Documente Academic
Documente Profesional
Documente Cultură
1
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
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.
2
Annexure-I
LIST OF ATTENDEES OF PMSSY MEETING HELD ON 3rd & 4thOct.’07
3
4
GENERAL SURGERY & OT
1. Modular OT 6-17
3. OT Light 21-23
(Harmonic Scalpel)
5
Technical Specifications for Modular OT
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
6
e) Suction & Oxygen Therapy products
- Bed Head Trunking System
i) Flat X-ray imaging screens step less, flicker free and dimmer
k) Surgical scrubs sinks – elbow action taps or knee operated or flow sensor operated
o) OT control panels
p) It should be closed circuit TV facility.
q) Service maintenance warranty for 3 years and good service backup
7
• 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.
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
8
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
9
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.
The air management system should be designed to achieved the following parameters:
10
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.
11
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.
The door controller should be sensing overload condition and in overload case the door
will automatically stop & reverse the direction of travel.
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.
12
The Panel should contain 6 or 9 service tiles as below:
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.
13
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 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.
14
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.
15
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.
16
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.
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
17
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
18
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
5 Environmental factors
6 Power Supply
None
19
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
8.4 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.
20
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.;
21
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.
5 Environmental factors
22
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
8 Documentation
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.
23
O T Light with 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.
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:
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)
All arms are freely rotatable (without stops) at all vertical joints.
24
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)
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.
25
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!)
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)
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.
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
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.
None
5 Environmental factors
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
6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.
7.4 Comprehensive training for lab staff and support services till familiarity with
the system.
8 Documentation
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.
33
Equipment Specifications for Video Thoracoscope
UNSPSC Code:
ECRI Code:
1 Description of Function
2 Operational Requirements
3 Technical Specifications
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.
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
6 Power Supply
36
6.2 UPS of suitable rating with voltage regulation and spike protection for 60
minutes back up.
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty
8 Documentation
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
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
5 Environmental factors
5.2 Thu unit shall be capable of operating in ambient temperature of 20-30 deg
C and relative humidity of less than 70%
39
89/366/EEC; EMC-directive.
6 Power Supply
6.1 Power input to be 220-240 VAC, 50Hz fitted with Indian plug
6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.
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
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.
41
Equipment Specifications for ULTRASONIC ASPIRATOR
UNSPSC Code:
ECRI Code:
1 Description of Function
2 Operational Requirements
2.1 The system should be quoted with the paediatric as well as adult handpieces.
3 Technical Specifications
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.
3.6 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.
3.10 It should have integral suction with vacuum pressure of-20 to -90 Kpa. in
continuous low noise and digital display.
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.
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
5.2 Thu unit shall be capable of operating in ambient temperature of 20-30 deg
C and relative humidity of less than 70%
44
6 Power Supply
6.1 Power input to be 220-240 VAC, 50Hz fitted with Indian plug
6.4 Suitable UPS with maintenance free batteries for minimum one-hour back-
up should be supplied with the system.
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
8.4 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.
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
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
5.2 The unit shall be capable of being stored continuously in ambient temperature
of 0 -50 deg C and relative humidity of 15-90%
6 Power Supply
6.2 UPS of suitable rating with voltage regulation and spike protection for 120
minutes back up.
7.1 The generator must be CF isolated applied device and defibrillator protection
must be available.
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
8.3 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.
50
Specifications for High Definition Laparoscopy 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
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
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
2 Operational Requirements
2.1 Medium capacity washer disinfector with minimal floor space is required for
CSSD, OT, ICU or Wards
3 Technical Specifications
3.2 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,
3.5 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.
3.8 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.
3.11 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
4.2 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
6 Power Supply
7.3 Comprehensive warranty for 2 years and 5 years AMC after warranty
8 Documentation
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.
58
Equipment Specifications for Washer Disinfectors(High Capacity)
UNSPSC Code:
ECRI Code:
1 Description of Function
2 Operational Requirements
2.1 High capacity washer disinfector with minimal floor space is required for
CSSD.
3 Technical Specifications
59
3.5 The hot and cold water connections should have check
valves, back valves, mud filters and siphonage protection.
3.10 Multi-level access code system with Special codes for: user,
maintenance, authorized person should be there.
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
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
6 Power Supply
7.4 Comprehensive warranty for 2 years and 5 years AMC after warranty
62
8 Documentation
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.
63
64
GENERAL MEDICINE, INTERNAL MEDICINE, TRAUMA,
ACCIDENT & EMERGENCY
List of Common Equipments of General Medicine, Internal Medicine, Trauma,
Accident & Emergency
65
Equipment Specifications for Cardiopulmonary Exercise Physiology Test System
with Treadmill
UNSPSC Code:
ECRI Code:
1 Description of Function
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 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:
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
7.1 Comprehensive warranty for 2 years and 5 years AMC after warranty
7.2 10 years warranty on Driving Motor.
8 Documentation
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
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.
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
None
6 Power Supply
71
7 Standards, Safety and Training
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
73
Set Pressure of Balloon app : 5.5kpa+/-2kpa
Maximum Flow Rate of Pump :app: 170ml/10sec
4 System Configuration Accessories, spares and consumables
74
8 Documentation
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
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
77
8 Documentation
78
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
79
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
80
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
81
8 Documentation
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
83
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.
LCD Monitor
14’’ Flat Screen color LCD Monitor(high Resolution)
84
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
None
7 Standards, Safety and Training
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
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
87
8 Documentation
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
(2) Should have latest touch screen for device configuration , impedance
measurement and signal control.
(d) Pulse frequency and oxygen sensor should be measured with a finger clip
attached to the interval pulse oximeter.
(h) Light sensor integrated in the base unit to measure actual time in bed.
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
(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.
(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
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
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
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
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
97
8 Documentation
98
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
99
4 System Configuration Accessories, spares and consumables
100
8 Documentation
101