caet de sarcini in engleza
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MINISTRY OF HEALTH & FAMILY WELFARE
NIRMAN BHAVAN, NEW DELHI 110 001
Technical Specifications of Common MedicalEquipments 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
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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 & Specificationsa. General Surgery & OT 4-63b. 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 underup 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 generalterms 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
& 4th
Oct.07
Sl.No. Name of Experts, Special Invitees. Name of Institute
1 Prof. Munir Khan, HOD (Surgery) SMC, Srinagar2 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. &
Head ( Gen. Surgery)
KMC, Kolkata
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
Medicine
BMC, Bangalore
18 Dr. DR Mhasde, Prof. & HOD
(Medicine)
Grant Medical College, Mumbai
19 Dr. D. Dalus, Prof. of Medicine TMC, Trivendrum20 Dr. Virsingh Negi, Prof. (Medicine &
Allied Spec.)
JIPMER, Pondichery
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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GENERAL SURGERY & OT
List of the Common Equipments of General Surgery and OT
1. Modular OT 6-172. OT Table Hydraulic 18-203. OT Light 21-234. OT Light with LED Technology 24-295. Operating Microscope 30-336. Video Thoracoscope 34-377. Holmium Laser 38-418. Ultrasonic Aspirator 42-469. Ultrasonic Cutting and Coagulation device 47-50
(Harmonic Scalpel)
10.High Definition Laparoscopic System 51-5311.Washer Disinfector Medium Capacity 54-5812.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 DepartmentStructural 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 anaestheticgases
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) swivelingb) Vertically movablec) Good maneuverability
o) OT control panelsp) 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 todissipate 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 berounded 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 theuse 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 architects 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 panels 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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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 -20C to +55C. 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 Surgeons 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 Clock2. Time Elapse Day Clock3. General Lighting System4. Medical Gas Alarm Panel5. Hand Free Telephone set with memory6. Temperature & humidity indicator with controller7. HEPA Filter Status module8. Room Pressure Indicator9. 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 DAMPERSPressure 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 STATIONCompact 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 WINDOWThe 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 section2. 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 mmi. Length: 1950 mm
2. 8. Table top should be completely detachable compatible withtransfer trolley
4 System Configuration Accessories, spares and consumables
4.1 System as specified
4.2 Accessories should includea. 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
3.9
3.10
Should have option of electro magnetic brakes to maintain the light in a
steady position
The light should have 360 degree turning radius with unbreakable head
Glass.
Light should automatically switch on in case of resumption of electricity
after power failure.
The handle should be Auto clavable & detachable.
I
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 : > 400C
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 45C 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)
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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
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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 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)
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2. 2* FBAS(Composite)3. Optional 1* SDI4. 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* USB8 Optional 1* Audio in/out
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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
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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 tiltableeyepieces, 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
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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
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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.
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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.
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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 cm2. Rod Lens Telescope 30 degree 10mm, Length 31 cm3. Trocar 6mm with blunt tip flexible cannula and silicone leaflet valve4. Trocar 9mm with blunt tip flexible cannula and silicone leaflet valve5. Trocar size 11mm with blunt tip flexible cannula and silicone leaflet
valve
6. Trocar size 11mm with blunt tip cannula with thread7. Manhes dissecting and grasping forceps size 5mm8. Kelly dissecting and grasping forceps size 5mm9. Babcock grasping forceps size 5mm10. Bowel grasper rotating 5mm11. Scissors rotating with connector pin, spoon blades, double action
jaw, size 5mm
12. Scissors rotating serrated, curved, conical and double action jawsize 5mm
13. Micro hook scissors and single action jaw, size 5mm14. Scissors dismantling rotating serrated, single action jaws bayonet
shaped size 5mm
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15. Needle driver Parrat-Jaw straight handle with ratchet length 33 cm16. Assistant Needle driver Flamingo Jaw straight handle length 33 cm17. Manhaes grasping forceps rotating size 5mm atraumatic single
action jaws18. Suction & irrigation with two way stop cock19. Bipolar & Monopolar high frequency cord with 5mm plug20.3 Chips Camera PAL having Digital Imaging Processor21.Cold Light fountain Xenon 175 power supply 100-125 / 220-240V
AC, 50/60 Hz complete
22. TFT Monitor PAL 19(inch) maximum resolution 1280x102423. Video Cart24. Fiber Optic cable25.0 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
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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.
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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 m
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
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resection) 10 Nos.
Fiber Stripper for End Fire Fiber 1 No.
Fiber Cutter, for all fibers 1 No.
Laser Safety Glasses & Goggles 3 Nos. eachFoot 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
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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.
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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.
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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.
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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
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5. Infusion bottle holder-1
6. Double foot switch-1
7. Cleaning brush for instrument lumen-2
8. Instrument connection cables- 29. 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 Requirementsof Safety for Electromagnetic Compatibility.or should comply with
89/366/EEC; EMC-directive.
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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.
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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.
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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 50C to 100C: 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.
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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 longb. Short Curved Coagulating shears- 5 mm dia, 14 cm long.c. Dissecting hook, 5 mm dia,10cm longd. 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, curvedmode, 36 cm long.
g. Laparoscopic Coagulating shears , 5mm dia , Curved mode, 45cmlong.
h. Laparoscopic hand activated Coagulating shears with clicker -5mmdia 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.
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a. 10 mm Coagulating shear capable of working in 3 modes flat, Blunt & Sharp.
b. 5 mm Laparoscopic Curved coagulating Shears, 360 degreerotable, capable of sealing blood vessels upto 5 mm diameterwith 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 protectionmust be available.
7.2 Should be FDA , CE,UL or BIS approved product
7.3 Manufacturer should have ISO certification for quality standards.
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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.
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Specifications for High Definition Laparoscopy System
High Definition Three Chip Camera System
1. Camera console 220 v with universal coupler & Autoclavable camera head2. Pure Digital signal with high definition video(1280*1024 native resolution)3. Resolution-2000 horizontal lines4. 8 specialty settings5. Integrated Flexible Scope filter6. Signal to Noise ratio-70 db7. Progressive scan technology both on camera head & console8. Brightness Control on console & camera head9. Aperture Control on console10.Inbuilt 16 step digital Image Enhancer on console11.Digital zoom & white balance on camera head12.Integrated Gain/shutter/Enhancement with brightness control13.Two peripheral control on camera head
Video Output
1. 2 DVI output2. 2 SVHS & 1 RGB out put3. One Composite out put
Automatic Light source
1. 220 V,300 W. Xenon Bulb(with one spare bulb)2. Elliptical Bulb technology3. Bulb Working life 5800hrs4. Digital Bulb life counter on light source5. Automatic /Manual Light Adjustment6. Stand By Mode7. Universal Jaw Assembly to adapt any make of fiber optic cable without adapter.
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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)
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Vass needle 12 cm length
Varss needle 15 cm length
Carbon-di-oxide gas tubing
Trocars sleeves 11 mm
Reducer 11/5 mm
4
4
4
4
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,
Maryland dissector 5mm with unipolar diathermy
2
2
Maryland dissector 5mm, high performance with bipolar
cutting
2
Atraumatic graspers, 5mm 2
Metzenbaum scissors (5cm) with unipolar diathermy
Metzenbaum scissors (5cm) high performance with bipolar
cutting
2
2
Fan retractors 5 mm 2
Laproscopic cautery lead 4
Suction irrigation device with two way valve 2
L shaped hook electrode 5mm
L shaped hook 5mm , high performance with bipolar cutting
2
Laproscopic bowel grasper 5mm, length 33-36 cm
Laproscopic spoon forceps 10mm length 33- 36 cm
2
2
Needle holder 5mm, 33 cm long 4
Laproscopic suction cannuala, 10 mm
Laparoscopic suction cannula 5 mm
2
2
Clip applicator 10 mm Large, Medium, Small Clips
Gall bladder extraction 5mm Large, Medium, Small Clips
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Hassan cannula
Lap
Eondotrainer
Port closure needleSterilization tray with cover 3 x 1
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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 93C 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
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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
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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)/ 50Hzas 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
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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 .
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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 93C 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,
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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.
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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
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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)/ 50Hzas 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
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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.
8.6 User list to be provided with performance certificate .
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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 66-692. Stress System with TMT 70-723. Video Enteroscope (Single Balloon) 73-754. Video Enteroscope (Double Balloon) 76-785. Video Endoscopy Complete System 79-826. Upper GI Endoscope 83-857. Sleep Screening Test 86-888. Sleep Lab Advanced 89-919. Lung Function Test System 92-9410.Lung Function Test System Advanced 95-9811.ERCP Scope 99-101
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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 subjects
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 EXERCISEPHYSIOLOGY 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 volumecalibration 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/s8) 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.
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(Specifications of treadmill enclosed).
13) A suitable interpretation program to evaluate the test results should beavailable.
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 inMedical Fitness Training.
The digital interface (RS 232) should allow the treadmill and all its functionsbeing controlled via an Ergospirometry measuring station or a PC (SW
program for control via virtuel User Terminal to be included). Currentvalues such as speed, gradient, time, index no., distance as well as pulse ratecan 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 theWHOLE 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 accelerationcaused 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 stepMotor 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-beatECG 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
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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 MeasurementIntegrated 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 aswell 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 ofthe 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, CycloVantage, HRCT, etc.) and should thus be evaluated.
Apart from on-line recording the software package Para Graphics HRCshould 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 andheight ; 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 use4. Full Resting ECG Evaluation 12 Leads with Computerized Reporting
Analysis of Waveform Morphology & Rhythm.
5. Computerized Treadmill Exercise Testing with 12 Leads, 3 leads ScreenShowing 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 D