Technical Specifications of Medical Devices For Ophthalmology Equipment

TECHNICAL SPECIFICATIONS OF MEDICAL DEVICES FOR
OPHTHALMOLOGY EQUIPMENT
Ministry of Health and Family Welfare

Government of India
INDEX
S.No DETAILS Page No
List of contributors
Introduction
1 Cryo Surgery Unit with retina probe
2 Ophthalmoscope – Direct
3 Ophthalmoscope – In direct
4 Slit lamp
5 Retino scope
6 YAG Laser
7 Operating Microscope
8 A-Scan Bio meter
9 Kerato meter
10 Auto Refractometer
11 Flash Autoclave
12 Applanation Tono meter
13 Phacomachine
14 Laser Photo coagulator*
15 IOL Operation set

LIST OF CONTRIBUTORS
S.NO EXPERTS DESIGNATION ORGANIZATION
1 Dr. K Ramesh Babu Addl. Professor and Head– JIPMER, Pondicherry.

Ophthalmology Department
2 Dr. B P Gulliani Consultant and Prof - Head, Safdarjang Hospital, New Delhi
Ophthalmology
3 Prof. Kirti Singh Head - Glaucoma Gurunanak Eye Center, New
Delhi.
4 Dr. Biju John Addl. Professor – Regional Institute of
Ophthalmology Department Ophthalmology, Trivandrum
5 Dr. Manoj Kumar Yadav Eye Specialist Dr. Ram Manohar Lohia
Hospital, New Delhi
INDUSTRY ASSOCIATION EXPERTS
1 Representatives from HLL- HITES
2 Representatives from IPC
3 Representatives from FICCI Association.
4 Representatives from MTAI Association.
5 Representatives from AIMED Association.
INTERNAL EXPERTS
1 Dr. S.B.Sinha Ex- Advisor - Healthcare NHSRC, New Delhi
Technologies
2 Er. Mohammed Ameel Senior Consultant- Healthcare NHSRC, New Delhi
Technologies
3 Er. Anjaney Consultant- Healthcare NHSRC, New Delhi
Technologies
4 Er. Ajai Basil Consultant- Healthcare NHSRC, New Delhi
Technologies
5 Er. P.S.Vigneshwaran Consultant- Healthcare NHSRC, New Delhi
Technologies
6 Er.Bharat Bhushan Consultant- Healthcare NHSRC, New Delhi
Technologies
7 Er. Pawan Kumar Fellow- Healthcare NHSRC, New Delhi
Technologies
8 Er. Purnima Dhamija Fellow- Healthcare NHSRC, New Delhi
Technologies
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INTRODUCTION
Medical devices are a very important part of health care and their use is increasing by the day. Technical
specifications play an important role in identification, selection and procurement of appropriate and
cost effective medical devices. Consistency and standardization in technical specifications promotes
positive competition and reduces effective costs. It also promotes uniformity in user training and smooth
maintenance of equipment. In order to address the variation in technologies many of which could be
add-ons, separate exercises were undertaken for specific categories of medical devices procured under
National Health Mission. The experts consulted for specifications formulation exercises included
clinicians, medical technologists, maintenance experts and also representatives from manufactures’
industry associations/government organizations.
National Health Systems Resource Centre which is also a WHO collaborating centre for priority
medical devices & health technology policy; in consultation with experts has formulated technical
specifications for commonly used medical devices. Specifications are suggestive in nature and any
specific requirement needs to be incorporated at the time of procurement. While effort has been made
to make the specifications as generic as possible and consensus and technical appropriateness has been
the corner stone of this technical exercise.
In the consultative meeting experts has mentioned the following activities needs to be considered
wisely while procuring medical devices.
(1) The public health facility that intend to house medical devices (especially electrical/electronic
based) must ensure before installation ,
(a) Proper grounding at electrical sockets,
(b) Wherever generator or UPS or solar power is used as back up energy source, should ensure the
stabilizer/surge protector to prevent malfunction of medical devices. The same may be undertaken at
facilities having voltage/energy fluctuations.
(2) Procurer may form rate contract on reagents/consumables anticipating yearly demand, on Medical
devices which require periodic supply of reagents/consumables for its day to day operation.
(3) Appropriate filtering mechanism to be housed at public facility to ensure maximum longevity on
Medical devices which operates efficiently depending on quality of pneumatics/water supply source.
(4) Ensure compliance for Medical devices which are regulated under various laws/regulatory body like
CDSCO, AERB, Pollution control Board, PC PNDT, PESO etc.
(5) Procurer/public health facility must ensure scheduling calibration and preventive maintenance (incl.
replacement of parts that are expected to be worn out after certain operation) as recommended in
Medical device manufactures operational/service manual.
(6) Wherever necessary warning/safety information required, has to be placed at public health facilities.
(7) User/ In-house service training to be procured along with Medical devices for effective utilization.
(8) Public health facility may actively engage with MoHFW initiative, Post market surveillance
/Materiovigilance program of India.
(9) Public health facility have to rely on manpower availability or utilization or IPD/OPD load factor to
decide on quantity of medical devices to be procured and not just on number of bed at each level.
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CRYOSURGICAL UNITS, OPHTHALMIC (CO2 and N2O)
Version no. : Ver_1
Date: 19/08/2018
Done by: (Name. Institution) HCT/NHSRC
NAME, CATEGORY AND CODING
UMDNS name Cryosurgical Units, Ophthalmic
UMDNS code(s) 11068
GENERAL
1. USE
1.1 Clinical purpose Cryosurgical units designed for applying extreme cold to eye tissues to
destroy abnormal cells. These units usually consist of a hollow probe
(cryo probe) that circulates a cryogenic substance (e.g. liquid nitrogen)
to form an ice crystal ball around the cells, which freezes the cells of
the tissues with which it comes into contact. Ophthalmic cryosurgical
units are used mainly to treat eye tumors (e.g., retinoblastoma), to
relieve ingrown eyelashes (trachiasis), for cryo extraction of intra
capsular cataracts, and/or to repair retinal detachment.
1.2 Used by clinical Ophthalmology - Operating theater, Operating room.
department/ward
TECHNICAL
2. TECHNICAL CHARACTERISTICS
2.1 Technical characteristics 1. Cryogen shall be CO2 and N2O.
(specific to this type of 2. Cryosurgical unit capable of achieving temperatures at the
device) cryo tip below -79°C (-110.2°F) for CO2, -89°C (-128.2°F) for
N2O.
3. Should have Active and Passive defrosting system.
4. Cryosurgical procedures require several different probe
designs. Special probes are used based on the surgical
procedures. Cryosurgical units with multiple probe tips can
enable physicians to perform a number of specialized
procedures. Should be supplied with all kinds of probes
required for ophthalmology and all cryo probes must be
autoclavable.
5. Operating pressure 400 to 850 psi.
6. The unit shall have a trigger mechanism to control the
freeze/thaw cycle (active defrost preferred but not essential),
removable circular, closed design cryo tips with flat surfaces
or with a cone extrusion not exceeding 5 mm, insulated cryo
shaft of length 170 mm to 200 mm, hose assembly (high
pressure) with cylinder connector, pressure gauge and relief
valve, and exhaust port to which a hose can be connected to
safely vent the exhaust gas.
7. Due to the adverse effects of chronic exposure to waste
anesthetic gases, nitrous oxide units should have scavenging
ability.
2.2 User's interface Manual
2.3 Software and/ or standard NA
of communication(where
ever required
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3. PHYSICAL CHARACTERISTICS
3.1 Dimensions(metric) NA
3.2 Weight (lbs, kg) NA
3.3 Noise (in dBA) NA
3.4 Heat dissipation NA
3.5 Mobility, portability Portable

4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ….)
4.1 Power requirements NA
4.2 Battery operated NA
4.3 Protection NA
4.4 Power consumption NA
5. ACCESSORIES, SPARE PARTS, CONSUMABLES
5.1 Accessories, (mandatory, 1. Cryo probes to according the specific use (Preferably 3 sizes
standard, optional); (1.5 mm, 2 mm, 3 mm)).
Spare parts (main ones); 2. Integral timer and temperature indicator.
Consumables/reagents 3. Should be supplied with rolling cart.
(open, closed system) 4. Should be supplied with unfilled cylinder for N2O or CO2.
BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS
6. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS
6.1 Atmosphere/Ambience 1. Operating Condition: Capable of operating continuously in
(air conditioning, ambient temperature of 5 to 40 deg C and relative humidity of
humidity, dust …) 15 to 90% in ideal circumstances.
6.2 User's care, Cleaning, 1. Disinfection: Parts of the Device that are designed to come
Disinfection & Sterility into contact with the patient or the operator should either be
issues capable of easy disinfection or be protected by a single use/
sterile disposable cover.
2. Sterilization required.
7. STANDARDS AND SAFETY
7.1 Certificates (pre-market, Should be US FDA/CE/BIS/CDSCO/ approved (USFDA/CE
sanitary,..); Performance requirements will be applicable only when the Indian standards
and safety standards like BIS/CDSCO are not available.)
(specific to the device 1. Manufacturer should have ISO 13485 certification for quality
type); Local and/or standards.
international
8. TRAINING AND INSTALLATION
8.1 Pre- installation Availability of 5 Amp/15 Amp. Electrical Socket.
requirements:
nature, values, quality,
tolerance
8.2 Requirements for sign-off Manufacturer and authorized supplier to perform installation, safety
and operation checks before handover.
Local clinical staff to affirm completion of installation.
8.3 Training of staff (medical, Training of users in operation and basic maintenance shall be provided.
paramedical, technicians) Advanced maintenance tasks required shall be documented.
9. WARRANTY AND MAINTENANCE
9.1 Warranty 3 years, including for all spares and calibration work.
10. DOCUMENTATION
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10. Operating manuals, set Should provide 2 sets(hard copy and soft copy) of:
1 manuals, other manuals 1. User, technical and maintenance manuals should be supplied in
English/Hindi/Regional language along with machine diagrams;
2. List of equipment and procedures required for local calibration and
routine maintenance;
3. Service and operation manuals(original and Copy) to be provided;
4. Advanced maintenance tasks documentation;
5. Certificate of calibration and inspection,
6. Satisfactory certificate for any existing installation from government
hospital.
10. Other accompanying List of essential spares and accessories, with their part number and
2 documents cost;
11. Notes
11. Service Support Contact Contact details of manufacturer, supplier and local service agent to be
1 details (Hierarchy Wise; provided;
including a toll Any Contract(AMC/CMC/add-hoc) to be declared by the manufacturer.
free/landline number)
11. Recommendations or Any warning sign would be adequately displayed.
2 warnings
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CRYOSURGICAL UNITS, OPHTHALMIC (LIQUID
NITROGEN)
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Cryosurgical Units, Ophthalmic
UMDNS code(s) 11068
GENERAL
1. USE
1.1 Clinical purpose Cryosurgical units designed for applying extreme cold to eye tissues to
destroy abnormal cells. These units usually consist of a hollow probe
(cryo probe) that circulates a cryogenic substance (e.g. liquid nitrogen)
to form an ice crystal ball around the cells, which freezes the cells of
the tissues with which it comes into contact. Ophthalmic cryosurgical
units are used mainly to treat eye tumors (e.g., retinoblastoma), to
relieve ingrown eyelashes (trachiasis), for cryo extraction of intra
capsular cataracts, and/or to repair retinal detachment.
1.2 Used by clinical Ophthalmology - Operating theater, Operating room.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Cryogen shall be Liquid Nitrogen.
(specific to this type of 2. Cryosurgical unit capable of achieving temperatures at the
device) cryo tip below --196°C (-320.8°F).
3. Should have Active and Passive defrosting system.
4. Cryosurgical procedures require several different probe
designs. Special probes are used based on the surgical
procedures. Cryosurgical units with multiple probe tips can
enable physicians to perform a number of specialized
procedures. Should be supplied with all kinds of probes
required for ophthalmology and all cryo probes must be
autoclavable.
5. Operating pressure 400 to 850 psi.
6. The unit shall have a trigger mechanism to control the
freeze/thaw cycle (active defrost preferred but not essential),
removable circular, closed design cryo tips with flat surfaces
or with a cone extrusion not exceeding 5 mm, insulated cryo
shaft of length 170 mm to 200 mm, hose assembly (high
pressure) with cylinder connector, pressure gauge and relief
valve, and exhaust port to which a hose can be connected to
safely vent the exhaust gas.
2.3 Software and/ or NA
standard of
communication(where
ever required
6|Page

4.3 Protection NA
5.1 Accessories, (mandatory, 1. Cryo probes to according the specific use (Preferably 3 sizes
standard, optional); (1.5 mm, 2 mm, 3 mm)).
Spare parts (main ones); 2. Integral timer and temperature indicator.
Consumables/reagents 3. Should be supplied with rolling cart.
(open, closed system) 4. Should be supplied with unfilled cylinder for N2O or CO2.
7.1 Certificates (pre-market, 1. Should be US FDA/CE/BIS/CDSCO/ approved (USFDA/CE
sanitary,..); Performance requirements will be applicable only when the Indian
and safety standards standards like BIS/CDSCO are not available.)
international
requirements:
tolerance
8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before
handover. Local clinical staff to affirm completion of installation.
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10. DOCUMENTATION
10.1 Operating manuals, set Should provide 2 sets(hard copy and soft copy) of:
manuals, other manuals 1. User, technical and maintenance manuals should be supplied in
hospital.
10.2 Other accompanying List of essential spares and accessories, with their part number and
documents cost;
11. Notes
11.1 Service Support Contact Contact details of manufacturer, supplier and local service agent to be
details (Hierarchy Wise; provided; Any Contract (AMC/CMC/add-hoc) to be declared by the
including a toll manufacturer.
11.2 Recommendations or Any warning sign would be adequately displayed.
warnings
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OPHTHALMOSCOPE – DIRECT
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Ophthalmoscopes, Direct
UMDNS code(s) 12817
GENERAL
1. USE
1.1 Clinical purpose Handheld ophthalmoscopes designed for examining the eye (mostly
the back of the eye, the fundus) by providing a non inverted image of
the eye. The instruments usually consist of a light source to project the
light into the eye through the pupil, a mirror, and a wheel of lenses of
varying strength to provide a magnified view of the eye and to adjust
the focus of the view. They produce an upright, or un reversed,
magnified image of the eye, at approximately 15 times magnification.
Direct ophthalmoscopes are used mainly to detect eye conditions or
eye diseases.
1.2 Used by clinical Ophthalmology Department
department/ward
TECHNICAL
2.1 Technical characteristics 1. Available with LED/Halogen light source.
(specific to this type of 2. Magnification up to x15 from direct vision to maximum
device) magnification.
3. Red-free, blue and polarization filters and Anti-reflection lens.
4. Should have small and large spot sizes, fixation targets, slit aperture,
hemi-spot and cobalt blue filter.
5. Should be rechargeable battery with Charger / battery/ mains
operated.
6. At least 3 apertures and fixation star.
7. Range of lenses not smaller than -30D to +20D with steps not greater
than 1D.
8. Dust free sealed optics and aspherical optical system.
standard of
communication(where
ever required
3.5 Mobility, portability Supplied in protective case for clean storage and safe transport.
4.1 Power requirements 220 to 240V, 50 Hz
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4.2 Battery operated Internal batteries, rechargeable preferred compatible with both 2.5 V
and 3.5 V batteries or handles provided; Led display indicating the
charging status.
4.3 Protection Yes
4.4 Power consumption To be specified by Vendor
5.1 Accessories, (mandatory, a. Bulb – 2 nos
standard, optional);
Spare parts (main ones);
Consumables/reagents
(open, closed system)
international 3. ISO 10942:2006 Ophthalmic instruments -- Direct
ophthalmoscopes.
requirements:
tolerance
8.2 Requirements for sign-off i. Supplier to perform installation, safety and operation
checks before handover.
ii. Local clinical staff to affirm completion of installation.
10. DOCUMENTATION
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hospital.
documents cost;
11. Notes
details (Hierarchy Wise; provided;
warnings
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OPHTHALMOSCOPE – INDIRECT
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Ophthalmoscopes, Indirect
UMDNS code(s) 12818
GENERAL
1. USE
1.1 Clinical purpose Head-worn ophthalmoscopes designed for examining the eye (mostly
the back of the eye, the fundus) by providing an inverted image of the
fundus. These instruments usually consist of a light source attached to
a headband to project the light into the eye through the pupil and a
converging lens placed in front of the patient's eye. They produce an
inverted, or reversed, image of 2 to 5 times magnification of the entire
retina, a field of view much larger than that of direct ophthalmoscopes.
Indirect ophthalmoscopes are used mainly to detect eye conditions or
eye diseases.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Available with LED/Halogen light source. (Desirably LED).
(specific to this type of 2. Magnification up to x5.
device) 3. Red-free, blue and polarization filters.
4. Should have stereo optical system with small pupil feature.
5. Should have synchronized adjustment of convergence parallax.
standard of
communication(where
ever required
4.1 Power requirements 220 to 240V, 50 Hz
4.2 Battery operated Internal batteries, rechargeable preferred compatible with both 2.5 V
and 3.5 V batteries or handles provided; Led display indicating the
charging status.
4.3 Protection Yes
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5.1 Accessories, (mandatory, a. Three pencils,
standard, optional); b. Fundus chart,
Spare parts (main ones); c. Sclera depressor,
Consumables/reagents d. 20D condensing lens with anti reflecting coating.
(open, closed system) e. Bulb – 2 nos, Bulb holder, Bulb cover.

international 3. ISO 10942:2006 Ophthalmic instruments -- Direct
ophthalmoscopes.
requirements:
tolerance
handover.
10. DOCUMENTATION
hospital.
documents cost;
11. Notes
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warnings
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SLIT LAMP
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Slit Lamp
UMDNS code(s) 12281
GENERAL
1. USE
1.1 Clinical purpose Ophthalmic diagnostic instruments designed for examining the eye
(mostly the anterior part of the eye) using an illumination system
combined with a binocular microscope. The instruments usually consist
of illumination sources with a mechanism that provides a slit beam of
light into the eye with different types of illumination (e.g., direct or
indirect, focal or diffuse, background illumination), a binocular
microscope for viewing the magnified slit image, and a control
component for adjusting the focus of the microscope and the slit (e.g.,
slit rotation, slit width); some also have refraction mirrors to direct
light to a camera mounted above the microscope. Slit lamps provide a
magnified view of eye structures (e.g., eyelid, sclera, iris, crystalline
lens and cornea); some instruments can also examine the retina using
specific lenses. Slit lamps are used mainly in the diagnosis of eye
conditions.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Should have LED with adjustable and good illumination.
(specific to this type of 2. Should have facility for applanation tono meter if required.
device) 3. Type of microscope: Binocular
4. Should have 3 step magnification and total magnification is
grater than 10x.
5. Should have slit width ≥ 0-10 mm, adjustable.
6. Should have slit length ≥ 0-10 mm, adjustable.
7. Should have standard filters: Minimum: blue, green (red-
free), heat absorption. A broader selection of filters increases
the functionality of the slit lamp.
8. Rotation is between 0-180°.
9. Should be supplied with motorized table.
10. Should have a longitudinal movement of at least 90mm
11. Should have a lateral movement of at least 95mm.
12. Should have a vertical movement of at least 30mm.
13. Should have a chin rest vertical movement of at least 55mm.

standard of
communication(where
ever required
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3.3 Noise (in dBA) <50 dB
3.5 Mobility, portability NA

4.1 Power requirements Should operate from 200 to 240Vac, 50 Hz input supply.
4.2 Battery operated Should be supplied with suitable online UPS with at least half an hour
backup.
4.3 Protection Yes
5.1 Accessories, (mandatory, 1. Focusing Test rod & dust cover;
standard, optional); 2. Slit lamp dust cover,
Spare parts (main ones); 3. Rack, manual and motorized guard,
Consumables/reagents 4. 90D/70D Lens

6.1 Atmosphere/Ambience 1 .Operating Condition: Capable of operating continuously in ambient
(air conditioning, temperature of 5 to 40 deg C and relative humidity of 15 to 90% in
humidity, dust …) ideal circumstances.
6.2 User's care, Cleaning, 1. Disinfection: Parts of the Device that are designed to come into
Disinfection & Sterility contact with the patient or the operator should either be capable of
issues easy disinfection or be protected by a single use/ sterile disposable
cover.
7.1 Certificates (pre-market, 1. Should be US FDA/CE/BIS/CDSCO approved (USFDA/CE
international 3. Electrical safety conforms to the standards for electrical safety
IEC 60601-1-General requirements (or equivalent BIS
Standard).

8.1 Pre- installation NA
requirements:
tolerance
handover.
10. DOCUMENTATION
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hospital.
documents cost;
11. Notes
warnings
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RETINOSCOPE
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Retinoscopes
UMDNS code(s) 23679
GENERAL
1. USE
1.1 Clinical purpose Retinoscopy is a technique to obtain an objective measurement of the
refractive error of a patient's eyes. The examiner uses a retinoscope to
shine light into the patient's eye and observes the reflection (reflex) off
the patient's retina.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Available with LED light source.
(specific to this type of 2. Should be interchangeable to plane mirror and concave mirror mode
device) by sleeve movement
3. Should have an external focusing sleeve which is easy to grip.
4. Should have crossed-linear polarizing filter.
5. Should allow one-hand operation for streak focus.
6. Available with 360º streak rotation.
7. Should have 100% dust proof housing and multi-coated optics.
2.3 Software and/ or In built
standard of
communication(where
ever required
3.3 Noise (in dBA) <50 dB
3.4 Heat dissipation NA.
4.1 Power requirements Should operate from 200 to 240Vac, 50 Hz input supply.
4.2 Battery operated Yes, Should be rechargeable battery with Charger.
4.3 Protection Yes
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5.1 Accessories, (mandatory, 1. Should have a carrying case.
standard, optional); 2. Bulb – 2 nos
Spare parts (main ones); 3. Rechargeable battery – 1 no
Standard).

8.1 Pre- installation NA
requirements:
tolerance
handover.
10. DOCUMENTATION
hospital.
documents cost;
11. Notes
Any Contract(AMC/CMC/add-hoc) to be declared by the manufacturer.
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including a toll

warnings
OPHTHALMIC LASERS - PHOTOCOAGULATING

(ARGON, DYE, KRYPTON AND FREQUENCY-DOUBLED ND:YAG)
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Lasers, Nd:YAG, Frequency-Doubled, Ophthalmic
UMDNS code(s) 18217
GENERAL
1. USE
1.1 Clinical purpose Nd:YAG frequency-doubled lasers, usually operated in pulsed
modes, used to coagulate abnormal vascular tissue in the retina and
other photocoagulation procedures in the eye. They are typically
coupled to a bio microscope slit lamp or an indirect
ophthalmoscope.
department/ward
TECHNICAL
2.1 Technical characteristics BEAM CHARACTERISTICS:
(specific to this type of 1. Should have treatment laser type Argon, Dye, Krypton, and
device) Frequency-Doubled Nd: YAG.
2. Principal wavelengths shall be 530-540 nm.
3. Delivered power of different lasers shall be as
i. Argon blue-green 3 W,
ii. Argon green 1 W,
iii. Dye 1 W,
iv. Krypton green 1.5 W,
v. Krypton yellow 1.5 W,
vi. Krypton red 1 W,
vii. Nd: YAG 1 W.
4. Delivery Mode - Single, repeat.
5. The amount of time the patient is exposed to activated laser
energy shall be 0.01-2 Sec.
6. Repeat time shall be 0.1-2 Sec
7. Spot diameter @ retina shall be 50-1,000µm
AIMING BEAM:
1. Wavelength shall be 630 nm
2. Power shall be <1 mW.
DELIVERY SYSTEM TYPE:
1. Slit lamp is required.
2. Intraocular probe is required.
3. Hand piece(s) is required.
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2.3 Software and/ or standard As Applicable
ever required
3.3 Noise (in dBA) Noise-free system
3.4 Heat dissipation Should maintain nominal temp and the heat should be disbursed
through a cooling mechanism
3.5 Mobility, portability Stationary.
4.1 Power requirements Electrical Requirement : 200-230 VAC 50/60 Hz single phase
4.2 Battery operated Online UPS shall be Provided
4.3 Protection Stabilizer to be provided
4.4 Power consumption To be specified by vendor.
5.1 Accessories, (mandatory, Dust covers- 1
standard, optional); Allen Key - 1 set
Spare parts (main ones); spare bulb - 2 Nos
Consumables/reagents Should be supplied with motorized table
(open, closed system) Should provide protective goggles to be exclusive for ND-Yag Laser
iridotomy and capsulotomy lens,(2 each)
Appropriate UPS backup
2. Storage condition: Capable of being stored continuously in ambient
temperature of 0 to 40 deg C and relative humidity of 15 to 90%
6.2 User's care, Cleaning, Sterilization not required.
Disinfection & Sterility
issues
Standard).

8.1 Pre- installation requirements: Availability of 5 Amp/15 Amp. Electrical Socket.
nature, values, quality, tolerance
handover.
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10. DOCUMENTATION
English/Hind/Regional language along with machine diagrams;
hospital.
documents cost;
11. Notes
warnings
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OPHTHALMIC LASERS - PHOTO DISRUPTING
(Q-SWITCHED ND:YAG)
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Lasers, Nd:YAG, Ophthalmic
UMDNS code(s) 16947
GENERAL
1. USE
1.1 Clinical purpose Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) lasers,
usually Q-switched, used to cause a photo disruptive effect in the
eye (e.g., posterior capsulotomy), forming a plasma and generating
immense localized mechanical shock waves (micro explosions) that,
when highly focused, can destroy tissue. These lasers have built-in
slit-lamp bio microscopes or are coupled to a slit-lamp or indirect
ophthalmoscope by fixed mirrors.
department/ward
TECHNICAL
2.1 Technical characteristics 1.BEAM CHARACTERISTICS:
(specific to this type of i. Operating mode: Q-switched
device) ii. Mode structure: Fundamental
iii. Energy range: Single pulse, 0.3-10mJ
iv. Pulse width shall be 4 n sec
v. Burst shall be 1-3 pulses/burst
vi. Repetition rate
a. Single pulse shall be 1-2 Hz
b. Burst shall be 1 Hz.
vii. Spot size shall be 10 µm
viii. Cone angle shall be 16 deg
2. AIMING BEAM:
i. Type: Dual Laser
ii. It should have variable intensity
3. COMPATIBLE SLIT LAMP
i. Magnification shall be ≤25x
ii. Working distance shall be 100 mm
4. DISPLAYS/CONTROLS
i. Selected energy is required
ii. Shot selection is required
iii. Power output is required
iv. Shot counter is required
5. Calibration method shall be automatic.
6. COOLING REQUIREMENTS: Air
ever required
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5.1 Accessories, (mandatory, i. Contact lens
standard, optional); ii. TV, 35 mm adapter
Spare parts (main ones); iii. Head restraint
iv. Tonometer
v. Dust covers- 1
vi. Allen Key - 1 set
vii. Spare bulb - 2 Nos

2. Storage condition: Capable of being stored continuously in
ambient temperature of 0 to 40 deg C and relative humidity of
15 to 90%.

issues
Standard).

requirements:
tolerance
handover.
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8.3 Training of staff (medical, Training of users in operation and basic maintenanc shall be provided.
9.1 Warranty 3 years, including all spares and caliberation.
10. DOCUMENTATION
english/Hindi language along with machine diagrams;
4. Advanced maintenance tasks documntation;
hospial.
documents cost;
11. Notes
warnings
25 | P a g e
PHOTOABLATING OPHTHALMIC LASERS
(EXCIMER OPHTHALMIC LASERS)
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Lasers, Excimer, Ophthalmic
UMDNS code(s) 17702
GENERAL
1. USE
1.1 Clinical purpose Excimer lasers, usually Q-switched, used for corneal ablation (i.e.,
photorefractive keratectomy) and other ophthalmologic procedures
(e.g., surgical creation of a communication between the lacrimal sac
and the nasal cavity). A typical system incorporates a patient table,
physician's chair, and computer system. Some systems have built-in
slit lamps.
department/ward
TECHNICAL
2.1 Technical characteristics 1. BEAM CHARACTERISTICS:
(specific to this type of i. Wave length shall be 193 nm
device) ii. Power output at tissue shall be 0-3 W
iii. Energy should be 10 mJ/pulse
iv. Energy density shall be 150-200 mJ/cm²
v. Delivery modes shall be Continuous, pulsed
vi. Beam diameter shall be 1-5mm
vii. Pulse repetition frequency shall be 10-200 Hz
viii. Pulse width should be 10-15 nsec
2. AIMING BEAM:
i. Wave length shall be 630 nm
3. COMPATIBLE SLIT LAMP
iii. Magnification shall be ≤25x
iv. Working distance shall be 100 mm
4. DISPLAYS/CONTROLS
i. Selected energy is required
ii. Shot selection is required
iii. Power output is required
iv. Shot counter is required
5. Calibration method shall be automatic.
6. Cooling Requirements: Air
7. Computer system is required with optimal configuration.
8. Type of Laser Gas Cylinders Halogen gas

ever required
26 | P a g e
5.1 Accessories, (mandatory, 1. Contact lens
standard, optional); 2. Head restraint
Spare parts (main ones); 3. Dust covers- 1
4. Allen Key - 1 set
5. Spare bulb - 2 Nos

15 to 90%.

issues
7.1 Certificates (pre-market, i. Should be US FDA/CE/BIS/CDSCO approved (USFDA/CE
(specific to the device ii. Manufacturer should have ISO 13485 certification for
type); Local and/or quality standards.
international iii. Electrical safety conforms to the standards for electrical
safety IEC 60601-1-General requirements (or equivalent
BIS Standard).

requirements:
tolerance
handover.
8.3 Training of staff (medical, Training of users in operation and basic maintenanc shall be provided.
27 | P a g e
9.1 Warranty 3 years, including all spares and caliberation.
10. DOCUMENTATION
english/Hindi language along with machine diagrams;
4. Advanced maintenance tasks documntation;
hospial.
documents cost;
11. Notes
warnings
28 | P a g e
KERATO METER - MANUAL
Version no. : Ver_1
Date: 19/08/2018
Done by : (name. institution) HCT/NHSRC
UMDNS name Ophthalmometers
UMDNS code(s) 12811
GENERAL
1. USE
1.1 Clinical purpose Ophthalmic measuring instruments designed for objectively
determining the curvature of the anterior corneal surface and the
refraction of the eye (e.g., diopter, cylinder axis) by projecting
illuminated images onto the patient's cornea. The instruments usually
consist of light sources, a pair of objects to be projected onto the
cornea, a telescope with prisms and lenses for reflecting and observing
images, a device for adjusting the positions of the reflected images,
and the software appropriate to calculate the corneal curvature and
the refractive power. Ophthalmometers are used mainly for pre
assessment for refractive corneal surgery and for contact lens fitting.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Should have (15x / 10x) eye piece.
(specific to this type of 2. Should measure corneal refractive power measuring range
device) from 36 to 52 D in steps of 0.25D steps.
3. Should measure corneal radius of curvature measuring range
from 6.5 to 9.4 mm in steps of 0.05mm.
4. Should have high accuracy of measurements.
5. Should have dust cover and spare bulb.
6. Should be supplied with motorized table.
7. Should have well illuminated circular mires with + sign.
2.3 Software and/ or Inbuilt
standard of
communication(where
ever required

4.2 Battery operated No
4.3 Protection NA
29 | P a g e
4.4 Power consumption To be specified by service provider

5.1 Accessories, (mandatory, 1. Lamp (12v 10w): 5 No
standard, optional); 2. Calibrating Device – 1 No
15 to 90%
issues
international

requirements:
tolerance
handover.
10. DOCUMENTATION
hospital.
30 | P a g e
documents cost;
11. Notes
warnings
31 | P a g e
AUTO REFRACTOMETER
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Refractometers
UMDNS code(s) 15169
GENERAL
1. USE
1.1 Clinical purpose Measuring instruments used to determine the ratio of the velocity of
light in a vacuum to the velocity of light in another medium (i.e., index
of refraction).
department/ward
TECHNICAL
2.1 Technical characteristics 1. Should have in the system.
(specific to this type of 2. Should have refractive measurement sphere from -25 to
device) +22D in steps of 0.25D.
3. Should have refractive measurement cylinder from -10 to
+10D in steps of 0.25D.
4. Should have refractive measurement axis angle from 1 to 180º
in steps of 1º.
5. Should have at least 0, 12 and 13.5 vertex distance.
6. Should measure a minimum pupil diameter of 2.5mm.
7. Should have at least 5 inches LCD/LED display.
8. Should have vertically adjustable chin rest of at least ±25mm.
9. Should have motorized table.
standard of
communication(where
ever required

4.1 Power requirements Electrical Requirement : 200-230 VAC 50/60 Hz
4.3 Protection NA
32 | P a g e
5.1 Accessories, (mandatory, Calibrating Device – 1 No.
15 to 90%
issues
and safety standards standards like BIS/CDSCO / is not available.)
international
requirements:
tolerance
handover.
10. DOCUMENTATION
hospital.
documents cost;
11. Notes
33 | P a g e
warnings
APPLANATION TONOMETER
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Ophthalmic Tono meters, Applanation
UMDNS code(s) 10168
GENERAL
1. USE
1.1 Clinical purpose Ophthalmic tono meters designed to determine intraocular pressure
by measuring the force required to flatten the cornea apex by a fixed
amount. These instruments are typically small and reusable
instruments and are attached to a slit lamp; the tono meter includes a
tip to be applied to the cornea and a manually controlled spring that
applies a variable force on the cornea through the tip.
department/ward
TECHNICAL
2.1 Technical characteristics 1. Range of Measurement 0-80 mmHg
(specific to this type of 2. Movement of Light Circle 1.53 x 2 = 3.06mm
device) 3. Prism Diameter 7mm
4. Prism Range of Movement 3mm
5. Should be compatible with all models of slit lamps.
standard of
communication(where
ever required
3.3 Noise (in dBA) Noise Free System
3.4 Heat dissipation Should maintain nominal temperature and the heat should disbursed
through a cooling mechanism.
4.3 Protection NA
34 | P a g e
5.1 Accessories, (mandatory, 1. Calibration Bar,
standard, optional); 2. Prism
Spare parts (main ones); 3. Tonometer Mount base to fix with optics.
2. Storage condition: Capable of being stored continuously in ambient
issues
and safety standards standards like BIS/CDSCO / is not available.)
international
requirements:
tolerance
handover.
10. DOCUMENTATION
hospital.
documents cost;
11. Notes
warnings
35 | P a g e
PHACOMACHINE
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Phaco emulsification Units, Cataract Extraction
UMDNS code(s) 17596
GENERAL
1. USE
1.1 Clinical purpose Ophthalmic surgery units designed for removal of cataractous lenses
by the insertion of a probe that cuts and emulsifies the lenses using
ultrasonic waves (phacoemulsification). These units consist of a hollow
probe (i.e., a phaco probe) that includes an irrigation sleeve, an
oscillating tip that converts electric energy into ultrasonic waves, and a
channel for aspiration of lens fragments; the units also include a
vacuum pump and controls for the output levels, irrigation rate, and
mode of operation. Phacoemulsification units are used in ophthalmic
offices for cataract extraction surgery.
department/ward
TECHNICAL
2.1 Technical characteristics 1. OPERATIONAL MODES:
(specific to this type of i. System should have following operation modes:
device) Irrigation, Ultrasound, Irrigation/Aspiration (I/A) system,
Diathermy and Vitrectomy.
2. ULTRA SOUND SYSTEM:
i. Hand Piece type: Piezoelectric, made up of Titanium.
ii. Frequency: 25-80 kHz.
iii. It should be autoclavable.
3. IRRIGATION/ASPIRATION (I/A)SYSTEM:
i. System should have dual pump (Peristaltic and
Venturi) user can switch between the two pumps
during surgery with Max. Vacuum (peristaltic: 500
mmHg) with 1 mmHg pump increment.
ii. Reflux method: Gravity / Pump reversal.
iii. Tubing shall be re usable.
iv. I/A Hand pieces shall be autoclavable with port
diameter of 0.2-0.5 mm.
v. Collection container size shall be 1-60 cc.
4. ANTERIOR VITRECTOMY:
i. Guillotine type hand piece with variable speed shall
be preferred.
ii. Hand piece shall be re usable and autoclavable.
iii. Control Panel or linear cut rate control by foot pedal.

2.3 Software and/ or As Applicable.
standard of
communication(where
ever required
36 | P a g e
4.1 Power requirements Electrical Requirement : 200-230 VAC 50/60 Hz.
4.2 Battery operated An UPS with 30 minutes back up shall be provided.
4.3 Protection Stabilizer to be provided.
5.1 Accessories, (mandatory, 1. Phaco hand piece – 1no
standard, optional); 2. Phaco tips -4 nos
Spare parts (main ones); 3. Anterior vitrectomy packs including cutters and other
Consumables/reagents disposables – 25 nos
(open, closed system) 4. Cassettes and disposables – 12 nos.
15 to 90%
6.2 User's care, Cleaning, Sterilization is required for hand piece, tips and forceps.
issues
Standard).
requirements:
tolerance
10. DOCUMENTATION
37 | P a g e
hospital.
documents cost;
11. Notes
warnings
38 | P a g e
MICROSURGERY SET - CATARACT
Version no. : Ver_1
Date: 19/08/2018
Done by : (name.institution) HCT/NHSRC
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
1.1 Clinical purpose Set of instruments which are used for cataract surgeries.
Used by clinical Ophthalmology Department
1.2
department/ward
TECHNICAL
List of instruments 1. Barraquer wire speculum, Large
2. Suture tying forceps curved
3. MC Pherson forceps
4. MC Pherson Corneal Forceps, 1X2 teeth
5. Sup. Rectus Forceps
6. Castroviejo Corneal Scissors, Universal
7. VannasCapsulotony Scissors, Angled
8. Barraquer Needle Holder, Microjous W/o Lock
2.1 9. Simcoe I/A Cannula, Direct
10. BP Handle – 11 no blade
11. Sinkey 11 lens Manipulating Hook
12. Phaco Chopper
13. Iris Repositor
14. Utrata Forceps
15. Sterilization Box
16. Tenotomy Scissors
17. Steel Bowl
2.2 User's interface NA
Software and/ or NA
standard of
2.3
communication(where
ever required
3.5 Mobility, portability Supplied in protective SS case for clean storage and safe transport.
4.3 Protection NA
39 | P a g e
Accessories, (mandatory, MVR 2.8, 3.2
standard, optional); Blade 11,15.
5.1 Spare parts (main ones);
Atmosphere/Ambience Operating Condition: Capable of operating continuously in ambient
6.1 humidity, dust …) ideal circumstances.
Storage condition: Capable of being stored continuously in ambient
User's care, Cleaning, 1. Disinfection: Parts of the Device that are designed to come into
6.2 issues easy disinfection or be protected by a single use/sterile disposable
cover.
Certificates (pre-market, Should be US FDA/CE/BIS/CDSCO approved (USFDA/CE requirements
sanitary,..); Performance will be applicable only when the Indian standards like BIS/CDSCO are
and safety standards not available.)
(specific to the device Manufacturer should have ISO 13485 certification for quality
7.1 type); Local and/or standards.
international The surgical instruments should be made using top quality medical
grade hardened stainless steel with defined specifications like AISI-410,
AISI-420, AISI-304, AISI-303, AISI- 440 etc. using guidelines of ASTM
standard F899-94 and ISO 7153 and with a dull finish.
Pre- installation NA
requirements:
8.1
tolerance
8.2 Requirements for sign-off NA
Training of staff (medical, Training of users in operation and basic maintenance shall be provided.
8.3
9.1 Warranty 3 years
10. DOCUMENTATION
Operating manuals, set Should provide 2 sets(hard copy and soft copy) of:
manuals, other manuals 1. User, technical and maintenance manuals should be supplied
in English/Hindi/Regional language along with machine
diagrams;
2. List of equipment and procedures required for local
calibration and routine maintenance;
10.1
3. Service and operation manuals(original and Copy) to be
provided;
6. Satisfactory certificate for any existing installation from
government hospital.
Other accompanying List of essential spares and accessories, with their part number and
10.2
documents cost;
11. Notes
40 | P a g e
Service Support Contact Contact details of manufacturer, supplier and local service agent to be
11.1
MICROSURGERY LID SET

Version no. : Ver_1
Date: 19/08/2018
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
1.1 Clinical purpose

1.2
department/ward
TECHNICAL
List of instruments 1. Desmarres Lid Retractor, Size 0
2. Jaeger Lid Plate
3. Fixation Hook, 2.0X1.5m, Small
4. Graefe Muscle Hook, Size 3.
5. Meyerhoefer Chalazion Curette, Size 2.
6. St. Martin Suturing Forceps 1X2 teeth
7. Fixation forceps, 1X2 teeth
8. Beer Cilia, Forceps
9. Berke Ptosis Forceps 20 mm
10. Snellen entropium Forceps, Left, Small
2.1
11. Snellen entropium Forceps, Right, Small
12. Mc Pherson Tying Forceps, Long Handle
13. Westcott Stitch Scissors
14. Eye Scissors, Curved, 4 1/2" Length
15. Stevens Tenotomy Scissors, Curved
16. Barraquer N. Holder, Short model, M. Jaws, w/o Lock.
17. Bard Parker Handle # 3
18. Castroviejo Caliper, Straight
19. Fixation Forceps, 2x3 Teeth, Angular.
Corneal Scissors
Software and/ or NA
standard of
2.3
communication(where
ever required
41 | P a g e
4.3 Protection NA
Accessories, (mandatory, NA
Atmosphere/Ambience 1. Operating Condition: Capable of operating continuously in
6.1
15 to 90%
cover.
Certificates (pre-market, 1. Should be US FDA/CE/BIS/CDSCO approved (USFDA/CE
7.1
international 3. The surgical instruments should be made using top quality
medical grade hardened stainless steel with defined
specifications like AISI-410, AISI-420, AISI-304, AISI-303, AISI-
440 etc. using guidelines of ASTM standard F899-94 and ISO
7153 and with a dull finish.
requirements:
8.1
tolerance
8.3
10. DOCUMENTATION
10.1
diagrams;
42 | P a g e
provided;
10.2
documents cost;
11. Notes
11.1
Recommendations or Any warning sign would be adequately displayed.
11.2
warnings
43 | P a g e
FOREIGN BODY REMOVAL SET
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Spuds, Eye
UMDNS code(s) 16025
GENERAL
1. USE
Clinical purpose A slender, probe-like device that is used to grasp and extract
1.1 foreign bodies from superficial tissue of the eye with minimum
trauma to that tissue.
1.2
department/ward
TECHNICAL
List of instruments 1. Barraquer wire speculum, Big
2. Desmarres Lid retractor, size 2
3. Golf club foreign body spud.
4. Beer Cilia forceps.
2.1 5. Jewelers forceps, standard
6. Castroviejo lacrimal Dilator, double end
7. Lacrimal canmula, straight, 23 G
8. Sterilization box, complete
9. Sterilization Box

Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
44 | P a g e
6.1
15 to 90%
cover.
7.1
international 3. The surgical instruments should be made using top quality
medical grade hardened stainless steel with defined
specifications like AISI-410, AISI-420, AISI-304, AISI-303, AISI-
440 etc. using guidelines of ASTM standard F899-94 and ISO
7153 and with a dull finish.
requirements:
8.1
tolerance
8.3
10. DOCUMENTATION
diagrams;
10.1
provided;
10.2
documents cost;
11. Notes
11.1
45 | P a g e
VISUAL ACUITY DRUM
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Optokinetic Drums
UMDNS code(s) 16476
GENERAL
1. USE
Clinical purpose Diagnostic ophthalmic devices designed to elicit and evaluate
the regular, involuntary movement of the eyeball (i.e.,
nystagmus). The devices are typically drum-like cylinders
covered with uniform white and dark vertical stripes with a
1.1
handle. The rotation of the devices can induce optokinetic
nystagmus, and then the examiner observes the patient's
abnormal eye responses. Optokinetic drums are used to
diagnose a variety of visual problems.
1.2
department/ward
TECHNICAL
List of instruments 1. Four Sides - English, Hindi - C or Regional Language or 'E' Chart
with inbuilt illumination
2.1 2. Friend Test/Duochrome
3. Worths Four dots test

Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
46 | P a g e
6.1
15 to 90%
User's care, Cleaning, 1. Disinfection: Parts of the Device that are designed to come
6.2 issues capable of easy disinfection or be protected by a single
use/sterile disposable cover.
7.1
international
requirements:
8.1
tolerance
8.3
10. DOCUMENTATION
diagrams;
10.1
provided;
documents cost;
10.2
47 | P a g e
11. Notes
11.1
11.2
warnings
48 | P a g e
PERIMETER- AUTOMATED
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Ophthalmic Perimeters, Automated
UMDNS code(s) 16918
GENERAL
1. USE
1.1 Clinical purpose Ophthalmic perimeters that perform visual field assessment
with little operator involvement. Currently, automated
perimeters perform static perimetry, as well as simultaneous
monitoring of the fixation of the eye. These instruments project
targets at predetermined locations in the visual field for patient
detection, using one or more procedures for field evaluation
(i.e., threshold, supra threshold, threshold-related). Automated
perimeters include a stimuli source (projection devices, light-
emitting diodes) with automated background illumination and
computing capabilities for test programming and data
processing, recording, and display.
department/ward
TECHNICAL
2.1 Technical characteristics It should have following features:
(specific to this type of
device) 1.True Goldman Standard Perimeter with Integrated
Hemispherical Bowl of 30cm radius with Touch screen.
2. Stimulus Type-LED
3. Stimulus Size-Goldman III
4. Stimulus Intensity-0-318cd/m2/≤1000asb
5. Stimulus Duration-adjustable from 0.2 second to more
6. Stimulus Colour-White to White and Blue-onWhite
7. Fixation Control-Video eye monitor and HeijlKraakau Blind
Spot Monitor
8. Patient Positioning0Motorized Chin rest with adjustable
height and in depth adjustable head rest
9. Static Perimetry Programs- Glaucoma (Screening, Threshold,
Localization), Macula (Screening, Threshold, Localization),
User defined programs
10. Threshold Test Strategies-Fast Threshold, Full Threshold,
Supra Threshold
11. Kinetic Perimetry Strategy-Automated Goldman Standard
2.3 Software and/ or As Applicable.
standard of
communication(where
ever required
49 | P a g e
4.1 Power requirements Electrical Requirement : 200-230 VAC 50/60 Hz.
4.2 Battery operated An UPS with 30 minutes back up shall be provided.
4.3 Protection Stabilizer to be provided.
5.1 Accessories, (mandatory, Standard Accessories:
standard, optional); 1. PC with 40 GB Hard Drive, 512 MB
Spare parts (main ones); 2. RAM, CPU-750MHz
Consumables/reagents 3. Online UPS
(open, closed system) 4. Laser jet Compatible Printer
5. Response Button
6. Support for Correction Lenses and Full
7. set of Thin Rim Lenses
8. Opaque Eye Patch
9. Automated Table/Stand
10. Protective Cover
15 to 90%
6.2 User's care, Cleaning, Sterilization is required for hand piece, tips and forceps.
issues
Standard).
requirements:
tolerance
50 | P a g e
10. DOCUMENTATION
hospital.
documents cost;
11. Notes
warnings
51 | P a g e
BINOMAGS/ MAGNIFYING LOUPE
Version no. : Ver_1
Date: 19/08/2018
UMDNS name Loupes, Binocular
UMDNS code(s) 25585
GENERAL
1. USE
Clinical purpose Loupes designed to be worn close to the practitioner's eyes to
provide stereo-optic (i.e., binocular) visual magnification of the
patient during medical examinations or procedures. Binocular
loupes are fitted with two sets of lenses, each as small as 1/2
inches (12.7 mm) or less, that can be attached to headbands or
1.1 eyeglasses worn by the health practitioner. Adjustable
parameters include magnification, optics, working distance,
mounting options, and illumination. Optional lights can be
added to the binocular loupes. Binocular loupes are used by
specialists such as ophthalmologists, surgeons, dermatologists,
and dentists.
1.2
department/ward
TECHNICAL
List of instruments 1. Should have 2.5 x magnification.
2. Should made up of Plastic.
2.1 3. Atleast 40 mm x 40 mm x 45 mm dimension.
4. Head band Type

Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
52 | P a g e
6.1
15 to 90%
User's care, Cleaning, 3. Disinfection: Parts of the Device that are designed to come
6.2 issues capable of easy disinfection or be protected by a single
use/sterile disposable cover.
7.1
international
requirements:
8.1
tolerance
8.3
10. DOCUMENTATION
diagrams;
10.1
provided;
documents cost;
10.2
53 | P a g e
11. Notes
11.1
11.2
warnings
TRIAL FRAME SET ( ADULT AND CHILD)

Version no. : Ver_1
Date: 19/08/2018
UMDNS name Eyeglasses, Frames, Trial
UMDNS code(s) 34357
GENERAL
1. USE
Clinical purpose Devices designed to hold lenses in an appropriate position in
front of the eyes during an ophthalmic lens and frames trial
procedure. Trial frames include graduated arcs and a linear rule
to determine the lenses' angular positions and to measure the
interpupillary distance; the frames usually allow the installation
1.1
of several (e.g., 3) trial lenses simultaneously. Trial eyeglass
frames are used in examination procedures to determine the
lenses and eyeglass frame characteristics needed for a particular
user, including a good frame adjustment to the nose and ears
position.
1.2
department/ward
TECHNICAL
Technical characteristics 1. Horizontal and Vertical bridge adjustment.
(specific to this type of 2. Adjustable Saddle Bridge.
device) 3. Separate PD adjustment for each eye to compensate for
assymetrical factors in facial structure.
4. Individual adjustment for length and angle.
2.1 5. Adjustment for rotating cylinders to correct the axis.
6. Scale with large easy to read numerals.
7. The space for lens holder ensures accurate additive reading.
8. PD scale: 24 - 38 mm for both right and left.
9. Nose height adjustments :Movebaleupto 14.5 mm.
10. Temple length adjustment sit can be sided up to 37 mm (Approx.)

Software and/ or NA
standard of
2.3
communication(where
ever required
54 | P a g e
Mobility, portability Supplied in protective case for clean storage and safe transport.
3.5
4.3 Protection NA
Atmosphere/Ambience NA
6.1 (air conditioning,
humidity, dust …)
User's care, Cleaning, 1.Disinfection: Parts of the Device that are designed to come into
6.2
issues easy disinfection or be protected by a single use/disposable cover.

Certificates (pre-market, NA
sanitary,..); Performance
and safety standards
7.1
(specific to the device
type); Local and/or
international
requirements:
8.1
tolerance
Training of staff (medical, NA
8.3
paramedical, technicians)
Standards Manufacturer should have ISO 13485 certification for quality
9.1
standards.
10. DOCUMENTATION
Operating manuals, set NA
10.1
manuals, other manuals
Other accompanying NA
10.2
documents
11. Notes
55 | P a g e
details (Hierarchy Wise; provided;Any Contract(AMC/CMC/add-hoc) to be declared by the
11.1
including a toll manufacturer.
56 | P a g e
TRAIL LENS SET
Version no. : Ver_1
Date: 19/08/2018
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
1.1 Clinical purpose
1.2
department/ward
TECHNICAL
Technical characteristics 1. The lenses should be of 20 mm aperture fitted in aluminium mount
(specific to this type of of 38 mm diameter, anodized red/ gold for negative power and
device) black/silver for positive power.
2. The Sphere lenses with handle and cylinder without handle.
3. The trial lenses should be good quality, the case made of melamine
poished wood, sturdy and attractive finish.
4. Lenses - spheres + and -.
2.1
a. 0.25 to 4.0 in 0.25 steps.
b. 4.5 to 6.0 in 0.5 steps.
c. 7.0 to 14.0 in 1.0 steps.
d. 16.0 to 20.0 in 2.0 steps
e. 0.25 to 3.5 in 0.25 steps
f. 4.0 to 6.0 in 0.5 steps
g. Prisms 1/2, 1, 2,3,4,5,6,8,10,12.
Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
57 | P a g e
Accessories, (mandatory, a. Red Glass and Green Glass
standard, optional); b. pin hole
5.1 Spare parts (main ones); c. Slit
Consumables/reagents d. Two baack discs
(open, closed system) e. Cross Cylinder +/- 0.25 and +/- 0.5
humidity, dust …)
6.2

Standards 1. Manufacturer should have ISO 13485 certification for quality
7.1
standards.
requirements:
8.1
tolerance
8.3
9.1 Warranty NA
10. DOCUMENTATION
10.1
10.2
documents
11. Notes
11.1
Recommendations or Any warning sign would be adequaetly displayed.
11.2
warnings
58 | P a g e
Digital Visual Acuity Chart System
Version no. : Ver_1
Date: 19/08/2018
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
Clinical purpose A Snellen chart is an eye chart that can be used to measure visual
1.1
acuity.
1.2
department/ward
TECHNICAL
Technical characteristics 1. Vision testing by snellen vision chart at different distances.
(specific to this type of 2. C and E charts.
device) 3. Logmar Charts
4. Testing Contrast Sensitivity.
5. Pediatric Vision Testing.
6. Educational Charts.
2.1
7. Red and Green Charts.
8. Ishihara Charts
9. Testing Peripheral Vision.
10. Astigmatic fan.
11. Should have functions in different languages.
12. Wide LED monitor.
Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
59 | P a g e
humidity, dust …)
6.2

Standards 1. Manufacturer should have ISO 13485 certification for quality
7.1 standards.
requirements:
8.1
tolerance
8.3
9.1 Warranty NA
10. DOCUMENTATION
10.1
10.2
documents
11. Notes
11.1
11.2
warnings
60 | P a g e
NEAR VISION CHART
Version no. : Ver_1
Date: 19/08/2018
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
Clinical purpose A Near Vision chart is used to screen uncorrected near visual acuity at
1.1
25 cm
1.2
department/ward
TECHNICAL
Technical characteristics 1. Animal Picture Chart for preverbal children.
(specific to this type of 2. Self illuminated.
2.1 device) 3. English, Hindi, Regional language, illiterate E and C Chart.
4. Plates made from high quality non reflective plastic.

Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
Accessories, (mandatory, a. Red Glass and Green Glass
standard, optional); b. pin hole
5.1 Spare parts (main ones); c. Slit
Consumables/reagents d. Two baack discs
(open, closed system) e. Cross Cylinder +/- 0.25 and +/- 0.5
humidity, dust …)
61 | P a g e
6.2

Certificates (pre-market, NA
sanitary,..); Performance
and safety standards
7.1
(specific to the device
type); Local and/or
international
requirements:
8.1
tolerance
8.3
9.1 standards.
10. DOCUMENTATION
10.1
10.2
documents
11. Notes
11.1
11.2
warnings
62 | P a g e
COLOUR VISION CHART
Version no. : Ver_1
Date: 19/08/2018
UMDNS name NA
UMDNS code(s) NA
GENERAL
1. USE
1.1 Clinical purpose It is used to measures your ability to tell the difference among colors
1.2
department/ward
TECHNICAL
Technical characteristics 1. Animal Picture Chart for preverbal children.
(specific to this type of 2. Ishiharascolour vision chart.
2.1 device) 3. Standard ishiharas pseudo - isochromatic plates in booklet form,
4. standard key for interpretation.

Software and/ or NA
standard of
2.3
communication(where
ever required
4.3 Protection NA
5.1

63 | P a g e
humidity, dust …)
6.2

7.1 standards.

requirements:
8.1
tolerance
8.3
9.1 Warranty NA
10. DOCUMENTATION
10.1
10.2
documents
11. Notes
11.1
11.2
warnings
64 | P a g e

Technical Specifications of Medical Devices For Ophthalmology Equipment

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Technical Specifications of Medical Devices For Ophthalmology Equipment

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TECHNICAL SPECIFICATIONS OF MEDICAL DEVICES FOR

Ministry of Health and Family Welfare

1 Cryo Surgery Unit with retina probe

8 A-Scan Bio meter

12 Applanation Tono meter

14 Laser Photo coagulator*

15 IOL Operation set

1 Dr. K Ramesh Babu Addl. Professor and Head– JIPMER, Pondicherry.

3.5 Mobility, portability Portable

3.5 Mobility, portability Portable

BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS

2.2 User's interface Manual

3.5 Mobility, portability NA

BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS

8. TRAINING AND INSTALLATION

5. ACCESSORIES, SPARE PARTS, CONSUMABLES

8. TRAINING AND INSTALLATION

11.2 Recommendations or Any warning sign would be adequately displayed.

OPHTHALMIC LASERS - PHOTOCOAGULATING

2.2 User's interface Manual

8. TRAINING AND INSTALLATION

BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS

6.2 User's care, Cleaning, Sterilization not required.

8. TRAINING AND INSTALLATION

2.3 Software and/ or standard As Applicable

BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS

6.2 User's care, Cleaning, Sterilization not required.

8. TRAINING AND INSTALLATION

3.5 Mobility, portability NA

5. ACCESSORIES, SPARE PARTS, CONSUMABLES

8. TRAINING AND INSTALLATION

3.5 Mobility, portability NA

2.2 User's interface Manual

MICROSURGERY LID SET

Used by clinical Ophthalmology Department

2.2 User's interface NA

2.2 User's interface NA

2.2 User's interface NA

TRIAL FRAME SET ( ADULT AND CHILD)

2.2 User's interface Manual

7. STANDARDS AND SAFETY

7. STANDARDS AND SAFETY

7. STANDARDS AND SAFETY

2.2 User's interface Manual

7. STANDARDS AND SAFETY

2.2 User's interface Manual

BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS

7. STANDARDS AND SAFETY

8. TRAINING AND INSTALLATION

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