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MINISTRY OF HEALTH & FAMILY WELFARE

NIRMAN BHAVAN, NEW DELHI 110 001

Technical Specifications of Common Medical


Equipments of
General Surgery & OT, General Medicine,
Internal Medicine, Trauma, Accident &
Emergency
Finalized on 3rd & 4th October- 2007

Procured Under PMSSY Scheme

Hindustan Latex Limited


(A Government of India Enterprise)
For
Ministry of Health & Family Welfare
INDEX

Contents Page No:

1. Minutes of the Meeting held on 3rd & 4th October, 2007 2

2. Attendee list of Experts/ Special Invitees 3

3. List of Common Medical Equipments & Specifications

a. General Surgery & OT 4-63

b. General Medicine, Internal Medicine, 65-101

Trauma, Accident & Emergency

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MINUTES OF THE MEETING HELD ON 3rd & 4th OCTOBER, 2007 FOR
SPECIFICATIONS VETTING/ FINALIZATION FOR COMMON
EQUIPMENTS OF GENERAL SURGERY, OT, GENERAL MEDICINE,
INTERNAL MEDICINE, TRAUMA, ACCIDENT & EMERGENCY
DEPARTMENTS FOR VARIOUS INSTITUTIONS UNDER UPGRADATION
– PMSSY SCHEME

Meeting of the Specification vetting committee constituted by Ministry of Health and


Family Welfare, Government of India for specification vetting /finalization for
GENERAL SURGERY, OT, GENERAL MEDICINE, INTERNAL MEDICINE,
TRAUMA, ACCIDENT & EMERGENCY DEPARTMENTS equipments was held on
3rd & 4th October 2007 at the premises of Hindustan Latex Limited, Noida on behalf of
Ministry of Health and Family Welfare under PMSSY scheme.

List of members of the Expert group, special invitees and representatives from Ministry
of Health and Welfare who attended are enclosed as Annexure I

The committee was constituted for drawing generic specifications for GENERAL
SURGERY, OT, GENERAL MEDICINE, INTERNAL MEDICINE, TRAUMA,
ACCIDENT & EMERGENCY DEPARTMENT equipments of various institutions under
up gradation for PMSSY scheme, so that the equipments required for each medical
college can be procured in bulk to get benefit of scale.

The committee discussed in detail the generic specifications for equipments listed,
required inclusions / deletions were made and final specification drawn, keeping in mind
the latest technology available, the infrastructure in concerned institutions and the general
terms and conditions of supply / maintenance.

The committee finalized specification of the equipments listed. (List enclosed)

The meeting ended with thanks to the chair.

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Annexure-I
LIST OF ATTENDEES OF PMSSY MEETING HELD ON 3rd & 4thOct.’07

Sl.No. Name of Experts, Special Invitees. Name of Institute


1 Prof. Munir Khan, HOD (Surgery) SMC, Srinagar
2 Dr G.H. Rathode, Prof. of Surgery BJ Medical College, Ahmedabad
3 Dr. Subnis Grant Medical College, Mumbai
4 Dr. S. Sarat Chandra, Prof. of Surgery JIPMER, Pondichery
5 Dr. J. Prasad RIMS, Ranchi
6 Dr. Manish Singhal AIIMS, Delhi
7 Dr. Tamal Kanti Chaudhary, Prof. & KMC, Kolkata
Head ( Gen. Surgery)
8 Dr. A.K. Khanna IMS, BHU, Varanasi
9 Dr. MSR Sharma, Prof. ( Gen. Surgery) SVIMS, Tirupati
10 Dr. Shiva Swamy BMC, Bangalore
11 Dr. Nizarudin, Asso. Prof. Surgery TMC, Trivendrum
12 Dr. Bhavin Yadav BJ Medical College, Ahmedabad
13 Dr. Bharat Shah BJ Medical College, Ahmedabad
14 Prof. MMA Kamli, HOD ( Medicine) SMC, Srinagar
15 Prof. K. Tripathi IMS, BHU, Varanasi
16 Dr. AN Shah, Prof. ( Medicine) BJ Medical College, Ahmedabad
17 Dr. C. Nagraj, Prof. & HOD Pulmonary BMC, Bangalore
Medicine
18 Dr. DR Mhasde, Prof. & HOD Grant Medical College, Mumbai
(Medicine)
19 Dr. D. Dalus, Prof. of Medicine TMC, Trivendrum
20 Dr. Virsingh Negi, Prof. (Medicine & JIPMER, Pondichery
Allied Spec.)
21 Dr. S. Siddharth Kumar, Assoc. SVIMS, Tirupati
22 Dr. S. Badrinath Project Coordinator for PMSSY,
JIPMER
23 Mr.S.K. Sinha, Biomedical Engineer Special Invitee from MOH F&W

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4
GENERAL SURGERY & OT

List of the Common Equipments of General Surgery and OT

1. Modular OT 6-17

2. OT Table Hydraulic 18-20

3. OT Light 21-23

4. OT Light with LED Technology 24-29

5. Operating Microscope 30-33

6. Video Thoracoscope 34-37

7. Holmium Laser 38-41

8. Ultrasonic Aspirator 42-46

9. Ultrasonic Cutting and Coagulation device 47-50

(Harmonic Scalpel)

10. High Definition Laparoscopic System 51-53

11. Washer Disinfector Medium Capacity 54-58

12. Washer Disinfector High Capacity 59-63

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Technical Specifications for Modular OT

Pre-fabricated Modular Operation Theatres Specifications

OBJECTIVES
The Main Objectives of Planning should be:
• Promote high standard of asepsis
• Ensure maximum standard of safety
• Optimize utilization of OT and staff time
• Optimize working conditions
• Patient & Staff comfort in terms of thermal, acoustic and lighting requirements
• Allow flexibility
• Facilitate coordinated services
• Minimizes maintenance
• Ensure functional separation of spaces
• Provide soothing environment
• Regulates flow of traffic

SPECIFICATIONS
a) Operation Theatre Department
Structural Steel shell with joint less sealed sterile coating
- Joint less prefabricated modular Operation Theatres
- Paneled Modular Wall & Ceiling System
- Ultra Clean Ventilation Through Ceiling (Vertical laminar flow system)
b) Integrated Air & Light Theatre Ceiling
- Hermetically sealing Hospital Doors
- Static Conductive Flooring

c) Medical Gases pipeline system:


- Medical Gas pipeline Equipment
d) Multi-Movement Ceiling & Wall Pendant Systems

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e) Suction & Oxygen Therapy products
- Bed Head Trunking System

f) Ceilings – Integral LightingSsystem


- Uniform diffusion of air into theatres
- Air and light diffusers
- Consists of plenum with conditioned air though HEPA filters.
g) AGSS – Anesthesia gas scavenging system and outlets suck the waste anaesthetic
gases

h) Hermetically sealed doors

i) Flat X-ray imaging screens step less, flicker free and dimmer

j) To provide writing board

k) Surgical scrubs sinks – elbow action taps or knee operated or flow sensor operated

l) To provide cascade pressure stabilizers

m) To provide operation theatre control panel

n) Ceiling suspension systems for monitor, anesthesia equipment surgical equipment

a) Versatile pendent (double arm) swiveling


b) Vertically movable
c) Good maneuverability

o) OT control panels
p) It should be closed circuit TV facility.
q) Service maintenance warranty for 3 years and good service backup

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• Floors should be smooth, non slip, impervous material conductive enough to
dissipate static electricity but not conductive enough to endanger personnel from
shock. The flooring should either be inset mosaic with least possible joints and
copper strips to carry away any static electricity produced or of joint less conductive
tiles. Conductive copper mesh and self levelling epoxy flooring may be done.
• Ceiling should be painted with washable paint and corners of the rooms should be
rounded off to prevent collection of dirt and dust.
• Power back up with provision of stand-by generating sets
• In operating rooms anaesthetic room(s) recovery room, holding area, colour of walls
and ceilings should be such that they do not alter the observers perception of skin
colour this will facilitate patient monitoring and management.
• OT should have facilities for high speed autoclaves/ sterilizers for immediate /
emergency requirements of sterilizing equipment (plate 9)
• Essential pharmaceutical storage including refrigeration facilities should be available
• There should be a waiting room with toilet facilities for patient attendants
• Pass-through cabinets that circulate clean air through them while maintaining
positive air room pressure allow transfer of supplies from outside the OR to inside it.
They help ensure the rotation of supplies in storage or can be used only for passing
supplies as needed from a clean center core (Plate 12)
• There should be emergency communication system that can be activated without the
use of hands.

Detailed Technical Specification for Modular Operation Theatre

1. WALLS & CEILING CONSTRUCTION:

The room wall will have two independent surfaces with a minimum opening in between.
The external walls of the room will be constructed with solid bricks with cement
plastering. The inner surfaces walls will be constructed with 1.60mm thick EGP steel

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panels backed by 12-mm gypsum board ( India gypsum make) these panels will have
flame resistance to BS1142 part 3
The inner surface walls will be fixed to the bricks wall with essential supports. There
should be minimum possible cavity/gap in between the solid and steel walls. The total
distance between the inside and outside surfaces of the operating room will be variable to
suit the architect’s layout, but will be sufficient for the flush mounting of equipments.

The individual wall panels will be spot welded together at equal intervals to render equal
support to the panels. Spot welding will be properly grinded to make the surface leveled.
All joints will be filled with metal filler and sanded flush on site ready to receive the
plastic finish.

Wall panel’s joints will be invisible after the final wall coating is applied.
The cavity between the inner and outer walls will be left with minimum obstruction for
the possible addition of equipment at a later date and to enable services, pipes, conduits
etc. to be run within the cavity. All wall mounted equipment will be flush mounted and
sealed into theatre.

The wall panels design and construction will allow for the installation and support of all
equipment and the provision of opening required for the installation, with out affecting
rigidity and strength.

Access boxes will be fitted to the rear of all wall mounted equipment to enable
maintenance to be carried out from outside the operating room.
All the sharp edges and corners will be in radius to avoid bacteria contamination.
The internal surfaces of the room walls will be sprayed with water based liquid plastic,
wall glaze or equivalent, approved by the architect to a minimum dry film thickness of
300 microns. The plastic coating will overlap the floor covering, ceiling system and
doorframes by 25 microns. The plastic coating will overlap the floor covering ceiling
system and doorframes by 25mm to provide a continuous sealed surface. The plastic

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coating will be non- reflective and the colour will be submitted to the architect for
approval.
All the four corners should have return air duct outlets, the grill of which should be made
of MS steel , duly powder coated with colour choice to suit the hospital.

2. CEILING FILTRATION SYSTEM (IMPORTED)


The ceiling filtration system should be designed to ensure unidirectional distribution of
sterile air with differential flow velocities decreasing from centre to perimeter of the
surgical theatre to ensure the cleanliness of all the area covered by the air flow. The
ceiling system should be quipped with HEPA filters with different performances
according to their position in the ceiling to achieve different flow velocities. The
complete filtration ceiling system should be factory assembled its holding structure, Filter
frames and top plenum should be made of AISI 304 stainless steel. Filtration ceiling
system should have HEPA filters, H according to EN 1822
The filtration ceiling system should have flow equalizer to achieve uniform & constant
air distribution over the whole surface it should also have connection for surgical lamp to
be fitted in place of any filter.

The air management system should be designed to achieved the following parameters:

F.S. 209 classification = 100 (100 particles/ft3)


Bacteriological class =B (5 CFU/m3)*
Particle decontamination kinetics CP =5 min
Biological decontamination kinetics CB = 5min
ECG-GMP Annex 1 classification = Class A
ISO 14644/1 classification = ISO 5

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3. DOOR AND FRAMES (HERMETICALLY SEALED DOORS):
To maintain sterically and the correct air pressure in the room, all doors into and out
should be of the sliding, hermetically sealing type. The door should meet following
specifications:
• Meets international quality & safety requirements.
• Doors should be wired to the current IEE regulations & BS7971 standard
• Motor should be DC 24V 70 W brush less DC Motor
• Noise level of movement should not be more then 60 decibel.
• Controller should be microprocessor based and be CE marked.
• Power efficiency should be .95 (in AC 100V full load).
• The track should be made up of single piece extruded aluminum.
• Environment temperature should be -20°C to +55°C.
• Starting time should be able to regulate from .5second to 23 second & starting
speed should be 600 mm per second.
• Electrical safety codes for high & low voltage system
• Design should meet HTM 2020/2021 standards.
The doorframe should be made of high quality anodize aluminum and the door panel
should be made of compact laminate that can withstand high abrasion. To ensure efficient
sealing of the doors frames should be provided. They will consist of reinforced
plasterboard panels faced with the same laminate as the doors.

The door should seal on all four edges in the closed position & should be surface installed
type.

The track of the door should be constructed with high quality door lock with aluminum
extrusion, fixed firmly to the walls.

Nylon runner guides should be fixed to the door in such a way they do not obstruct
trolley movement through the door.

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The doorframes should be edged with an aluminum extrusion & with concealed fixings
that are adjustable during installation to ensure a 100% hermetic seal is achieved.

Vision panels, 300mm X 300 mm should be provided in the doors.

The door controller should be sensing overload condition and in overload case the door
will automatically stop & reverse the direction of travel.

The controller should be capable of either being operated by elbow switches/foot


switches, radar switch (touch less sensor). All doors should be able to be operated easily
manually in the event of failure of the power supply or the automation unit.

OPERATION THEATRE CONTROL PANEL:

The surgeon control panel should meet Electrical safety codes for high & low voltage
system, wired to the current IEE regulations.

The room Surgeon’s control panel should be designed to cope with changing technology
& equipment in operating environments. Control Panel will be user friendly & ease of
operating & maintaining purpose.

The panel should be “Membrane” type; configured to incorporate all the services that
operation room staff required. The fascia should be made with superior quality UV
resistance membrane with sterilization feature.

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The Panel should contain 6 or 9 service tiles as below:

1. Time Day Clock


2. Time Elapse Day Clock
3. General Lighting System
4. Medical Gas Alarm Panel
5. Hand Free Telephone set with memory
6. Temperature & humidity indicator with controller
7. HEPA Filter Status module
8. Room Pressure Indicator
9. Music control

Time day clock should be digital type & clocks having high brightness characters.

Time Elapsed Day Clock should be digital type & clocks having high brightness
characters.

Temperature indicator should indicate the room temperature which should be connected
to the local pressure switches of Air-Conditioning System. Indicators should be digital
type & clocks having high brightness characters, not less than 30 mm in height.

Central Lighting system should incorporate all the necessary controls of the lighting
system inside the theatre.

The medical gas alarm should indicate High, Normal & Low gas Pressure for each gas
service present in the operating system & should have an audible buzzer with mute
facility. Pressure sensors should be connected to MGPS for monitoring the pressures.

A hand free set Telephone System should be incorporated in the panel with memory type
card.

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The control panel should be designed for front- access only. All internal wires should be
marked with plastic Ferrule type cable markers for ease of identification.

5.DISTRIBUTION BOARD:
All high voltage equipment should be installed in a separate enclosure.
The remote cabinet should house the operating lamp transformers, mains failure relays,
electrical distribution equipment & circuit protection equipment for all circuits within the
operating theatre.

All internal wiring should terminate in connectors with screw & clamp spring
connections of the clip- on type mounted, on a DIN rail & labeled with indelible
proprietary labels. Individual fees or miniature circuit breakers should protect all internal
circuits.
6. X RAY VIEWING SCREENS
The system should have electrical safety codes for high & low voltage system. The
theatre is to be equipped with a 2 plate X-ray viewing screen. It should be designed to
provide flicker free luminance for the film viewing purpose. It should be installed flushed
with theatre wall for hygienic and ease of cleaning purpose .The X-Ray viewing screen
should be designed for the purpose of front access.

The X-Ray viewing screen should be illuminated by 4 pieces of high frequency


fluorescent lamps and the dimming is controlled by the usage of dimming ballast with the
PCB that is mounted inside the box.

The diffuser should be able to diffuse the light evenly and to provide enough luminance
for film viewing. It should be made of high quality opaque acrylic sheet. The film should
be held firmly by using spring – loaded clips for ease of mounting and demounting. The
body should be built by using electrolyzed steel with powder coating. It should work on
PCB button control system.

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7. PRESSURE RELIEF DAMPERS
Pressure relief dampers should be provided in each room to prevent contamination of air
from clean and dirty areas. Suitably sized air pressure relief damper should be
strategically placed, enabling differential room pressure to be maintained and ensure that
when doors are opened between clean and dirty areas. Counter- weight balancing system
should be provided in the PRD to maintain positive pressure inside the operation room.
Air pressure stabilizers should have unique capability of controlling differential pressure
to close tolerance. The PRD should remain closed at pressure below the set pressure and
should open fully at pressure and should open fully at pressure only fractionally above
the threshold pressure.

The body should be epoxy powder coated as per standard BS colors.


First class electrolyzed steel plate should be used for body and with high grade SS304
stainless steel for blades.

8. OPERATION THEATRE FLOORING (ANTISTATIC CONDUCTIVE TILES):-


A floor screed should be provided, flat to within a tolerance of +/- 3mm over any 3 metre
area. Onto this sub-floor, a self –leveling compound should be laid prior to lying of the
floor finish.
Copper grounding strips (0.05 mm thick , 50 mm width) should be laid flat on the floor
in the conductive adhesive and connect to copper wire of grounding . The floor finish in
the operating room should be 2mm Conductive PVC tiles, laid on a semi-conductive
adhesive base. The floor finish should terminate at the room perimeter passing over a
concealed cove former and continuing up the wall for 100mm. All joints should be
welded with electrodes of the same compatible material to provide a continuous sealed
surface. The floor should have an electrical resistance of 2.5 * 10 to 106 Ohms, as per
DIN 51953 ATM F-150 or NFPA 99, B1 class of fire resistance and should meet UL
standard 779. Fulfils product requirements as per EN 649.

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9. STORAGE UNIT:
The storage unit should be made with 1.50 mm thick EGP Zinc coated steel panels. The
storage unit should be divided 2 equal parts and each part should have individual glass
doors with high quality locking system. Each part will be provided with glass racks.

10. OPERATING LIST BOARD:


One operating list board should be provided in each operating theater. It should be made
of ceramic having Magnetic properties and should be flushed to the wall of the operating
room.
11. HATCH BOX:
A Hatch should be provided in each operation theater to remove waste materials from the
operation theater to Dirty linen area just adjacent to Operation Theater. Each Hatch
should be equipped with two doors and the door should be operated electronically. The
Hatch should be designed in such a way that only one door should be opened at one time
.The UV light should be so installed that it is kept on while both the doors are closed,
this UV light has to be automatically turned off in case of opening of either of the doors.
There shall be indicators on both side of the OT so that door open / close status can be
monitored from both ends.

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12. SCRUB STATION
Compact surgical scrub sink should be designed for use in OT complex providing
Surgeons with a convenient sink for pre – OT scrub up. Each fixture should be fabricated
from heavy gauge type 304 stainless steel and should be seamless welded construction,
polished to a stain finish. The scrub sink should be provided with a front access panel
which should be easily removed for access to the water controlled value, waste
connections, stoppers and strainers. Hands free operation should include infra red sensors
with built-in range of adjustment.
Thermostatic mixing, valve control should be located behind the access panel and
maintain constant water temperature. User defined setting of 1 to 3 min are available.
This timing should be adjustable to meet individual application requirements. Provided
with infrared sensors, thermostatic control taps with fail safe temperature controls. All
units should have reduced anti- splash fronts. Knee operated switch should be there.

13. VIEW WINDOW


The view window of specified size shall be providing consisting of:
Double insulated fixed glazing with not less than 5mm thick toughened glass.
Window frame shall be powdered coated Aluminium of approved shape flush mounted
with wall paneling

Motorized horizontal Venetian Blinds of powder coated Aluminium strips of vista level
or equivalent of approved shade including necessary accessories. The motor shall be of
reputed brand approved by Engineer – in – charge. The Venetian blinds should be
motorized for 90 degree rotational

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Equipment Specifications for OPERATION TABLE HYDRAULIC

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Hydraulic operating Tables are simple tables for performing surgical
procedures and it works without electrical power.

2 Operational Requirements

2.1 OT Table is required for general surgery and should have X-Ray
transluscent tops.

3 Technical Specifications

3.1 1. Four section table top with divided foot section


2. Table top should be constructed from a high-pressure laminate to
permit x-ray penetration and fluoroscopy
3. All table positioning, i.e., height, back section, lateral tilt,
trendelenburg, and anti-trendelenburg, except foot and head section
should be operated hydraulically
4. Should have a manual position selector, whose location should be
interchangeable between foot and head end
5. The casings on the frame and centre supporting column should be
made of hygienic stainless steel
6. Mattress should be radio lucent and suitable for fluoroscopy
7. Measurements :( all dimensions are approximated to +/_ 10 %
variations)
a. Height: 730-1040 mm
b. Side tilt: + 15 degrees
c. Back section adjustment: - 15 degrees to 70 degrees
d. Foot section adjustment: - 90 to 0 degree, detachable

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e. Trendelenburg: 25 degree
f. Anti trendelenburg: 25 degree
g. Head section adjustment: -40 to -30 degree, detachable
h. Maximum width: 555 mm
i. Length: 1950 mm
2. 8. Table top should be completely detachable compatible with
transfer trolley

4 System Configuration Accessories, spares and consumables

4.1 System as specified

4.2 Accessories should include


a. Padded arm rest with straps - pair with damps
b. Anesthesia screen with clamps
c. Side supports: pair with clamps
d. Shoulder supports: pair with clamps
e. Knee crutches: pair with damps
f. X-ray cassette tray
g. Kidney bridge
h. SS bowl with clamps
i. Infusion rod with clamp

5 Environmental factors

6 Power Supply

None

7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product

7.2 Manufacturer should be ISO certfied for quality standards.

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7.3 Should have local service facility .The service provider should have the
necessary equipments recommended by the manufacturer to carry out
preventive maintenance test as per guidelines provided in the
service/maintenance manual.

7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.

8.4 List of important spare parts and accessories with their part number and
costing

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

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Equipment Specifications for Operation Theatre
Light

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Surgical lights illuminate the surgical site for optimal visualization of small,
low-contrast objects at varying depths in incisions and body cavities.

2 Operational Requirements

2.1 The light should comprise of 2 units, one major(diameter around 90 cm) and
one minor (diameter around 55 cm). Each unit should have a central light
bulb.
Should have a facility of continuous brightness adjustment.
Should be shadow free

2.2 Should have provision of direct recording & display of operating field via
an autofocus, motor driven zoom lens, with digital video camera with high
definition resolution recordable on hard drive/ DVD/ Mini DV tapes. All
cables should be through the central supporting pillar of light.Each should
have a single bulb with reserve.

3 Technical Specifications

3.1 The light should be easily maneuverable and should have a swivel radius of
at least 150 cms and height adjustment of at least 100 cms

3.2 Each unit should provide more than 250000 lux light at 4200 k colour
temperature

3.3 The optimum colour temperature of the light should be between 42000 –
47000 kelvin, with colour rendering index of atleast 90.;

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3.4 Each unit should provide a prefocussed beam of light with atleast 50 cms
depth of field.

3.5 It should be a cool light and should not interfere with the laminar air flow
system. The absorption of infrared radiation should be more than 99% and
infrared radiation to feet at 100000 lux should be less than 35 w per sq
metre

3.6 Each unit should have halogen lamp of average life of 1000 hours – 25
spare bulbs should be included

3.7 There should be reserve light source (halogen) with automatic activation in
case of a fuse bulb

3.8 Should have option of electro magnetic brakes to maintain the light in a I
steady position
3.9 The light should have 360 degree turning radius with unbreakable head
Glass.
Light should automatically switch on in case of resumption of electricity
3.10 after power failure.
The handle should be Auto clavable & detachable.

4 System Configuration Accessories, spares and consumables

4.1 System as specified-

5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.

5.2 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50deg C and relative humidity of 15-90%

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5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%

6 Power Supply

6.1 Power input :220-240V/ 50 Hz AC Single phase or 380-400V AC 50 Hz


Three phase fitted with appropriate Indian plugs and sockets.

6.2 Suitable Servo controlled Stabilizer/CVT

7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product

7.2 Manufacturer/Supplier should have ISO certification for quality standards.

7.3 Electrical safety conforms to standards for electrical safety IEC-60601-1


General Requirements

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of important spare parts and accessories with their part number and
costing.

8.4 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.5 List of Equipments available for providing calibration and routine


Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.

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O T Light with LED Technology

Surgical light system based on LED technology

Extremely flat, compact and aerodynamically surgical light based on innovative LED
technology.
The light head consists of several, systematically arranged light emitting modules, using
multitudinous LEDs to form a multi-lens matrix for a shadow free and homogeneous
illumination of the surgical field.

Surgical light consisting of:

Central axis, horizontal extension arm, height adjustable spring arm, vertical and
horizontal bow and the one-point suspended light head consisting of 5 or 3 light emitting
modules.

Suspension system:

Main light on lowermost axis position:

Extension arm: 850mm (if 1 or 2 extension arms per axis) or 700mm (if 3
extension arms per axis) respectively
Length of spring arm: 930mm (iLED 5), 910mm (iLED 3)

Operating distance: 70-150cm

Operating range: 2272mm (iLED 5), 2050mm (iLED 3)

All arms are freely rotatable (without stops) at all vertical joints.

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Number of stops: 1 (2 at iLED 3)

At which joint: connection between horizontal bow and light head (and connection
between vertical and horizontal bow with iLED 3)

Rotation range joints with stop : > 400°C

Light system:

Surgical light with cold and shadow-free light, high lighting intensity and very
homogeneous large- area and in-depth illumination of the surgical field through unique
multi lens matrix technology.

The colour temperature is adjustable in 4 steps from 3500K to 5000K. Within a light
combination, in order to avoid an undesirable mix of light colour from two separate light
heads, when adjusting the colour temperature on one light head, it is, as a standard
setting, automatically synchronized with the other light heads. This synchronization can
be switched off and on as needed at the touch of a button.

Light field adjustment from 22cm to 30cm and focusing via steriliseable handle in the
center of the light head. It is operated by turning clock-wise in an ergonomic angle of not
bigger than 45°C to reach the respective maximum or minimum setting.

All light heads can be dimmed in a range of 10% to 100%. The colour temperature of the
light remains constant in all dimming levels and is not subject to unwanted changes.
Activation and deactivation of the endo-light level (10% remaining lighting intensity) via
the dimmer control on one light head is, as a standard setting, synchronized for all other
light heads within the light combination. It can, if the need arises, be adjusted separately
for each light head at the touch of a button.

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Exceptional in-depth illumination and avoiding of cast shadows by means of an
adjustable shadow correction for 4 pre-defined

Situation through switching on and off and adjusting the lighting intensity of different
parts of the light emitting surface respectively. (Only iLED5!)
Switching the light head on and off is possible in a sterile manner directly at the light
head as well as on the optional wall control panel. From one single control panel either
only the respective light head or the complete light combination can be switched on and
off simultaneously. Switching on and off is without any restriction in terms of holding
time after switching off or with regard to the nominal light values after switching on.
No heat emission through IR radiation.
High fail-safely through optical light system consisting of 184 (iLED5) or respectively
111 (iLED3) single LEDs each with its own lens. In case of failure of one source (LED),
the illumination of the light field is not affected. Even in case of failure of a second or
more light sources, negative effects on the illumination of the surgical fields remain
limited to a minimum.
Gaps and spaces between the single light emitting modules of the light head support the
effect of laminar air flow systems.
Sterilizeable knob at the lower side of the light head for control of all light function
(dimming, endo-light colour temperature adjustment shadow control, switching on\off
and if applicable, camera zoom and picture rotation) by the surgical team itself (LED5!)

Ligting intensity at 1 m distance: 160,000 Lux (LED5)


130,000 Lux (LED 3)

Size of light field at 1 m distance: 22-30 CM


Homogeneous light cylinder : 75 cm
Colour temperature : 3500- 5000K
Colour rendering index : RA 95
Residual illumination with one shadower: 156.800 Lux (iLED 5)

26
94.120 Lux (iLED 3)
Residual illumination with two shadower: 102.400 Lux (iLED 5)
67.600 Lux (ILED 3)
Residual illumination with tube : 147.200 lux (i LED 5)
113.100 lux (I LED 3)
Resiudal illum with tube and 1 shadowder : 132.800 lux (iLEd 5)
76.700 lux (iLED3)

Resiudal illum with tube and 1 shadowder: 75.000 lux (iLED5)


55.900 lux (I LED 3)

Luminosity factor : 280 im/W


Temperature increase at surgical site : max. 1o degree C
Life span of main light source : > 20.000h
Nominal lamp power : 184 x 1W (I LED 5)
111 X 1w (iLED 3)

Power input (per light head) : 200 W (I LED 5)


120 W (iLED 3)
Supply Voltage : 90- 240 V AC
24 V DC
24 V AC
Protection class :1

Light Head:
Made of powder coated aluminum diecast with smooth and clean surfaces that are easy
and safely to clean.
Dust and Splash – proof
One – point suspended
Diamer : 823 mm (Iled 5) or 690 mm (iLED3) respectivey

27
Temperature at working conditions above : approx 45 degree C
Underneath < 1 degree C

The light head can be pre-equipped with preparation and the respective cabling for the
camera system.

Camera :
1CCD chip camera for installation either in the central handle of the light head ao at a
separate carrying arm.
Control of the camera functions via external control unit . In addition , picture rotation
and camera zoom can be adjusted via the sterelisable knob at the respective light head
(only iLED 5 ! )

Signal transmission and power supply via inlaying cabling with slip rings in all vertical
joints.

Chip 1/6 “ CCD


Standard PAL / NTSC
Pixels 800,000 PAL, 680,000 NTSC
Zoom 25 * optical , 12 * digital
Lens f+2.4mm(far) bis 60 mm (tele), F1.6 bis F2.7
Signal/ Noise ratio 49 dB
Shuter ¼ bsi1/10000s , 20 steps(NTSC)
1/3 bis 1/10000s, 20 steps (PAL)
Horizontal resolution 470 TV lines ( NTSC), 460 TV lines ( PAL)
Min illumination 3.0 lux (50 IRE)
White balance automatic/ manually
Gain automatic / manually ( -3 bis 28 dB , 16 steps)

Yn-/ Outputs at the control unit :


1. 2 * Y/C (S- Video)

28
2. 2* FBAS(Composite)
3. Optional 1* SDI
4. Optional MPEG 2/4 via LAN connector
Further connectors
5 1* LAN connector ( RJ 45)
6 1* Serial interface (RS 232 or 485-)
7 Optional 1* USB
8 Optional 1* Audio in/out

29
Equipment Specifications for Operating Microscope

UNSPSC Code:
ECRI Code:

1 Description of Function

None

2 Operational Requirements

None

3 Technical Specifications

3.1 (1) Motorized zoom magnification, 6:1 ratio


(2) Magnification from 1.8x to 15.8x or more with 10x eyepiece
(3) Variable working distance from 207 mm (+/- 25 mm) to 470 mm
(+/- 25 mm) through motorized multi focal lens.
(4) Pair of wide-field eyepieces for spectacle wearers 10x, dioptric
setting + 5D to - 5D
(5) Ergonomic handles with buttons for motorized control of focus
and zoom both hand & foot.
(6) Facility for adjusting speed of the focusing motor to adapt for
different magnifications.
(7) 300W xenon illumination and 12V/150W same independent
Xenon back up lamp through fiber optic cable.
(8) Inclinable binocular tube, inclinable over range of minimum 0-
180 Deg.
(9) Facility for spot illumination
(10) Floor stand with electromagnetic brakes with freedom of
movement in all 6 axis.
(11) Floor stand should have adjustable carrying capacity, not less

30
than 13 kgs.
(12) system should be upgradable for neuronavigation&
flouroscence.
(13) Tool tracking facility
(14) It should have a graphic display LCD with background
illumination with at least 6 user defined settings.
(15) It should stabilize less than 3 sec. & should rebooted less than 1 min.
(16) Camera should be independent of microscope.
(17) there should be a facility of a manual balance.

3.2 Essential Accessories:


(1) Stereoscopic coobservation attachment for second observer with tiltable
eyepieces, minimum 0-160 Deg.
(2) Integrated Beam Splitter
(3) 3-Chip CCD HD (high definition) output camera with c-mount for
connecting with the microscope & recording on a hard drive on mini DV
disks.
(4) Digital video recording facility with appropriate video editing software.

3.3 Optional Accessories:


(1) Diploscope (face to face attachment)
(2) 12-function footswitch
(3) Digital still camera for attachment with microscope

4 System Configuration Accessories, spares and consumables

None

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0-50deg C and relative humidity of 15-90%

5.2 The unit shall be capable of operating in ambient temperature of 20-30 deg

31
C and relative humidity of less than 70%

6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug

6.2 Resettable overcurrent breaker shall be fitted for protection

6.3 Voltage corrector /stabilizer of appropriate ratings meeting ISI


Specifications. (Input 160-260 V and output 220-240 V and 50 Hz)

6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.

7 Standards, Safety and Training

7.1 Manufactures/Supplier should have ISO certificate to Quality Standard.

7.2 Should be compliant with IEC 61010-1:(or any international equivalent eg


EN/UL 61010) covering safety requirements for electrical equipment for
measurement control and laboratory use

7.3 Should be FDA, CE, UL or BIS approved product

7.4 Comprehensive training for lab staff and support services till familiarity with
the system.

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


maintenance support as per manufacturer documentation in service /
technical manual.

8.4 List of important spare parts and accessories with their part number and
costing

32
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job description of the hospital technician and
company service engineer should be clearly spelt out.

8.6 Compliance Report to be submitted in a tabulated and point wise manner


clearly mentioning the page/para number of original catalogue/data sheet.
Any point, if not substantiated with authenticated catalogue/manual, will not
be considered.

33
Equipment Specifications for Video Thoracoscope

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 A Thoracoscope is a thin, tube-like rigid endoscope instrument with a light


and a lens for viewing.

2 Operational Requirements

2.1 Thoracoscope with video processing and monitoring is required

3 Technical Specifications

3.1 SPECS OF SCOPE:


1. Direction of view should be zero degree.
2. Minimum of 100 degree (app) of field of view.
3. Range of observation from 5 mm to 90 mm.(app)
4. Angulations of tip not less than 200 deg(Up) and 90 deg( down)with right
to left movement of minimum 100 deg.(app)
5. Insertion tube outer diameter of less than 8 mm with a working length of
not less than 250 mms.
6. Distal end of less than 8 mm.
7. Instrument channel of more than 2.5 mm
8. Compatible with the video system specified.

3.2 Video processor with light source & Monitor


1. Power supply 200-240 V A/C
2. PAL type video signal. The camera should be 3 chips CCD with high
definition (HD) Output with provision of recording on hard disk, mini DV:
disk or tape.

34
3. Controls for color adjustment, to enhancement and balance settings.
4. Controls to freeze images enhance a portion of frozen image (zoom &
post-processing).
5. Patient and physician data input keyboard.
6. Operates on Xenon lamp.
7. Emergency lamp.
8. Compatibility with the gastro scope and colonoscope duodenoscope and
Enteroscope
9. 19” LCD color monitor with XGA resolution.

4 System Configuration Accessories, spares and consumables

4.1 System as specified

4.2 1. Rod lens Telescope 0 degree 10mm , Length 31 cm


2. Rod Lens Telescope 30 degree 10mm, Length 31 cm
3. Trocar 6mm with blunt tip flexible cannula and silicone leaflet valve
4. Trocar 9mm with blunt tip flexible cannula and silicone leaflet valve
5. Trocar size 11mm with blunt tip flexible cannula and silicone leaflet
valve
6. Trocar size 11mm with blunt tip cannula with thread
7. Manhes dissecting and grasping forceps size 5mm
8. Kelly dissecting and grasping forceps size 5mm
9. Babcock grasping forceps size 5mm
10. Bowel grasper rotating 5mm
11. Scissors rotating with connector pin, spoon blades, double action
jaw, size 5mm
12. Scissors rotating serrated, curved, conical and double action jaw
size 5mm
13. Micro hook scissors and single action jaw, size 5mm
14. Scissors dismantling rotating serrated, single action jaws bayonet
shaped size 5mm

35
15. Needle driver Parrat-Jaw straight handle with ratchet length 33 cm
16. Assistant Needle driver Flamingo Jaw straight handle length 33 cm
17. Manhaes grasping forceps rotating size 5mm atraumatic single
action jaws
18. Suction & irrigation with two way stop cock
19. Bipolar & Monopolar high frequency cord with 5mm plug
20. 3 Chips Camera PAL having Digital Imaging Processor
21. Cold Light fountain Xenon 175 power supply 100-125 / 220-240V
AC, 50/60 Hz complete
22. TFT Monitor PAL 19”(inch) maximum resolution 1280x1024
23. Video Cart
24. Fiber Optic cable
25. 0 degree, 30 degree & 60 degree upward & downward angulated
Rongeur forceps 33 cm shaft.
26. 90 degree & 45 degree punch with 30 cm shaft.
27. Clip Applicator 5 mm & 10 mm.
28. Fan Retractor.
29. Endo GI stapler for stapling Bronchi & Vessels.
30. Needle Holder 5 mm & 33 cm long.

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%

5.2 The unit shall be capable of operating continuously in ambient temperature


of 10 -40 deg C and relative humidity of 15-90%

6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug

36
6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.

7 Standards, Safety and Training

7.1 Should be FDA, CE, UL or BIS approved product

7.2 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.

7.3 Manufactures/Supplier should have ISO certificate to Quality Standard.

7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


maintenance support as per manufacturer documentation in service /
technical manual.

8.4 List of important spare parts and accessories with their part number and
costing

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job description of the hospital technician and
company service engineer should be clearly spelt out.

37
Equipment Specifications for HOLMIUM LASER GENERATOR

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 The laser should be capable for use in soft tissue vaporization and resection,
like procedures such as Prostate vaporization and prostate resection (enucleation

2 Operational Requirements

2.1 The laser should also be useful in treatment of Bladder Tumor, Urethral
Strictures or any other soft tissue application

3 Technical Specifications

3.1 Laser Type: Solid State Laser System

3.2 Wavelength: 2.0 – 2.25 µm

3.3 Power to tissue: Adjustable upto 80 Watts

3.4 Pilot Beam: To guide the laser

3.5 Beam transmission: Flexible Fibers for use in resection


Vaporization: To pass through Ureteroscopes / Resectoscopes

3.6 Control panel: LCD-display with display of parameters

3.7 Selected and simultaneous display of energy delivered for each


procedure

3.8 Cooling system: Internal closed circuit refrigerant cooling system

4 System Configuration Accessories, spares and consumables

4.1 ACCESSORIES: Side Firing Fibers (for Vaporisation) – 10 Nos.


Resterilisable End Firing Fibers (For soft tissue

38
resection) – 10 Nos.
Fiber Stripper for End Fire Fiber – 1 No.
Fiber Cutter, for all fibers – 1 No.
Laser Safety Glasses & Goggles – 3 Nos. each
Foot Switch

4.2 Following should also be quoted as standard accessory


1. Laser Prostate Resectoscope set including
• Outer Sheath- 27 Fr, with 2 Stop Cocks
• Resection Sheath- 24 Fr, for the above outer sheath
• Telescope – 1 No. With 30 deg direction of view
• Visual Obturator – 1 no.
• Working Element for Laser probes – 1 No.
2. Tissue Morcellator
• Electro Mechanical tissue morcellator with changeable
blades for use in morcellation and removal of tissue post-
prostate enucleation. Should include morcelloscope
complete set, control box, handpiece, 2 sets of blades,
suction device and cleaning brushes.

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0-50deg C and relative humidity of 15-90%

5.2 Thu unit shall be capable of operating in ambient temperature of 20-30 deg
C and relative humidity of less than 70%

5.3 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with

39
89/366/EEC; EMC-directive.

6 Power Supply

6.1 Power input to be 220-240 VAC, 50Hz fitted with Indian plug

6.2 Resettable overcurrent breaker shall be fitted for protection

6.3 Voltage corrector/stabilizer of appropriate ratings meeting ISI


Specifications.( Input 160-260 V and output 220-240 V and 50 Hz)

6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.

7 Standards, Safety and Training

7.1 Manufactures/Supplier should have ISO certificate to Quality Standard.

7.2 Should be compliant with IEC 61010-1:(or any international equivalent eg


EN/UL 61010) covering safety requirements for electrical equipment for
measurement control and laboratory use

7.3 Should be FDA , CE,UL or BIS approved product

7.4 Comprehensive training for lab staff and support services till familiarity with
the system.

7.5 Comprehensive warranty for 2 years and 5 years AMC after warranty

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


maintenance support as per manufacturer documentation in service /
technical manual.

40
8.4 List of important spare parts and accessories with their part number and
costing.

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.6 Compliance Report to be submitted in a tabulated and point wise manner


clearly mentioning the page/para number of original catalogue/data
sheet.Any point ,if not substantiated with authenticated catalogue/manual,
will not be considered.

41
Equipment Specifications for ULTRASONIC ASPIRATOR

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Ultrasonic aspirators use mechanical ultrasonic vibration and an


irrigation/suction system to fragment and remove soft tissue and high-water-
content growths from various parts of the body.

2 Operational Requirements

2.1 The system should be quoted with the paediatric as well as adult handpieces.

3 Technical Specifications

3.1 Surgical aspirator should be based on magneto-restriction or piezoelectric


technology.

3.2 The hand piece must be cool if required to prevent overheating by coaxial
flow of water.

3.3 The hand pieces should be autoclavable and without need to dismantle for
autoclaving.

3.4 The vacuum pump should provide preferable the suction of > 600mm of
Hg.

3.5 It should incorporate an Electro-surgical unit fitted on ultrasonic hand piece


for coagultion and cutting function.

3.6 The console unit should house control panel storage for footswitch,
electrical cords and self-contained suction apparatus.

3.7 The unit should include all necessary control preferably color-coded, which
may include amplitude, irrigation, aspiration and tissue select mode.

42
3.8 It should have safety features like optical signal for failed hand pieces and
signal for failed unit.

3.9 It should have on and off button.

3.10 It should have integral suction with vacuum pressure of-20 to -90 Kpa. in
continuous low noise and digital display.

3.11 It should preferably have 2 liter capacity container of unbreakable material


with level sensor and anti-overflow system.

3.12 Hand piece should be light, preferable 20 KHz and amplitude should be
>130 micrometers

3.13 The hand piece should be able to accommodate selection of tips for wide
range of applications. It should have inbuilt water cooling system &also
should be able to differentiate tissue barriers with tactile feedback. It
should be sterilizable by autoclave and ethylene oxide. Both curved &
straight hand piece should be available.

3.14 The internal diameter of tips should range form 1.0 to 2.0mm.

3.15 The irrigation pump should be inbuilt in the unit, the irrigation output 0-
65ml/min.

3.16 All hand-pieces/ instruments should be detachable.

4 System Configuration Accessories, spares and consumables

4.1 ACCESSORIES:
1. Trolley with suction canister.
2. Ultrasonic probe-curved, 2 each of variable length with extra laproscopic
probes 23 KHz and 35 KHz.
3. Assembly kit for aspirator- 1
4. Aspirator with 2 liters suction bottle with disposable secretion bag-1

43
5. Infusion bottle holder-1
6. Double foot switch-1
7. Cleaning brush for instrument lumen-2
8. Instrument connection cables- 2
9. Suction / irrigation tubing (5meter each), silicon twin tube-2.
10. Double set of cable and tubing clips- 10sets.
11. Metal puncture tube - 2
12. Sterilizing cassette with silicon mat and textile filter-2.

4.2 CONSUMABLES:
1. Textile filters for sterilizing cassette-10 pieces.
2. Suction/ Irrigation tubing (5 meter each) - 10 pieces.
3. Cable and tube clips - 5X 10 pieces.
4. Suction and Irrigation tubing, silicon twin tube (4.5 meters each) - 5
pieces
5. Disposable secretion bags 2 liters- 2 pieces.
6. Connection nipple, suction tube / secretion reservoir - 5 pieces.
7. Internal flushing tube - 5 pieces.
8. Protective cover-4 pieces.

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0-50deg C and relative humidity of 15-90%

5.2 Thu unit shall be capable of operating in ambient temperature of 20-30 deg
C and relative humidity of less than 70%

5.3 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.

44
6 Power Supply

6.1 Power input to be 220-240 VAC, 50Hz fitted with Indian plug

6.2 Resettable overcurrent breaker shall be fitted for protection

6.3 Voltage corrector/stabilizer of appropriate ratings meeting ISI


Specifications.( Input 160-260 V and output 220-240 V and 50 Hz)

6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.

7 Standards, Safety and Training

7.1 Manufactures/Supplier should have ISO certificate to Quality Standard.

7.2 Should be compliant with IEC 61010-1:(or any international equivalent eg


EN/UL 61010) covering safety requirements for electrical equipment for
measurement control and laboratory use

7.3 Should be FDA , CE,UL or BIS approved product

7.4 Comprehensive training for lab staff and support services till familiarity with
the system.

7.5 Comprehensive warranty for 2 years and 5 years AMC after warranty

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


maintenance support as per manufacturer documentation in service /
technical manual.

8.4 List of important spare parts and accessories with their part number and
costing.

45
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.6 Compliance Report to be submitted in a tabulated and point wise manner


clearly mentioning the page/para number of original catalogue/data
sheet.Any point ,if not substantiated with authenticated catalogue/manual,
will not be considered.

46
Equipment Specifications for Ultrasonic Cutting & Coagulation Device

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Ultrasound is the basis for an efficient surgical instrument: the Ultrasonic
Cutting & Coagulation Device cuts and coagulates by using lower
temperatures than those used by electrosurgery or lasers. Ultrasonic Cutting
& Coagulation Device technology controls bleeding by coaptive coagulation
at low temperatures ranging from 50ºC to 100ºC: vessels are coapted
(tamponaded) and sealed by a protein coagulum.

2 Operational Requirements

2.1 The system is required for Open & Laparoscopic Surgical Procedures

3 Technical Specifications

3.1 1.Ultrasonic generator generating ultrasound at app 55.5 khz


frequency
2. Hand-piece with in-built transducer & silicon cable
3. Hand-switch activation adopter for blade & hook probe
4. Cart to house the generator and accessories
5. Dual foot-switch attachment
6. Stand-by mode for better safety
7. System diagnostics and troubleshooting guide
8. Warning system for malfunctioning cable, probe etc
9. Power entry filters to suppress electromagnetic disturbances to monitors
10. It should have dual foot switch receptacles to connect two footswitches to
allow simultaneous use by 2 surgeons.
11. It should have a vibration range of 50-100micrometer.

47
4 System Configuration Accessories, spares and consumables

4.1 B) Accessories
1. Foot-switch with max and min pedals and cable.
2. 5 mm blade system adopter
3. Hand switch adopter
4. Open Surgery Instruments:
a. Coagulating shears – 10 mm dia, 20 cm long
b. Short Curved Coagulating shears- 5 mm dia, 14 cm long.
c. Dissecting hook, 5 mm dia,10cm long
d. Hand Activted Coagulting shears with Clicker – 5 mm di ,Curved
mode 23 cm long.
5.Endoscopic Surgery Instruments:
a. Dissecting Hook, 5mm dia, 32 cm long.
b. Curved Blade , 5mm dia, 32 cm long.
c. Laparoscopic Coagulating shears , 10mm dia , 34cm long.
d. Laparoscopic Coagulating shears , 5mm dia ,knife mode, 34cm long.
e. Laparoscopic Coagulating shears , 5mm dia , curved mode, 36cm
long.
f. Laparoscopic Hand Activated Coagulating shers , 5mm dia, curved
mode, 36 cm long.
g. Laparoscopic Coagulating shears , 5mm dia , Curved mode, 45cm
long.
h. Laparoscopic hand activated Coagulating shears with clicker -5mm
dia curved mode, 36cm long.
C) Probes
1. It Should have both 5 mm & 10 mm instruments.
2. It should have the following types of shears for open & laparoscopic
surgery.

48
a. 10 mm Coagulating shear capable of working in 3 modes –
flat, Blunt & Sharp.
b. 5 mm Laparoscopic Curved coagulating Shears, 360 degree
rotable, capable of sealing blood vessels upto 5 mm diameter
with clicker & integrated bilateral integrated hand control to
enable precise operation of system by hand.
3. All Hand Pieces should be steam autoclavable.

5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.

5.2 The unit shall be capable of being stored continuously in ambient temperature
of 0 -50 deg C and relative humidity of 15-90%

5.3 The unit shall be capable of operating continuously in ambient temperature of


10 -40deg C and relative humidity of 15-90%

6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug

6.2 UPS of suitable rating with voltage regulation and spike protection for 120
minutes back up.

7 Standards, Safety and Training

7.1 The generator must be CF isolated applied device and defibrillator protection
must be available.

7.2 Should be FDA , CE,UL or BIS approved product

7.3 Manufacturer should have ISO certification for quality standards.

49
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

7.5 Electrical safety conforms to standards for electrical safety IEC-60601 / IS-
13450

7.6 Should have local service facility .The service provider should have the
necessary equipments recommended by the manufacturer to carry out
preventive maintenance test as per guidelines provided in the
service/maintenance manual.

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine Preventive
Maintenance Support. as per manufacturer documentation in service/technical
manual.

8.4 List of important spare parts and accessories with their part number and
costing.

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.6 Compliance Report to be submitted in a tabulated and point wise manner


clearly mentioning the page/para number of original catalogue/data sheet.Any
point ,if not substantiated with authenticated catalogue/manual, will not be
considered.

50
Specifications for High Definition Laparoscopy System

High Definition Three Chip Camera System

1. Camera console 220 v with universal coupler & Autoclavable camera head
2. Pure Digital signal with high definition video(1280*1024 native resolution)
3. Resolution-2000 horizontal lines
4. 8 specialty settings
5. Integrated Flexible Scope filter
6. Signal to Noise ratio-70 db
7. Progressive scan technology both on camera head & console
8. Brightness Control on console & camera head
9. Aperture Control on console
10. Inbuilt 16 step digital Image Enhancer on console
11. Digital zoom & white balance on camera head
12. Integrated Gain/shutter/Enhancement with brightness control
13. Two peripheral control on camera head
Video Output
1. 2 DVI output
2. 2 SVHS & 1 RGB out put
3. One Composite out put

Automatic Light source


1. 220 V,300 W. Xenon Bulb(with one spare bulb)
2. Elliptical Bulb technology
3. Bulb Working life 5800hrs
4. Digital Bulb life counter on light source
5. Automatic /Manual Light Adjustment
6. Stand By Mode
7. Universal Jaw Assembly to adapt any make of fiber optic cable without adapter.

51
Fiber optic Cable
6.5mm*7.5 feet Snap Fit cable

Monitor
19’’ Flat Panel Monitor Colour

Insufflator
40Liter of high flow
Microprocessor controlled unit
Soft Approach Pressure control for safe recovery of abdominal pressure
Gas heating
LCD based central display monitor with multilingual text & graphics
AV warning signal

Laparoscopes, Fully Autoclavable with working length 300mm


Wide angled distortion free view
Universal adaptor for other light sources
Yellow Glass index for optimum evenness of focus & contrast
0 degree, 10mm
30 degree, 10 mm
0 degree , 5mm
Flexible video telescope

Specifications
Laparoscopic hand instruments (reusable) with 310mm working length, take apart
locking / unlocking mechanism, rotable with interchangeable handle with monoploar
diathermy attachment ( Except trocars and veress needle)

52
Vass needle 12 cm length 4
Varss needle 15 cm length 4
Carbon-di-oxide gas tubing 4
Trocars sleeves 11 mm
4
Reducer 11/5 mm
2
Trocars sleeves 5.5 mm 4
Trocars (pyramidal tip) 10 mm 4
Trocars (pyramidal tip) 5 mm 4
Trocars washer 5 mm 100
Trocars washer mm 50
Laproscopic biopsy forceps 5 mm, 2
Maryland dissector 5mm with unipolar diathermy 2
Maryland dissector 5mm, high performance with bipolar 2
cutting
Atraumatic graspers, 5mm 2
Metzenbaum scissors (5cm) with unipolar diathermy 2
Metzenbaum scissors (5cm) high performance with bipolar 2
cutting
Fan retractors 5 mm 2
Laproscopic cautery lead 4
Suction irrigation device with two way valve 2
L shaped hook electrode 5mm 2
L shaped hook 5mm , high performance with bipolar cutting
Laproscopic bowel grasper 5mm, length 33-36 cm 2
Laproscopic spoon forceps 10mm length 33- 36 cm 2
Needle holder 5mm, 33 cm long 4
Laproscopic suction cannuala, 10 mm 2
Laparoscopic suction cannula 5 mm 2
Clip applicator 10 mm Large, Medium, Small Clips
Gall bladder extraction 5mm Large, Medium, Small Clips

53
Hassan cannula
Lap
Eondotrainer
Port closure needle
Sterilization tray with cover 3 x 1

54
Equipment Specifications for Washer Disinfectors( Medium Capacity)

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Washer/decontaminators are designed to clean instruments and utensils by


removing blood, bone, fat, and other organic debris that can adhere to
crevices, providing a substrate for growth of microorganisms

2 Operational Requirements

2.1 Medium capacity washer disinfector with minimal floor space is required for
CSSD, OT, ICU or Wards

3 Technical Specifications

3.1 Thermo disinfection should achieved by the temperature of up to 93°C and


maintaining it for a designed period of time & temperature which can be
modified according to the special need and standards.

3.2 Should equip with two dosing pump of chemical / detergent products under
a complete micro-processor control. Dosage of liquid detergent should be
carried out automatically by means of a pump and can easily be regulated
for agents with varying concentration

3.3 The construction of the body should be high quality polished Stainless
Steel AIAI 304 and the internal chamber should be made up of acid-
resistant AISI 316 stainless steel,

3.4 Chamber volume should be more than 100 liters

3.5 The hot and cold water connections should have check valves, back valves,
mud filters and siphonage protection. The Machine should have its own

55
integrated water heater so that the machine can function properly in
absence of external warm water source

3.6 Water should be taken into the chamber directly to avoid separate cleaning
and disinfection of integrated water tanks.

3.7 High efficiency dryer with filter and pre filter.

3.8 Should have at least three factory preset programs and at least two user
selectable programs. The program should be available for selection at the
touch of a button.

3.9 Control panel should have LED/LCD indications for cycle selection , phase
indication ,remaining program time indication ,cycle complete indication,
digital temperature reading, and fault indications.

3.10 Should not occupy more than 1 sq meter of floor space.

3.11 Should be provided with minimum 3 rotating wash arms with removable
caps facilitating easy cleaning of the inner surfaces of the wash arm. Wash
arms can be removed without any tools

4 System Configuration Accessories, spares and consumables

4.1 System as specified

4.2 Accessories to be quoted separately and will be addes for evaluation and will
be frozen for future additional purchases.
1. Sterilization Basket of app 45 liters capacity.-01
2. Rack for Anesthesia instruments with drying-01
3. Mis instrument & Ophthalmology basket with approximately 100 liters,60
liters and 30 liters sizes with lid- 03( 1 of each size with Lid)
4. Rubber shoe Rack for 25-30 shoes-01
5. Laboratory sector basket with height 150 and 210 mm -02( 1 of each size)
6.Dividers in 4 different sizes- 04( 01 in each size)
7.Narrowmesh internal basket of app 70, 35 and 15 liters.with LID -03( 01

56
of each size with Lid)
8. Independently removable, sliding wash shelves- 04

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%

5.2 The unit shall be capable of operating continuously in ambient temperature


of 10 -40deg C and relative humidity of 15-90%

6 Power Supply

6.1 Power input to be 220-240VAC(Single Phase),/400-440 V (3 Phase)/ 50Hz


as appropriate fitted with Indian plug

7 Standards, Safety and Training

7.1 Should be compliant to ISO 13485: Quality systems - Medical devices -


Particular requirements for the application of ISO 9001
applicable to manufacturers and service providers that perform their own
design activities.

7.2 Shall be certified to be meeting the Electrical Safety requirements stated in


IEC 61010-2-45: Particular requirements for washer
disinfectors used in medical, pharmaceutical, veterinary and laboratory
fields.

7.3 Comprehensive warranty for 2 years and 5 years AMC after warranty

8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine

57
maintenance support as per manufacturer documentation in service /
technical manual.

8.4 List of important spare parts and accessories with their part number and
costing.

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.6 User list to be provided with performance certificate .

58
Equipment Specifications for Washer Disinfectors(High Capacity)

UNSPSC Code:
ECRI Code:

1 Description of Function

1.1 Washer/decontaminators are designed to clean instruments and utensils by


removing blood, bone, fat, and other organic debris that can adhere to
crevices, providing a substrate for growth of microorganisms

2 Operational Requirements

2.1 High capacity washer disinfector with minimal floor space is required for
CSSD.

3 Technical Specifications

3.1 Thermo disinfection should achieved by the temperature of


up to 93°C and maintaining it for a designed period of time
& temperature which can be modified according to the
special need and standards.

3.2 Should equip with two dosing pump of chemical / detergent


products under a complete micro-processor control. Dosage
of liquid detergent should be carried out automatically by
means of a pump and can easily be regulated for agents
with varying concentration

3.3 The construction of the body should be high quality


polished Stainless Steel AIAI 304 and the internal chamber
should be made up of acid-resistant AISI 316 stainless steel,

59
3.5 The hot and cold water connections should have check
valves, back valves, mud filters and siphonage protection.

3.6 Water should be taken into the chamber directly to avoid


separate cleaning and disinfection of integrated water tanks.

3.7 High efficiency dryer with a pre-filter and a HEPA filter


Class H13/14

3.8 System should provide for setting up practically an


unlimited number of user programs. There should be at
least 10 listed programs in line with proven requirements of
items. The programs should be available for selection at the
touch of a button

3.9 TFT / LCD Touch-screen colour control panel and


information display cycle selection , phase indication as
text,remaining program time indication ,cycle complete
indication as text and with a green led, pressure
graph,temperature graph,fault indication

3.10 Multi-level access code system with Special codes for: user,
maintenance, authorized person should be there.

3.11 Integrated printer

3.12 Should be able to insert and download User identification


and load tracking data can into full tracking data systems by
a bar code reader.

3.13 Should be able to review the operation online, download the


process data into server or PC by using a Flash Memory
Card, or
a direct Ethernet line.

3.14 Should not occupy more than 1 sq meter of floor space.

60
3.15 Should have separate connections for Cold, Warm and
Demineralized water. The Machine should have its own
integrated water heater so that the machine can function
properly in absence of external warm water source

3.16 Should have rails to accomodate up to eight racks for


different types of loads.

3.17 Miscelaneous instruments basket in three sizes- app 100, 60


and 30 liters( 1 each)

3.18 Should be provided with 5 rotating wash arms with


removable caps facilitating easy cleaning of the inner
surfaces of the wash arm. Wash arms can be removed
without any tools.

3.19 Should have at least three factory preset programs and at


least two user selectable programs. The program should be
available for selection at the touch of a button.

4 System Configuration Accessories, spares and consumables

4.1 System as specified.

4.2 Accessories to be quoted separately and will be addes for evaluation and will
be frozen for future additional purchases.
1. Sterilization Basket of app 45 liters capacity.-01
2. Rack for Anesthesia instruments with drying-01
3. Mis instrument & Ophthalmology basket with approximately 100 liters,60
liters and 30 liters sizes with lid- 03( 1 of each size with Lid)
4. Rubber shoe Rack for 25-30 shoes-01
5. Laboratory sector basket with height 150 and 210 mm -02( 1 of each size)
6.Dividers in 4 different sizes- 04( 01 in each size)
7.Narrowmesh internal basket of app 70, 35 and 15 liters.with LID -03( 01

61
of each size with Lid)
8. Independently removable, sliding wash shelves- 04

5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%

5.2 The unit shall be capable of operating continuously in ambient temperature


of 10 -40deg C and relative humidity of 15-90%

6 Power Supply

6.1 Power input to be 220-240VAC(Single Phase),/400-440 V (3 Phase)/ 50Hz


as appropriate fitted with Indian plug

7 Standards, Safety and Training

7.1 Should be certified to be meeting Standard performance and design


requirements stated in ISO/DIS 15883-1 Washer-disinfectors - Part 1:
General requirements and in Part 2: Requirements and tests for surgical
instruments, anaesthetic and respiratory equipment, hollowware, utensils,
glassware etc.,

7.2 Shall be certified to be meeting the Electrical Safety requirements stated in


IEC 61010-2-45: Particular requirements for washer
disinfectors used in medical, pharmaceutical, veterinary and laboratory
fields.

7.3 Should be equipped with the highest level - Class C -independent,


full process verification recording system.The critical process values i.e.
temperatures,times, pressures, detergent dosage time, flow & volume, errors,
as well as descriptive cycledata can be independently recorded by three
different means for Quality Assurance System.

7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

62
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

8.2 Certificate of calibration and inspection.

8.3 List of Equipments available for providing calibration and routine


Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.

8.4 List of important spare parts and accessories with their part number and
costing.

8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

8.6 User list to be provided with performance certificate .

63
64
GENERAL MEDICINE, INTERNAL MEDICINE, TRAUMA,
ACCIDENT & EMERGENCY
List of Common Equipments of General Medicine, Internal Medicine, Trauma,
Accident & Emergency

1. Cardiopulmonary Exercise, Physiology Test system with Treadmill 66-69

2. Stress System with TMT 70-72

3. Video Enteroscope (Single Balloon) 73-75

4. Video Enteroscope (Double Balloon) 76-78

5. Video Endoscopy Complete System 79-82

6. Upper GI Endoscope 83-85

7. Sleep Screening Test 86-88

8. Sleep Lab Advanced 89-91

9. Lung Function Test System 92-94

10. Lung Function Test System Advanced 95-98

11. ERCP Scope 99-101

65
Equipment Specifications for Cardiopulmonary Exercise Physiology Test System
with Treadmill

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Cardiopulmonary exercise testing (CPT) system gives a breath-by-breath


measurement for comprehensive functional analysis of a subject’s
cardiopulmonary, respiratory and metabolic systems.
2 Operational Requirements

2.1 System complete with Treadmill and Analysis software is required.


3 Technical Specifications

3.1 SPECIFICATIONS FOR AN BREATH BY BREATH EXERCISE


PHYSIOLOGY TEST SYSTEM

1) The unit should be a compact unit for spirometry and allied parameters,
mounted on a suitable trolley.
2) The system should measure VO2,VCO2,RQ,VE, spirometry / flow-
volume , AT etc.
3) The system should be interfaced to a PC with the following specifications

Intel Pentium Core 2 Duo 2.7Ghz and above PC system with 120 GB HDD ,
512 MBRAM , 1.44MB FDD , 52 x DVD RD/WR drive , Serial /
Parallel/USB ports , 17” Colour LCD/TFT monitor , Keyboard , Mouse.
HP colour inkjet printer
4) The system should have a fully automatic and computerized volume
calibration system.
5) The system should measure Nutritional parameters.
6) The system software should operate under windows XP environment.
7) The system should have a bidirectional volume sensor with the following
specifications:-
Volume: 0 to 10 lit.
Accuracy: 50 ml or 2%
Resolution: 3 ml
Flow: 0 to 15 l/s
8) System should have oxygen & CO2 analyzer with response time less than
80 msecs.
9) The system should record data breath by breath and intrabreath.
10) The system should have a unit to automatically detect ambient
conditions such as pressure, temperature, and humidity.
11) It should be have a 12 channel ECG unit integrated into the system.
12) It should be interfaced a treadmill system.

66
(Specifications of treadmill enclosed).
13) A suitable interpretation program to evaluate the test results should be
available.
14) The system should have the following:
a) Bodyplethysmography supplement.
b) PFT Supplement: FRC – Helium and Diffusion single breath
3.2 SPECIFICATION OF TREADMILL

The new generation of treadmills especially designed in accordance with


high safety and quality requirements in Pneumology, Cardiology, Stress
Testing, Endurance Training, Rehabilitation, Sports Medicine as well as in
Medical Fitness Training.

The digital interface (RS 232) should allow the treadmill and all its functions
being controlled via an Ergospirometry measuring station or a PC (SW
program for control via virtuel User Terminal to be included). Current
values such as speed, gradient, time, index no., distance as well as pulse rate
can be transferred to the Ergospirometry measuring station.
For safety purposes the unit should be equipped with an emergency switch
which stops the treadmill at any stage of operation, and which switches the
WHOLE system powerless.

Technical Specifications:

Speed:adjustable from 0 - 22 km/h optional: 0 - 30 km/h


Resolution:0.1 km/h; 0.5 %
Gradient: 0 - 24 %: electrical engine brake prevents acceleration
caused by body weight at gradient; optional: reverse operation 0 to -24% for
downhill running (up to 5 km/h)
Resolution: 0.5 %
Acceleration:7 intensities (3 ... 131 sec from 0 to max.) manual or also
selectable via program step
Slow down:7 intensities (3 ... 131 sec from max. to 0) manual or also
selectable via program step
Motor power: 2.2 kW
Motor: maintenance-free and efficient rotary current asynchronic motor (CE
mark) with V-belt, low noise and smooth running
Heart rate measurement: POLAR wireless, 1-channel receiver, beat-to-beat
ECG precise measurement automatic load control according to
preprogrammed heart rate (target pulse)
Interface: RS232 (V 24) incl. PC-, CosRec-, CosCom- ECG, Oxycon and
serial printer protocol
Programs: fixed memory locations incl. test programs Conconi, Ellestad,
Naughton, etc. in combination with User Terminal Platform: wear-resistant
and shock-absorbing

67
Usable platform area:app 150 x 50 cm (L x W)
Total dimensions: app 210 x 82 x 150 cm (L x W x H)
Weight: app approx. 200 kg
Packing: app 223 x 107 x 83 cm (L x W x H); approx. 294 kg
Handrails:metallic railing in front and at both sides
2. User terminal with HR Measurement
Integrated User Terminal with high contrast LC display. Complete with
POLAR Heart Rate Measurement system and heart rate dependent load
control. Current values such as speed, gradient, time, index no., distance as
well as pulse rate should be legibly presented on the LCD. Programs should
be available with fixed memory locations incl. test programs Conconi,
Ellestad, Naughton, etc.
3. Following should be should be available
a)Para graphic Software:-
The PC-software package Para Graphics should provide on-line recording of
the load parameters and the heart rate in the form of graphs on the colour
screen. The data should be exported to other programs (e.g. POLAR, Cyclo
Vantage, HRCT, etc.) and should thus be evaluated.
Apart from on-line recording the software package Para Graphics HRC
should provide a heart-rate controlled training. It should work automatically
to control the speed of the treadmill according to the desired range of the
heart rate that should be programmed.
The following data should be recorded on-line:
Time [s]
Speed [km/h]
Heart rate [bpm]
Elevation [%]
Distance [km]
b) Rehabilitation attachment:- comfortable joint adjustment in width and
height ; with scale; the Reha attachment should be fixed to the lateral
railings of the Treadmill. the Reha attachment should be folded together, and
should not need to dismantle it after use
4. Full Resting ECG Evaluation 12 Leads with Computerized Reporting
Analysis of Waveform Morphology & Rhythm.
5. Computerized Treadmill Exercise Testing with 12 Leads, 3 leads Screen
Showing Advanced waveforms Analysis. Accurate ST Segment
Measurement, Heart Rate, BP Measurement should include noninvasive BP
measurement from time to time during treadmill evaluations.
6. Facility for programmability for all variety of protocols.
7. Trend Charts for Heart Rate BP & ST shifts in at least 3 leads available at
the end of the test.
8. Minute to minute Evaluation of all leads available at the end of the test.
9. 12 lead Printout to be available as & when necessary during the test.
10. Stable Reusable Electrode that gives clear good quality online ECG.
11. ST Analysis of all 12 leads at maximum ST Depression & at Maximum

68
METs should be available at the end of the test.
12. Minute to minute evaluation of HR, BP, METs, Speed , Percentage of
elevation of Treadmill Belt, ST Analysis in minimum 3 selected leads or
maximum ST Depression out of all leads should be available at the end of
the test.
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 All consumables required for installation and standardization of system to be
given free of cost.
5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.
5.2 The unit shall be capable of being stored continuously in ambient
temperature of 0 -50 deg C and relative humidity of 15-90%
5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40 deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 Suitable Servo controlled Stabilizer/CVT
7 Standards, Safety and Training

7.1 Comprehensive warranty for 2 years and 5 years AMC after warranty
7.2 10 years warranty on Driving Motor.
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spares and accessories with their part number and costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

69
Equipment Specifications for Stress Test System with TMT

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Exercise stress testing systems offer a wide array of unique diagnostic
software options to evaluate myocardial function. Automatic arrhythmia
detection, ST-segment analysis, and T-wave alternans are a few examples.
In conjunction with a treadmill or ergometer, these systems provide a
controlled environment for the observation of the effects of increases in
myocardial oxygen demand: exercise-induced systolic hypotension,
exercise-induced angina, and/or the appearance of a heart murmur during
exercise.
2 Operational Requirements

2.1 System complete with PC, Software, TMT and necessary cables is required.
3 Technical Specifications

3.1 1. System should acquire and analyze 12 leads.

2. System should be based on Windows platform with 17” color monitor


having minimum resolution 1280 x 1024. 80 GB HDD, CD-RW, Mouse,
UPS for analyzer.

3. Wireless patient module between patient and analyzer thus providing


wireless transmission of patients ECG / remote patient preparation. The
wireless module must have display for ECG waveform, electrode impedance
check, low battery/ lead fail display.

4. Should provide standard Full Interpretation of Supine ECG with


reasoning.

5. Display of real time 12 lead diagnostic quality ECG waveform, average


complexes beat of all 12 leads with superimposed color comparison along
with digital value of ST level and slope. Display the graph on the recording
paper.

6. Automatic detection, display, Storage and review of arrhythmia, Heart


Rate, Double Product and METS. It should have online HR METs and ST
running trends available on the screen during exercise.

7. System should have ability to manual edit of J & Isoelectric point during
exercise. Filters for line frequency and special filters to reduce noise and

70
baseline artifacts without compromising the ECG frequency response.

8. System should have full disclosure play back, review and storage of
patient ECG raw data for unlimited numbers depending upon size of the
hard disk. The unit should have the ability to readjust “J-ST” interval
measurement + 1 m sec points and generate a new report from stored raw
ECG data.

9. System should provide multiple and customizable printing formats as per


user’s choice on A-4 size high resolution thermal printer for online real time
printings. Compatible laser printer for printing reports on plain paper also to
be supplied.

10. System must have ECG trigger output to interface with external
automatic devices.

11. Heavy Duty Treadmill (Imported): Noise free TREADMILL with speed
ranging from 0.5 to 20 kmph and grade of 0 – 22% with suitable servo
stabilizer.

12. Automatic Stress test Non Invasive Blood Pressure Monitor, compatible
with the treadmill stress Test System for bi-directional exchange of data
between the monitor and analyzer. Optional Pulse Oximetry (SpO2)
integrated with NIBP Module to be quoted separately.of enlarged complex
and facility of dynamic lead selection for maximum ST changes. Display of
1mm graph on the monitor should be similar to
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 All consumables required for installation and standardization of system to be
given free of cost.
5 Environmental factors

None

6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz


6.2 Suitable Servo controlled Stabilizer/CVT

71
7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product


8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.

72
Equipment Specifications for Video Enteroscope (Single balloon)

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Single-Balloon Endoscopy System allows ease of insertion and makes not
only diagnosis but also treatment of the entire small intestine a reality.
2 Operational Requirements

2.1 Enteroscope should be compatible with the commonly used light sources.
3 Technical Specifications

3.1 Direction of View : Forward


Observation Range app: 6~100mm
Field of View min 140 Degrees
Specifications enteroscope:
Distal End Diameter app: 9.5 mm
Flexible Portion Diameter app: 9.2 mm
Bending Capability (Up/Down) 180 Degrees / 180 Degrees
Bending Capability (Left/Right) at least 150 Degrees / 150 Degrees
Forceps Channel Diameter more than 2.5mm
Working Length not less than 2,000mm
Video output to be compatible with the video processor specified.
3.2 Video processor with light source & Monitor
1. Power supply 200-240 V A/C
2. PAL type video signal.
3. Controls for color adjustment, to enhancement and balance settings.
4. Controls to freeze images, enhance a portion of frozen image (zoom &
post-processing).
5. Patient and physician data input key board..
6. Operates on Xenon lamp.
7. Emergency lamp.
8. Compatibility with the gastro scope and colonoscope duodenoscopE and
Enteroscope
9. 15” LCD colour monitor with XGA resolution.
3.3 Over-tube Specifications :
Outer Diameter app:13.2mm
Inner Diameter app:10.8mm
Distal End Diameter app: 9.8mm
Outer Diameter (Balloon) : 40mm
Working Length app:1,350mm
3.4 Balloon Pump Controller with Remote Switch Specifications

73
Set Pressure of Balloon app : 5.5kpa+/-2kpa
Maximum Flow Rate of Pump :app: 170ml/10sec
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 1. Biopsy forceps :3 each
2. Foreign body grasper (basket type) 2
3. Polypectomy snare:2
4. Standard tip canula:2 types – 10 ea
5. Sphincterotome for side viewing duodenoscope only (wire guided, triple
lumen) – 10
6. Mechanical lithotripter :5
7. Polypectomy cautery system :1
8.Guide wires 2 types ( 0.025 “F, 0.035 “ in diameterF); length 450 cm, non-
kinkable with stripes to detect movement – 5
9.Basket for retieving stones with memory filaments – 5
10.Balloons 11mm diameter and wire guided – 5
11.Single pigtail stents – 7 cm, 10 cm long; 7 F and 10 F diameter – each 10
12.Stents – straight 7 F and 10F; 7 cm and 10 cm long – each 10 in number
5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%
5.2 The unit shall be capable of operating continuously in ambient temperature
of 10 -40 deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Comprehensive warranty for 2 years and 5 years AMC after warranty.

74
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job description of the hospital technician and
company service engineer should be clearly spelt out.
8.6 User list to be provided with performance certificate.

75
Equipment Specifications for Video Enteroscope (Double balloon)

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Double-Balloon Endoscopy System allows ease of insertion and makes not
only diagnosis but also treatment of the entire small intestine a reality.
2 Operational Requirements

2.1 Enteroscope should be compatible with the commonly used light sources.
3 Technical Specifications

3.1 Direction of View: Forward


Observation Range app: 6~100mm
Field of View min 140 Degrees
Specifications Enteroscope:
Distal End Diameter app: 9.5 mm
Flexible Portion Diameter app: 9.2 mm
Bending Capability (Up/Down) 180 Degrees / 180 Degrees
Bending Capability (Left/Right) at least 150 Degrees / 150 Degrees
Forceps Channel Diameter more than 2.5mm
Working Length not less than 2,000mm
Video output to be compatible with the video processor specified.
3.2 Video processor with light source & Monitor
1. Power supply 200-240 V A/C
2. PAL type video signal.
3. Controls for color adjustment, to enhancement and balance settings.
4. Controls to freeze images, enhance a portion of frozen image (zoom &
post-processing).
5. Patient and physician data input key board..
6. Operates on Xenon lamp.
7. Emergency lamp.
8. Compatibility with the gastro scope and colonoscope duodenoscopE and
Enteroscope
9. 15” LCD colour monitor with XGA resolution.
3.3 Over-tube Specifications :
Outer Diameter app:13.2mm
Inner Diameter app:10.8mm
Distal End Diameter app: 9.8mm
Outer Diameter (Balloon) : 40mm

76
Working Length app:1,350mm
3.4 Balloon Pump Controller with Remote Switch Specifications
Set Pressure of Balloon app : 5.5kpa+/-2kpa
Maximum Flow Rate of Pump :app: 170ml/10sec
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 1. Biopsy forceps :3 each
2. Foreign body grasper (basket type) 2
3. Polypectomy snare:2
4. Standard tip canula:2 types – 10 ea
5. Sphincterotome for side viewing duodenoscope only (wire guided, triple
lumen) – 10
6. Mechanical lithotripter :5
7. Polypectomy cautery system :1
8.Guide wires 2 types ( 0.025 “F, 0.035 “F in diameter); length 450 cm, non-
kinkable with stripes to detect movement – 5
9.Basket for retieving stones with memory filaments – 5
10.Balloons 11mm diameter and wire guided – 5
11.Double pigtail stents – 7 cm, 10 cm long; 7 F and 10 F diameter – each
10
12.Stents – straight 7 F and 10F; 7 cm and 10 cm long – each 10 in number
5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%
5.2 The unit shall be capable of operating continuously in ambient temperature
of 10 -40 deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Comprehensive warranty for 2 years and 5 years AMC after warranty

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8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job description of the hospital technician and
company service engineer should be clearly spelt out.
8.6 User list to be provided with performance certificate.

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Equipment Specifications for VideoEndoscopy Complete System

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 The ERCP scope is a flexible tube, approximately the size of a finger. It
contains a lens and a light source that allows the endoscopist to view images
on a monitor where it is magnified many times so the endoscopist can see
small changes in the tissues.
2 Operational Requirements

2.1 The ERCP scope should also contains channels that allow the endoscopist to
take biopsies and introduce or withdraw fluid, air and instruments and
should be supplied with all accessories.
3 Technical Specifications

3.1 Upper GI Scope (Adult )


1. Direction of view should be zero degree.
2. Minimum of 130 degree of field of view.
3. Range of observation atleast from 5 mm to 90 mm.
4. Angulations of tip up at least 180 degrees and down 90 degrees with right
and left movement of at least 100/100 degrees.
5. Insertion tube diameter of less than 10 mm .
6. Distal end diameter of not more than 10.5 mm
7. Instrument channel of more than 2.5 mm
8. Working length of not less than 1000mm
9. Should be compatible with the video system specified

3.2 Upper GI Scope(Pediatrics)


1. Direction of view should be zero degree.
2. Minimum of 130 degree of field of view.
3. Range of observation atleast from 5 mm to 90 mm.
4. Angulations of tip up at least 180 degrees and down 90 degrees with right
and left movement of at least 100/100 degrees.
5. Insertion tube diameter of less than 10 mm .
6. Distal end diameter of not more than 10.5 mm
7. Instrument channel of more than 2.5 mm
8. Working length of not less than 1000mm
9. Should be compatible with the video system specified
3.3 Lower GI Scope(Adult)
1.Direction of view should be zero degree.
2. Minimum of 130 degree of field of view.
3. Range of observation at least from 5 mm to 90 mm.

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4. Angulations of tip up at least 180 degrees and down 90 degrees with right
and left movement of at least 100/100 degrees.
5. Inner diameter optimal
6. Distal end diameter of not more than 10.5 mm
7. Instrument channel of more than 2.5 mm
8. Working length of not less than 2000mm
9. Should be compatible with the video system specified
10.Endotherapy compatible
11.Fully immersible in disinfectant solution
3.4 Lower GI Scope(Pediatric)
1. Direction of view should be zero degree.
2. Minimum of 130 degree of field of view.
3. Range of observation atleast from 5 mm to 90 mm.
4. Angulations of tip up at least 180 degrees and down 90 degrees with right
and left movement of at least 100/100 degrees.
5. Inner diameter optimal
6. Distal end diameter of not more than 10.5 mm
7. Instrument channel of more than 2.5 mm
8. Working length of not less than 1500mm
9. Should be compatible with the video system specified
10.Endotherapy compatible
11.Fully immersible in disinfectant solution
3.5 DUODENO VIDEOSCOPE (Side viewing for ERCP)
1. Field of vision more than 100 deg.
2. Direction of view 5deg backward / oblilque
3, Depth of view app 5-50 mm
4. Distal end outer diameter not exceeding 13.5
5. Insertion tube outer diameter not exceeding 13 mm
6. Bending angulation should be at least up 120 deg, down 90 deg, Right
110 deg Left 90 deg
7. Working length not below 1200 mm
8. Instrumental channel not less than 4 mm
9. Compatible with video system specified

3.6 Video processor with light source & Monitor


1. Power supply 200-240 V A/C
2. PAL type video signal.
3. Controls for color adjustment, to enhancement and balance settings.
4. Controls to freeze images, enhance a portion of frozen image (zoom &
post-processing).
5. Patient and physician data input key board..
6. Operates on Xenon lamp.
7. Emergency lamp.

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8. Compatibility with the gastro scope and colonoscope duodenoscope and
Enteroscope
9. 15” LCD colour monitor with XGA resolution.
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 1. Biopsy forceps :3 each
2. Foreign body grasper (basket type) 2
3. Polypectomy snare:2
4. Standard tip canula:2 types – 10 ea
5. Sphincterotome for side viewing duodenoscope only (wire guided triple
lumen) – 10
6.Mechanical lithotripter :5
7. Polypectomy cautery system :1
8.Guide wires 2 types ( 0.025 “F, 0.035 F“ in diameter ); length 450 cm,
non-kinkable with stripes to detect movement – 5
9.Basket for retrieving stones with memory filaments – 5
10.Balloons 11mm diameter and wire guided – 5
11.Double pigtail stents – 7 cm, 10 cm long; 7 F and 10 F diameter – each
10
12.Stents – straight 7 F and 10F; 7 cm and 10 cm long – each 10 in number
5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%
5.2 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Manufacturer should be ISO certfied for quality standards.
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

81
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

82
Equipment Specifications for Upper GI Endoscope

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Gastroscopes are used to view and administer therapy to the interior of the
esophagus and the stomach for diagnosing and managing upper-GI disorders
(e.g., ulcers and other lesions). Therapeutic GI procedures performed
through the scope’s working channels typically include biopsies,
electrosurgery, and laser surgery.gastroscopes, duodenoscopes, and
choledochoscopes—also called upper-gastrointestinal (GI) endoscopes—
2 Operational Requirements

2.1 Upper GI Scope compatible with commonly used camera and light sources
is required.
3 Technical Specifications

3.1 1. Direction of view should be zero degree.


2. Minimum of 130 degree of field of view.
3. Range of observation atleast from 5 mm to 90 mm.
4. Angulations of tip up at least 180 degrees and down 90 degrees with right
and left movement of at least 100/100 degrees.
5. Insertion tube diameter of less than 10 mm .
6. Distal end diameter of not more than 10.5 mm
7. Instrument channel of more than 2.5 mm
8. Working length of not less than 1000mm
9. Should be compatible with the video system specified
10.Video Processor

• Digital Signal Processing for signal received from a colour CCD


chip.
• Compact Light weight (9-10 Kg) and ergonomically designed.
• Able to display high resolution & real color imaging.
Output :RGB , Y/C, Composite(with Simultaneous Output
Possibility
Colour adjustment : Chroma(Red & Blue Color) control with appx 14
increments
Edge/Structure ENH : 4 to 8 levels of switchable settings (for Both edges
& structures)
Image Display Size : 3 or 4 different sizes of Image display on monitor
possible for
Small /Medium/ procedural Convenience
Full Height)

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Users Data Preset :For individual user’s setting of functions(5 or more
users)
Scope’s Identification : Data such as scope’s model and serial number
comments,
Cumulative uses check period, owner, Customers
ID etc.
Memorization of : the setting for functions such as Color,
Enhancement, Irish,
Selected Setting White balancing etc. retainable when
power is off/on.

11.Xenox Light Source(300 Watts)

Automatic Brightness Control : With Servo Diaphragm Method


Internal Memorization battery : For Storing Selected Settings in Light
Source even if the
Power is off.
Main Lamp : Xenon Short-arc Lamp (300 Watts) with
switching
Regulator Mechanism.
Main Lamp Life : Appx. 500 hrs on continuos use
Emergency Lamp : Halogen 12V 100 Watts with apprx 100hrs or
more life.
Power Supply : 220-240 V Ac,Freq 50/60 Hz,Input Current 3
A
Weight : Around 15-16 Kg or less

LCD Monitor
14’’ Flat Screen color LCD Monitor(high Resolution)

4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 1. Biopsy forceps :3 each
2. Foreign body grasper (basket type) 2
3. Polypectomy snare:2
4. Standard tip canula:2 types – 10 ea
5. Sphincterotome for side viewing duodenoscope only (wire guided, triple
lumen) – 10

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6. Mechanical lithotripter :5
7. Polypectomy cautery system :1
8.Guide wires 2 types ( 0.025 “F, 0.035 “ in diameterF); length 450 cm, non-
kinkable with stripes to detect movement – 5
9.Basket for retieving stones with memory filaments – 5
10.Balloons 11mm diameter and wire guided – 5
11.Double pigtail stents – 7 cm, 10 cm long; 7 F and 10 F diameter – each
10
12.Stents – straight 7 F and 10F; 7 cm and 10 cm long – each 10 in number
5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%
5.2 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

None
7 Standards, Safety and Training

7.1 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Manufactures/Supplier should have ISO certificate to Quality Standard.
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

85
Equipment Specifications for Sleep Screening Test

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Sleep lab system is required to study the sleep disorders by recording and
analyzing the parameters like EEG,SPO2 ETC when the patient is sleeping.
2 Operational Requirements

2.1 The sleep system is required with all the equipments and computer with
analysis software with printer
3 Technical Specifications

3.1 SLEEP LAB- WITH EEG FACILITY


Should have;
• flow/pressure (nasal cannula/mask)
• oral flow (Thermistor) Sensor
• snore (by nasal pressure or by neck vibration sensor Piezo element)
• abdominal movement .
• Chest wall movement (by Xact trace RIP belts or by Piezo element
sensors)
• SPO2 average
• SPO2 beat-to-beat
• Pulse rate
• Pulse waveform
• Body position Sensor
• Flow limitation.
• Event marker
• Activity
• Limb movement
• Autoset information.
• Batteries; 2AA alkaline batteries (more than 10 hours duration 2AA
rechargeable batteries
• Housing construction; Injection moided plastic covered with almunium
shield.
• Number of channels; 7 sensors, 14 derived signals.
• Recording capacity; more than 10 hours
3.2 Computer specification :CPU Pentium IV 2.7 GHz and above;128/64 MB
RAM;1.44 MB Floppy drive;80 GB Hard Disk Drive; High Speed DVD/CD
Rom 52 X: Serial and parallel ports ;Keyboard (IOS) , Mouse and Mouse
Pad; Preloaded latest MS Windows Versions; SVGA Monitor size
15”;Inkjet printer; Modem 56K;latest anti-virus SOLOMAN & NORTON.

86
3.3 Complete software and hardware to interface the system and analyze the
results of parameters recorded.
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 All media and consumables for setting up and standardization should be
provided free of cost.
5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.
5.2 The unit shall be capable of being stored continuously in ambient
temperature of 0 -50 deg C and relative humidity of 15-90%
5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product


7.2 Shall be certified to be meeting the safety standards IEC- 60601-2-26 PART
2: Particular requirements for safety of EEG Systems.
7.3 Manufacturer should be ISO certified for quality standards.
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty
7.5 Should have local service facility .The service provider should have the
necessary equipments recommended by the manufacturer to carry out
preventive maintenance test as per guidelines provided in the
service/maintenance manual.

87
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job description of the hospital technician and
company service engineer should be clearly spelt out.
8.6 User list to be provided with performance certificate.

88
Equipment Specifications for Sleep Lab (Advanced)

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Sleep lab system is required to study the sleep disorders by recording and
analyzing the parameters like EEG, SPO2 ETC when the patient is sleeping.
2 Operational Requirements

2.1 The sleep system is required with all the equipments and computer with
analysis software with printer
3 Technical Specifications

3.1 SPECIFICATIONS OF SLEEP SYSTEM

(1) Ambulatory polysomnography with 26 channels and upto 8 of these


should be EEG , should be light and compact. The basic unit should not be
more than 500 gm. including batteries.

(2) Should have latest touch screen for device configuration , impedance
measurement and signal control.

(3) Following parameters should be recorded ;

(a) 8 AC signals for EEG,EOG,EMG,ECG and IC-EMG.

(b) flow by using a thermistor (nasal-oral) or using a nasal cannula.

(c) Effort should be measured using piezoelectrical sensors.

(d) Pulse frequency and oxygen sensor should be measured with a finger clip
attached to the interval pulse oximeter.

(e) Snoring detected by a microphone.

(f) Body position (back,stomach,left,right) by means of an integrated body


position sensor in the patients yoke box.

(g) Estimation of sleep and wake phases should be measured using


accleration sensor attached to patient wrist.

(h) Light sensor integrated in the base unit to measure actual time in bed.

(i) NCPAP/BiPAP pressure and flow.

89
(j) Possibility for software to generate a sum of both effort signals, and heart
frequency generated from ECG.

(k) Necessary signals (EEG, EOG.EMG) required for sleep staging should
be bundled into one cable/plug harness.

(l) Sleep Stage Analysis should be based on criteria of R & K. The average
frequency value of the central EEG lead should be calculated, sleep spindles,
K-complexes, REMs and movement arousals should be detected and
displayed.

(m) The displayed amount of sleep interruption within specific time intervals
should provide information about the disorder of sleep architecture.

(4) Should have built – in pulse oximeter, display should be 120 x 64 pixel
b/w , touch screen memory = PCMCIA or compact flash card , 96 MB
memory , optional 160 MB. Pulse Oximeter – 75% - 100% Range

(5) 7 aux. Channels to connect to external sources like PH , et CO2 ,


temperature , Oesophagus pressure , NPT etc.

(6) Software based on windows platform and after transferring the data to
PC , the data should be analyzed automatically with a clear over view of the
final result.

(7) Computer assisted analysis or even complete manual evaluations should


be possible. The analysis software should also evaluate measurements of
children and infants taken specific aspects such as periodic breathing into
consideration.

(8) The yoke box incl. Integrated body position sensor should not be more
than 250 gms.

(9) Internal storage of raw data and automatic gain adjustment for perfect
amplification of the respiratory signals should be possible.

(10) Computer specification :CPU Pentium Core 2 Duo 2.7 GHz and
above;512 MB RAM;1.44 MB Floppy drive;120 GB Hard Disk Drive; High
Speed DVD/CD Rom 52 X: Serial .USB and parallel ports ;Keyboard (IOS)
, Mouse and Mouse Pad; Preloaded latest MS Windows Versions;LD/TFT
SVGA Monitor size 17”;Inkjet printer; Modem 56K;latest anti-virus
SOLOMAN & NORTON.
.

90
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 All consumables required for installation and standardization of system to be
given free of cost.
5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility. or should comply with
89/366/EEC; EMC-directive.
5.2 The unit shall be capable of being stored continuously in ambient
temperature of 0 -50 deg C and relative humidity of 15-90%
5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product


7.2 Manufacturer should be ISO certified for quality standards.
7.3 Shall be certified to be meeting the safety standards IEC- 60601-2-26 PART
2: Particular requirements for safety of EEG Systems.
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.

91
Equipment Specifications for Lung Function Test System

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Pulmonary function tests are a group of procedures that measure the
function of the lungs, revealing problems in the way a patient breathes. The
tests can determine the cause of shortness of breath and may help confirm
lung diseases, such as asthma, bronchitis or emphysema. The tests also are
performed before any major lung surgery to make sure the person won't be
disabled by having a reduced lung capacity
2 Operational Requirements

2.1 Complete with all hardware and software is required


3 Technical Specifications

3.1 The system should be able to measure spirometry and flow volume
parameters and sub divisions, Maximum Ventilation Volume(MVV),Lung
Volume including TLC,RV& FRC by multibreath closed circuit Helium
Dilution.
3.2 Should be able to perform diffusion studies.
3.3 Broncho Provocation/ Histamine Challenge Test Software
3.4 System should incorporate Precision Dry Rolling Seal Spirometer(11-13
Litres)/ heated Pneumotech for highest accuracy and reproducibility and
Flow Volume Differentiator (Resistance less than 1 cm of H2O /Liters/Sec
a)Volume resolution < 8ml
b.)Accuracy < 0.5%
c)Flow Range+/- 15 Liters/Sec.
3.5 Should have linear analyzers for
Helium Analyzer: Range 0-15% Helium Accuracy+/- 0.1 %
Carbon Monoxide Analyzer: Range0- 0.350%CO, Accuravy+/- 0.1%
Oxygen Analyzer: Range: Range 0-100% Accuracy +/- 0.1%
3.6 Gas Control Module with Automatic Filling circuit.
3.7 System should have automatred O2 compensation during FRC test.
3.8 System should also have fully automated Calibration/Test procedure with
computer.
3.9 Computer specification :CPU Pentium IV 2.7 GHz and above;128/64 MB
RAM;1.44 MB Floppy drive;80 GB Hard Disk Drive;High Speed DVD/CD
Rom 52 X: Serial and parallel pOrts ;Keyboard (IOS) , Mouse and Mouse
Pad;Preloaded latest MS Windows Versions;SVGA Monitor size 15”;Inkjet

92
printer;Modem 56K;latest anti-virus SOLOMAN & NORTON.
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 Should be supplied complete with Computer Interfacing
package,cables,Trolley,PFT Software, Manual and standard accessories
4.3 Should be supplied complete with Gas mixture cylinders( at least 2 cubic
metres)
a)Helium Cylinder-01
b)Cylinders Diffusion Mixtures-02
5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.
5.2 The unit shall be capable of being stored continuously in ambient
temperature of 0 -50 deg C and relative humidity of 15-90%
5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product


7.2 Manufacturer should have ISO certification for quality standards.
7.3 Electrical safety conforms to standards for electrical safety IEC-60601-1
General Requirements
7.4 Should comply with ATS/ ECCS Guidelines.
7.5 Should have local service facility .The service provider should have the
necessary equipments recommended by the manufacturer to carry out
preventive maintenance test as per guidelines provided in the
service/maintenance manual.
8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.

93
8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spares and accessories with their part number and costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

94
Equipment Specifications for Lung Function Test System (Advanced)

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 Pulmonary function tests are a group of procedures that measure the
function of the lungs, revealing problems in the way a patient breathes. The
tests can determine the cause of shortness of breath and may help confirm
lung diseases, such as asthma, bronchitis or emphysema. The tests also are
performed before any major lung surgery to make sure the person won't be
disabled by having a reduced lung capacity
2 Operational Requirements

2.1 Complete system is required along with control software, PC and a printer.
3 Technical Specifications

3.1 SPECIFICATION FOR A COMPUTERISED PFT SYSTEM

1) The System should be an economically oriented lung function measuring


system for the determination of the static and dynamic lung volumes using
the classical FRC- Helium rebreathing and the Diffusion Capacity by using
the single Breath technique. It should also be possible to measure Diffusion
Capacity (DLCO) by the Rebreathing technique for patients with
distribution impairments of the lungs, to minimise patient co-operation.
2) The system should measure the following :
a) Slow and forced spirometry (Inspiratory and Expiratiory Flow Volume
Curve)
b) Lung subvolumes - Functional residual Capacity (FRC), Residual Volume
(RV) . Total Lung Capacity (TLC) by FRC-Helium multiple breath
technique .
c) Diffusion capacity of the lung, by single breath technique.
d) Diffusion capacity of the lung by the multiple breath technique.
3) The system should measure the following parameters :
a) Slow and forced Spirometry,
VT, BF, MV, ERV, FVC, FEV1, VCin, VCex, MEF 50, MEF 75, PEF,
MVV etc.
b) Lung Subvolumes : FRC, RV, TLC, RV%TLC etc.
c)Diffusion capacity of the Lungs : DLCO-SB , DLCO – RB.
4) The system should have an easy to exchange, bidirectional heated
pneumotach with the following specifications. :
Range - Should be 0 to 20 lit/sec.
Accuracy - Should be +/-2%
Resistance - Should be less than 0.05 KPa/ lit/sec.
5) The system should have carbon monoxide analyser, He analyser and O2

95
Analyser with the following specifications:
a) Carbon monoxide analyser : Range - Should be from 0 to 0.4%
Resolution/Accuracy should be 0.0002%/0.0003%
Reproducibility should be 0.0006%
b) He Analyser :
Range - Should be 0 to 9.5%
Resolution/Accuracy should 0.005% /0.05 %
Reproducibility should be 0.02%
c) O2 analyser
Range - Should be 0 to 100%.
Resolution / Accuracy should be 0.05% / 1.0%
Reproducibility should be 0.1%.
6) The system should have a demand valve unit for direct breathing (no
inspiratory bag) from pre-mix gas container, to minimise wastage of gas.
7) The computer system should have the following specification:
Branded - Pentium Core 2 Duo processer 2.7 GHz and above
120 GB HDD,
512 MB RAM,
1.44 MB FDD,
DVD RD/WR
Serial / Parallel Ports/USB,
15” TFT Monitor.
Keyboard,
Mouse.
HP colour inkjet printer
ORIGINAL WINDOWS XP PROFESSIONAL
OEM O.S.WITH SERVICE PACKS 2
8) System software should have facility for entry of patient data and saving
of this information in a data base system Software should be MS-windows
based . It should be possible to configure different report out put formats.
9) It should be possible to upgrade the system to the following :
a) Airway resistance by shutter method.
b) Respiratory impedance by Impulse Oscillometry system.
c) Respiratory muscle strength, Respiratory drive.
d) Compliance - Static / Dynamic system.
e) Body Plethysmography.
f) Aerosol Provocation system.
g) Ergospirometry & Stress test ECG.
h)Breathing Analysis for children.
10) The system should have fully computerised calibration procedure for
flow sensor and gas analysers. The system should also have a check
procedure during start-up.
11) It should be possible to integrate/connect the system in a local Area
Network (LAN). The data base must be accessed in a novel authorised
operating system.

96
12) The software for diffusion must have program for patient training of
DLCO Test without gas.
13) The software must be able to be set values for discard volume, Alveolar
time & other parameters according to user requirement.
4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 Should be supplied complete with Computer Interfacing
package,cables,Trolley,PFT Software, Manual and standard accessories
4.3 Should be supplied complete with Gas mixture cylinders( at least 2 cubic
metres)
a)Helium Cylinder-01
b)Cylinders Diffusion Mixtures-02
5 Environmental factors

5.1 Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements


of Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.
5.2 The unit shall be capable of being stored continuously in ambient
temperature of 0 -50 deg C and relative humidity of 15-90%
5.3 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Should be FDA , CE,UL or BIS approved product


7.2 Manufacturer should be ISO certified for quality standards.
7.3 Electrical safety conforms to standards for electrical safety IEC-60601 / IS-
13450
7.4 Should comply with ATS/ ECCS Guidelines.
7.5 Should have local service facility .The service provider should have the
necessary equipments recommended by the manufacturer to carry out
preventive maintenance test as per guidelines provided in the
service/maintenance manual.

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8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

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Equipment Specifications for ERCP scope

UNSPSC Code:
ECRI Code:
1 Description of Function

1.1 The ERCP scope is a flexible tube, approximately the size of a finger. It
contains a lens and a light source that allows the endoscopist to view images
on a monitor where it is magnified many times so the endoscopist can see
small changes in the tissues.
2 Operational Requirements

2.1 The ERCP scope should also contains channels that allow the endoscopist to
take biopsies and introduce or withdraw fluid, air and instruments and
should be supplied with all accessories.
3 Technical Specifications

3.1 DUODENO VIDEOSCOPE (Side viewing for ERCP)


1. Field of vision more than 100 deg.
2. Direction of view 5deg backward / oblilque
3, Depth of view app 5-50 mm
4. Distal end outer diameter not exceeding 13.5
5. Insertion tube outer diameter not exceeding 13 mm
6. Bending angulation should be at least up 120 deg, down 90 deg, Right
110 deg Left 90 deg
7. Working length not below 1200 mm
8. Instrumental channel not less than 4 mm
9. Compatible with video system specified
3.2 Video processor with light source & Monitor
1. Power supply 200-240 V A/C
2. PAL type video signal.
3. Controls for color adjustment, to enhancement and balance settings.
4. Controls to freeze images, enhance a portion of frozen image (zoom &
post-processing).
5. Patient and physician data input key board..
6. Operates on Xenon lamp.
7. Emergency lamp.
8. Compatibility with the gastro scope and colonoscope duodenoscope and
Enteroscope
9. 15” LCD colour monitor with XGA resolution.

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4 System Configuration Accessories, spares and consumables

4.1 System as specified


4.2 1. Biopsy forceps: 3 each
2. Foreign body grasper (basket type) 2
3. Polypectomy snare:2
4. Standard tip canula:2 types – 10 ea
5. Sphincterotome for side viewing duodenoscope only (wire guided triple
lumen) – 10
6. Mechanical lithotripter :5
7. Polypectomy cautery system :1
8.Guide wires 2 types ( 0.025 “F, 0.035 F“ in diameter ); length 450 cm,
non-kinkable with stripes to detect movement – 5
9.Basket for retrieving stones with memory filaments – 5
10.Balloons 11mm diameter and wire guided – 5
11.Double pigtail stents – 7 cm, 10 cm long; 7 F and 10 F diameter – each
10
12.Stents – straight 7 F and 10F; 7 cm and 10 cm long – each 10 in number
5 Environmental factors

5.1 The unit shall be capable of being stored continuously in ambient


temperature of 0 -50 deg C and relative humidity of 15-90%
5.2 The unit shall be capable of operating continuously in ambient temperature
of 10 -40deg C and relative humidity of 15-90%
6 Power Supply

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug


6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7 Standards, Safety and Training

7.1 Shall be certified to be meeting safety standard IEC 60601-2-18 part 2


Particular requirements for the safety of endoscopic equipment.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Manufacturer should be ISO certfied for quality standards.
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty

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8 Documentation

8.1 User/Technical/Maintenance manuals to be supplied in English.


8.2 Certificate of calibration and inspection.
8.3 List of Equipments available for providing calibration and routine
Preventive Maintenance Support. as per manufacturer documentation in
service/technical manual.
8.4 List of important spare parts and accessories with their part number and
costing.
8.5 Log book with instructions for daily, weekly, monthly and quarterly
maintenance checklist. The job descriptin of the hospital technician and
company service engineer should be clearly spelt out.

101

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