1 and
60601-2 (as relevant)

8 TRAINING AND INSTALLATION


8a. Pre-installation requirements: nature, values, quality, tolerance - NA
8b. Requirements for sign-off - NA
8c. Training of staff (medical, paramedical, technicians) OPTIONAL(Depending upon scope
of work order) - Training of users in operation and basic maintenance shall be provided
9 WARRANTY AND MAINTENANCE
9a. Warranty - 3 years
9b. Maintenance tasks 3 years CMC
9c. Service contract clauses, including prices Downtime:- 48 hours or after penalty clause
will be active.
Local clinical staff / authorized officer on behalf of purchaser to affirm completion of
installation
10 DOCUMENTATION
10a. Operating manuals, service manuals, other manuals - Necessary catalogues, technical
write up in English shall be attached with the offer both in hard and soft copies.
10b. Other accompanying documents - List to be provided of important spares and
accessories, with their part numbers and cost. Certificate of calibration and
inspection to be provided.
11 NOTES
11a. Recommendations or warnings - Any recommendations for best use and
supplementary warning for safety should be declared

Page 19 of 22
Blood Bank Refrigerator/ Serology Refrigerated for Blood Banks
(200 Bags Capacity)
1 Clinical purpose - A refrigerator for storing whole blood or red cell packs in a blood bank.
A refrigerator for storing various reagents and /or patient samples.
2 TECHNICAL CHARACTERISTICS
2a. Technical characteristics (specific to this type of device) - Compression type
refrigerator that uses CFC free refrigerant gas.
Construction: Internal: Stainless steel (min. 22g) (S.S. V2 A- 1.4301)
External: Solid outer Corrosion Resistant (at least 1mm thickness), CFC free insulation
Drawers: Roll out type, Stainless steel scratch resistant material, perforated on the
bottom for perfect and homogeneous distribution of cold air. The separators, if provided

in the drawers, should be such that blood bags are held in a vertical position with the
lable side visible.
Door: Glass door, Automatic closing of the front door below opening angle of 90 deg C
and opening angle limited to 110 deg C, Insulation and gasket should be silicon.
Polyurethane insulation should be minimum 80mm thickness. Door opening audio and visual
display alarm.
Temperature Range: 2 deg C to 6 deg C and adjustable with setting accuracy of ±0.1
deg C with set temperature of 4 deg C. User parameter settings: set point, high alarm
point, low alarm point, buzzer off time, C/F temperature choice.
Minimum Compressor Starting Voltage: 22% below nominal voltage
Internal Temperature Control: Electronic temperature control, range +2 deg C to +6
deg C with setting accuracy of ±1 deg C whatever the load, Fan air cooling.
External Ambient Temperature: Performs in an ambient temperature of +10 deg C to
+40 deg C.
Hold over time: A full load of blood packs at +4 deg C (±1 deg C) takes at least 30
minutes to rise to above +6 deg C. Internal temperature hold over time in case of power
failure should be at least 1.5 hrs.
Cooling Down Time: A full load of plasma packs at +25 deg C takes a maximum of 13
hrs for all the packs to reach below +6 deg C
Temperature Monitoring: Digital temperature (LED) display with 0.1 deg C graduation,
Temperature recording device, Microprocessor control for operation with integrated
audio visual temperature alarm function with digital monitoring display. Independent
safety thermostat to avoid negative temperatures. Atleast 2 temperatures sensors:
Sensor for temperature monitoring shown on front display, sensor for managing use of
Temperature recording device: Visual and audible alarm system indicating unsafe
temperatures. Battery backup for alarm system indicating unsafe temperatures. Seven
days graphic temperature recorder with range of -10 deg C to +20 deg C with supply of
free charts for a period of one year. Ideal compressor running time of 27% at room
temperature. Door locks should be available. Audio and visual alarm for variation in
temperature, Interior lightening, Auto defrosting.

Page 20 of 22
2b. Capacity - As required by the blood bank (200 plasma bags of 350/450 mL each)
2c. Settings - Manual
2d User's interface - Manual
2e Software and/or standard of communication(where ever required) - Built in

3 PHYSICAL CHARACTERISTI CS
3a. Noise (in dBA) Noise factor should not exceed 60 decibels.

4 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ....)


4a. Power Requirements input voltage - 220/240V 50Hz
4b. Battery operated - NA
4c. Tolerance (to variations, shutdowns) - NA
4d. Protection - A line voltage corrector of appropriate rating will form part of standard
configuration.
4e. Power consumption - NA
4f. Other energy supplies – NA

5 ACCESSORIES, SPARE PARTS, CONSUMABLES


5a Accessories & spareparts - Complete with comprehensive set of spare parts and a suitable
capacity voltage stabilizer. The make, rating, model, description, specifications, price,
quantity of each
item shall be furnished separately.

6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS


6a. Atmosphere / Ambiance (air conditioning, humidity, dust ...) - Capable of being stored
continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.
Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative
humidity of 15 to 90%.
6b. Additional Requirements - All equipments should specify Design qualifications,
Installation qualifications, Operational qualifications and performance qualifications,
validation and calibration
reports should have traceability towards applicable national/ international standards.
Performance, efficiency, other factors such as distortion etc. as applicable be also
furnished. Complete construction, details in respect of material specification, thickness,
finish etc. are to be furnished.
6c. User's care, Cleaning, Disinfection & Sterility issues - Complete unit to be easily
washable and sterilizable using both alcohol and chemical disinfectant.
7 STANDARDS AND SAFETY
7a. Product certifications - European CE or US FDA certified
7b. Quality certifications ISO 13485 certified
7c. Electrical Safety Equipment meets electrical safety specifications of IEC 60601-1 and
60601-2 (asrelevant)

8 TRAINING AND INSTALLATION

Page 21 of 22
8a. Pre-installation requirements: nature, values, quality, tolerance - NA
8b. Requirements for sign-off - NA
8c. Training of staff (medical, paramedical, technicians) OPTIONAL (Depending upon
scope of work order) - Training of users in operation and basic maintenance shall be provided

9 WARRANTY AND MAINTENANCE


9a. Warranty 3 years.
9b. Maintenance tasks 3 years CMC
9c. Service contract clauses, including prices - Downtime: 48 hours or after penalty clause
will be active. Local clinical staff / authorized officer on behalf of purchaser to affirm
completion of installation
10 DOCUMENTATION
10a. Operating manuals, service manuals, other manuals - Necessary catalogues,
technical write up in English shall be attached with the offer
both in hard and soft copies.
11 NOTES
11a. Recommendations or warnings - Any recommendations for best use and
supplementary warning for safety should be declared

Page 22 of 22

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