Approved Specifications of Biomedical Equipment

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ANNEX-A

FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)


No. PSHD/PC/5-102/2023
GOVERNMENT OF THE PUNJAB
Dated Lahore the 1st June 2023
FINALIZED TECHNICAL SPECIFICATIONS
ITEME NAME WITH DESCRIPTION

Sr# ICU/OT
01 ICU VENTILATOR
(A) Ventilation: Microprocessor controlled powerful ventilation system mounted on trolley
LCD/TFT color screen 15” Minimum.
Patient Range: Pediatrics and Adult capability
Breathing classification: Pressure control, Volume control and pressure control with set Volume Breath.
Autoclavable reusable patient tubing circuit for peads and adult (01 each)
Modes of Ventilation:
Volume control
Assisted CMV
Pressure control
PS
Assist Pressure support
CPAP SIMV+ Pressure support
Non-invasive ventilation
Bi-level Ventilation
Control: Set & measured parameters simultaneously.
Measurement range/ specification:
Inspiratory tidal volume: 20 to 2000ml or better.
Respiratory frequency: 10-100 bpm or better.
SIMV breath frequency: 1-50 bpm or better.
Inspiratory pressure: 10-80 cm H2O or better.
Inspiratory flow: 80 cm H2O or better.
I : E ratio :1:4/4:1
PEEP: 0 -20 cm H2O or better.
FiO2/ O2 delivery: 21 – 100% (through paramagnetic sensor non-consumable or galvanized fuel/
consumable cell with free replacement for five years)

Monitoring Parameters for set and measured value simultaneously:

Total breath rate.


Oxygen concentration measurement
FIO2 monitoring capability
Expired minute volume
Peak expiratory flow
I : E ratio
Peak Pressure
Mean pressure Lung Mechanics with pressure and volume loops.
Others Control And Functions:
Back up ventilation
Pause time INSP
Microprocessor gas delivery system

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Breath circuit Compliance Compensation
Expiratory hold/ Inspiratory hold
Panel lock for safety
Pressure/ flow trigger sensitivity
Trigger sensitivity indication
Alarms:
Apnea
AC power failure
High and low Expired minute volume
High and low peak air way pressure
High and low breath rate
FiO2 variation
Low and high base line pressure
Gas supply source failure
Low battery

Humidifier: Automatic compensation controlled heated humidifier with temperature monitoring at air
way and humidification chamber with alarm for low/ high limits with water trap in the patient circuit.

Nebulizer: Nebulization of the patient (Built-In/External)

Supply requirements: Electric 220V/50Hz with internal chargeable battery backup min for 1.0 hr.

Compressor
Low Noise external Compressor system for powerful ventilation.

Autoclaveable Test Lung (Qty-01)

Note:
THE WARRANTY OF EQUIPMENT WILL INCLUDE ALL CONSUMABLES LIKE BATTERIES, OXYGEN
SENSOR AND FLOW SENSOR ETC

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
01 ICU VENTILATOR
(B) Ventilation: Microprocessor controlled powerful ventilation system mounted on trolley
LCD/TFT color screen 12” Minimum.
Patient Range: Pediatrics and Adult capability
Breathing classification: Pressure control, Volume control and pressure control with set Volume Breath.
Autoclave able reusable patient tubing circuit for peads and adult (01 each)
Modes of Ventilation:
Volume control
Assisted CMV
Pressure control
PS
Assist Pressure support
CPAP SIMV+ Pressure support
Non-invasive ventilation
Bi-level Ventilation
Control: Set & measured parameters simultaneously.

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Measurement range/ specification:
Inspiratory tidal volume: 20 to 2000ml or better.
Respiratory frequency: 10-70 bpm or better.
SIMV breath frequency: 1-50 bpm or better.
Inspiratory pressure: 10-60 cm H2O or better.
Inspiratory flow: 60 cm H2O or L/min or better.
I : E ratio :1:4/4:1
PEEP: 0 - 20 cm H2O or better.
FiO2/ O2 delivery: 21 – 100% (through paramagnetic sensor- non-consumable or galvanized fuel/
consumable with free replacement for five years)
Monitoring Parameters for set and measured value simultaneously:
Total breath rate.
Oxygen concentration measurement
FIO2 monitoring capability
Expired minute volume
Peak expiratory flow
I : E ratio
Peak Pressure
Mean pressure
Lung Mechanics with pressure and volume loops.
Others Control And Functions:
Back up ventilation
Pause time INSP

Microprocessor gas delivery system


Breath circuit Compliance Compensation
Expiratory hold/ Inspiratory hold
Panel lock for safety
Pressure/ flow trigger sensitivity
Trigger sensitivity indication
Alarms: Apnea ,AC power failure, High and low Expired minute volume
High and low peak air way pressure
High and low breath rate
FiO2 variation
Low and high base line pressure
Gas supply source failure
Low battery

Humidifier: Automatic compensation controlled heated humidifier with temperature monitoring at air way
and humidification chamber with alarm for low/ high limits with water trap in the patient circuit.

Nebulizer: Nebulization of the patient (Built-In/External)

Supply requirements: Electric 220V/50Hz with internal chargeable battery backup min for 1.0 hr.

Low noise Air turbine supply source for long term ventilation

Autoclaveable Test Lung (Qty-01)

Note: THE WARRANTY OF EQUIPMENT WILL INCLUDE ALL CONSUMABLES LIKE BATTERIES,
OXYGEN SENSOR AND FLOW SENSOR ETC.

Page 3 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
02 ICU MONITOR

Operating Features and Characteristics:


Non-fade TFT/LCD color display
Electro-surgical interference suppression/protection
Defibrillator protection
Freeze and cascade facility.
Waveform traces speed; 25 / 50mm/sec.
Screen size: min. 12” TFT/LCD colour display.
Parameters:
ECG :
Numeric: heart rate.
Waveform : Real time and freeze ECG trace
NON-INVASIVE BLOOD PRESSURE (NIBP):
Method: Oscillometric principle
Numeric: systolic, diastolic and mean pressure Selectable auto inflate interval settings
Rising cuff/continuous pressure display.
Temperature:
Numeric: temperature selectable in ºC/ºF.
Pulse Oximetry:
Numeric: 0-100% oxygen saturation measuring range.
Waveform-plethysmograph pulse with pulse strength indication. Reusable sensor electrode.
Arrhythmia Analysis:
Arrhythmia analysis and ST analysis.
Respiration:
Breathe rate display and settable apnea alarms. Sweep speed; 6.25, 12.5 mm/sec.
INVASIVE BLOOD PRESSURE (IBP):
IBP Dual Channel /Three Channel
CAPNOGRAPHY (etC02)
Main or side Steam measurement
Other Features:
48 Hours Trend data; graphical and tabular
Alarms:
High & low (settable) on all parameters Visual and audible indication of alarms.
Printer
Built in Printer Two / Three Channel
Operating Requirements:
AC 220 V/50Hz Built-in rechargeable battery for at least 1 - 2-hour AC power failure at full parameter.
Note:
The system must be complete with all sensors, probes, cables or any other accessories required for
measuring all the above selected parameters for adult and paediatrics; reusable type.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
03 ANESTHESIA MACHINE WITH VENTILATOR

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Comprehensive latest anesthesia machine for pediatric and adults applications to administer anesthetic
agents in precise control and flow manner. Mobile 3-gases O2/N2O/AIR. It must comprise of the following
components:
- Non-interchangeable pipeline inlets
- Pipeline & cylinder gauges for O2, N2O and AIR
- Central gas/ electronically driven unit.
- The machine will be run on the central medical gases and require the hose for connection. A 10m
hose pair both for Oxygen and Nitrous Oxide will be the part of the machine. For emergency, Pin
indexed cylinder yokes for Oxygen (One) & N2O (One) will be installed in the machine.
- Cylinders will be provided (2xO2 and 2xN2O: Pin Indexed BS standard)
- Gas outlet and O2 flush control
- One auxiliary O2 outlet
- Lockable castors (front)
- Impact resistant & easy to clean frame
- Stainless steel/fiber work surface
- Absorber bag support arm
- Three gas flow meters for precise control and monitoring of gases.
- Pre calibrated Vaporizer of Isoflorane; temperature and flow compensated.
- Drawer unit not less than 6’’ high approx
- Power outlet with 4 socket outlets to connect the auxiliary equipment.
- CO2 absorber. Complete with valve for bag/ventilator, manometer, breathing bags, breathing
tube, mounts and Y-piece. Additional breathing hose and connector.
- Scavenging system passive type
- Machine should be capable of holding two vaporizers at least
ANESTHESA VENTILATOR:
Anesthesia Ventilator with minimum 10” or more color LCD/TFT Screen. The ventilator shall also be
capable of ventilating pediatric patients. The ventilator shall have following features as a minimum
requirement:
- Volume Preset Time Cycled Ventilator (IPPV Mode)
- Pressure Controlled and pressure support Modes
- Breathing Mode Selection (Standby / Volume / Spontaneous and Pressure)
- Built in Oxygen Monitor
- Inverse I:E ratio Capability
- Gas Specific Input Connectors (Air or Oxygen ISO or ANSI Standards)
- Tidal Volume from 20ml to 1400ml
- Rate or Frequency 4 to 60 bpm or better
- PEEP
- Inspiratory Pressure Limit
- Pressure and Volume Curves
- Power Supply 220 VAC, 50 Hz
- Battery Backup (30 Minutes or more)
- Low / High FiO2 Alarm
- Incorrect Rate or Ratio alarm
- Mains Failure alarm
- Low battery alarm.
The ventilator shall be supplied with complete drive hose and power cable.
- 220V, 50 Hz operated.

Note: Annual maintenance kits (needs to replace annually) will be included in the warranty period as per
manufacturer’s guidelines. The warranty of equipment will be including batteries, oxygen sensor and flow
sensor. It will be delivered with all sensors, cables required for measurement of all mentioned parameters.

Page 5 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Country of Manufacturer: USA/Europe/Japan
Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
04 SYRINGE PUMP
Syringe pump for fluid administration. Flow Rates: 0.1 - 200 ml/hr.
Digital display of set parameters.
Universal Syringe acceptance capability with its identification for disposable, Plastic, Size, 10, 20, 50 ml.
Drive Accuracy. ±3%
Display of drug name, Infusion rate, infused volume and volume to be infused.
Drug Library
Automatic adaptation of controls according to syringe /infusion set.
Quick freed/rapid infusion facility.
Rechargeable battery and mains operated 220V, 50Hz.
Safety alarm audible and acoustic for occlusion end of infusion, low battery.
Battery backup 2-3 Hours.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
05 INFUSION PUMP
Operates on any brand of infusion set
Automatic control of infusion rate independent of venous or arterial pressure
Solution container height and solution viscosity.
Bolus function automatic.
Air bubble detector.
Automatic pressure release after occlusion.
Automatic switchover to keep-vein-open (KVO) rate of 1.0 ml/hr (or previous rate, whichever is less).
Compatible with commonly available Infusion sets.
Portable operation from self-contained rechargeable battery with 03 hours or more operation time.
ON/OFF:
Light indicates main or battery operation
Detects a “no flow” situation i.e. empty container
LED/LCD digital display which indicates flow rate
Infused volume
Volume to be infused
Volume balance
Infusion time
Remaining time
Battery capacity
Occlusion level
Medication name and Drug Library
INFUSION RATE: 0.1-999.9 ml/hr in 1 ml increments
INFUSION TIME: 99 to 95 hours
AUTOMATIC RATE CALCULATION: On total volume + time
VOLUME LIMIT SELECTION: From 1 -999 ml, Accuracy of above parameters +/- 5%
KVO RATE: 1– 3.0ml/hr
AUDIBLE AND VISUAL ALARMS:
Activated by: Empty Container
Occlusion

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Low Battery
Open Door
Air-in-Line
Internal Malfunction
End of infusion.
BATTERY:
Rechargeable maintenance free dry batteries with 3 hours or more operation when fully charged.
SAFETY FEATURES:
Door locks while functioning

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
06 PULSE OXIMETER (DESKTOP)
Non-invasive measurement of oxygen saturation and pulse rate with LED/ LCD display.
Large display screen for plethesmography waveform
Desktop model
Display of Oxygen Saturation and Pulse Rate.
Oxygen Saturation measurement range from 0 -100%. Pulse strength perfusion indication
Pulse Rate measurement from 30-200 bpm or more
Visual and audible indication of alarms.
High and low alarms settings.
Adult finger and pediatric sensor (reusable type)
220 V/50Hz with minimum 2 hours battery backup.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
07 ULTRASONIC NEBULIZER HEAVY DUTY
For nebulization of respiratory tracts.
Hospital grade for continuous operation.
Ultrasonically generated uniform and highly dense particles of 0.5-5 to 1.0-5.0 microns size.
Approximately 65-70% of particles of less than 4 micron size.
Autoclave able delivery pipes. Air flow of 20 L/min.
Quiet operation with noise level of less than 40dB.
Nebulizing time setting from 0-30 min.
Medication Cup Capacity: 150 ml
Power: 220 V, 50 Hz
Delivery pipe/masks (all sizes).
Stainless steel arm for flexible hose.
Complete with bacteria filter
Trolley, Local made

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 7 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
08 ICU MOTORZED BED
The mattress platform consists of four sections:
a backrest, a fixed lying surface, a knee rest and a footrest.
Backrest in solid laminate for x-ray translucency
Built in Rechargeable Battery
Sleeping position by means of one button
Relax Position by means of one button
Bed Length: Approx: 7 ft
Bed Width with Side rails: Approx 3 ft
Bedside rails length: Approx: 3 ft
Height Electrically adjustable
Electric High Low Position (Height adjustment from 450-750mm)
The electrically adjustable backrest
Electric Trendelenburg/ Anti-Trendelenburg
The angle of backrest at least 70°.
Castors Ǿ 125 mm. with central brake system.
Safe working load 230KG approx.
Quick release for CPR.
Hand Remote Control system for different positions
220VAC, 50Hz Operation.
Receptacles for IV rod.
Horizontal protective bumpers.
IV Rod Fixed Double Curve
MATTRESS:
Mattress (pressure reduction), High elasticity (resilience), Progressive hardness increase at deeper
indentation (better bearing power), Small dynamic fatigue, Fire-retardant characteristics and with
washable cover.
BED SIDE CABINET:
Laminated bedside table with MDF top panel, door, drawer and open space, castors dia 40 mm.
OVER-BED TABLE:
Reading/ meal table on base Colum at the left side Height adjustable

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
09 VIDEO LARYNGOSCOPE
Light weight Video Laryngoscope with minimum 2’’ LCD with different disposable blades 2, 3, 4 (Qty-20
each) in case of disposable blades or Reusable blade of 2, 3, 4 size (one each) in case of re-usable
blade.
Medical grade thermoplastic or eq material.
Rechargeable battery with charger or disposable battery (in case of disposable/non-rechargeable battery,
firm shall provide one spare original battery along with each unit.

Optional:
The bidder shall quote separate price for each size of disposable blade (in case of disposable blades
system only)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 8 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
10 SUCTION MACHINE
Mobile Suction Unit with twin jar system having capacity up to 2 or 3 litre each jar, autoclavable
(polysulfone).
25 – 30 liters/minutes at 640-750mm Hg.
Noise level should be 50dB or less
Vacuum continuously adjustable.
10x bacterial filter
Complete aspiration set with tubing
Overflow safety Device
220V/50Hz. I Phase
Trolley with lockable wheels

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
11 CEILING OPERATING LIGHT
Operating Lamp for spring balanced ceiling suspension, consisting of a main lamp, head hermetically
sealed and dust proof; supported by a standard arm.
Light intensity of light 160,000 Lux at 1-meter distance.
Color rendering index 95 at least.
Color Temperature 4300-4500 Kelvin.
Field of illumination focusable between 15-25 cm.
LED Lights with 30,000hr life.
Light intensity/ brightness controller.
Complete with transformer for 220V/50Hz AC. With Two sterilizable handles.

Optional: Battery backup for 30 minutes

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
12 OPERATION TABLE
Mechanical/ Hydraulic Operation Table.
Table Top (Radiolucent) with antistatic mattress 4/5 sections and equipped with X-Ray cassette
holder.
Sturdy table for minimum patient weight of 150 kg handling capability.
base with cover, 4 swivel castors
Table Top:
 Head plate
 Back plate
 Seat plate
 Leg plate.
Movement:
 Full Length Radio translucent table top with X-Ray Cassette
 Up and down movement height range: Approx. 750-900mm
 Trendelenberg/Reverse Trendelenberg position
 Lateral tilt Approx. 15° or better
 Back plate: Approx. up 60°/down 40-50° or better

Page 9 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
 Manual Leg plate movement: Approx. up 20°/down 90°
Accessories:
 Arm rest with clamp
 Anesthesia screen
 Large width body strap
 Adjustable bottle holder rod

Optional;
 Leg traction device
 Upper limb traction device
 Nailing device for lower limbs
 Divided Leg Section

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
13 ELECTROHYDRAULIC OPERATING TABLE
Electrohydraulic/Electro Mechanical
Weight bearing capacity of 250kg or more
5 Sectional operation Table with two leg section.
Table top equipped with radiolucent material.
The mattress covers with washable, antistatic material.
X-ray Cassette holder for X-Ray
Electric Height adjustment: 730 to 1000 mm or more.
Electric Trendelenberg and Reverse Trendelenberg: 25° degree and -25° or better.
Electric lateral tilt: 20° degree and -20° degree or better.
Electric backrest adjustment: 70° degree and -15° degree or better.
Manual leg section adjustment: 20° degree and -90° or better.
220-230 V, 50 Hz.
Hand control unit.
Remote controlled as well as control in base of the table
Battery backup control of table in case of main power failure.

Accessories:
1. Pair of Arm rest with clamp
2. Anesthesia screen
3. Large width body strap
4. Adjustable bottle holder rod
5. Shoulder support
6. Pair of Knee Crutches.
7. Lateral Support.

Optional (ACCESSORIES): End-user to specify.


Kidney Elevator/Kidney bridge/Kidney position

ORTHOPAEDIC ACCESSORIES:
Stainless steel
Leg traction device with boots for adult for both legs, straps etc.
Accessory trolley.
Upper limb traction device

Page 10 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Nailing device for lower limbs
Divided Leg Section

OPHTHALMOLOGY/ENT ACCESSORIES
Eye/ ENT head rest.

UROLOGY / GYNECOLOGY ACCESSORIES


/Dutesche Tray

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
14 ELECTROSURGICAL UNIT
Microprocessor based electrosurgical unit for normal and under water cutting usages.
Automatic self-test function.
Operation in Radio Frequency range.
Controls for cutting, coagulation, spray and blends.
Mono polar cutting power of 300 watts.
Mono polar coagulation power of 120 Watts.
Bipolar coagulation power of 80 Watts.
Spray coagulation mode.
Floating output with bipolar coagulation.
Different gradations of blending of cutting and coagulation power.
Digital display of all controls and set values of cutting and coagulation power.
Audio and visual alarms on fault occurrence.
Earth free patient circuit.
Reusable Silicon patient plate (Adult and Paeds one each).
Double paddle foot switch, explosion proof.
Monopolar handle with cord.
Bipolar forceps with cord.
Trolley (local) with two shelves having anti-static lockable wheels. 220V, 50 Hz.
Accessories/ electrodes:
 Attachment for Monopolar Coagulation Handle with 2 Activating Buttons
 Knife Electrode, 25mm Long
 Surgical Electrode, Ball-Shaped, 4mm Dia Wire Loop Electrode, 10mm Dia
 Needle Electrode, Str. Isolated, 125 mm Ball Electrode, 5mm Dia
 Needle Electrode, 100mm
 Bipolar Cable for Forceps with Flat Socket
 Bipolar Coagulation Forceps, 220mm

Minor deviation in standard sizes of accessories is acceptable.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 11 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
15 CPAP (ADULT)
A device for delivery of continuous positive airway pressure (CPAP) to the patient at a preselected
pressure for adults.
Airway pressure range to be user settable Display of CPAP Pressure.
CPAP range: 4–20 mbar
Adjustable Ramp time and pressure Provision of overpressure safety valve Humidifier with patient
circuit (reuse able).
Noise level less than 50dB
Rechargeable battery with at least 4hrs backup time 220V, 50Hz
Accessories;
Humidifier
Pollen filter
Reusable Continuous flow with breathing circuits Flow mask

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
16 MODULAR OPERATION THEATRE
WALL PANELING SYSTEM
Material – Galvanized or Stainless steel AISI304 or tempered glass with gauge and thickness of metal
sheet of min. 0.8 mm or more. Glass thickness 6mm to 10 mm.
Glass panel reinforced by minimum 0.8mm galvanized sheet or aluminum and supported by Gypsum
board 6 mm or better
Plaster board on back of panel 6 mm or more.
Finish – Should be Powder Coated in any Color with antimicrobial protection.
Joints–The wall panels should be fixed on the sub‐structure leaving intermediate space between the
panel sand will be filled with silicon seal or gasket. Resistant to UV, detergents, bactericidal products.
Corners–Wall to wall and wall to ceiling connections should be rounded or coved made of metal
sheet powder coated finishing like the wall panels and smoothly integrated with the wall panels.
Services/utilities Outlet Panel– should be provided for the on‐wall utility and service outlets at least on
two walls with minimum four sockets of each. In addition to pendant.
No of gas outlet I.O to Specify
Sub‐Structure Profiles‐Floor rails should be made of galvanized steel sheet of appropriate thickness
with base height. Fastened with screws and dowels over leveled screed. The sectional supports should
be suitable to support the wall panels.

AIR TIGHT CLEAN ROOM SUSPENDED CEILING SYSTEM


General Description– The clean room suspended ceiling system should be made of specified material
having specialized durable powder coating with integrated antimicrobial protection on the face side
in specified color.
Material–Ceiling panels should be made of galvanized steel sheet 0.60 mm- 0. 80 mm thick, with air
tight mechanism.
Finish– The ceiling panels should be powder coated in color having bactericidal properties.
Dimension – 600 x 600mm or 1200 x 600 mm Approx.

PERIPHERAL LIGHTS FOR OPERATING ROOM


s of recessed type for linear fluorescent lamps with 1000 lux or as per
ISO Standard, should be designed for clean room suspended ceilings.

Qty Should be specified in BOQ)

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
X‐RAY VIEWER FOR OPERATING ROOM
Recessed/Built‐in type, LED X‐Ray viewer integrate able with the modular wall system

CLEAN ROOM FLOORING


Should be static dissipative homogenous vinyl roll or sheet size of 2.0 mm thickness sliced from highly
compressed solid block of homogenous material.

AIR TIGHT AUTOMATIC SLIDING DOOR FOR OPERATING ROOMS WITH ELECTRONIC PRIVCY
GLASS
finish or powder
coated outer skin fully
urethane foam

–300 x 1500mm or 400 x 600 mm double glazed (safety glass) with electronic privacy
having control button provided near the door or surgeon control Panel accessible from inside of the OT.
– 2set of photo cells in door frame along with infrared sensor at door drive level on inner
and outer side of the door.

MEDICAL CABINET FOR OPERATING ROOM


The construction of the cabinets ’body should be self‐supporting, welded–without the inside
frame sand rivets, entirely made of stainless steel/tempered glass
The cabinet body should be built‐in to the supporting profile integrated with
modular wall system.
The cabinet body and doors should be flushed with wall panel surface. Cabinets should
be sealed with a hermetic removable silicone seal.
The doors should be made of double steel plates with glazing. Safe Glass, set in double
steel sheet window frame
The shelves with height adjustments, should be made of stainless steel 1mm thick,
supported from the bottom by trapeze profile
Shelves– 4-5 adjustable shelves
Dimension: As Per Required size

CEILING MOUNTED ANESTHESIA PENDANT


Ceiling mounted Anesthesia Pendant system should be powder coated, hygienically smooth surface,
impact and disinfectant resistant.
Shelves – 3 or 4 pcs
Drawer – 1 or 2 Pcs
No. of Arms: 02
Length of first Arm 1000 mm
Length of second arm 800 mm
Max. Degree of rotation at each arm: 300° or better Max.
Loading capacity:200Kg or better (Motorized Uplifting arm to lift the anesthesia machine as per
Compatibility.
Braking system: Electromagnetic or Electric or pneumatic brakes to control horizontal movement.
Electrical Sockets British Standard – 16 to 20 Pcs

Page 13 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
LAN Data ports RJ45 or equivalent for PC – 2 Pc
Oxygen Outlet: 2Pcs
Medical Air 4 Bar 2 pcs
Vacuum Outlet: 2 pcs
Nitrous Oxide Outlet 2 pcs
AGSS Out let 2 PCS (Active or Passive)
I.V Pole- 1 PC
Basket for Accessories.

CEILING MOUNTED SURGICAL PENDANT


Ceiling mounted Surgical Pendant system should be powder coated, hygienically
smooth surface, impact and disinfectant resistant
Shelves – 3 or 4Pcs
Drawer – 1 or 2 Pcs
No. of Arms: 2
Length of first arm: 1000mm Length of second arm:800mm
Max. degree of rotation at each arm: 300°
or batter Max.
loading capacity:200Kg or better
Braking system: Electromagnetic or electric or pneumatic brakes to control
horizontal movement.
Electrical Sockets British Standard – 16 to 20 Pcs
LAN Data ports RJ45 for PC – 1 Pc
Telephone Outlets RJ11 – 1Pc
Oxygen Outlet: 2Pcs
Medical Air 4 Bar: 2Pcs Vacuum Outlet: 2 Pcs
I.V Pole – 1 Pc
Basket for accessories

LAMINAR AIR FLOW CEILING SYSTEM


Laminar flow ceiling system should be round or square or rectangular base form to produce a germ‐and
particle lean area through unidirectional homogeneous, low turbulence laminar air flow. Return air grill
with fluff separator 08 set for each theater.
All components for the receptacle of the filter element should be made of corrosion‐proof
materials. Air tight welded filter intake made of aluminum

TECHNICAL DATA (All numerical values are approximate)


Total Air Flow: 6360 m3/h
AirVelocity:0.25m/s
Filter Class to EN1822: H14|99.998%
Initial Pressure drop: 115 Pa
Final Pressure drop (Recommended): 240 Pa
Size: 2800 x 2800 mm or Diameter: 3000mm According to Standard
Positive pressure should be maintaining inside the OT to prevent contamination of air from outside
OT OR As per drawing/actual requirement of the hospital.
Potential differential monitoring provision on surgeon pendant.

DEDICATED HYGIENIC AIR HANDLING UNIT (Euro vent / Cetiat / Equivalent certified)

-fan
Filter: At least three stage filtrations in AHU G4, F9 and F7

Page 14 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

OR as per drawing or actual requirement of the hospital


n Provision built in or equivalent.

s.)

Surgeon Control Panel.


tored operating
theatre systems and allows controlling and setting of the essential physical. Latest Type 20-25” TFT/LCD
Display.
Control & monitoring
- Dimming, White & RGB)

Temperature and Humidity Monitoring


- Alarm high/low.
Optional:

Note: The System Should be complete with all standard accessories to keep the smooth working
condition. All Minor Civil, electric, Plumbing and renovation work will be responsibility of bidders.
End User shall advertise such that the adjacent corridor and ancillary space for hygiene
environment shall be covered.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 15 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
17 PATIENT WARMING SYSTEM
Microprocessor controlled patient warming system for prevention of hypothermia.
Temperature control range of 32 - 39⁰C.
Individual control of blankets.
Set and actual temperature display. Temperature Measurement between warming system and patient
Low noise fan.
Fully automatic system for wide range of application. Complete system with filters.
Automatic stop in case of overheating.
Coupling for different type of blankets.

Accessories:
disinfectant and fluid resistant, replaceable type. If the firm
quote the disposable blankets, then it will bound to quote 10 disposable blankets for adults of each type.
The blanket sizes are approximate.

45x90 cm.

Minor variation in standard sizes of blankets are acceptable.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

PATHOLOGY/LABORATORY

18 BLOOD GAS ANALYZER


Detailed Requirement:
Microprocessor based Blood gas Analyzer to measure, blood gases
Principal: Assay technology: Potentiometric and Amperometric electrodes (pH & O2 electrode), and a
range of Ion-selective electrodes.
Sample Type: Whole blood (syringe and capillary) with recommended anticoagulant.
Test menu: pO2, pCO2, O2 saturation, pH,
Easy changing access to electrodes and reagents.
Automatic sample recognition and sampling.
Possibility of upgrade for data management
RS 232 or USB Interface
220V 50 Hz, AC

User Adjustable Settings:


Throughput: 24- 30 or more samples/hour
Sample Volume should be <120 μl
Analysis Time: Not more than 120 seconds nominal
Control panel with easy setting and monitoring of pCO2, pO2, pH
Measuring range: (In Between)
pCO2: 5 - 200 mmHg
pO2: 0 - 750 mmHg
pH: 6.000 - 8.000 pH

Page 16 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Displayed Parameters:
LCD display for results
Large storage memory for minimum of 150 results or more
System should be capable of two point calibration along with manual calibration
Calibration history at least 24 hours
System should have at least 3-4 programs for quality control

Accessories:
Complete with standard and operation accessories;
Consumables, reagents, calibrators, controls for startup.
Initial calibration and quality control
One roller mixer, fuses, dust cover etc.
Built-in or External Laser Printer
Imported Compatible Sine wave UPS for back up of up to 30 minutes

The firm must submit the cost of consumables/kits and details of reagent consumption and
Approximate cost per cycle along with the tender.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
19 CENTRIFUGE MACHINE
Speed 4400 – 6000 rpm.
Capacity 6 / 8x15ml of fixed angle rotor
Built in speedometer
Variable speed control
Lid locking and braking device
Time switch 0 to 30 minutes’
Digital display of time and speed. Brushless Motor system
Rotor Rpm calibration window
220 VAC 50 Hz

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
20 BLOOD STORAGE CABINET
(A) Detailed Requirement:
Stainless Steel / PP Interior
Automatic closing of the door Controlled fan cooling
Key/password operated power switch Safety door lock
Interior lighting
220V 50 Hz, AC
User Adjustable Settings:
Net capacity : 120 blood bags of 450ml or more
Non-modifiable temperature set point of +4°C
+25C ambient temperature.
Safety thermostat
Displayed Parameters:
Touch screen display /Digital temperature display
Temperature recording and online monitoring

Page 17 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Acoustical and visual alarm for temperature and power failure
Alarm system with battery backup
low and high alarm
Door opening alarm

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
20 BLOOD STORAGE CABINET
(B) Detailed Requirement:
Stainless Steel / PP Interior
Automatic closing of the door Controlled fan cooling
Key/password operated power switch Safety door lock
Interior lighting
220V 50 Hz, AC
User Adjustable Settings:
Net capacity : 50 to 80 blood bags of 450ml or more
Non modifiable temperature set point of +4°C
+25C ambient temperature.
Safety thermostat
Displayed Parameters:
Touch screen display /Digital temperature display
Temperature recording and online monitoring
Acoustical and visual alarm for temperature and power failure
Alarm system with battery backup
low and high alarm
Door opening alarm

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
21 SEMI-AUTOMATIC CHEMISTRY ANALYZER
Semi-automatic clinical chemistry analyzer with large display unit for showing values and graphs.
Wavelength selectable via individual filters in the range of UV-VIS 340 – 630 nm
Freely programmable against all commercially available chemistries.
Temperature controlled cuvette compartment.
Identification of upper and lower limits with built in or separate printer.
Dilution factor programmed in the system.
Suitable Online Sine wave UPS with Battery backup for 30 minutes
220V, 50 Hz operated.
The kits should be freely available in the market.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 18 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
22 FULLY AUTOMATIC CHEMISTRY ANALYZER
Microprocessor controlled fully automated chemistry analyzer
User programmable with built in bar code reader
Sample type: Serum, Plasma, Body Fluids etc.
Capability to re-run with automatic on-board sample dilution
Automatic Sample Quality Analysis for Lipemia, Hemolysis, Icterus
CD/USB Storage System
RS 232 interface for on line computer
220V, 50 Hz operated

User Adjustable Settings:


Minimum 30 tests on panel including ISE
Minimum 35-45 sample/QC positions and continuous loading of samples
300 tests/hr or above for a range of chemistries (Other than ISE i.e. Na+, K+, Cl–)
Spectral Range 320-690 nm
Diffraction grating wavelength 340, 405, 492, 505, 546, 578, 630 nm or more / Filter Wavelength 340,
405, 492, 505, 546, 578, 630 nm, one free position
Sample volume 2-50 µl

Displayed Parameters:
LCD Display Monitor
On board reagent refrigeration of 2-8 Degree Centigrade / On board reagent refrigeration compatible with
the kits.
Temperature control for assays at 37C
Self calibrating against known standards + Storage of QC results
Independent stat capability, facility of reflex testing
Automatic calibration of curves and results
Automatic flagging of results outside user defined limits
Data entry by keyboard, bar code reader
Bubble and sample level detector/Liquid Level Sensing on both Reagent and Sample Probe Minimum
data storage 10,000 tests

Accessories:
- With Built-in Thermal Printer or External Laser Printer
- Compatible Imported Online Sine wave UPS with Battery backup for 30 minutes
- Compatible RO System to operate the Chemistry Analyzer

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
23 ELECTROLYTE ANALYZER
ISE System, For measuring electrolytes K, Na, Cl in, plasma, Serum and Urine
Sample Volume according to design.
Simultaneous display of measured values.
Complete with standard and operation accessories including pack of reagents.
Built-in Printer.
Suitable online Sine wave UPS with Battery backup for 30 minutes
220V, 50 Hz operated.
The reagents should be freely available in the market.

Country of Manufacturer: USA/Europe/Japan

Page 19 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
24 HEMATOLOGY ANALYZER (3 PART)
Hematology counter, automated
Through put 60 samples / hour minimum.
3-Part differential with minimum 18 parameters Histograms for WBC, RBC and Platelet. Large LCD
display.
Auto calibration programme. Auto probe cleaning/ wiping.
Automated start up and shut down. Patient data entry and specimen recognition by keyboard/LCD
Touch Screen
Patient data and results storage for 200 patients or more.
RS232/ USB interface with printer
Consumables, reagents, calibrators, controls for startup.
Suitable online Sine wave UPS with Battery backup for 30 minutes
220V, 50 Hz operated.
The kits should be freely available in the market

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
25 HAEMATOLOGY ANALYZER (5 PART)

60 SAMPLE/HOUR

Detailed Requirements:
Automated Hematology Counter
Auto probe cleaning/wiping
RS232/USB interface
220V, 50 Hz operated
User Adjustable Settings:
Through put 60 samples/hour or more
Minimum 24 parameters 5-Part differential Hb, WBC, RBC, Hct, PLT, and derived values
Histograms for WBC, RBC and Platelet
Sample Volume: 120 ul of whole blood or less
Displayed Parameters:
LCD display with touch screen
Patient data entry and specimen recognition by keyboard/LCD Touch Screen/Bar Code
Patient data and results storage for 10,000 Results or more
Accessories:
With specimen mixer and auto sampler;
With Built-in Thermal Printer or External Laser Printer
Consumables, reagents, calibrators, controls for start up
Compatible Imported Online Sine wave UPS with Battery backup for 30 minutes

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 20 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
26 LABORATORY INCUBATOR
Microprocessor based PID control
Inner stainless steel and outer powder coated
Stainless steel chamber with adjustable shelves
At least two shelves made of stainless steel with adjustable height positions
The outer cabinet is to be rust resistant.
Chamber Capacity: 50-60 Liters or more
Adjustable temperatures upto 60°C
Stability: 0.50°C
Temperature Control display for accurate results.
Digital display to show the chamber temperature and time
Indicator lamps to show when the heater is active and if an over temperature condition exists the
over temperature safety cutout to be set by the user
Power Source 220V, 50Hz AC

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
27 LABORATORY MICROSCOPE
Standard clinical microscope with infinity color corrected optics Binocular head, adjustable inter papillary
distance.
Tube head with an inclination of 25/30 Degree or more.
Rotating quadruple/ quintuple nose piece.
Adjustable stage with Vernier scale and spring clip for slides, Co axial controls.
Condenser carrier, vertically/horizontal adjustable.
Bright field condenser
Aperture iris diaphragm.
Kohler illuminator LED
Variable intensity control system
Eyepiece lenses: - X 10 wide field, focusable
Objective lenses (Plan Achromat) 4x, 10x, 40x &100x

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
28 BLOOD BANK CENTRIFUGE

Refrigerated centrifuge machine (for blood Products preparation)

Detailed Requirement:
Refrigerated Centrifuge machine
Swing out rotor for blood bags
Brushless motor
Noiseless and vibration free
Imbalance detection
Lid safety interlock
220V 50 Hz, AC
User Adjustable Settings:
Integrated refrigeration system with a temperature range of -10C to +40C

Page 21 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Maximum speed 200-11,000 rpm or better
Relative centrifugal force (RCF) not less than 15,000 or better x g
Maximum capacity 4 x 500ml
Timing 0 to 60 minutes; continuous
Displayed Parameters:
Programmable
Digital display of programme speed, timing, braking
Self-diagnostic with error display
Over temperature alarm
Rotor Rpm calibration window
Accessories:
Complete with standard and operation accessories
Compatible Online Sine wave UPS with Battery backup for 30 minutes

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
29 LABORATORY REFRIGERATOR
Capacity 375-400 liters approx. or more
Construction-Pharmaceutical grade
Exterior finish: Acrylic finish baked on zinc galvanized/painted steel/PP or better
Interior finish: Acrylic finish baked on zinc galvanized/stainless steel/PP
front glass door
Shelves: 7/8 wire shelves SS/polyethylene-coated
max. load/shelf or drawer: 40 kg
Refrigeration and Temperature
Insulation HCFC-free rigid polyurethane foamed-in-place
Cooling method Forced air
Defrosting
Fully automatic
Refrigerant HFC Temperature control range 2 ~ 8°C (AT 0°C - 40°C no-load) Temperature sensor
Thermistor/PT 100
Temperature control Microprocessor
Alarms
External mounting power failure alarm
Remote alarm
Temperature recording

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
30 BLOOD WARMER
Blood warmer/Infusion warmer with silicon temperature insulation tubing,
Dry Heat Rapid warmer
Open system
Microprocessor controlled
Error code display
Low temperature Alarm system
LED/LCD Display
Different Temperature setting

Page 22 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Temperature up to 40°C or more
Heat protection sleeve/mechanism
Power: 220VAC, 50Hz
Complete with dedicated original stand and standard accessories
Blood Tubes (Qty:10)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

CARDIOLOGY

31 ECG MACHINE (6-CHANNEL)


Six Channels ECG on at least 3 – 5 inches LCD display or better
Display of six channel ECG simultaneously
Manual and Automatic Operation
Variable Gain: 1/2, 1, 2 cm / mV
Interpretation Software both Adult and Paeds
Recording Trace speed: 10 / 12.5, 25 and 50 mm / sec
Muscle artifact and AC (50 Hz) interference filters
Defibrillator Protection
Built-in battery operation with 60 mins / 15 ECGs Print
Paper Size: 100 – 110 mm or larger
Noise Filter and Baseline Correction
Thermal Recorder for printing out of Six Channels simultaneously
Paper Rolls / Z Folds / Recording Papers: Quantity = 10 (Each Roll Length minimum 20 meters)
Operating Requirement: AC 220 V & 50 Hz
Securing / fixation to the mobile Cart by strap or other means must be provided
Accessories:
Paediatric use with re-
usable electrodes (Qty:01)
)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
32 DEFIBRILLATOR
Biphasic transthoracic (external) defibrillator with LCD color display
Synchronized output with ECG.
Energy selection on control panel for external defibrillation.
Energy delivery on paddles for external defibrillation.
Energy selection and delivery on control panel for internal defibrillation.
Charging Indicators.
The energy range should be adjustable for peads and adults up to 200 Joules.
Charging Time for full energy will be less than 06 sec.
Coloured Screen Size of approx. 5 inch.
Display of HR, ECG through paddles and Lead I, II & III patient cable.
Built in recorder for printing of full summery on standard 50mm paper.
Alarms for High and low Heart rate, low battery warning.

Page 23 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Built-in Rechargeable battery with charger for minimum 50 shocks at max. energy.
Auto tester/ self-check.
External adults Paddles
Set of pediatric paddles
AC 220V / 50Hz operated.
Trolley (Local) with two shelves having antistatic lockable wheels.

Optional:
System should have pacing facility

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
33 BEDSIDE PATIENT MONITOR
Operating Features and Characteristics:
Non-fade TFT/LCD color display
Electro-surgical interference suppression/protection
Defibrillator protection
Freeze and cascade facility.
Waveform traces speed; 25 / 50mm/sec.
Screen size: min. 12” TFT/LCD colour display.

Parameters:
ECG:
Numeric: heart rate.
Waveform: Real time and freeze ECG trace
NON-INVASIVE BLOOD PRESSURE (NIBP):
Method: Oscillometric principle
Numeric: systolic, diastolic and mean pressure
Selectable auto inflates interval settings
Rising cuff/continuous pressure display.
TEMPERATURE:
Numeric: temperature selectable in ºC/ºF.
PULSE OXIMETRY:
Numeric: 0-100% oxygen saturation measuring range.
Waveform-plethysmograph pulse with pulse strength indication. Reusable sensor electrode.
ARRHYTHMIA ANALYSIS:
Arrhythmia analysis and ST analysis.
RESPIRATION:
Breath rate display and settable apnea alarms. Sweep speed; 6.25, 12.5 mm/sec.
OTHER FEATURES:
48 Hour Trend data; graphical and tabular
ALARMS:
High & low (settable) on all parameters Visual and audible indication of alarms.
OPERATING REQUIREMENTS:
AC 220V/50Hz
Built-in rechargeable battery for at least 1 - 2 hour AC power failure at full parameter.
WALL MOUNT BRACKET:
Wall mount bracket/ shelf shall be provided (local/ imported) for placing/ hanging the monitor on patient
bed side.
NOTE:

Page 24 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
The system must be complete with all reusable sensors, probes, cables or any other accessories
required for measuring all the above selected parameters for adult and paediatrics.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
34 ETT MACHINE
Dedicated Computer based ETT System
Analysis of ST levels, ST slopes and ST-index etc.
Report: 12 leads, rhythm and full disclosure arrhythmia, and exercise summary, trend.
Stress test review
Display of 12 channels
Color monitor of 15”.
TREADMILL
Programmable, medical grade, controllable from main unit.
Speed adjustable from 0-15 km/h
Emergency stop button
Bearing capacity of minimum 150kg
Automatic baseline drift control filter
Complete integrated full functional workstation
Power: 220 VAC/ 50Hz

Suitable Online Sinewave UPS for thirty minutes back up time on full load.

Optional:
Tango or equivalent Automatic Blood Pressure Measurement Device
ETT, cum ECG lead tester (Local/Imported)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
35 AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
Light weight, easy for transportation
Carrying case with handle
Biphasic, arrhythmia analysis
Output energy range upto 200J
Voice prompt Guidelines
Suitable for Paeds and Adult
Charging time less than 10 seconds
Battery backup of 03 hours or more
Indicators for status, shock, self-test, battery
Screen Size 2” or more

Accessories; Complete with standard Accessories, Disposable pads 06 (Adult 04+ 02 Paeds)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 25 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
36 AMBULATORY BLOOD PRESSURE MONITOR
Computerized Non-invasive, Ambulatory BP for continuous 24 hours or more switch
able monitoring
Operating Features and Characteristics:
Computerized Unit with LCD / LED Display
BP Measurement Range: 40 to 250 mmHg or better
Pulse Rate Range: 40 to 180 bpm or better
Data Retrieval System
Oscillometric System
Artifact and motion noise elimination
24 hours’ switchable summary and average hourly blood pressure
Day and Night analysis and % of readings over pre-selected limits
Parameters:
Report on Blood Pressure and Pulse Rate in tabular and graphical form summary report of data and
histograms
Settable and Independently Programmable measurements of BP taking intervals ranging from 15 to 120
minutes or better
Recorder:
Must be capable of recording and storing 200 or more BP readings
Each Recorder must include all standardized cuff sizes covering the entire diameter range (Qty:04)
Cuffs: Adult and Peads
Start and Stop facility for patient-initiated BP Reading
Operating Requirements:
Battery Capacity: Standard Alkaline Battery or Rechargeable Battery during operation having capacity of
150 measurements or better
Accessories:
Complete with all standard and allied accessories for the Measurement

Optional (If any):


Number of BP Cuffs needed (To be decided by the Procuring Agency and End-user)
BP Cuff Sleeves for better BP Cuff Support
Laptop / Desktop with minimum i5 or better for data analysis with permanent licensed
Operating System Windows and online pure sinewave UPS of 1 kVA
Laser Jet Printer or better

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
37 AMBULATORY (HOLTER) HR, ECG MONITORING
PC based Digital Holter Monitoring System with 48 hours or better ECG Monitoring
Recording Time 48 hr and the Number of Channels 3
Operating Features and Characteristics:
Computerized Unit with LCD / LED Display
Full disclosure reports and Superimposition feature, Analysis of ST Segment Slope, Heart Rate, R-R
Variability & Arrhythmias Detection and Analysis including Atrial Fibrillation Analysis, QT Analysis,
Pacemaker Detection and Analysis and all associated parameters of Cardiac Rhythm
Strip selection along with annotation and Measurement caliper
Reports:

Page 26 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
In tabular and summary form, Graphical and Analytical, Arrhythmia Data, Heart Rates (Minimum,
Maximum & Average), R-R Variability Time Domain Calculations of test duration, Ventricular and Supra
Ventricular Ectopic
Report Customization
Electronic Report Formats: PDF / XML / DICOM
ST Segment Reports:
Adjustment ST-Segment Criteria, Time Duration Maximum Deviation & Slope Deviation
Severity & Index Number
Recorders:
Solid-State Recorders (Qty:03)
3 channels simultaneous high resolution Holter Recorder and simultaneous acquisition (Solid State with
Event Marker, Time Clock)
Minimum 48 hours or longer recording time for 3 Channels
Sampling Rate: 175 / channel / sec in Normal Rhythm or above for 3 Channels
Operating Requirements:
Rechargeable battery alongwith charger
Accessories:
Complete with all Standard Accessories
Laptop with Minimum i7 or better for data analysis with permanent licensed Operating System
Windows
Laser Jet Printer or better

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
38 ECHOCARDIOGRAPHY MACHINE
A complete dedicated digital Echocardiography unit for wide range of premium performance Quantity
application of cardiovascular imaging in pediatrics and adult. Mobile trolley mounted system with built in
workstation / data management system for digital acquisition, storage and review of complete ultrasound
studies including static and dynamic clips in DICOM format, read/write zoom. Studies can be reviewed
and output to CD / DVD/MOD. The machine must have sharp and high quality image reproduction with
heavy duty performance. It should have minimum following specification :

Display: High resolution 1280x 1024 non-interlaced, flicker free. Display size Min. 19” Flat/TFT, tilt able
and swiveable type.

Operating Modes: B, 2D M-Mode, Power Doppler, HPRF, Spectral Doppler, Color Doppler, Velocity
Mode, PW Doppler, Duplex And Triplex Doppler, CW Doppler Steerable and ECG Gating,

Control Panel: Alphanumeric keyboard with built-in trackball.


10” Touch Control Panel
Direct access to system functions through dedicated keys.
Indicator lights identify activated keys.
Audio volume control with bidirectional / stereo speakers and foot switch
User selectable image magnification control.
Adjustable transmit focusing control.

Caliper / Measurements: 6 to 8 calipers for measurement per screen trace length measurements
for: Distance, angle, distance depth from skin line, area, circumferences, compound / volume, slope,
time, heart rate and acceleration.

Page 27 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

Application: Cardiac, Peripheral, pediatric, adult cephalic and trans esophageal with all required
software for measurements.

Operating Modes: 2D tissue, 2D angio flow, color M-Mode, tissue velocity M-mode, tissue strain
imaging, disynchrony imaging, continuous wave Doppler, tissue m-mode, pulse wave Doppler,
tissue velocity imaging, tissue tracking, tissue synchronization, blood flow imaging, blood flow angio
flow imaging.

Display Modes: Live and stored display format: full size and split screen. Review image format: for
still and cine, simultaneous capability B+PW, B+ CFM/TVI+PW, CW, B+ or triplex mode, , B+ color
split screen display. Tissue Imaging, 2D mode, , M-mode, color Doppler imaging, color flow imaging,
color Doppler imaging, color angio, color m-mode, blood flow imaging, blood flow angio imaging,
tissue velocity imaging, tissue velocity imaging mode, tissue synchronization imaging mode, PW /
HPRF Doppler, CW Doppler, contrast imaging, LVO Contrast, Vascular / abdominal contrast,
vascular calculations, cardiac measurements.

Frame Rate Min. 500fps in B-Mode and 100fps in Doppler mode.

Cine Memory Min. Cine Memory for 1000 frames or 250MB min.

Image Viewing Depth: 20 – 280 mm or more for cardiac application

Imaging Modes / Techniques: Tissue harmonic Imaging, Tissue Doppler Imaging, Color Angio,
Tissue Velocity Imaging

Tissue Imaging (Display real time Doppler shift information from moving tissue to better visualize
and quantity myocardial function). Capability to display time difference in myocardial motion in color
for CRT (Cardiac resynchronization therapy.
Quantitative strain rate imaging; An advanced quantitative technique of Tissue

Doppler Velocity. Strain rate is a measure of the contractile motion of myocardium. Auto-Tracking
contrast quantification: quantitative technique for on-line assessment of contrast agent images.

Contrast Plus Sequencing Technology: a real time, low mechanical index, non-linear imaging
technique for contrast agent examinations. The software should have the capability to show contrast
agent only, tissue only or contrast and tissue displays. Contrast Harmonic Imaging capability.
Vascular imaging software for carotids with IMT measurement.

Stress Echo ;
Integrated multi stage stress echo system for advance and flexible stress echo Acquisition and
measurement for LV B-Mode imaging. Quantitative analysis for contrast during stress examinations
Used with TDI protocols.

Storage Device
Built-in MOD/CD / DVD Drive WITH 10 DISKETTES.

System Dynamic Range Dynamic range minimum 200 dB or more

Communication Software System should conform to DICOM 3 communication software for: Image
Storage, print, Query / Retrieve, Network Communication.

Page 28 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Standard Transducers:
Linear Probe multi frequency to cover frequency of 6.0-8.0 MHz.
Multi frequency Phased array sector probe to cover 2.5 – 4.0MHz.
Multi frequency Phased array sector probe to cover 5.0 – 8.0MHz.
CW Pencil Probe

PROBES: Should be light weight, capable of multiple centre frequencies on transmit for 2D, color
Doppler PW/CW (Steerable) Imaging and to perform Harmonics.

PORTS: Video Output USB / RS 232 Networking

Accessories:
Online sinewave UPS for 10 min. backup time for complete unit including Printer.
Digital B/W Thermal Printer with 50 rolls of papers.
Jelly 20 L in bottles.

Future Upgrades: The unit should have the capability for up gradation of future software (shall be
provided free of cost within the warranty period).

Power Requirement 220-240VAC 50 Hz

Optional:
Digital Color Thermal Printer with 10 Packs of 100 sheets (Separate price)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485

RADIOLOGY

39 STATIC X-RAY MACHINE


Microprocessor based Floor/Floor to Ceiling mounted X-Ray Unit.
High frequency, 50kW X-Ray generator.
500 mA at 100 kV
kV Upto 125 kV with range from 40 to 125
Anatomical programmed radiography.
Digital display of all set parameters.
Rotating anode X-Ray tube, with dual focus 0.6 & 1.2 mm.
Anode heat storage capacity of at least 250 KHU or more / 150kHU with 30kHU dissipation
Electronic timer with exposure time of 1msec.
System with AEC facility.
Ionization chamber for table.
Capable of lateral radiography.
4-way floating X-Ray table Chest stands with Bucky.
Complete with grid 8:1 ratio.
Automatic over-load protection device and automatic line compensation.
3-phase, 380 V, 50 Hz.
Lead Apron (0.5mm lead eq) with hanger.

Page 29 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
X-Ray Cassettes with intensifying screen
8”x10” (01), 10”x12” (05), 14”x17” (02)

Electrical Distribution Box separate for X-Ray within X-Ray facility for X-Ray machine

Optional:
Lead Lining , procuring agency shall decide if not available:
The firm shall be responsible for Lead Lining in the X-Ray Room (approximate size 20x20 ft) and
coordinate with the PNRA for getting required certification/ approval.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
40 MOBILE X-RAY MACHINE
Mobile Microprocessor based X-Ray Unit.
High frequency,
30kW X-Ray Generator
300 mA at 100 kV
Digital display of all set parameters.
Rotating anode x-ray tube, with dual focus / Single Focus
Anode heat storage capacity of at least 120 KHU or more
Electronic timer with exposure time of 1-5 msec.
Automatic over-load protection device and automatic line compensation.
The unit should be battery Operated, motor driven.
220 V, 50 Hz.
Lead Apron (0.5mm lead eq) with hanger.
X-Ray Cassettes with intensifying screen 10”x12” (02), 14”x17” (01)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
41 IMAGE INTENSIFIER (C-ARM)
C-arm X-Ray unit mobile for Radiography, Fluoroscopy & Pulsed Fluoroscopy
Format of I.I. shall be 09” dual/ triple format
High frequency, power output of 2 kW or more.
40 to 110kv with one shot fluoroscopy facility of 6mA or more.
X-Ray tube with stationary anode/rotating
Focal spots of 0.6mm
Automatic fluoro dose control
controls for collimator, iris and blades diaphragms motorized with X-Ray grid
High sensitivity, CCD camera, 1024 x 1024 pixels with last image hold option
Display of 2x19” LCD/TFT monitors, medical grade
Digital memory of around 100,000 images
Noise reduction filter, last image hold Pulsed fluoroscopy, Edge enhancement, image inversion to be
provided
Real time digital image rotation
Angles, Annotation, distance measurement during display/processing
Post Processing
Display of exposed radiation
Fluoroscopy footswitch

Page 30 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Lead Apron with hanger (01)
Laser Localizer lights cross beam type
Single phase with line voltage of 220V, 50 Hz

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
42 DIGITAL X-RAY MACHINE
Digital Radiographic X-Ray system with single Flat Panel Detector for Bucky
Chest Stand and Table
Floor /Floor to Ceiling mounted X-Ray tube assembly
Multi leaf collimator
X-Ray Generator:
X-Ray Generator: 50 KW or better
High-frequency X-Ray generator with integrated control
500 mA at 100 KV.
1ms shortest exposure time.
Automatic exposure control (three chamber).
Organ programs to be available
Automatic over-load protection device and automatic line compensation.
3-phase, 380 V, 50 Hz
X-Ray Tube:
Exposure voltage 140 kV or more.
Focal spot 0.6 mm and 1.2 mm or better.
Anode heat storage capacity of at least 250 KHU or more / 150kHU with 30kHU dissipation
Flat Panel Detector (Wireless) for Chest stand and Table Qty-01
Flat panel detector with active image size of 14"x17" approx.
Cesium (CsI), Amorphous Silicon (a-Si) scintillator or better
Pixel size 150 μm or better.
Spatial Resolution 3.5 lp/mm or better
Matrix size approximately 2300 x 2800 or better (more than 6.0 million pixels).
14 bits or better detector depth.
Time for data acquisition, transmission and viewing for full image to be 10 sec.or less.
Patient Table: Four-way floating tabletop,
Access the patient from all sides. Head to toe cassette and detector cover range.
Patient weight bearing capacity 175 kg approx. or more
Chest Stand:
Vertical Bucky Stand
Complete with Grid 8:1 or better
Vertical movement range 150cm approx.
Automatic Exposure Control System with ionization chamber for table and chest stand
Digital Imaging System/ Workstation;
High Resolution digital imaging system for processing and visualization with DICOM connectivity.
Storage of 10,000 or more images.
Imaging System should be capable of patient data management and study Administration;
• Exposure and post processing
• Image documentation, archiving, display of image markers.
• Organ program selection and configuration.
• Image processing functions such as rotate, mirror, zoom, window, filter, insert comment line etc.
• The system to have SW/HW to attain higher detail contrast (soft tissue and bone) Reduced noise with
the multi-scale procedures for images post processing.

Page 31 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
• 19” TFT high contrast, anti-glare, flicker free, high viewing angle (170°) colour display.
DICOM Functions include: Send, print and CD Write.
Online sinewave UPS for the digital system 5 KVA for 20 minutes backup or more as per load of system

Accessories;
One PC system (Core i7 ,9th or better generation) along with Laser printer for reporting purposes
Lead glass size 1.5 mm or better: size 80 cm x 100 cm.
Compression belt.
Lead Aprons 0.5 mm (Qty-03)
Thyroid shield: 0.5 mm pb (Qty-03)
Lead goggle and gonadal shields (Qty-03)
DICOM 3.0 compliant Grayscale
Dry LASER/Thermal Printer
(AGFA/FUJI/KONICA/CARESTREAM or equivalent)

Should have minimum productivity of 150 films/ hour in mixed sizes.


Printer should be capable of printing 08x10, 10x12, 11x14, 14x14 & 14x17 size films or eq.
Minimum resolution should be 10 pixels/mm with 12-bit gradation.
1000 x14x17” Dry LASER/thermal films
PNRA will be responsibility of the firm.
X-Ray Film Viewer , LED Type (Double film) with Auto film sensing

Optional:
- Complete Site renovation, Console, including lead shielding of the room and doors, Air-
Conditioning, False ceiling, painting, Antistatic flooring, Electrical DB, Earthing and Power cable
from Main Transformer to X-Ray Room DB, Will be the responsibility of the supplier. The installation
will be a turnkey project and any modification in the existing site will be the responsibility of the firm.
The firm will be responsible for complete interface free installation keeping in view the requirement and
recommendation of manufacturers and its surroundings to ensure artifacts examinations/procedures.
- UPS 80KVA or better for 10 minutes backup of the whole system

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
43 COMPUTERIZED RADIOGRAPHY SYSTEM
One Digitizer/ Reader Unit, Multiple Plates Type System
Should be capable to read X-Ray exposed Rigid Imaging Plates (IP) of all Standard sizes in inches/cm.
The productivity of reading / digitizing should be minimum 70 IPs/Hr.
Reading function 100 μm and 50 μm
Should support resolution 10 pixels / mm or more.
One Radiographer Console with users software’s: (Unit) CR console with LCD
Should be capable to enter & edit Patient ID.
Should support Image Preview & Quality Assurance.
Should have temporary storage capacity of up to 2,000 or more images.
Should comply with DICOM Conformance 3.0 and have standard functions for future connectivity with
PACS or other DICOM Modalities inclusive of Print, Storage, etc.
Dry Laser/Thermal Printers with high throughput providing 2 size online
DICOM 3.0 Compliant Gray Scale Dry format printers.
Should have minimum productivity of 150 films/ hour in mixed sizes
Printer should have feed plates of size 14 x 17, 8 x10, 10 x 12, 11 x 14 or eq.
Minimum resolution should be10 pixels/mm and 12-bit gradation.

Page 32 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Matrix size should have 100 μm and 50 μm
Three 14x17nch (Set of IPs & Cassettes).
Three 10x12inch (Set of IPs & Cassettes)
Three 8x10inch (Set of IPs & Cassettes)
DICOM capability
DICOM 3 capability for Send, Receive, Archive, Retrieve and Print.
Power Requirement:
Single phase with line voltage of 220V, 50 Hz

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
44 AUTOMATIC FILM PROCESSOR
High throughput. Continuous roller transport
Sheet film, 10x10cm-35x43cm sizes (14"x17") High through put more than 75 sheets (35 x 43cm).
Forced hot air circulation method
Piping installed in the DEV and FIX racks.
Processing solution temperature; Controlled by the temperature control tank with heater heating and
wash water cooling.
Drying temperature; Controlled automatically according to a fixed temperature setting.
220 V, 50 Hz.
Original Trolley/Stand.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
45 ULTRASOUND MACHINE
Digital Ultrasound Scanner with digital beam former.
The System should be capable to handle multi frequency probes.
Probes:
Multi frequency Convex Probe with center frequency between 3 to 5 MHz
Measurement Modes: B, M and combination thereof.
M. Mode sweep: 4 speed or more.
Gray scale: 256
Sensitivity time gain: 6-8 steps
Depth: 24 cm or more
Focusing system: 3 steps and dynamic
Adjustable acoustic power
Frame rate: 80 frames/ sec or more
Keyboard: Alpha numeric with track ball / Touch pad
Tissue Harmonics: Tissue Harmonic imaging
Cine memory of 256 frames minimum
Post processing: Image inversion, edge/echo enhancement correlation / persistence/Dynamic
range/Gamma Curve.
Image magnification 4x or more in real time.
Display Monitor: 10”-12” LCD / TFT screen
Operating Voltage: 220V, 50 Hz
UPS of appropriate capacity (min. 30 mins) on line type sine wave to be placed on trolley of USG
Machine OR built-in backup of minimum 30 min.

Page 33 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Gel: 05 liters in tubes
Trolley compatible with the machine for smooth operations and transportation (Local)
20 High Density / High Glossy thermal paper Rolls

Thermal Printer 256-Gray scale (Sony, Mitsubishi or equivalent)

OPTIONAL:
Multi-frequency Endocavity Probe with center Multi-frequency between 5 - 8 MHz (90-150 degree)
Multi frequency Linear transducer of frequency range from 4 – 11MHz or more

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
46 COLOR DOPPLAR SYSTEM (RADIOLOGY)
High resolution Digital Color Doppler Ultrasound Scanner for abdominal & vascular work with fully digital
beam former. Trolley type system.
Operating Modes:
- 2D, M and Combination, Power Doppler, Spectral Doppler, Colour Doppler, PW, Duplex.
- Tissue Harmonic Imaging Image:
- Full screen split and dual select screen formats.
Control Section:
- Alpha numeric key board and built-in trackball
- 10” Touch Control Panel
Computing System: Computer system with;
- Key board freeze facility including foot switch control.
- Cine memory for 300 Images.
- Imaging Frames: 400fps
- Dynamic range 200 db.
- DVD/ CD drive.
- High resolution 19” color monitor.
- Digital acquisition, storage and review of complete ultrasound studies with built in hard disk.
- The studies can be stored on to CD or DVD.
- DICOM compatible.
Measurements & Software’s:
- Measurement of length, angle, distance, depth, area, circumference velocity and volume.
- Tissue Harmonic Imaging.
- Contrast Specific Imaging.
- Vascular analysis.
- Pediatrics imaging.
Transducers & ports:
- Linear probe multi frequency range of 5 to 10 MHz.
- Convex probe/sector with multi frequency central frequency (3-5) MHz.
- Thermal printer: B/W Digital printer with 20 paper rolls of high density
- Compatible Online Sine wave UPS with thirty minutes back up time.

Optional:
- Micro convex/phase array Sector probe; multi frequency with central frequency of 5-6.5 MHz for
Peads)
- Color printer (Sony, Mitsubishi) with 10 boxes of paper roll of HD (Separate Price).
- Multi frequency endocavity probe (6-8 MHz)

Page 34 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
47 OPERATING MICROSCOPE (EYE)
Floor stand mount microscope body with zoom (ratio 1:5 or better).
Linear/Continuous zooming
XY coupling
Built-in coaxial illumination with red reflex.
Motorized fine focusing and manual or motorized coarse focusing
Objective f=175mm/ f=200 mm
Binocular tube: inclined at a fixed / variable angle
Eyepiece: 10 X or 12.5X with dioptric adjustment
Halogen/LED illumination with controllable intensity with/without fiber optic cable
Water proof foot control panel.
Sterilizable protective caps for all drive knobs
Accessories:
06 spare halogen lamps (in case of halogen illumination).
Dust cover.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
48 OPERATING MICROSCOPE (ENT)
Floor mounted stand with counterbalanced arm and Microscope body with linear motorized zoom (1:6) or
better
Motorized fine focusing
Adjustable speed for focus and zoom
Continuously variable focal length 225 to 400 mm without changing front lens
Binocular tilt able 0⁰ to 180⁰ with IPD adjustment
Coaxial illumination Variable spot illumination Eyepieces 10X/12.5X with dioptric adjustment
Fully apochromatically corrected optics with high light transmission
Dust cover Sterilization protective caps for all drive knobs
LED/Xenon illumination with controllable intensity 180 Watt or better
Waterproof foot control panel
HD camera attachment
Recorder with hard drive and 30” LCD / LED screen

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
49 BIOMETER (A-SCAN)
Ultrasonic bio-meter for manual or automatic freezing system when valid measurement is detected.
Measurement of axial length, ACD and lens thickness, features measurement of 5 or more reading with
adjustable gates/Gain.
Standard deviation of multiple scans, fully digitized display of real time echograms.
Solid probe with fixation light.
Audio feedback for probe alignment.

Page 35 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
With standard formulae
Accessories :
Compatible laser printer for all data

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
50 OPHTHALMIC YAG LASER
Nd- YAG Laser.
Laser Wave length: 1064nm.
Delivered Power: 8-10mJ
Pulsed Length: 2 to 4nsec.
Aiming Beam
Cooling system
Spot size: Less than 20 microns
Application Lens 2Nos.
Power: 220V, 50 Hz.
With Locally made motorized table.
With compatible imported online UPS with dry batteries for 15 minutes back up.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
51 PHACOEMULSIFICATION UNIT
Main console with surgeon setting programming & dust cover.
Phaco modulation choice of single multiple and continuous mode
Multiple Programmability
4-6 Piezo Electric Crystal
Bipolar Coagulation /Endo diathermy Capability
Vacuum 5-500 mmHg.
Provision for 2.3 & 2.8 mm incisions.
Programmable foot pedal.
Peristaltic pump.
Irrigation/ Aspiration and phaco emulsification.
I/A collection cassette or bag
I/A test chamber
Irrigation sleeves
Phaco needle 30 deg different types like bevel round (Qty: 06).
Disposable Vitrectomy cutter (Qty:10)
Phaco hand piece with lock and sterilization box
With local made Trolley.
With compatible imported online UPS with dry batteries for 15 minutes back up.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
52 AUTOREFRECTOMETER WITH KERATOMETER
With auto measurement & printout with standard accessories.
Manual or motorized chin rest movement.

Page 36 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Measuring range:
Spherical: ±17D or better.
Cylinder: ±6 D or better.
Axis: 1 to 180⁰.
Pupil distance: Max 85mm (increment 1mm).
Display: LCD monitor with printer.
Electric power: 220V AC, 50Hz.
With paper roll, dust cover and cleaning kit.
On locally made motorized table.
Corneal radius of curvature 6.6mm to 9.2mm or better.
Corneal refractive power ranging from 36.5D to 51D or better.
Axis of corneal astigmatism 0 to 180⁰.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
53 SLIT LAMP
Binocular tube with vertical type and eye width adjustment.
Efficient Illumination system.
Eyepieces with dioptric adjustment 10x.
Slit length: variable.
Tilt mechanism.
Slit image rotation: 0 to 180°
Filters: UV, Heat absorbing, red free and cobalt blue.
With provision for hanging type applanation tonometer.
On locally made motorized table
Dust cover
Plastic breath-shield
Chin-rest papers.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 37 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
54 AUDIOMETER
Frequency Range : Up to 8kHz
Pure Tune Audiometery
Bone conduction
White noise (built-in): (-10 to 95) Db HL or better
Narrow band noise
Signal type : (Steady/ Continuous, Pulse)
Special Test: (ABLB, SISI, Tone/Decay Test)
Accessories:
AC Headrest
BC Headrest
Microphone (Talk forward & Talk back)
Patient Response switch
Compatible printer

Optional Technique:
Speech Audiometry with Accessories
Free field audiometry (free field audiometry) : Frequency 125 Hz- 8Khz and free field
Audiometry intensity: (-10 Db HL to 90 db HL) or better
High frequency audiometry (8khz to 16 khz) or better
VRA setup

Optional accessories:
Pair of insert earphone
Speech audiometry accessories
Free field audiometry accessories
HF Head set in case HF Air conduction
Special test (MLB, Lombard test, strenger test, High, Frequency audiometry, tinnitus matching test
VRA setup accessories:
Virtual stimulator, LCD/ LED Monitor, DVD Player, Toys, Light effects, powerful free, field system
The system must be quoted with all standard accessories pertaining to different quoted techniques.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

DENTAL

55 DENTAL CHAIR/UNIT WITH ACCESSORIES


Dental Chair with hydraulic / electric chair movement, headrest and standard backrest.
Preset chair positions: start and rinsing position. Programmable chair positions.
Last memory holds function.
Low chair position with emergency treatment position.
Chair movement will be controllable by dentist and assistant touch panels, as well as the
multifunctional foot control.
Main switch to control air, water and power.
Chair-instrument lock enables safe operation; the chair is locked while an instrument is working.
With safety system, backrest and seat movement can be stopped once it meets obstacle.

Page 38 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Dentist Element
Hanging arm hoses, instrument side tray. Height of dentist element will be adjustable.
Control panel can be used for operating functions, such as chair movement, preset and
programmable positions.
Cup filler, bowl rinsing, operating light on/off and intensity adjustment.

Equipped With:
1 three way syringe.
3 hand piece hoses for air turbine or air motor. 1 air pressure guage.
1 silicon mat which can be sterilized.
Assistant Element
With an angle adjustable support arm. With suction filter system for easy cleaning
Full-functional touch panel mounted on the assistant element.

Equipped With:
2 High speed Non-Fiber Optic Air turbine (Push type) with two spare rotors
1 High speed Fiber Optic Air turbine (Push type)
1 slow speed air motor with straight & contra angle attachments (Push type) 1 built in Electric scalar
(Peizo Type) with three tips
1 Air Compressor oil free minimum tank capacity 24 liter 1 three-way syringe
1 saliva ejector Water Unit
Fresh Water bottle (1.5L)
A switch to choose city water or fresh water bottle Programmable cup filler and bowl rinsing systems. Air
venturi /motorized system and air water separator Extra safe hygiene distilled water bottle attachment.

Operating Light (LED Type)


Brightness is 23,000 Lux, LED type
Light on/off and intensity can be controlled both from dentist as well as assistant’s side

Dental Working Stools (Qty-02)


Mobile on 5 castors
Height of seat and backrest is adjustable. Backrest angel is adjustable and lock able

Water Treatment Unit


Water treatment unit for supplying the treated water to the unit. Locally assembled with
USA/Europe/Japan Parts.

Light Cure Unit


LED type Light curing unit consist of Base unit with holder for hand piece
Hand piece
Digital Timer for adjusting of different time settings.
Standard cable operation
Standard light probe.

Cautery Unit
Dental Cautery machine

DENTAL INSTRUMENT SETS


(05sets with each Unit) LOCAL, FDA Approved)
Dental Forceps Kit (1x12)
Teeth extraction forceps, upper anterior, straight, upper premolar, upper molar, (right and left), lower
anterior, BD forceps, lower full molar forceps

Page 39 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Bannet forceps, cross bar elevators (right and left),
Filling Instruments
Amllagam gun, burnisher (Small, Medium, and Large), carver, matrix band retainer and strips, pastel and
mortar, glass slab, cement spatula, plugger all sizes, condenser (Small, Medium, and Large),
Examination Sets Diagnostic kit : mouth mirror, probe, twizer, excavator, plastic instruments,
Cross Bar Elevator
Periostial Elevator all sizes (Small, Medium, and Large),
Guage Elevator (1x3) (Small, Medium, and Large) curve root elevators,
Bone Files (Small, Medium, and Large),
Wire Cutter (Small, Medium, and Large), carbide tips
Plaster Instrument (Spatula)
Impression bowl, Spatula, trays all sizes
Wax Knife
Wax Carver
Measurement Gauge
Blade Handle
Hand Scaling Instrument
Periodontal scaler
Inter Dental Scaler
Periodontal measuring Probe
Note: The firm will be responsible for complete installation including minor civil works related to water
draining system.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
56 DENTAL AUTOCLAVE
Portable Horizontal Steam Sterilizer;
Class B (stand alone with internal tank),
one manual door
Water feeding system with water tank sensor to check the water quality and a water distiller for
production of water for the Sterilizer.
Stainless Steel Chamber of 304/316L
Temperature Range 121 0 C &1340 C
Digital display for pressure, cycle, time
Fully automatic, programmable microprocessor type
Capacity 20-25 liters
4-5 piece of stainless steel/Aluminum trays compatible with the steam sterilization.
One piece of holder for unloading of trays. 220V, 50Hz

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
57 DENTAL X-RAY MACHINE (MOBILE)
Compatible with Digital Sensors and Traditional Films
100% imported Scissor arm and mobile stand from the original manufacturer
Short exposure times especially suitable for digital imaging
Microprocessor controlled
Tube Current 3.5 mA or better
Tube voltage 60-70 kV or better

Page 40 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Focal point 0.7mm or better with filtration system
Exposure time automatic adjustable
Patient types: Child and Adult
Automatic Selection of dose by Tooth selection
Timer with integrated circuit Tube head with 360° rotations with beam limiter Power on light signal,
x-ray emission light signal

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485
58 DENTAL OPG MACHINE
Digital OPG System
Patient immobilization positioning
Adjustment to the jaw width
Automatic radiation management for different images
Programs:
Standard panoramic
Pediatric Program
Image of left or right-hand side
Constant magnification of Dentition
Artifact-reduced image
Maxillary Sinuses image program
Temporo mandibular joint
Bitewing image
Lateral Ceph, PA, AP and Corpus View program through Ceph Arm
Technical data
Multi-pulse High frequency generator: 100-120 kHz
X-ray generator: 60-80 KV, 6-10 mA – or more
Sensor: CMOS/CCD
Panoramic exposure time: 14 Second or better
Patient positioning laser lights: 02
Useable to sitting/standing and wheelchair position

Software;
Manufacturer’s software for patient data, filters and image analysis
Manufacturer’s DICOM support software for image printing on DICOM Printer
Branded PC with following configurations: Ci7 latest Generation or better, 8GB RAM, 1TB Hard Disk,
1GB Dedicated Graphic Card & 23” HD LED Monitor with Keyboard & Mouse
DICOM Printer (Agfa / Carestream /Konica/ Fuji or equivalent)
Pure Sine Wave Online UPS to take load of X-ray, PC with 10-15 Backup time (Separate Price is
mandatory)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers (Compliance of any two quality standards is mandatory)
Manufacturing Standard: Must conform to the requirements of ISO 13485

PEADS/NURSERY/OBS

Page 41 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
59 FETAL HEART RATE DETECTOR (DESKTOP)
Desktop
Microprocessor controlled equipment.
LCD display with visualization of at least fetal heart rate.
Ultrasound working frequency in the range 2MHz to 3MHz +10%.
Sensitivity to detect fetal heart beats of at least a 10-12 weeks fetus.
High sensitivity equipment compatible probe: 2 - 3 MHz.
Heart rate measurement range not smaller than 50-210 bpm.
220 V/50Hz with 2-hour battery backup.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
60 CTG MACHINE
Single and Twin Ultrasound
LCD Color Display
Fetal monitor for Antepartum monitoring
Ultrasound and transducer with marker and recorder for FHR
Twins Detector Capability Fetal ECG capability Alarms: Low; Bradycardia, High; Tachycardia, Strip chart
recorder/ printer Paper size: 120 mm or more Paper Speed: 1,2,3 cm/sec
Complete with belt, abdominal fixer / fastener of transducer
Paper easily available with the market
Trolley, Local made
Power: 220V/50Hz AC

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
61 VACUUM EXTRACTOR
Oil free and noise free, vibration free suction unit Noise level 50dB or less.
Aspiration rate of 25-30 liter per min at 0-640 mmHg
Vacuum continuously adjustable
Vacuum meter in mmHg or kPa and regulator, on / off switch
Casing with carry handle and fitting rail
Suction tubing (2)
silicone tubing with coupling connection Suction bottle (2), autoclave able 2 liters each (polysulfone).
10X bacterial filter
Vacuum Extractor with various combination of silicon cups Silicon cup 50 mm & Silicon 60 mm;
sterlizable/ autoclave able, Foot Vacuum Regulator
220V/50Hz. I Phase
Trolley with lockable wheels

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 42 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
62 LAPAROSCOPY MACHINE
Imaging system should have backward and forward compatibility and modularity
for futures upgrade and with latest image enhancement modules for better image
quality and identifications of the landmarks and pathology for better outcomes of
the surgery

UHD minimum of 1920 x 1080 pixels with the method of Progressive Scanning
Telescope:
i. Diameter 10 mm, 0oworking length 290-340 mm
ii. 10 mm straight, 30o view working length 290-340 mm
iii. 5 mm straight forward “0” degree
iv. 5 mm forward oblique “30” degree
Camera Full CCD or 3CMOS (1920x1080 Pixels)
v. Camera control unit and video camera Head, Pal system.
vi. Integrated (image processing model)
vii. Power supply accordingly
Special Feature Required:
viii. Automatic or manual while balance
ix. Powerful video signal processing
x. Image enhancement modes.
xi. Picture in picture mode control via camera head button or monitor
xii. Control of peripheral i.e., light source, recording system parameter via
camera head button or console
xiii. Still image capturing in full HD quality (JPEG) format via camera head
buttons
xiv. Video capturing in full HD quality (MPEG 4 format) via camera head buttons
xv. Should have compatibility with video scope of same brand.
xvi. Max. resolution: 1920 x 1080 -pixel, progressive scan
xvii. Video Output: HDMI OR DVI OR SDI
xviii. Composite signal to BNC Socket.
xix. S-Video Signal to 4-pin mini–Din Socket (2X)
xx. RGB Signal to D-Sub Socket.
xxi. DV Signal to DV Socket (only with DV Module)
Monitor:
or better with Resolution 1920x1080
from the same manufacturer

quote the xenon light source it


will be compulsory to quote and supply 5 xenon lamps of each unit.)

-50 Liter/min complete in all respect with all standard accessories

graded video recorder with storage capacity of 500


GB or more.

Page 43 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

Accessories:
(i) Online 2KVA UPS with 30 min backup to be provided locally
(ii) cylinder 240CFT with complete accessories (to be supplied locally) certified
by respective agency
(iii) Imported storage boxes for instruments and optics
(iv) Imported disinfection Boxes
(v) Standard Cleaning Set as manufacturer recommendations for cleaning of tubular
shafts and other instruments

LIST OF INSTRUMENTS REQUIRED FOR GENERAL SURGERY


Note: the minor variation in size and type of the instruments would be acceptable.
The size of instruments is approximate. The mentioned shape and style of instruments is for reference
and may be quoted their equivalent.

Hasson Cone:
vi) Trocar size 10/11 mm with cannula & multifunction valve length 10.5cm pyramidal tip & conical tip
one.
vii) Maryland dissecting forceps slightly curved with Cannula pin for unipolar coag Dia 5mm, length 30-
36 cm, insulated, relatable.
viii) Dissecting forceps insulated rotatable needle nose.
ix) Reddick-Olsen dissecting and grasping Forceps, heavy.
x) Dissecting and Grasping forceps, alligator jaws with connector pin for unipolar coagulation, size
5mm. (rotatable, straight)
xi) Dissecting and Grasping Forceps, (Kelly’s)with connector pin for unipolar coagulation, size 5mm.
length 30-36 cm length, double action jaw.
xii) Dissecting and grasping forceps, (Kelly’s)with connector pin for unipolar coagulation, size 5mm36
cm length, double action jaw grasping forceps with teeth with connector pin for unipolar
coagulation, size 5mm double action jaw with ratchet.
xiii) Multifunction grasping forceps, 1x2 teeth with connector pin for unipolar coagulation, size 5mm
xiv) Bowel grasping forceps, two rows of traumatic teeth without connector pin for unipolar
coagulation, size 5/10mm.
xv) Bowel Grasping Forceps With connector pin for unipolar coagulation, size 5/10mm.
xvi) Babcock Grasping Forceps rotating, dismantling with connector pin for unipolar coagulation, size
5/10mm. (with ratchet).
xvii) Babcock Grasping Forceps rounded without connector pin for unipolar coagulation, size
5/10mm.
xviii) Claw forceps, single/double/action jaw, with teeth, size 5/10mm, length 33-36, 01short,
rotating consisting of Mattel or sterilizable handle with ratchet, outer tube, insulated, forceps
insert.
xix) Clip applicator (medium large) & medium, rotating, ratchet with clips.
xx) Tenaculum forceps, rotating, size 5/10 mm, length 33-36 cm, and Mattel or sterilizable handle with
ratchet, outer tube, insulated, and forceps insert.
xxi) Metzenbaum scissors, curved rotating, with connector pin for unipolar coagulation, size 5 mm,
length 33-36 cm insulated handle, outer tube, insulated.
xxii) Curved/angled scissors, rotating, size 5mm, length 33-36cm: insulated handle, outer tube,
insulated.
xxiii) Micro scissor curved 5mm, insulated with diathermy Lead.
xxiv) Hook scissor single action jaws, size 5 mm, length 33-36 cm: insulated handle, outer tube,
insulated, insert
xxv) Scissor straight 5mm insulated with diathermy.
xxvi) L Shaped dissecting electrode /diathermy size 5mm, insulated, length 33-36 cm (L-hook

Page 44 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
dissector).
xxvii) Coagulating and dissecting electrode, spatula-shaped, blunt with connector pin for unipolar
coagulation, size 5 mm, working length 33-36cm.
xxviii) (Injection) Aspiration needle 5mm.
xxix) Biopsy forceps insulated (5mm).
xxx) Bipolar diathermy electrode.
xxxi) Uterine cannula, with 2 cones, large and small spring-loaded fixation for forceps with luer lock
adaptor for cleaning.
xxxii) Uterine tenaculum forceps, length 22cm.
xxxiii) Suction and coagulation cannula, 3mm, with connector pin for unipolar coagulation, 30cm.
xxxiv) Dissecting electrode l and j shaped.
xxxv) Needle holder 5 mm
xxxvi) Needle grasper 5 mm
xxxvii) Thread manipulator 5 mm
xxxviii) Retractor 10 mm (3 blade)
xxxix) Knot pusher.
xl) Diathermy Leads Autoclavable.
xli) Bipolar Forceps and Leads.
xlii) Clip applicators.
xliii) Trocar with trocar sleeve 05mm Approx.
xliv) High flow verses needle.
Optional:
w working length 290-340 mm
Note: Minor deviation in shape and sizes will not be consider reason of rejection.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
63 LED PHOTOTHERAPY UNIT
Overhead infant phototherapy unit; LED type
Spectral irradiance:
a. High Irradiance: Up to 40 μW/cm2/nm or more.
b. Low Irradiance: As low as 20 μW/cm2/nm or below.
Wavelength range between 430-490 nm
LED lamps life: Min. 50,000 hours
Height adjustment 1260 mm to 1550 mm from light (±5% tolerance for height adjustment)
Lamp unit tilting position
Effective surface area minimum 50 cm x 30 cm at minimum 35 cm, from the light
source
Maximum noise 40 dB or less
Operating Voltage 220 V/ 50 Hz
Hour Meter for standard and intensive modes.

ACCESSORIES:
Eye protector pads

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 45 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
64 BABY WARMER
Mobile Baby warming system with bassinet.
Microprocessor controlled heating system.
Fail safe system.
Mobile with antistatic castor, lockable, bumper guard.
Manual heat output control: 0% to 100%
Skin and Manual temp control settings
Digital Display range of temperature: LCD / LED
Heating power/ source: 500 W Quartz/ Ceramic
Selection for operating modes: Skin and Manual
Audio Visual Safety Alarms for power failure, over temperature
Pivot arm technology for heating.
Head can be moved in both directions allowing X- Ray procedure without moving the baby.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
65 INFANT INCUBATOR
Intensive care incubator microprocessor controlled with digital display of set /measured temperature,
humidity.
Incubator hood double/triple wall, doors at front and back.
Bed surface (600 x 350 mm) (approx.) with mattress tilt able head and foot end.
Integrated X-Ray tray to accommodate X-Ray cassettes from outside without moving the baby.
4 x elbow hand ports.
Noise level inside the hood 45 - 50 dBA.
X-Ray compatible hood/mattress with tray
Display of Oxygen Concentration in the incubator.
Temperature Regulation:
Air Temperature setting range:25-37/ 37º-39ºC
Skin temperature setting range:34-37/ 37º-38ºC
Display resolution: 0.1ºC
Humidity Regulation:
Water Reservoir Capacity: 1000 ml Setting/display Range: (35 – 90%)
Alarm Safety Signals:
Visual and audible battery buffered/ powered alarms for, skin and air control temperature deviations,
over temperature skin / over temperature air control,
Humidity Control, Fan failure,
Base with drawer’s unit, lockable antistatic Casters.
Standard Accessories:
Air sensor, skin sensors, humidity sensor, IV Pole, replaceable bacterial filter, Rails at head and foot
end. Mattress with cover. Oxygen Hood

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

ORTHOPEDIC

Page 46 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
66 ORTHOPEDIC DRILL/SAW, ELECTRIC
Corded electric hand piece with quick release drill attachments Instrument forward reverse and
oscillating mode
Hand piece and all attachment should be Autoclaveable
Control method: triggered
Speed: 0-1100rpm or better
Cannulation: 4.1mm
Saw type reciprocating
Speed :0-8000 cycle/min or better
Quick change attachments locking mechanism sagittal saw attachment,
Burrs/Blades, Oscillating saw with separate Hand Piece, Wire and pin drive
attachments. K-wire driver, Reamer attachment and Drill Bit attachment.
Accessories:
Sterilization Container

Minor variation in standard sizes is acceptable.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
67 ORTHOPEDIC DRILL/SAW, PNEUMATIC
Complete Pneumatic Drill System
Drill hand piece for drilling driven by compressed dry Nitrogen 99.95% pure.
Operating pressure: 100-110 psi
Operating Speed: Min 900 RPM or better
Fully Autoclaveable up to 3 bar Pressure (134⁰C)
Hand piece with Variable Speed Trigger
One hand operation
“Forward / Reverse control” right on instrument base
ATTACHMENTS:
Pneumatic Hose (5 meters)
Jacobs Chuck with key and Keyless Jacobs Chuck
Nitrogen Regulator
Coupling connecting system
High Torque Reaming Coupler
Automatic wire driver for wires from 0.7 mm to 1.6 mm.
Automatic pin driver for wires from 1.7 mm to 3.2 mm.
Standard Twist Drill 1.6 x 127mm
Standard Twist Drill 2.0 x 127mm
Standard Twist Drill 2.4 x 127 mm
Standard Twist Drill 2.8 x 127 mm
Standard Twist Drill 3.2 x 127 mm
Standard Twist Drill 3.6 x 127 mm
Sterilize able Hand Pieces
Standard Sterilization Case
2xNitrogen Cylinders (Approx. 40L water capacity, BS colour coding) with pressure
gauge and fittings.
Complete system ready to use.

Minor variation in standard sizes is acceptable.

Page 47 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Optional;
Sagittal Saw Attachment
Reciprocating Saw Attachment

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

UROLOGY

68 COMPUTERIZED HEMODIALYSIS MACHINE


Various Dialysis Therapies including double needle system & Single Needle with Single Pump.
Dialysis machine system should be open consumable types
Variable Bicarbonate & Acetate Concentration. And no binding on consumable or disposable
Bicarbonate profiling with monitoring/Proportion/ Dialysate Profiling Variable temperature control
Water Inlet pressure requirement: 1.5 to 6 Bar maximum
Heparin Pump Automatics top & Bolus with flow ratefrom0.1-9.9ml/hour
Programmable Ultra filtration with controller varying rate
Ultra-filtration with or without diffusion
Automatic priming with display
Dialysis machine with Digital Touch/Graphical TFT/LCD display.
Service diagnostic and calibration mode on display
Touch/Electronic control off low rate and blood flows
Automatic clean, disinfect and rinsing mechanism, built in heat disinfect system
• Should be capable to record disinfection history/Last disinfection history
BloodPump:50 to 500ml/minute
• Variable Dialysate Flow: from 300 to 700ml or better
Temperature Control: up to 39 deg. C. (Adjustable)
• Arterial Pressure Monitor, Venous Pressure Monitor
• Ultra-filtration Rate Control: Range of UR 0.0 to3.00 Kg-hour or above.
Air Bubble Detection: Air bubble detector alarm threshold.
Blood leak Detection, Sodium profiling
• Online B.P Monitoring System
Battery backup for at least 15 - 20 min,220V,50Hz

Water Treatment Unit (as per mentioned qty) :


Complete with pre-filtration of charcoal, sand water softener, ultraviolet sterilize able automatic water
pressure system and R.O. Including all special high-quality P.V.C Pipes/fittings/tanks, motors, stainless
steel pumps and other fittings.
The quality of the water standard must be certified or as per recommendations of the manufacturer of
Dialysis machines.
Capacity of water treatment Unit will be 30 Liters per hour/machine.
Continuous online monitoring of Ph and conductivity.
All components of System will be imported and can be assembled locally.

Optional:
Pediatric Mode (System should have ability to be used on pediatric patients)
• Dialysis Adequacy Monitoring (Kt/v or URR) with graphical Display
• Dry powder bicarbonate concentrate facility
• Endo toxin retention filter

Page 48 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
69 URETROSCOPE (ADULT) COMPLETE WITH ACCESSORIES HD
Uretero-renoscope, Autoclavable, Semi Rigid Tip size 6-9Fr, Angle: 5-12 degree
Working Length: 43cm
Instrument Channel with lateral offset eye piece or Equivalent Silicone
automatic valve, ø 3.9 mm, 5 pieces / package Rubber cap for
instrument channel
Flexible cleaning brush for instrument channel Grasping
Forceps (Compatible with sets) Biopsy Forceps
(Compatible with sets)
2-3 prong forceps (Compatible with Set)
Sterilization Tray compatible with sets

Light Source
Lamp type: LED Light Source
Lamp life: 20,000 or more
Control: Knob or Buttons
Light guide cable: Diameter 3.5mm or more, length minimum 200 to 300 cm.
Power Requirements: 220 V, 50 Hz

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

MISC.

70 STERILIZATION EQUIPMENT

NOTE:
The given below is the designed turnkey solution of complete hospital, in case of requirement of
complete new system, procuring agency need to define the items required and quantities of each items
as per the bed strength of hospital.
In case of requirement of any of the given below equipment, with in the running/equipped hospital,
Procuring agency may select the required items and define the quantities as per its actual requirement.

01.CLEANING & WASHING UNIT:


).(10% deviation is acceptable if
Imported )
-50 mm backsplash.
-chrome steel/SS sheet.

stand pipe and with siphon trap.


02 No’s of integrated Spray Guns for dematerialized water/ air with 08 cleaning nozzles (with
each gun), hose, table lead through.

Page 49 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

-chrome steel or SS design.


d be acceptable (export quality).

valuation.
Note: Imported/Local should be specified by the procuring agency as per their requirement.

02.HIGH END WASHING /DISINFECTION / DRYING UNIT:

chamber, washing arms made of high quality stainless steel AISI 316 L

unloading side.

syringes, hollow wares etc.

8/10/12 DIN basket Capacity.

-10 standard pre-set cycle programs.


ort cycle disinfection program (30-40 mins) with pre Heating tank.

condensate drain.
-400V.

STANDARAD ACCESSORIES: (IO Procuring Agency to Specify quantity)


8/10/12 Baskets.
8/10/12 DIN Baskets.

-in Thermal Printer (IO to specify) Machine are equipped with software having printer facility if
procuring agency required they may add as additional printer. For individual machines thermal printers will
be included.

OPTIONAL ACCESSORIES :( IO to specify and add as per requirement).

Surgery /Laparoscopic instruments cart.


Central Dosing Pump.

Page 50 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Preferably for setups consisting of 3 or more washer central dosing system for effective management
and utilization of detergents and chemicals. (IO to specify).

03.HEAVY DUTY STEAM STERILIZER

integrated steam generator as backup.

neumatic two doors pass through system.

standard accessories.

04/06/08/ STU, rectangular shape. (I/O Procuring agency to specify as per design
requirement).
of AISI 316 L/Ti.

-in water saving system and automatic heat exchanger with condensate
cooling device.

Documentation/ Software Documentation for machine and cycle data.

and operate
the individual machine component from HMI.

for monitoring and controlling of parameters during power shedding provided locally.

ACCESSORIES: (IO Procuring Agency to Specify The quantities).

-in Thermal Printer (IO to specify) Machine are equipped with software having printer facility if
procuring agency required they may add as additional printer. For individual machines thermal printers
will be included.

04 ULTRASONIC CLEANER
-in/integrated/Standalone.
ted of corrosive resistant 304 SS.

05 INTEGRATION SOFTWARE: (IO to specify)

Page 51 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

configured with software.


The software Package includes:

communication.
o Store cycle data on an external PC.

le.

OPTIONAL:
Traceability Software: To ensure and monitor the information of each batch. Standard accessories to
execute the operations.

06 MANUAL TROLLEY WASH


nd carts.

-2 meters

07 TRANSPORT AND DISTRIBUTION TROLLEY

NOTE: The procuring agency to specify that the required Transport and distribution trolley for CSSD
will be Local/ Imported.

In Case of Local:

(SWG=18)

08 PAPER DISPENSING TROLLEY


Movable paper dispenser trolley made of stainless steel for storing of sterilization paper sheets at
packing tables.

NOTE: The procuring agency to specify that the required paper dispensing trolley for CSSD will be
Local / Imported.
In Case of Local:

ent Certifications (ISO 9001, ISO14001 or equivalent)

Page 52 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

09 PAPER SEALING MACHINE

printing mechanism.

10 CUTTING DEVICE

-grinding,
-1000mm.

11 TAPE DISPENSER

12 BASKET TROLLEY

ze approx. 600x1500x450mm.

NOTE: The procuring agency to specify that the required basket trolley for CSSD will be Local
/ Imported.

In Case of Local:

or gauge (SWG=18).

13 FREE STANDING BASKETS RACK


rack.

NOTE: The procuring agency to specify that the required furniture/Trollies for CSSD will be Local
/ Imported.
In Case of Local:

14 PACKING TABLE

r two drawers,

NOTE: The procuring agency to specify that the required packing table for CSSD will be Local

Page 53 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
/ Imported.
In Case of Local:

14001 or equivalent)

15 LINEN TABLE

mm).

NOTE: The procuring agency to specify that the required linen table for CSSD will be Local
/ Imported.
In Case of Local:

g type argon should be ensured for quality & finish standards.

16 MODULAR WIRE BASKET


loading/unloading equipment,
Sterilizers as well as storage racks and distribution trolley.

size.

NOTE: The procuring agency to specify that the required modular wire basket for CSSD will be Local
/ Imported.
In Case of Local:

17 MESH BASKET.
0mm) standard DIN trays
with handle.
NOTE: The procuring agency to specify that the required mesh basket for CSSD will be Local
/ Imported.
In Case of Local:

ess or gauge (SWG=18)

Page 54 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
18 CLOSED TRANSPORT TROLLEY
of stainless steel,

NOTE: The procuring agency to specify that the required closed transport trolley for CSSD will be
Local
/ Imported.
In Case of Local:

14001 or equivalent).

19 AUTOMATIC TROLLEY WASH (Optional Procuring agency to specify the requirement)

-spray mechanical washer.


ergent solution washing, clean rinsing, thermal/chemical disinfection and drying
of transport carts, containers, tote bins, bowls, basin and other bulk items, Hospital beds,
Operation tables, Close cart trolley. (I/O Procuring agency to specify the requirements items).

allowing only one door to be open at any given time.


t.

chamber for safe operations.

evenly along both sides of the chamber with jet spray nozzles placed evenly in each vertical tube
from floor to ceiling.

ped with Universal


cart that can handle containers, tote bins, basins, etc.

-3 Pumps are self-priming and dosing levels are controlled by cycle parameters.
hine and cycle data.

20 REVERSE OSMOSIS SYSTEM


RO system should be compatible with the CSSD equipment requirement and in accordance with
the quality of the local water where it is being installed (Standard component like Sand filter
activated carbon Membrane etc.)

21 TABLE TOP STERILIZER

-B type sterilizer
Different type of programs Temperature range 134⁰C

22 OIL FREE AIR COMPRESSOR

Page 55 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

23 FLOOR CLEANING/ POLISHING MACHINE


As per requirement.

23 THERMO DISINFECT ABLE SHOES


Sizes 39/40/41/42 Total 40 Pairs.

SPECIAL TERMS & CONDITIONS IN CASE OF TURN KEY PROJECT:


-key project major civil works (Building construction.) and provision of facilities (Water,
Gas and electricity) at the site shall be responsibility of Institute. Whereas, all those piping, minor
civil works, platforms, erection of mechanical/ electrical/ instrumentations, installation &
commissioning shall be the responsibility of the Contracting firm inside the CSSD room as per
international standards.
red for safe operations.

submission of bid in written form.


vil
work/electric work /Accessories (local)/facilities in break up form. Competition should be made on
collective price.

pipes will be used as per standards. The complete


flooring of CSSD with PU anti-bacterial sheet, ceramic tiles on walls, dumpa false ceiling will be installed.
The partitioning will be made with 2mm Aluminum sheet.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
71 STEAM STERILIZER (LARGE)
Horizontal Steam Sterilizer. One door
Built-in Electric Steam Generator
Stainless Steel Chamber of 316L
Water Tank Sensor for water quality checking
Temperature Range 121 0 C & 1340 C
Digital touch screen display min 4” for pressure, cycle, time etc.
Fully automatic, programmable microprocessor type for types of hospital load.
There should be Vacuum, Bowie Dick tests facility.
Capacity 200L Approx, Horizontal type
Stainless steel compatible trays for sterilization.

Water Treatment:
There will be a water treatment unit for sterilizer which must be regenerate regularly by the firm. Local
with imported components.
Washing Counter:
2-2.5 meters length, Local with imported guns (02)
Ultrasonic Cleaner:
Ultrasonic Cleaner/ washer approx 25-30L capacity.
Packing Table:
Packing/ inspection table with illuminator. (Local/ Imported)

Optional (quote separate price)


Packing/ sealing machine

Page 56 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Packing Paper, different sizes

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
72 STEAM STERILIZER (MEDIUM)
Horizontal type Steam Sterilizer, One door
Built-in Electric Steam Generator
Stainless Steel Chamber of 316L
Water Tank Sensor for water quality checking
Temperature Range 121 0 C & 1340 C Digital touch screen/key pad display min 4” for pressure, cycle,
time etc.
Fully automatic, programmable microprocessor type
There should be Vacuum, Bowie Dick tests facility.
Capacity 100 Liters Approx
Stainless steel compatible trays for sterilization.
System should be with water treatment unit

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
73 AUTOCLAVE SMALL
Portable Horizontal Steam Sterilizer
Water feeding system with water tank sensor to check the water quality and a water distiller for
production of water for the Sterilizer.
Stainless Steel Chamber of 304/316L
Temperature Range 121 0 C &1340 C Digital display
Fully automatic, programmable microprocessor type
Capacity 20-25 liters
4-5 piece of stainless steel/Aluminum trays compatible with the steam sterilization. One piece of holder
for unloading of trays.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
74 CENTRAL MEDICAL GAS SUPPLY SYSTEM
(I/O may select any or all components from the following items as per requirement)

The given below is the designed turnkey solution of complete hospital, in case of requirement of
complete new system, procuring agency need to define the items required and quantities of each items
as per the bed strength of hospital.
In case of requirement of any of the given below equipment, with in the running/equipped hospital,
Procuring agency may select the required items and define the quantities as per its actual requirement.

APPLICABLE STANDARDS/ CONFIGURATION:


The Medical gas Pipe line should strictly comply with the international standards and configuration for
requirements of HTM 2022 or latest, however, ISO 7396-1 or latest can also be used. It would be the
choice of the bidder for adherence to any standard which would be mentioned in the bid. The objectives

Page 57 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
are to ensure the following:
a) Non-Interchangeability Between Different Pipeline Systems By Design;
b) Continuous Supply Of Gases And Vacuum at Specified Pressures By Providing
Appropriate Sources;
c) Required Flow Rates In Particular Areas/ Outlets;
d) Use Of Suitable Materials;
e) Cleanliness Of Components;
f) Correct Installation;
g) Provision Of Monitoring, Controls and alarm at single site.
h) Correct Marking Of The Pipeline System;
i) Following Of Testing And Commissioning Protocols;
j) Maintaining The Purity Of The Gases Delivered By The Pipeline System;
k) Correct Operational Management.

AUTOMATIC-MANIFOLD FOR OXYGEN


The Manifold shall be a fully automatic type & shall switch from left and right bank without fluctuation
in delivery supply line pressure &without the need for external power./ Delivery supply line Pressure
with external power for switching between cylinder Manifold pure sine wave UPS with 4 hrs. Backup
should be required.
In case of VIE option then automatically the manifold will be with VIE.
(VIE tanl capacity to be defined by I.O.)

CAPACITY.
(2 x 4), (2 x 8), (2 x 12), (2 x 16) & (2 x 20) with capacity of 80-90 /100-120, m3/h. @ 4-5 bar (The
procuring agency to select the required manifold capacity. Other than the defined, bank capacity may be
increased or decreased as per requirement).
FUNCTION.
-contained shuttle-valve/Solenoid valve (Ups Mandatory for Solenoid valve).

parameters (High, low Pressure) for cylinder manifolds.

side cylinder bank


Connection.

AUTOMATIC-MANIFOLD FOR NITROUS OXIDE


The Manifold shall be a fully automatic type & shall switch from left and right bank without fluctuation
in delivery supply line pressure &without the need for external power./ Delivery supply line Pressure
with external power for switching between cylinder Manifold pure sine wave UPS with 4 hrs. Backup
should be required.

CAPACITY.
(2 x 4), (2 x 8), (2 x 12), (2 x 16) & (2 x 20) with capacity of 30-40/70-90, m3/h. (The procuring agency
to select the required manifold capacity. Other than the defined, bank capacity may be increased or
decreased as per requirement).

FUNCTION.
-contained shuttle-valve/Solenoid valve (Ups Mandatory for Solenoid valve).
display unit for monitoring and alarm of different
parameters (High, low Pressure) for cylinder manifolds.

Page 58 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
cylinder bank.

AUTOMATIC-MANIFOLD FOR CARBON DIOXIDE & ENTONOX (As per requirement)


Note: Carbon dioxide is commonly used as an insufflation gas for minimal invasive
surgery (laparoscopy, endoscopy, and arthroscopy) to enlarge and stabilize body cavities to provide
better visibility of the surgical area.
Entonox is used for short-term pain relief and calming of anxiety during a range of painful procedures. It
is used most commonly at GOSH for procedures such as chest drain removal, dressing changes, lumbar
punctures, pin site cleaning, joint injections or botulinum toxin injections.
The Manifold shall be a fully automatic type & shall switch from left and right bank without fluctuation
in delivery supply line pressure without the need for external power./ Pressure with external power for
switching between cylinder Manifold pure sine wave UPS with 4 hrs. Backup should be required.

CAPACITY
(2 x 4), (2 x 8), (2 x 12), (2 x 16) & (2 x 20) with capacity of 30-40/70-90, m3/h. (The procuring agency
to select the required manifold capacity. Other than the defined, bank capacity may be increased or
decreased as per requirement).

FUNCTION
-contained shuttle-valve/Solenoid valve (Ups Mandatory for Solenoid valve).

parameters (High, low Pressure) for cylinder manifolds.

shut off valve and battery / bank alarm for left and right
cylinder bank.

GAS OUTLETS (BS/DIN SYSTEM)


Gas outlets, complete in Box/casing gas Specific, Self-sealing valve, indexed to eliminate
interchangeability /erroneous tapping of gas, and cover plate as per Standard Design requirements of the
bidder with following color coding.

te/blue

BED HEADS UNIT FOR ICU


• Each unit consists of: 1,500 mm and above
• Horizontal type with railing
• Built in over bed Light with ON/OFF switch.
• Built in reading Light with ON/OFF switch.
• Provision for Nurse Call/ Alert Button
• Gas outlets (1x Vacuum, 2x Air, 2x Oxygen complete fitted).
• Electrical provisions;
• Electrical sockets: 6 Nos. & 2Nos. Multi Pin Plug and above schuko/ F-type All wiring
conforms to standards, ground/earth
• Monitor shelf with railing clamp
• IV pole with railing clamp

Page 59 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
• Separate ducts for Electrical &Gas Pipes.

BED HEAD UNIT FOR WARDS & PRIVATE ROOMS


• Each unit consists of: 1,000 mm and above
• Horizontal type
• Built in over bed Light with ON/OFF switch.
• Built in reading Light, with ON/OFF switch.
• Provision for Nurse Call/ Alert Button
• Gas outlets (1x Vacuum, 1x Air, 2x Oxygen complete fitted).

-type All wiring


conforms to standards, ground/earth

ALARM AREA WITH REMOTE SENSORS


Digital Display Alarm area with remote sensors for two/three/four/five/six gases. (Procuring agency to
specify in accordance with the requirement)
Individual display and sensor module.
Self-diagnostic & error message display readable for ease of maintenance psi, kPa or bar readout.
Test & Mute Button, low alarm condition.

MULTIPLE ZONE VALVE BOX


Multiple zone valve box for two/three/four/five/six gases. (Procuring agency to specify in accordance
with the requirement)
Each wall type zone valve box shall consist of the following Components. A steel valve box/Aluminum
which can house two to six shutoff ball valves.
Pressure gauges to display the pressure of various gases.
NIST Connection)

OXYGEN & AIR FLOW METER WITH S.S PROBE


FOR Adult
Autoclaveable humidifier bottle) S.S probes Oxygen Flow meter
complete set from 1 to 15 l.p.m.
For Neonate (Dial Type)
Peads (0-5 l.p.m.) with dial type for precise and controlled supply to newborn.

VACUUM REGULATOR WITH GAUGE / DIGITAL


The Vacuum Controller should be connected to Wall Source of Vacuum using direct probe or rail
mounting System. Vacuum Levels 0 to 750 mm Hg complete with 1 Liter suction Bottles, Unbreakable/
Autoclave able (2 each). Complete with overflow safety
system.
For neonate / Peads (0-150 mmHg) or better.

COPPER PIPING
Supply and installation of seamless medical graded(ISO13348EN.) copper pipe, deoxidized and
degreased along with required fitting etc., various sizes /diameter as per Drawing of the project and
Design standard of the bidder with matching color indications of out lets. The sizes will vary from
minimum of 12mm to onward as per design offered by the firm to ensure the pressure and flow
12,15,22,28,35,,42,54 and 76 mm;
Oxygen: White
Air: Black/ B&W Stripes
Nitrous: Blue

Page 60 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
Vacuum: Yellow Carbon Dioxide Grey stripes

ANESTHESIA SCAVENGING SYSTEM


Passive/ Active Anesthetic Gas Scavenging System designed to remove exhaled anesthetic gas
mixtures from operating theatres.

DUPLEX/ TRIPLEX MEDICAL VACUUM SYSTEM


(Procuring agency to define the requirement out of duplex or triplex medical vacuum system)
The capacity of Vertical Vacuum System is 500/ 1000 / 1500 / 2000/ 2,500 L/min per vacuum
pump
(The mentioned specifications are in accordance with the 2500 L/min. The procuring agency
may define the Capacity as per its actual requirement, in case of any other option selection; all
the other feature values will be changed according to the selection of required capacity as per
Manufacturer’s standard design.
Vacuum level @ -450 mm Hg.
Vibration Isolation, Pads, Hour meters, Circuit barkers, Vacuum pump run lights.
Tank mounted system. Complete with filters.
100% as per design flow to fulfill the requirement of Hospital by keeping in view of future extension.

MEDICAL COMPRESSED AIR STATION.


(Procuring agency to define the requirement out of duplex or triplex medical air compressor
system)
Medical Air Plant with Breathable Air. Elimination of Toxic Gases such as carbon dioxide,
Nitrogen dioxide, Nitrogen monoxide, Carbon monoxide; and other pollutants as per European
Pharmacopeia standard system compliance to MDD clause II B.

COMPRESSOR
Compressor unit.

imum of each compressor: - 2500 liters/min/FAD at 10


bars or better.
-vibration base.
compressor System are 500/ 1000 / 1500 / 2000/
L/min or as per design per medical compressor
(The mentioned specifications are in accordance with the 2500 L/min. The procuring agency
may define the Capacity as per its actual requirement, in case of any other option selection,
all the other feature values will be changed according to the selection of required capacity
as per manufacturer’s standard design)

RESERVOIR

of the design flow


whichever is higher

AIR DRYER

-46 to -80oC
int monitoring on LCD Panel

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)

FILTRATION SYSTEM

-filter /Post filter (As per HTM /ISO.)


-off valves on an assembly panel.

interrupting the air supply.


ompressed air output.

REDUCER PANEL COMPRESSED AIR

Pressure and shut off valve with assembly panel size 4 and 7 bar separately.
block according to requirement, Incl. Shut off valve and
pressure gauge for every distribution block, complete assemble panel with incoming
and outgoing copper pipe for complete system.

CONTROL
be capable to run air compressor and dryers automatically with warning system
with alarm.
Monitoring of alarms conditions for the compressor room.

without any interruption.


POWER:
Power Supply- 3 Phase, 380 – 400V/50 Hz.

Ceiling Mounted Anesthesia Pendant

smooth surface, impact and disinfectant resistant.


– 3 or 4 pcs
Drawer – 1 or 2 Pcs

-800 mm
o or better(max)
– 200 kg or better (Motorized Uplifting arm to lift the anesthesia machine as
per compatibility)
ic brakes to control horizontal movement.

– 2 Pc

dical Air 4 Bar 2 pcs

- 1 PC

Ceiling Mounted Surgical Pendant


be powder coated, hygienically
smooth surface, impact and disinfectant resistant.
– 3 or 4Pcs

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
– 1 or 2 Pcs

x).

ic brakes to control horizontal movement.

PC – 2 Pc

- 1 PC

SPECIAL TERMS & CONDITIONS:


1. The item like manifold, outlet, Area Alarm, Multiple Zone valve Box, may be of same manufacturer.
2. The Vacuum System, medical air compressor and Pendant may be of different manufacturer but
should be supplied by the same manufacturer of medical gas pipeline system.
3. All equipment must be according to international safety standard.
4. The color of outlets, piping and cylinder for recognition will be BS type for all the system
equipment.
5. The drop outlet/ Connection will be flushed surface. Separate ducts for piping and electrification

Warranty:
The warranty period shall be unconditional for all essential equipment to keep MGPLS
functional which include all parts/Consumables of equipment’s, (Like seal, kits, pipes fittings, batteries
of ups).
Firm will be responsible to maintain flow and pressure in Hospital.
During the period of machine functioning before signing of formal installation of report rectification of
error or replacements of faulty part shall be the responsibility of supplying firm without any financial
implication or liabilities at the institute or end-user.
The warranty shall start from date of signing of installation report.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485
75 FOWLER BED WITH ACCESSORIES
Over all dimensions: 39” W x 90” L x 21” H Approx
Main Frame: Made of 16 SWG pipe 1” x 2” rectangular pipe section CO2 welded together at corners.
End of Pipes be covered with special plastic bushes Mattress Frame: Should be in 4 parts
The 2nd part fixed and 3 moveable parts made of 1” x 1” longitudinal & ¾” cross pipes of steel square
pipe of 16SWG.
The end of each moveable part should be attached to the main frame by means of bolt having metal
reinforced ABS plastic hinges.
FIXED SIZES (Approx):
1) Head Raise part: 24¾” x 33”
2) Fixed Part: 7” x 33”
3) Knee Bridge Part: 11½ x 33”
4) Leg Rest part: 24½ “ x33” Bedding area made of ABS mesh.
Head Raise & Knee Raise by means of two crank

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ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
The moving lifting pipe at both places be of 16SWG 1 – 1/4” rounded pipe across Head part with
triangular brackets of 5/16” thick x 1- 1/4” x 12 plate and knee bridge part with triangular bracket of 3/8”
thick steel plate at ends panel.
The foot part should have vascular position with a comb mechanism for moving of foot part in knee
bridge position.
A surface bearing must be fixed for friction free movement
The handle of the cranks should be retractable and collapsible and be made in one piece of ½” steel
rod.
Cranks main screw made of dia: ¾” for knee steel rod with square / ACMI type of threading with safe
limit mechanism.
Head & Foot Part of Mattress frame have (Mattress stay) steel brackets CO 2 welded for keeping the
mattress in proper place.
High quality head & foot panels made of ABS material. The height of head panel is greater than foot
side; imported.
The panels of both ends are protected by MS pipe from being damaging while moving/ pushing of
the bed.
Foundation Frame:
Made of 16 SWG 1” x 2” Rectangular pipe welded together at corner.
Bed is provided with I.V. Rod, S.S 5/8” dia, adjustable from (36” to 50”), with 4Nos Non traumatic
prongs/ hooks. The provision is made to attach the IV rod on both side of the patient between mid and
foot end area. Foot end should have hooks for urine bags hanging on both sides and N.G bag hook at
head end of both sides.
Bumpers:
Four 6” rounded bumpers of made of flexible material at all corners.
Castors:
5 “ ball bearing rust proof, water proof , high quality Tante or eq. twin wheel castors with individual &
swivel brake .
Finish:
All metals part to be chemically degreased / derusted through phosphate treatment and covered
with Antimicrobial polyester powder coating.
Welding:
All metal parts should be welded by CO2 gas.
Side Rails:
Foldable side guards with smooth rounded plastic top and steel bars. Fixed to the bed on both sides
covering 70% of platform length when engaged. Steel locking mechanism for strength. Minimum height
when in use 30 cm from mattress platform; imported.
Mattress:
Best quality mattress foam of 4” thickness having density of 35-36 kg/m3. Water proof Rexene cover
having best quality jersey and Zipper (as per approved sample).

BED SIDE LOCKER:


Powder coated sheet steel construction. Galvanized steel sheet 20 SWG. Two drawers with one bottom
compartment. Built-in handles for durability. Plastic top laminated with raised edges on 3 side’s .75mm
twin castors rust proof waterproof, two lockable. Casters with rubber tires for noise free operation on
floors. Buffers on all four corners. Compatible with the offered bed in color and functionality. All metal
parts should be welded by CO2 gas.
Approx. overall size: 18” W x 15” D x 34” H (Approx).

OVER BED TABLE:


Powder coated Mild steel construction. Stainless steel internal column. Gas spring assisted height.
Height adjustable from 70 to 100cm adjustment. Compatible with the offered bed in color and

Page 64 of 65
ANNEX-A
FINALIZED STANDARDIZED SPECIFICATONS OF BIOMEDICAL EQUIPMENT (SSBE)
functionality. Plastic top laminated with rounded edges and cup/glass holders Approx. top size: 80 x
32 cm (Approx). 50mm twin casters. Casters with rubber tires for noise free operation on floors.Base
covered with stainless steel sheet for use as foot rest. All metal parts should be welded by CO2 gas.

ATTENDANT BENCH:
MS Pipe/ tube base structure (1”x1½”) with aluminum paint. Full Wooden Top of rose wood ¾” thick (best
quality). Size of the bench is 60” x18”x15” (LxHxW) approx.

Colour:
The theme colour of main items should be blue, blue shades.

Minor deviation in standard sizes are acceptable

LOCAL
76 DERMATOME
Electric dermatome.
Precise thickness of the graft from 0.1 to 1.0mm in 0.1mm increments.
Graft width of 80mm assures optimum performance in combination
The use of width-reducing clamps on the dermatome head allow cutting of smaller graft widths.
Thickness adjustment can be fixed to prevent accidental change of graft thickness during cutting.
Safe and quick blade replacement.
Standard Cutting width: 75-85mm
Cutting width using clamps: 25-35, 65-75, 50 mm
Graft thickness: 0.1 to 1.0mm (0.1 increments)
 Stroke of blade: 3.0mm
 Power supply: 220-240 V/ 50Hz
 Disposable stainless steel.
Each unit supplied with:
 Width reducing clamps
 Dermatome blades
 Bottle of Lubricating oil
Autoclave/ Sterilization case with lid

Minor Variation in standard sizes are acceptable.

Country of Manufacturer: USA/Europe/Japan


Quality Certificate: FDA 510K for USA/ CE MDD/MDR for European (NANDO notified bodies)/ Jp
MHLW for Japanese manufacturers
Manufacturing Standard: Must conform to the requirements of ISO 13485

Page 65 of 65

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