Critical Care Block - Equipment Technical Specification

TECHNICAL SPECIFICATION OF
MEDICAL EQUIPMENT FOR

CRITICAL CARE BLOCK UNDER
PM-ABHIM
HEALTHCARE TECHNOLOGY DIVISION, NHSRC

TABLE OF CONTENETS
Sl. No Name of the Equipment
1. Motorized ICU Bed
2. ICU Ventilator
3. Syringe Pump
4. Infusion Pump
5. Laryngoscope
6. AMBU Bag
7. Aneroid BP Apparatus
8. Ophthalmoscope – i) Direct
ii) Indirect
9. ECG Machine-12 Channel
10. Portable Ventilator
11. Mobile X-ray Machine (100 mA X-Ray)
12. Portable Ultrasound
13. Defibrillator
14. Arterial Blood Gas (ABG) Analyzer
15. Weighing Scale-Adult
16. Suction Machine-Foot & Electric Operated
17. Patient Stretcher
18. Wheelchair
19. Glucometer
20. Stethoscope
21. Manual Bed 4 Section
22. Multipara Monitor
23. OT Table
24. OT light
25. Anesthesia Workstation
26. Surgical Diathermy
27. Blood Fluid Warmer
28. Radiant Warmer
29. Hemodialysis Machine
30. Dialyzer Reprocessor
31. CPAP
32. Bi-PAP
33. LDR Bed
34. Fetal Doppler
35. Pulse Oximeter
36. Multipara Monitor with Central System
37. Infrared Thermometer
38. CRRT Machine
MOTORIZED ICU BED
Version no.: 01
Date: September 2023
Done By: HCT/NHSRC
NAME AND CODING
GMDN Name Basic electric hospital bed
GMDN Code 34870
GENERAL
1. USE
ICU beds are special hospital beds designed for ICUs to take
1.1 Clinical Purposes care of critical patients and can be operated electro-
mechanically. ICU beds facilitate comfortable transfer to and fro
and has a provision of bedside diagnostic including X-ray
investigations. Thus, they provide safety, comfort and
convenience to the patients and caregivers alike.
Used by clinical ICU (Intensive Care Unit)

1.2 department/ward
TECHNICAL
2. TECHNICAL CHARACTERISTICS
Technical 1. Should have fully motorised 4 sections and sectional
Characteristics mattress.
2. Should have 4 separate electrically operating
function through embedded control panel/handheld
wired remote control for Height adjustment (Hi-Low),
Back rest, Knee rest and Trendelenburg/Reverse
Trendelenburg.
3. The bed frame should be made of Stainless-steel SS
2.1 (304)with epoxy coating.
4. Should have ABS/polymer moulded head and foot
boardpanels detachable.
5. Should have ABS/polymer moulded swing down
safety siderailing on both sides.
6. Should have a provision for carrying out whole body
X-ray at the bedside.
7. Should have digital/analog indicators for angle
display.
8. Should have one touch key provision on control panel for CPR
position and manual CPR option in case of automatic system
failure.
9. Bed position adjustments should have:
i) Back Rest angular movement in range from 0-70
degree or more.
ii) Knee rest angular movement in range from 0-45
degree or more.
iii) Trendelenburg and Reverse Trendelenburg: 0-12
degree or more.
10. Should have a therapeutic Weight bearing up to 150-200 Kg

11. Should have heavy duty casters made up of Stainless Steel
(304) ball bearing/ABS/Polyester with dual locking
arrangement.
12. Should have provision for holding IV pole on four corners.
13. High density foam mattress washable and detachable in 4
parts
14. Should have battery backup of at least 1 hour
15. Clearance between Bed Base frame and Floor surface in
adjustable range from mm: 120-150 mm
2.2 User's Interface Electro-mechanical (motorised)
Software and/ or NA
standard of
2.3 communication
(wherever required)
3. PHYSICAL CHARACTERISTIC
3.1 Dimensions (in cm) 1. Length: 2100-2300 mm

2. Width: 900-1100 mm
3.2 Weight To be specified by the Manufacturer/Supplier;
3.3 Noise Less than 50dB;
3.4 Heat Dissipation Not applicable
3.5 Mobility/Portability Should be easily movable with minimal physical effort.
4. ENERGY SOURCE (electricity, UPS, solar, \gas, water, CO2 ........... )
4.1 Power inputs 220 +/- 10% VAC, 50 Hz
4.2 Power consumption To be specified by Manufacturer/Supplier;

Battery backup Battery backup with inbuilt charger shall be provided.
4.3
5. ACCESSORIES. SPARE PARTS AND CONSUMABLE

Accessories, I. Should be provided with IV rods;
5.1 (mandatory,
Standard, II. Mattress as per the specs specified in Section (2.1)
operational); III. Side rails
Spare parts (main IV. X-ray cassette tray, Urine bottle holder and drainage bottle
ones) holder
Consumable/reagent
s (open, closed
system)
6. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS

Atmosphere Capable of operating continuously in ambient temperature of -10
6.1 /Ambiance (air to 60 deg C and relative humidity of upto 90% in ideal
conditioning, circumstances.
humidity, dust ...)
User’s care, Easy to clean and disinfect.

6.2 Cleaning,
Disinfection &
Sterility issues
7. STANDARDS & SAFETY

Certificates (pre- 1. Should be CDSCO approved.
market, sanitary); 2. Should comply with BIS standards.
Performance and 3. Should comply with USFDA/European CE standards incase of
safety standards non-availability of BIS standards.
7.1 (specific to the 4. Should conform to ISO 13485 quality standards.
device type); Local 5. Should conform to IEC 60601-1 General requirements of
and/or international electrical safety standards.
8. TRAINING AND INSTALLATION

Pre-installation To be specified by manufacturer and compatible electrical
requirements: nature, accessories as per Indian standard set-up.
8.1 values,
quality, tolerance
Requirements for Supplier to perform safety and operation check before hand over.
8.2
sign-off
Training of staff Training of User on operation and basic maintenance.
(medical,
8.3 paramedical,
technicians)
9. WARRANTY AND MAINTENANCE

Warranty 3 years including all spare parts and accessories.
9.1
10. DOCUMENTATION
Operating Should provide 2 sets (hard copy and soft copy) of:
manuals, service 1. User, technical and maintenance manuals should be supplied
manuals, other in English/Hindi language along with machine diagrams.
manuals 2. Service and operation manuals (original and Copy) to be
provided.
3. Satisfactory certificate for any existing installation from
10.1
government hospital
10.2 Other accompanying List of essential spares and accessories with their part number
documents and cost.
11. NOTES
Service Support Contact details of manufacturer, supplier and local service
Contact details
agent to be provided.
(Hierarchy Wise;
including a toll
11.1 free/landline number)
11.2 Recommendations or Any warning sign should be adequately displayed.

warnings
ICU Ventilator
Version no.: 01
Done by: (name / HCT/ NHSRC
institution)
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERAL
1. Use
1.1 Clinical purpose Mechanical ventilators are life support devices that move gas (e.g.,
air and/or oxygen) to and from a patient's lungs. These devices may
provide temporary or permanent respiration for patients who cannot
breathe on their own, or who require assistance maintaining
adequate ventilation. It can be used in two modes Invasive (Tube
Inside trachea) and Non-invasive (through face mask/nasal tube)
ventilation.
1.2 Used by clinical ICU
department/ ward
TECHNICAL
2. Technical characteristics
2.1 Technical 1. Should have facilities for Invasive and Non-Invasive ventilation.
characteristics
(specific to this 2. Microprocessor Control suitable for Pediatric and adult ventilation.
type of device) 3. Electromagnetic Compatible Hinged arm holder for holding the
circuit.
4. Should have built in touch colour screen TFT display of minimum
10” or more for display of waveforms and Monitored value.
5. Should have inbuilt facility to upgrade with EtcO2.
6. Facility to Measure and display: -
a) Status indicator for ventilator mode.
b) Battery indication.
c) Pressure Vs time Vs volume Vs time, flow Vs time 3 curves/
waveforms.
d) Alarm setting.
7. Automatic compliance and leakage compensation for circuit and
ET Tube.
8. Should have facility of logbook, for events and alarms with date &
time.
9. Should have following settings.
a) Tidal volume (Minimum at least 50ml, Maximum up to 2000ml)
b) Inspiratory Pressure (upto 80 cm of H20)
c) Respiratory rate 1 to 80 bpm.
d) Apnoea back up rate.
e) CPAP/PEEP
f) Pressure support.
g) Fi02
h) Pause Time
i) Pressure & flow Trigger
j) Inspiratory flow up to 120 Lpm.
10. Monitoring and Display of the following Parameters.
a) Airway Pressure (Peak & Mean).
b) Tidal volume (Inspired & Expired).
c) Minute volume (Inspired & Expired
d) Respiratory mechanics.
e) Spontaneous Minute Volume.
f) Total Frequency.
g) F102 dynamic.
h) Intrinsic PEEP.
i) Plateau Pressure.
j) Resistance & Compliance.
k) Use selector Alarms for all measured & monitored parameters.
l) Occlusion Pressure.
m) Pressure Flow & Volume curves.
11. Modes of Ventilation equipped with newer modes of
ventilation: -
a) Assist /control.
b) Volume Control.
c) Pressure control.
d) Pressure support.
e) SIMV with pressure support (Pressure and volume control).
f) PEEP.
g) Inverse ratio Ventilation.
h) Non-invasive ventilator- BIPAP, CPAP.
i) Apnea Ventilation, User selectable, volume & pressure control.
12. Should have built in safety alarms for Airway Pressure High &
low, Minute volume, High & low, power failure, Low oxygen, High
Respiratory Rate, Air Source in-operable.
13. Should have inbuilt exhalation filter.
14. Compressor should be of same company inbuilt/ mounted with
ventilator assembly.
15. Should have compatibility with existing central pipe line.
16. Humidifier
a) Servo controlled heated Respiratory Humidifier.
b) Temperature of delivered Gas on LED display.
c) Temperature should be adjustable.
d) Jar should be autoclavable
17. Nebulization assembly compatible with ventilator and circuit.
18. Should have interface facility.
19. Flow Sensor-Should have life more than 1 year.
20. Expiratory Unit- Life should be more than 3yrs.
21. Data storage facility for at least 24hrs.
22. Internal rechargeable battery at least 30min. backup.
23. Should be supplied with compatible UPS.
2.2 User's interface Manual
2.3 Software and/or In-built

standard of
communication
(wherever
required)
3. Physical characteristics
3.1 Dimensions NA
(metric)
3.2 Weight (lbs, kg) NA
3.3 Noise (in dba) N.A.
3.4 Heat dissipation NA
3.5 Mobility, portability Mobile
4. Energy source (electricity, Ups, solar, gas, water, cO2 )
4.1 Power 220 +/- 10% VAC, 50 Hz
requirements
4.2 Battery operated Battery backup of atleast one hour.
4.3 Protection NA
4.5 Power As specified by manufacturer
consumption
5. Accessories, spare parts, consumables
5.1 Accessories a) Patient breathing circuit of silicone for Adult & Paediatric
(mandatory,
standard, optional) (reusable).
Spare parts (main b) Non-invasive ventilator mask reusable for adult (3sizes) and
ones)
paediatric according to age- 4 set each.
Consumables /
c) ET tube cuff pressure monitor and HME filter - 10.
reagents (open,
closed system)
6. Environmental and departmental considerations
6.1 Atmosphere / Capable of operating continuously in ambient temperature of -10 to
ambiance (air 60 deg C and relative humidity of upto 90% in ideal circumstances.
conditioning,
humidity, dust ...)
6.2 User's care, To be specified by manufacturer
cleaning,
Disinfection &
sterility issues
7. Standards and safety
7.1 Certificates (pre- 1. Should be CDSCO approved.
market, sanitary, 2. Should comply with BIS standards.
..); performance 3. Should comply with USFDA/European CE standards incase of
and safety non-availability of BIS standards.
standards (specific 4. Should conform to ISO 13485 quality standards.
to the device type); 5. Should conform to IEC 60601-1 General requirements of
local and/or electrical safety standards.
international
8. Training and installation
8.1 Pre-installation To be specified by manufacturer and compatible electrical
requirements: accessories as per Indian standard set-up
nature, values,
quality, tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand over
sign-off
8.3 Training of staff Training of users in operation and basic maintenance shall be
(medical, provided.
paramedical,
technicians)
9. Warranty and maintenance
9.1 Warranty • 03 years
• Preventive Maintenance visits at least once in each quarter
10. Documentation
10.1 Operating manuals, Should provide 2 sets (hard copy and soft copy) of:
service manuals, 1. User, technical and maintenance manuals should be supplied in
other manuals English/Hindi language along with machine diagrams.
2. Service and operation manuals (original and Copy) to be
provided.
government hospital
10.2 Other List of essential spares and accessories, with their part number and
accompanying cost.
documents
11. Notes
11.1 Service support Contact details of manufacturer, supplier and local service agent to
contact details be provided.
(hierchy Wise;
including a toll
free/landline
number)
11.2 Recommendations Any warning sign should be adequately displayed.
and Warnings
SYRINGE PUMP
Version no. : 02
Done by : (name / institution) HCT/ NHSRC
NAME AND CODING
GMDN name Syringe pump
GMDN code(s) CT111
GENERAL
1. USE
1.1 Clinical purpose Designed to precisely drive the plunger of a syringe down
its barrel to infuse a solution when it must be
administered with a high degree of volume accuracy
and rate consistency.
1.2 Used by clinical NICU/PICU/Critical Care
department/ ward
TECHNICAL
2.1 Technical characteristics 1. Flow rate programmable range at least from 0.1 to
(specific to this type of 200 ml/hr, in steps of 0.1 ml/hr; and at least from 100 to
device) 1200 ml/hr in steps of 1 ml/hr.
2. Saves last infusion rate even when the AC power
is switched off.
3. Bolus rate should be programmable to approx 500
ml, with infused volume display.
4. Selectable occlusion pressure trigger levels
selectable from 300, 500 and 900 mmHg.
5. Must work on commonly available 20, 30 and 50 ml
syringes.
6. Accuracy of ±2% or better.
7. Maximum pressure generated ≤ 20 psi.
8. Automatic detection of syringe size and proper
fixing.
9. Anti-bolus system to reduce pressure on sudden
release of occlusion.
10. Pause infusion facility required.
11. Self-check carried out on powering on.
12. Comprehensive alarm package required
including: occlusion alarm, near end of infusion pre-
alarm and alarm, volume limit pre-alarm and alarm,
low battery pre-alarm and alarm, AC power failure,
drive disengaged, syringe loading error, maintenance
required.
13. Should include KVO (Keep vein open) enabling
feature.
14. It should be an open system compliant.
2.2 User's interface Automatic
2.3 Software and/or standard Inbuilt
of communication
3. PHYSICAL CHARACTERISTICS
3.1 Dimensions (metric) NA
3.3 Noise (in dBA) Noise free
3.5 Mobility, portability Portable
4. ENERGY SOURCE
4.1 Voltage (value, AC or DC, 220 +/- 10% VAC, 50 Hz
monophase or triphase)
4.2 Battery operated Internal rechargeable battery having atleast 4 to 6
hours backup for 10ml/hr flow rate with 50ml syringe.
4.3 Protection Battery powered alarm for power failure or
disconnection.
4.4 Power consumption As specified by manufacturer.
5. ACCESSORIES, SPARE PARTS, CONSUMABLES
5.1 Accessories Clamp for mounting pump on IV stand.
(mandatory,
standard, optional) Battery, syringe holder, PMO lines
Spare parts (main
ones)
Consumables /
reagents (open,
closed system)
BIDDING / PROCUREMENT TERMS /
DONATION REQUIREMENTS
6.1 Atmosphere / Ambiance Capable of operating continuously in ambient
(air conditioning, temperature of -10 to 60 deg C and relative humidity of
humidity, dust ...) upto 90% in ideal circumstances.
6.2 User's care, Cleaning, To be specified by manufacturer
Disinfection & Sterility
issues
7. STANDARDS AND SAFETY
7.1 Certificates (pre-market, 1. Should be CDSCO approved.
sanitary, ..); Performance 2. Should comply with BIS standards.
and safety standards 3. Should comply with USFDA/European CE standards
(specific to the device incase of non-availability of BIS standards.
type) 4. Should conform to ISO 13485 quality standards.
5. Should conform to IEC 60601-1 General
requirements of electrical safety standards

8.1 Pre-installation Supplier to perform installation, safety and operation
requirements: nature, checks before handover.
values, quality, tolerance
8.2 Requirements for sign-off Supplier to perform safety and operation check before
hand over.
8.3 Training of staff (medical, Training of users in operation and basic maintenance
paramedical, technicians) shall be provided.
• Preventive Maintenance visits at least once in
each quarter.
10. DOCUMENTATION
10.1 Operating manuals, User, technical and maintenance manuals to be supplied
service manuals, other in English/Hindi language along with mavhine diagram.
manuals
10.2 Other accompanying List of important spares and accessories, with their
documents part numbers and cost.
11. NOTES
11.1 Other information Contact details of manufacturer, supplier and local
service agent to be provided.
11.2 Recommendations or Any warning sign should be adequately displayed
warnings
INFUSION PUMP
Version no. : 02
Done by : (name/institution) HCT/NHSRC
NAME AND CODING
GMDN name Infusion Pump (Volumetric)
GMDN code(s) CT 1821
GENERAL
1. USE
1.1 Clinical purpose An infusion pump infuses fluids, medication or nutrients
into a patient's circulatory system. It is generally used
intravenously, although subcutaneous, arterial and
epidural infusions are occasionally used.
1.2 Clinical department/ward Emergency, Operation Theatre, Critical care
TECHNICAL
2.1 Technical characteristics 1. Flow rate programmable range at least from 0.1 to 200
ml/hr, in steps of 0.1 ml/hr; and at least from 100 to 1200
ml/hr in steps of 1 ml/hr.
2. Saves last infusion rate even when the AC power is
switched off.
3. Bolus rate should be programmable to approx. 500 ml,
with infused volume display.
4. Selectable occlusion pressure trigger levels selectable
from 300, 500 and 900 mmHg.
5. Accuracy of ±2% or better for set parameters.
6. Maximum pressure generated 20 psi.
7. Pause infusion facility required.
8. Self-check carried out on powering on.
9. Comprehensive alarm package required including:
occlusion alarm, near end of infusion pre-alarm and alarm,
volume limit pre-alarm and alarm, low battery pre-alarm
and alarm, AC power failure, drive disengaged.
10. It should be open system
2.2 User's interface Automatic
2.3 Software and/or standard of Inbuilt
communication
3.3 Noise (in dBA) Noise free
3.4 heat dissipation NA
3.5 Mobility, portability Yes
4. ENERGY SOURCE
4.1 Power Requirements 220 +/- 10% VAC, 50 Hz
4.2 Battery operated Internal rechargeable battery having a minimum of 2 hours

backup
4.3 Protection Battery powered alarm for power failure or disconnection
4.4 Power consumption As specified by manufacturer
5.1 Accessories (mandatory, Clamp for mounting pump on IV stand
standard, optional)
Spare parts (main ones)
Consumables/reagents
(open, closed system)
6. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS
6.1 Atmosphere/Ambiance (air Capable of operating continuously in ambient
conditioning, humidity, dust ...) temperature of -10 to 60 deg C and relative humidity of
up to 90%.
6.2 User's care, Cleaning, Easy to clean and maintain.

Disinfection &
Sterility issues
sanitary, ..); Performance and 2. Should comply with BIS standards.
safety standards (specific to 3. Should comply with USFDA/European CE standards
the device type); Local and/or incase of non-availability of BIS standards.
international 4. Should conform to ISO 13485 quality standards.
5. Should conform to IEC 60601-1 General requirements
of electrical safety standards.
8.1 Pre-installation requirements: To be specified by manufacturer and compatible electrical
nature, values, quality, accessories as per Indian standard set-up
tolerance
hand over
8.3 Training of staff (medical, Training of users in operation and basic maintenance shall
paramedical, technicians) be provided.

10. DOCUMENTATION
10.1 Manuals Should provide 2 sets (hardcopy) of: -
1) User, technical, maintenance and service manuals to be
supplied along with machine diagrams.
2) List of equipment and procedures required for local
calibration and routine maintenance.
3) Certificate of calibration to be provided by the
manufacturer.
10.2 Other accompanying List of important spares and accessories, with their part
documents numbers and cost
11. NOTES
11.1 Other information Contact details of manufacturer, supplier and local service
11.2 Recommendations Any warning signs should be adequately displayed

or Warnings
LARYNGOSCOPE
Version no. : 02
Done by : (name / HCT/ NHSRC
institution)
NAME AND CODING
GMDN name Laryngoscopes
GMDN code CT 1723
GENERAL
1. USE
1.1 Clinical purpose To view the vocal cords and glottis and to facilitate tracheal
intubation.
1.2 Used by
clinical PICU/NICU, OT, EMR, ICU/HDU
department/wa
rd
TECHNICAL
2.1 Technical 1. Fiber optic Laryngoscope - preferably should be reusable using
characteristics the latest LED technology.
(specific to this 2. The main body of the handle should incorporate an excellent
type of device)
grip & should feel even wearing a glove.
3. The light source should light when the blade is placed into the
operating position.
4. The unit should allow the blade to be inserted easily & should
provide a positive locking mechanism when moved into the closed
position.
5. Should have handle with universal adapter for interchangeable
blades.
6. The laryngoscope should be supplied in leather/hard case
preferably high impact plastic with internal soft cushion material
for easy portability and protection.
7. The blades should be re-usable and autoclavable preferably
made of S/Steel (MS-304) of high quality.
2.2 Settings NA
2.3 User’s interface Manual
2.4 Software and/or NA
standard of
communication
(wherever
required)
3.1 Dimensions NA
(metric)
3.2 Weight (lbs, kg) Light weight
Noise (in dBA), NA
3.4 heat
dissipation
3.5 Mobility, Portable
portability
4. ENERGY SOURCE
4.1 Power NA
Requirements
4.2 Battery operated Yes
4.3 Protection NA
4.4 Power NA
consumption
5.1 Accessories Batteries, blades of various neonatal sizes
(mandatory, Handle
standard, 5 LED should be given as spare
optional)
Spare parts
(main ones)
Consumables /
reagents (open,
closed system)
Ambiance (air 60 deg C and relative humidity of upto 90% in ideal circumstances.
conditioning,
humidity, dust
...)
6.2 User’s care, Should be autoclavable
Cleaning,
Disinfection &
Sterility
issues
7.1 Certificates 1. Should be CDSCO approved.
2. Should comply with BIS standards.
3. Should comply with USFDA/European CE standards incase of
non-availability of BIS standards.
4. Should conform to ISO 13485 quality standards.
8.1 Pre-installation NA
requirements:
nature, values,
quality, tolerance
8.2 Requirements NA
for sign-off
8.3 Training of staff NA
(medical,
paramedical,
technicians)
9.1 Warranty 03 years
10. DOCUMENTATION
10.1 Operating Should provide 2 sets (hard copy and soft copy) of:
manuals, User, technical and maintenance manuals should be supplied
service in English/Hindi language along with machine diagrams.
manuals,
other
manuals
10.2 Other NA
accompanying
documents
11. NOTES
11.1 Service Contact details of manufacturer and supplier should be provided..
Support
Contact details
(Hierchy Wise;
including a toll
free/ landline
number)
11.2 Recommendati Any recommendations for best use and supplementary warning for
ons or safety should be declared
warnings
AMBU BAG
Version No: 02
Done by: (Name/Institution) HCT/NHSRC
NAME AND CODING
GMDN name -
GMDN code -
GENERAL
1. USE
1.1 Clinical purpose An Ambu bag, is a handheld tool used to provide ventilation
(positive pressure) who is not breathing or who is breathing
inadequately. It consists of a self-inflating bag, one-way valve,
mask, and an oxygen reservoir.
1.2 Used by clinical Emergency department, Operation Theatre, Ambulance,

department/Ward Resuscitation kit.
TECHNICAL
2.1 Technical characteristics
(specific to this type of 1. Bag should be made up of silicone, latex free, double
device) layered rubber and should retain sensitivity, resistant to
rough use.
2. Inlet end of the bag should have separate port for
oxygen supplement.
3. Outer port should be such that re-breathing valve or
non-return valve can be attached.
4. Should be supplied with oxygen reservoir bag and
should deliver tidal volume of 250/500/750 & 1000 ml.
5. Should be autoclavable.
6. Should be provided with a carry case.

standard of
communication
(wherever required)
3.3 Noise (in dBA) NA
3.5 Mobility, portability NA
4. ENERGY SOURCE
4.1 Power Requirements NA
4.2 Battery operated NA
4.3 Protection NA
4.4 Power consumption NA
5.1 Accessories (mandatory, NA
standard and optional);
spare parts (main ones)
and Consumables/
Reagents (Open/Closed
System)
6.1 Atmosphere/Ambiance Capable of operating continuously in ambient temperature of -
(air conditioning, 10 to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust...) circumstances.
6.2 User's care, Cleaning, Autoclavable face mask
issues
7.1 Certifications (Pre-Market, 1. Should be CDSCO approved.
Sanitary,), Performance 2. Should comply with BIS standards.
and Safety Standards 3. Should comply with USFDA/European CE standards incase
(Specific to the device of non-availability of BIS standards.
type); Local and/or 4. Should conform to ISO 13485 quality standards
international
requirements: nature,
8.2 Requirements for sign-off NA
8.3 Training of staff (medical, Training of users in operation and basic maintenance shall be
paramedical, technicians) provided.
OPTIONAL (Depending
upon scope of work order)
9.1 Warranty 03 Years
10. DOCUMENTATION
service manuals, other • User, technical and maintenance manuals should be
manuals supplied in English/Hindi/ Regional language along with
machine diagrams.
10.2 Other accompanying NA

documents
11. NOTES
11.1 Service Support Contact Contact details of manufacturer and supplier should be
details (Hierarchy Wise; provided.
including a toll
free/landline number)
11.2 Recommendations or NA
warnings
BP APPARATUS (ANEROID)
Version no. : 02
NAME AND
CODING
GMDN name Sphygmomanometers
GMDN code(s) 13106
GENERAL
1. USE
1.1 Clinical purpose Measures blood pressure non-invasively by displaying the pressure in
a cuff wrapped around a patient's arm. The systolic and diastolic
pressure is usually assessed by listening to Korotk off sounds
generated by arterial blood flow using a stethoscope simultaneously.
1.2 Used by clinical All clinical departments
department/ward
TECHNICAL
2.1 Technical 1) Should be based on non-mercurial aneroid based
characteristics measurement technology.
(specific to this 2) Should be able to measure blood pressure in adult as well as
type of device) pediatric patients.
3) Should have a dial type display, with a hook which can be
attached to the blood pressure cuff.
4) Pressure measurement range should be 0 to 300 mm Hg
systolic and 40 to 200mm Hg diastolic.
5) Pressure measurement accuracy of +/- 3 to 5mm Hg
6) Manual inflation of blood pressure cuff.
standard of
communication
(wherever required)
3.3 Noise (in dBA), heat NA
dissipation
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 )
4.3 Protection NA
5.1 Accessories Adult arm cuffs of size medium & large and pediatric size, inflation
(mandatory, standard, bulb, tubing.
optional) Dial mano meter.
Spare parts (main
ones)
Consumables /
reagents (open,
closed system)
conditioning,
humidity, dust ...)
6.2 User's care, NA
Cleaning,
Disinfection &
Sterility issues
market, sanitary, ...); 2. Should comply with BIS standards.
Performance and safety 3. Should comply with USFDA/European CE standards incase of
standards (specific to non-availability of BIS standards.
the device type); Local 4. Should conform to ISO 13485 quality standards.
and/or international
values, quality,
tolerance
8.2 Requirements for sign- Supplier to perform safety and operation check before hand over.
off
(medical, paramedical,
technicians)
10. DOCUMENTATION
10.1 Operating manuals, User manuals to be supplied in English language along with machine
service manuals, diagrams.
other manuals
documents
11. NOTES
11.1 Service Support NA
Contact details
(Hierchy Wise;
including a toll free/
landline number)
warnings
OPTHALMOSCOPES – DIRECT
Version no. : 02
NAME, CATEGORY AND CODING
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 funds) by providing a non-
inverted image ofthe eye. The instruments usually consist of
a light source to projectthe light into the eye through the pupil,
a mirror, and a wheel of lensesof varying strength to provide
a magnified view of the eye and to adjust the focus of the
view. They produce an upright, or unreversed, magnified
image of the eye, at approximately 15 times magnification.
Direct ophthalmoscopes are used mainly to detect eye
conditions oreye 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, slitaperture, hemi-spot and cobalt blue filter.
5. Should be rechargeable battery with Charger / battery/
mainsoperated.
6. At least 3 apertures and fixation star.
7. Range of lenses not smaller than -30D to +20D with
steps notgreater than 1D.
8. Dust free sealed optics and aspherical optical system.
2.3 Software and/ NA
or standard of
communication (where
ever required)
3.1 Dimensions(metric) NA
3.5 Mobility, portability
Supplied in protective case for clean storage and safe
transport.
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ….)
4.1 Power requirements 220 +/- 10% VAC, 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
4.4 Power consumption To be specified by Vendor
5.1 Accessories, Bulb – 2 nos
(mandatory, standard,
optional); Spare
parts (main ones);
Consumables/
reagents (open,
closed system)
6.1 Atmosphere/ambiance (air Capable of operating continuously in ambient temperature of
conditioning, humidity, -10 to 60 deg C and relative humidity of upto 90% in ideal
dust …) circumstances.
6.2 User's care, Cleaning, To be specified by manufacturer.
issues

7.1 Certificates (pre- market, 1. Should be CDSCO approved.
sanitary,..); Performance 2. Should comply with BIS standards.
type); Local and/or 4. Should conform to ISO 13485 quality standards.
international 5. Should conform to IEC 60601-1 General requirements of
electrical safety standards

8.1 Pre- installation NA
8.2 Requirements for Supplier to perform installation, safety and operation

sign-off checksbefore handover.
(medical, provided.
paramedical,
technicians)
9.1 Warranty 3 years, including for all spares and calibration work.
10. DOCUMENTATION
10.1 Operating manuals, Should provide 2 sets(hard copy and soft copy) of:
set manuals, other
User, technical and maintenance manuals should be
manuals
supplied inEnglish/Hindi/Regional language along with
machine diagrams.
10.2 Other accompanying List of essential spares and accessories, with their part
documents number andcost.
11. Notes
11.1 Service Support Contact Contact details of manufacturer, supplier and local service
details (Hierarchy Wise; agent tobe provided.
landline number)
11.2 Recommendations or Any warning sign would be adequately displayed.

warnings
OPTHALMOSCOPES, INDIRECT
Version no. : 02
NAME, CATEGORY AND CODING
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 funds. These instruments usually
consist of a light source attached toa headband to project
the light into the eye through the pupil and aconverging lens
placed in front of the patient’s eye. They produce aninverted,
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.
1.2 Used by clinical Ophthalmology Department
department/ward
TECHNICAL
2.1 Technical characteristics 1. Available with LED/Halogen light source. (Desirably
(specific to this type of LED).
device) 2. Magnification up to 5x.
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.
2.3 Software and/ NA
or standard of
ever required
3.5 Mobility, portability Supplied in protective case for clean storage and safe
transport.
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ….)
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. Three pencils,
standard,optional); Spare b. Funds chart,
parts (main ones); c. Sclera depressor,
Consumables/reagents d. 20D condensing lens with anti reflecting coating.
e. Bulb – 2 nos, Bulb holder, Bulb cover.
BIDDING/PROCUREMENT TERMS/DONATION
REQUIREMENTS
6.1 Atmosphere/Ambiance Capable of operating continuously in ambient temperature of
(air conditioning, -10 to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust …) circumstances.

issues

sanitary,..); Performance 2. Should comply with BIS standards.
type); Local and/or 4. Should conform to ISO 13485 quality standards.
international 5. Should conform to IEC 60601-1 General requirements of
8.1 Pre- installation NA
values, quality,
tolerance
8.2 Requirements for sign- Supplier to perform installation, safety and operation checks
off beforehandover.
(medical, paramedical, provided.
technicians)
9.1 Warranty 3 years, including for all spares
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 inEnglish/Hindi/Regional language along with
machine diagrams;
2. Service and operation manuals(original and Copy) to
be provided;
3. Advanced maintenance tasks documentation.
documents number andcost;
11. Notes
details (Hierarchy Wise; agent tobe provided.
landline number)
warnings
ECG MACHINE – 12 CHANNEL
Version no. : 02
NAME AND CODING
GMDN name Electrocardiographs, multichannel
GMDN code(s) 11411
GENERAL
1. USE
1.1 Clinical purpose Continuously detect, measure and display a patients
echocardiogram (ECG) through leads and sensors attached to
the patient.
1.2 Used by clinical Radiology Department
department/ ward
TECHNICAL
2.2 Technical 1) Simultaneous 6 Channel ECG recording with 12 lead
characteristics simultaneous acquisition.
(specific to this type
of device) 2) Should have a digital display of 6 channel ECG and
should have three modes (Automatic, Manual and
rhythm).
3) Heart rate measurement range to be at least 30 bpm

to 250 bpm, with accuracy better than ± 5bpm.
4) Heart rate trend display of at least previous 24 hours.
5) Arrhythmia detection facility required; minimum

gradation of 1 bpm.

2.4 Software and/or Inbuilt
standard of
communication
3.4 heat dissipation Should maintain nominal temperature and the heat should be
disbursed through a cooling mechanism.
3.5 Mobility, portability Stationary
4. ENERGY SOURCE
4.1 Power Requirements 220V ± 10%, 50 Hz
4.2 Battery operated Battery powered, silence able alarm for power failure.
Battery charger to be integral to mains power supply, and to
charge battery during mains power operation of unit.
Internal, replaceable, rechargeable battery allows operation
for at least one hour in the event of power failure.
4.3 Protection NA
5.1 Accessories 12 lead ECG cable.
(mandatory, 2 sets of spare fuses (if non-resettable fuses are used)
standard, 5 tube electrode gel (if required)
optional)
Spare parts
(main ones)
Consumables/re
agents (open,
closed system)
BIDDING/PROCUREMENT TERMS/DONATION
REQUIREMENTS
6.1 Atmosphere/Ambianc Capable of operating continuously in ambient temperature of -
e (air conditioning, 10 to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust...) circumstances.
issues
market, sanitary, ..); 2. Should comply with BIS standards.
Performance and 3. Should comply with USFDA/European CE standards incase
safety standards of non-availability of BIS standards.
(specific to the device 4. Should conform to ISO 13485 quality standards.
type) 5. Should conform to IEC 60601-1 General requirements of
electrical safety standards.
requirements: nature, accessories as per Indian standard set-up
values, quality,
tolerance
8.2 Requirements for Supplier to perform installation, safety and operation checks
sign-off before handover.
8.3 Training of staff Training of users in operation and basic maintenance shall
(medical, be provided.
paramedical,
technicians)
• Preventive Maintenance visits at least once in each
quarter
10. DOCUMENTATION
10.1 Operating manuals, Should provide 2 sets (hardcopy) of:-
service manuals, other 1) User, technical, maintenance and service
manuals manuals to be supplied along with machine
diagrams.
2) List of equipment and procedures required
for local calibration and routine maintenance.
3) Certificate of calibration to be provided by the
manufacture
11. NOTES
11.1 Service Support Contact details of manufacturer, supplier and local service
Contact details agent to be provided.
(Hierchy Wise;
including a toll
free/landline
number)
11.2 Recommendations or Any warning signs would be adequately displayed.
warnings
Portable Ventilator
Version no.: 01
Done by: (name / HCT/ NHSRC
institution)
NAME AND CODING
GMDN name Intensive-care ventilators
GMDN code(s) CT2175
GENERAL
1. Use
1.1 Clinical purpose to provide automated, alveolar ventilatory support for patients
during interhospital or intrahospital transport, and in emergency
situations. It is typically a compact, lightweight, rugged device with
internal batteries to power it during patient transport.
1.2 Used by clinical Emergency /Critical Care
department/ ward
TECHNICAL
2.1 Technical 1. Modes of ventilation:
characteristics
(specific to this a) Volume controlled.
type of device) b) Pressure controlled.
c) Pressure support.
d) Synchronized intermittent mandatory ventilation (SIMV).
e) Assist/control mode.
f) PEEP.
2. Alarms required: FiO2, minute volume, pressure, PEEP, apnoea,
occlusion, high respiration rate, disconnection.
3. System alarms required: power failure, gas disconnection, low
battery, vent inoperative, self diagnostics.
4. If alarm silencing feature is incorporated, it must be temporary
and clearly displayed when activated.
5. Air and externally supplied oxygen mixture ratios fully controllable.
6. Inlet gas supply (O2) pressure range at least 35 to 65 psi.
7. Medical air compressor integral to unit, with inlet filter.
8. Visual and audible alarms Accessories and tubing should be
supplied for adult, pediatric & neo-natal size requirements.
9. The following variables should be controllable by the operator:
a) Tidal volume up to 100 ml.
b) Pressure (inspiratory) up to 80 cm H2O.
c) Volume (inspiratory) up to 120 l/min.
d) Respiratory rate: up to 60 breaths per minute.
e) SIMV Respiratory Rate: up to 40 breaths per minute.
f) PEEP up to 20 cm H2O.
g) Pressure support up to 45 cm H2O.
h) FiO2 between 21 to 100 %.
i) Inspiratory and expiratory times up to at least 2 sec and 8 sec
respectively
2.2 User's interface Manual and Automatic

standard of
communication
(wherever
required)
3.1 Dimensions NA
(metric)
4. Energy source
4.1 Power 220 +/- 10% VAC, 50 Hz
requirements
4.2 Battery operated With atleast 6 hours battery backup.
4.3 Protection NA
4.5 Power As specified by manufacturer
consumption
5. Accessories, Spare parts, Consumables
5.1 Accessories a) Full face mask, breathing circuit, carry bag, filters.
(mandatory,
standard, optional) b) Battery, leakage adapter.
Spare parts (main
ones)
Consumables /
reagents (open,
closed system)
ambiance (air 60 deg C and relative humidity of upto 90% in ideal circumstances.
conditioning,
humidity, dust ...)
cleaning,
Disinfection &
sterility issues
..); performance 3. Should comply with USFDA/European CE standards incase of
and safety non-availability of BIS standards.
to the device type); 5. Should conform to IEC 60601-1 General requirements of
local and/or electrical safety standards.
international
nature, values,
quality, tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand over
sign-off
(medical, provided.
paramedical,
technicians)
10. Documentation
service manuals, 1. User, technical and maintenance manuals should be supplied in
other manuals English/Hindi language along with machine diagrams.
provided.
government hospital
10.2 Other List of essential spares and accessories, with their part number and
accompanying cost.
documents
11. Notes
contact details be provided.
(hierchy Wise;
including a toll
free/landline
number)
11.2 Recommendations Any warning sign should be adequately displayed.
and Warnings
Mobile X-ray Machine (100 mA X-Ray)
Version no.: 02
Done by: (name / institution) HCT/ NHSRC
NAME AND CODING
GMDN name Radiographic Units, Mobile
GMDN code(s) 13272
GENERAL
1. Use
1.1 Clinical purpose Mobile X-Ray unit is required to perform X-Ray studies in
emergency & trauma departments & at bed side in wards & ICU.
1.2 Used by clinical Radiology Unit
department/ ward
TECHNICAL
2.1 Technical Compact, easily transportable mobile radiographic unit suitable for
characteristics bed side X-Ray in Emergency, ward, ICU, Operation Theatre &
(specific to this type of also in the radiology department for conventional radiography.
device)
X-ray Generator:
1. High frequency X-Ray generator having frequency of 20 KHz or

more suitable for radiography should be provided.
2. Power output of generator should be 20 KW Radiography KV

range should be 40-120 KV or more. mA range (rad.): 100 mA or
more.
Control:
1. A very compact, Soft touch Control panel having following

functions & indications should be provided. The panel can
be supplied in floor or wall mount with spill proof design
following features should be on the control panel.
2. Machine ON/OFF switch, Digital display of KV & mAs, KV

& mAs increase and decrease switches. Tube focal spot
selection switch, Ready and x-ray on switch with
indicators.
3. Bucky selection switch.
4. Self-diagnostic programme with indicators for earth fault

error, KV error, filament error & Tube's thermal overload.
X-Ray Tube:
1. Tube should have one number stationary anode and thermally
protected
2. Anode heat storage capacity of tube should be more than 140

KHU. One number manual collimator with aluminium filter & for
adjustment of exposure area.

standard of
communication
(wherever required)
3. Physical Characteristics

3.3 Noise (in dba) Noise free system
3.4 Heat dissipation Should maintain nominal temperature and the heat should be

4.1 Power requirements 220 V AC +/- 10%, 50 Hz
4.3 Protection NA
4.4 Power consumption To be specified by manufacturer.
4.5 Other energy supplies NA
5.1 Accessories
(mandatory, standard, Machine should be provided with following accessories:
optional);Spare parts
(main ones); Parts :
Consumables / reagents 1. Two numbers of BARC approved whole body lead aprons with
(open, closed system) all attachments.
2. One pair of 8-meter HV Cable
.
6.1 Atmosphere / ambiance Capable of operating continuously in ambient temperature of -10
(air conditioning, to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust ...) circumstances.
6.2 User's care, cleaning, 1. To be specified by manufacturer
Disinfection & sterility
issues
7. Standards and Safety
7.1 Certificates (pre-market, 1. Should be CDSCO and AERB approved.
sanitary, ..); 2. Should comply with BIS standards.
performance and safety 3. Should comply with USFDA/European CE standards incase of
the device type); local 4. Should conform to ISO 13485 quality standards.
and/or international 5. Should conform to IEC 60601-1 General requirements of
8. Training and Installation

values, quality,
tolerance
8.2 Requirements for sign- Supplier to perform safety and operation check before hand over.
off
8.3 Training of staff Training of users on operation and basic maintenance.
technicians)
9. Warranty and Maintenance
9.1 Warranty 03 years including all spares.
Preventive maintenance visits at least once in each quarter.
10. Documentation
service manuals, other 1. User, technical and maintenance manuals should be supplied in
manuals English/Hindi language along with machine diagrams.
provided.
5. Certificate of calibration and inspection.
government hospital.
documents
11. Notes
contact details (hierchy be provided.
Wise; including a toll
Recommendations or Any warning sign should be adequately displayed.
11.2
warnings
Portable Ultrasound
Version 02
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERAL
1. USE
1.1 Clinical purpose An assembly of devices designed for extracorporeal and / or
intracorporeal (endosonography or endoscopic) imaging procedures
involving the heart and blood vessels. Included are software packages
that support a variety of static or real-time cardiac specific imaging
applications used to diagnose anatomical defects of the heart,
determine blood flow characteristics and functional anatomical
problems associated with myocardial infarction.
1.2 Used by clinical Radiology
department/ward
TECHNICAL
2.1 Technical 1. A typical configuration for a cardiac ultrasound system consists of
characteristics a scanner and software, several single- or multi frequency
(specific to this transducers, a TEE probe, color Doppler, M-mode, CFM, cardiac
type of device) analysis software.
2. Phased array transducers required.
3. Following transducers are to be supplied:
• A-2.0-5.0 MHz Multi frequency Convex Transducer-One.

• B-5.0-12.0 MHz Multi frequency Linear transducer-One.
• C-5.0-8.0 MHz or more Endo Cavitory probe-One.
4. Transesophageal Echocardiogram - TEE scanning capability.
5. Penetration depth of at least 30 cm.
6. Digital and caliper measurement functions required for both

distance and area.
7. Alphanumeric annotation to be possible.
8. Measurement accuracy to be better than 2% over 10cm distance.
9. Doppler display to indicate blood flow both numerically and in

colour.
10. System that is DICOM compatible for communication efficiency.
3D or 2D image for cardiac studies in adults, children and infants
11. ZOOM in real time at least 4X and ZOOM for frozen image at
least 20X.
12. Equipment dynamic range, at least, 180 dB.
2.2 User's interface Patient Communication system: An integrated intercom and

automated patient instruction system API should be provided.
2.3 Software and/or The hardware and software included should allow the following
standard of application: Cardiac and stress echo; tissue differentiation to clearly
communication show the walls of the left ventricle and regional wall motion
(wherever required) abnormalities. Left ventricle wall abnormalities software; abdominal;
obstetrical and gynecological; peripheral and deep vascular.
3.3 Noise (in dBA), Noise free system
3.4 Heat dissipation Heat Dissipation: Should maintain nominal Temp and the heat should be
4.2 Battery operated 3 Hours
4.3 Protection NA
4.4 Power To be specified by manufacturer
Consumption
5.1 Accessories All probes required for frequency range stated. It is recommended
(mandatory, include the type of transducers and the minimum transducers with
standard, harmonics.
optional);
Spare parts (main
ones);
Consumables /
reagents (open,
closed system)
BIDDING / PROCUREMENT TERMS / DONATION REQUIREMENTS
6.1 Atmosphere / Capable of operating continuously in ambient temperature of -10 to 60
Ambiance (air deg C and relative humidity of upto 90% in ideal circumstances.
conditioning,
humidity, dust ...)
Cleaning,
Disinfection &
Sterility issues
..); Performance 3. Should comply with USFDA/European CE standards incase of non-
and safety availability of BIS standards.
to the device type); 5. Should conform to IEC 60601-1 General requirements of electrical
Local and/or safety standards
international
8.1 Pre-installation To be specified by manufacturer and compatible electrical accessories
requirements: as per Indian standard set-up.
nature, values, PCPNDT Act clearance.
quality, tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand over.
sign-off
(medical, provided.
paramedical,
technicians)
Preventive Maintenance visits at least once in each quarter.
10. Documentation
Operating manuals, Should provide 2 sets (hard copy and soft copy) of:
set manuals, other 1. User, technical and maintenance manuals should be supplied in
10.1 2. Advanced maintenance tasks documentation.
4. 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
Service Support Contact details of manufacturer, supplier and local service agent to be
Contact details provided.
(Hierarchy Wise;
11.1
including a toll
free/landline
number)
Recommendations Any warning sign should be adequately displayed.
11.2
or warnings
DEFIBRILLATOR
Version no. : 02
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERL
1. USE
1.1 Clinical purpose To detect cardiac arrhythmias in a sudden cardiac arrest
patient, and then audibly/visually instructs an operator to
enable it to activate defibrillation of the heart through
application of electrical shocks to the chest surface.
1.2 Used by clinical Emergency/ICU/Cardiac care
department/ward
TECHNICAL
2.1 Technical 1. Unit should be lightweight compact and portable.
characteristics 2. Unit should have facility for Automatic External
(specific to this type Defibrillation and manual defibrillation.
of device)
3. Should be able to deliver shock from 50-200 joules in
biphasic mode via metal chest pads.
4. Should having design protection to avoid passage of
current to the user.
5. The whole system should have an inbuilt
recorder.
2.2 User's interface The monitor should have a color display with a three
channel display.
2.3 Software and/or Inbuilt
standard of
communication
(where ever required)
3.1 Dimensions (metric) Compact
3.4 Noise (in dBA), heat <60dBA; adjustable heart rate alarm as well as paddles &
dissipation ECG cable disconnection alarms.
4. ENERGY SOURCE
4.2 Battery operated Rechargeable battery backup of approximately 5 hours.
4.3 Protection NA
5.1 Accessories Chest paddles
(mandatory, ECG cable; Recording paper rolls; Disposable pads;
standard, optional)
Spare parts (main
ones)
Consumables /
reagents(open, closed
system)
6.1 Atmosphere / Capable of operating continuously in ambient temperature of
Ambiance(air -10 to 60 deg C and relative humidity of upto 90% in
conditioning, idealcircumstances.
humidity, dust ...)
6.2 User's care, To be specified by manufacturer.
Cleaning,
Disinfection &
Sterilityissues
7.1 Certifications 1. Should be CDSCO approved.
3. Should comply with USFDA/European CE standards
incase of non-availability of BIS standards.
5. Should conform to IEC 60601-1 General requirements of
electrical safety standards.
8.1 Pre-installation To be specified by manufacturer and compatible
requirements: nature, electricalaccessories as per Indian standard set-up
values, quality,
tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand
sign-off over.
8.3 Training of staff Training of users in operation and basic maintenance
(medical,paramedical, shallbe provided.
technicians)
quarter.
10. DOCUMENTATION
10.1 Operating 1. User, technical and maintenance manuals to be supplied in
manuals, service English/Hindi language along with machine diagrams.
manuals, other
2. Advanced maintenance tasks required shall be
manuals
documented.
10.2 Other List of important spares and accessories, with their part
accompanying numbers and cost.
documents
11. NOTES
11.1 Service Support Contact details of manufacturer, supplier and local service
Contact details agent to be provided.
(Hierchy Wise;
landline number)
11.2 Recommendations Any warning sign should be displayed adequately.
or warnings
ARTERIAL BLOOD GAS (ABG) ANALYZER
Version no.: 02
Done by: (name/institution) HCT/NHSRC
NAME AND CODING
GMDN name Blood gas analyser IVD, laboratory
GMDN code(s) 56661
GENERAL
1. USE
1.1 Clinical purpose An electrically powered laboratory instrument intended to
be used for the quantitative in vitro measurement of blood
pH, partial pressure of oxygen (pO2) and partial pressure
of carbon dioxide (pCO2), and the calculation of other
blood gas parameters [e.g., bicarbonate (HCO3-), base
excess, arterial-alveolar gradient] in a clinical specimen.
1.2 Clinical department/ward Clinical Diagnostic Laboratory
TECHNICAL
2.1 Technical characteristics • Essential Measured parameters; pH, pCO2, pO2,
tHb, Barometric Pressure, Na+, K+, Ca++, Cl-. All
these parameters should be measured
simultaneously.
• Should have minimum 15 calculated parameters
including SaO2, Bi carbonate (HCO3), Standard
HCO3, Base Excess of Blood (BE), Base Excess of
extra cellular fluid.
• Sample volume-less than 100ul.
• Should have minimum process time (less than 5
min).
• Warm up time should be less than 30 minutes.
• Maintenance free electrodes
• Fully automatic liquid calibration of all parameters at
user-defined intervals.
• Should be with numeric keypad, graphic / LCD
display, and inbuilt printer. Should have interface for
PC compatibility.
• QC should be based on test parameters.
• Automatic result processing, test ordering and
provision for bi-directional LIS interface should be
available.
• Automatic data archiving and customizable layout.
• Should have provision for data backup.
2.2 User's interface LCD/Graphical Display

2.3 Software and/or standard of In-built
communication
3.3 Noise (in dBA) Noise pressure level: ≤60 dB
3.4 Heat dissipation Should maintain nominal temperature and the heat should
be disbursed through a cooling mechanism

4.2 Battery operated Yes at least 30 minutes backup

4.3 Protection NA
5.1 Accessories (mandatory, • Reagents for minimum 200 tests should be provided
standard, optional) along with the machine.
Spare parts (main ones) • Electrodes for all the parameters specified -01 set.
Consumables/reagents • Quality control tools/reagents for minimum 200 tests or
as per requirement.
upto 90% in ideal circumstances.

Disinfection &
Sterility issues
the device type); Local and/or incase of non-availability of BIS standards.
5. Should conform to IEC 60601-1 General requirements of

nature, values, quality, accessories as per Indian standard set-up
Tolerance
8.2 Requirements forsign-off Supplier to perform installation, safety, and operation
checks before handover.
8.3 Training of staff (medical, Training of users in operation and basic maintenance.
paramedical, technicians)
eachquarter.
10. DOCUMENTATION
10.1 Manuals Should provide 2 sets (hardcopy) of: -
1) User, technical and maintenance manuals to be
supplied in English/Hindi language along with
machine diagrams.
2) List of equipment and procedures required for
localcalibration and routine maintenance.
3) Certificate of calibration and inspection;
Documents numbers and cost.
11. NOTES
serviceagent to be provided.
11.2 Recommendations Any recommendations for best use and supplementary

or Warnings warning for safety should be declared.
WEIGHING SCALE-ADULT
Version no.: 02
NAME AND CODING
GMDN name
GMDN code(s)
GENERAL
1. USE
1.1 Clinical purpose Weighing scale is used to measure body mass.
1.2 Used by clinical OPD
department/ ward
TECHNICAL
2.1 Technical characteristics 1. Should be made of sturdy mechanical structure
(specific to this type of to support/withstand heavy workload in public
device) health centre.
2. Platform size 350 x 350 mm (Tolerance +/- 10%)
3. Measuring capacity should be at least 150 kg
with accuracy up to 100 gms.
4. The display should be LCD/LED with four digits.
The size of display should be minimum height 24
mm for clear visibility.
5. The scale should operate on electricity as well as
on inbuilt re-chargeable batteries.
6. The reading should get locked automatically at
stable weight and there should be an indication
for the same.
7. The scale should have readings in SI system
(Kgs and Gms).
8. The scale should have auto off feature when not
in use.
9. It should be able to record weight in less than 05
seconds.
10. Built in rechargeable battery.
2.2 User’s interface LCD/ LED display.
2.3 Software and/or standard NA
of communication
(Wherever required)
3.3 Configuration N.A.
3.4 Noise (in dBA) N.A.
4. ENERGY SOURCE (Electricity, UPS, Solar, Gas, Water, CO2 )
4.1 Power Requirements 220 V AC +/- 10%, 50 Hz
4.2 Battery operated Rechargeable battery
4.3 Protection NA
standard, optional), Spare
parts (main ones),
Consumables /
reagents (open, closed
system)
6.1 Atmosphere / Ambiance NA
(air conditioning, humidity,
dust ...)
6.2 User’s care, Cleaning, Easy to clean
Disinfection & Sterility issues
sanitary, 2. Should comply with BIS standards.
..); Performance and safety 3. Should comply with USFDA/European CE
standards (specific to the standards incase of non-availability of BIS
device type); Local and/or standards.
requirements of electrical safety standards.
8.1 Pre-installation requirements: NA
nature, values, quality,
Tolerance
technicians)
each quarter
10. DOCUMENTATION
10.1 Operating manuals, service NA
manuals, other manuals
documents
11. NOTES
11.1 Service Support Contact Contact details of the manufacturer should be
details (Hierchy Wise; provided.
including a toll free/landline
number)
11.2 Recommendations or Any warning sign should be displayed adequately.
warnings
SUCTION MACHINE-FOOT & ELECTRIC OPERATED
Version no. : 02
Done by: (name/institution) HCT/NHSRC
NAME AND CODING
GMDN name
GMDN code
GENERAL
1. USE
1.1 Clinical purpose To aspirate fluids, secretions, or other foreign
materials from a patient's airway by means of
suction
1.2 Used by clinical Emergency, ICU, OT, HDU
department/ ward
TECHNICAL
2.1 Technical characteristics 1. Should be designed for draining blood and other
(specific to this type of fragmented secretions in emergency settings.
device)
2. Should be operable both electrically and foot
operatedduring non-availability of electricity.
3. Should be fitted with oil immersed noiseless
motorizedvacuum pump.
4. Cabinet should be made of stainless steel (MS-304).
5. Should have two lightweight, clear glass or
unbreakable polycarbonate Jar on the top having
minimum capacity of 2 Ltr each fitted with rubber
airtightlids and having overflow safety device.
6. Should have a motor of minimum ½ HP capacity
singlephase 1440 RPM with control knob.
7. Should have vacuum at least between 100 mmHg to
atleast 575 mm Hg ± 10 regulable with vacuum control
knob.
8. Should be mounted on 4 castor wheels, nylon
material, heavy duty, movable in all directions.
of communication
(wherever required)
3.3 Noise (in dBA) Noise free operation
Heat dissipation NA
3.4
4. ENERGY SOURCE
4.3 Protection NA
5.1 Accessories (mandatory, Collection bottles, clear unbreakable jar (one set extra)
standard, optional); Spare
parts (main ones);
Consumables/ reagents
6.1 Atmosphere/Ambiance Capable of operating continuously in ambient
(air conditioning, temperatureof -10 to 60 deg C and relative humidity of
humidity, dust...) upto 90% in ideal circumstances.

issues
3. Should comply with USFDA/European CE
standardsincase of non-availability of BIS standards.
requirementsof electrical safety standards
requirements: nature, electricalaccessories as per Indian standard set-up
8.2 Requirements for sign-off Supplier to perform installation, safety and operation
paramedical, technicians) shallbe provided.
OPTIONAL (Depending
upon scope of work
order)
eachquarter
10. DOCUMENTATION
Operating manuals, User, technical and maintenance manuals to be
10.1 service manuals, other suppliedin English/Hindi language along with machine
manuals diagrams.
documents
11. NOTES
11.1 Service Support Contact details of manufacturer should be provided.
Contact details
(HierchyWise; including
a toll
11.2 Recommendations or Any recommendations for best use and
warnings supplementarywarning for safety should be declared.
PATIENT STRETCHER
Version no. : 02
institution)
NAME AND CODING
GMDN name -
GMDN code -
GENERAL
1. USE
1.1 Clinical purpose A patient trolley is a bed on wheels for moving patient in hspitals.
1.2 Used by All Departments

clinical
department/wa
rd
TECHNICAL
2.1 Technical 1. Overall Dimension: 1985 mm (L) x 610 mm (W) x 810 mm (H).
characteristics (Specific to this type of
(specific to this 2. Frame work:
type of device)
• Vertical member- Thickness of tube Cut size diameter of
tubing pipe- 18 Gauge 31.75mm
• Horizontal member - 18 Gauge 31.75mm
3. Removable stretcher made of curved CRCA Sheet 20 SWG
supported on tubular frame having steel supports under the sheet.
4. Wheels: 4 Nos. swivel caster wheels are fitted in front and rear
side of the wheel 150mm diameter x 38mm with plug diameter
32.5mm fitted with thrust bearing and solid rubber wheels with
sleeve 21mm thick fork 10 SWG zinc plated. King pin is 14.5mm;
length of plug is 65mm inclusive of collar.
5. Handle should be made of SS-304.
6. All the steel components should be pre-treated for de-greasing.
de-rusting and phosphating. After proper pre-treatment, the steel
components should be epoxy powder coated and oven baked at
temp. Above 200 °C to provide scratch resistance surface coating
film thickness 45-50 microns
2.2 Settings NA
2.3 User’s interface NA
standard of
communication
(wherever
required)
3.1 Dimensions NA
(metric)
Noise (in dBA), NA
3.4 heat
dissipation
3.5 Mobility, Mobile
portability
4. ENERGY SOURCE
4.1 Power NA
Requirements
4.3 Protection NA
4.4 Power NA
consumption
5.1 Accessories NA
(mandatory,
standard,
optional)
Spare parts
(main ones)
Consumables /
reagents (open,
closed system)
6.1 Atmosphere / NA
Ambiance (air
conditioning,
humidity, dust
...)
6.2 User’s care, Easy to clean and maintain.
Cleaning,
Disinfection &
Sterility
issues
requirements:
nature, values,
quality, tolerance
8.2 Requirements NA
for sign-off
(medical,
paramedical,
technicians)
10. DOCUMENTATION
manuals, User, technical and maintenance manuals should be supplied
service in English/Hindi language along with machine diagrams.
manuals,
other
manuals
10.2 Other NA
accompanying
documents
11. NOTES
11.1 Service Contact details of manufacturer and supplier should be provided..
Support
Contact details
(Hierarchy
Wise; including
a toll free/
landline
number)
11.2 Recommendati Any recommendations for best use and supplementary warning for
ons or safety should be declared
warnings
Wheelchair
Version no.: 02
NAME AND CODING
GMDN name Wheel Chairs
GMDN code(s) 14449
GENERAL
1. USE
1.1 Clinical purpose Chairs mounted on large wheels, designed for indoor (e.g.,
hospital, institution, home) or outdoor transportation of
patients or individuals with impaired walking ability.
1.2 Clinical department/ward All Department
TECHNICAL
2.1 Technical characteristics 1. Overall size 670 mm W x 1120mm D x 920 mm H.
2 Should be made of 16-gauge SS 304 grade tube frames
and 16-gauge SS 304 sheet for seat & back rest.
3. Should have a fixed arm rest.
4. Should have Reticulated and breathable cushion.
5 Should have minimum 6 swivel nylon caster front wheel,
24" bicycle type rear wheel with pneumatic tyre.
6. Two handles are provided with hand grips.
7. Back wheel fixing bolt shall be covered with cup type
nut.
8. Should have braking system on both side.
9. All pipes & Footrest should be made of aluminum
2.3 Software and/or standard of NA
communication
4. ENERGY SOURCE
4.3 Protection NA
standard, optional)
6.1 Atmosphere/Ambiance (air NA
conditioning, humidity, dust ...)
6.2 User's care, Cleaning, Easy to clean

Disinfection &
Sterility issues
7.1 Certificates (pre-market, Should conform to ISO 13485 quality standards.
sanitary, ..); Performance and
safety standards (specific to
the device type); Local and/or
international
tolerance
8.3 Training of staff (medical, NA


10. DOCUMENTATION
10.1 Manuals NA

Documents
11. NOTES
11.1 Other information NA
11.2 Recommendations NA
or Warnings
GLUCOMETER
Version no.: 02
NAME AND CODING
GMDN name Glucose self-testing
GMDN code(s) CT296
GENERAL
1. USE
1.1 Clinical purpose It intended to be used together for testing, either at the
point-of-care or in self-testing by a layperson, for the
quantitative measurement of glucose and/or ketones in a
whole blood clinical specimen.
1.2 Clinical department/ward All
TECHNICAL
2.1 Technical characteristics 1. Should be open system having compatibility with any
make of available glucose strips in open market.
2. Should have LCD display screen and auto shut off
feature when not in use.
3. Display of the sugar reading should be in mg/dl.
4. Should have reading range/linearity from 20 to 700
mg/dl.
5. Should have a maximum reading time of less than 10
seconds
3. Should be supplied with autoinjector pen and
disposable lancets.
4 Should have the feature of automatic code detection of
glucose strips.
5. Should have a minimum memory of 100 tests
2.2 User's interface LCD
2.3 Software and/or standard of Inbuilt
communication
3.1 Dimensions (metric) Handheld Device
3.2 Weight (lbs, kg) Handheld Device
3.5 Mobility, portability Handheld Device

4.1 Power Requirements Battery powered
4.2 Battery operated 3-volt lithium coin cell battery or 2 x (AAA) Alkaline
Batteries
4.3 Protection NA
5.1 Accessories (mandatory, Glucose strips (able to use capillary blood samples) with
standard, optional) availability in local market
conditioning, humidity, dust ...) temperature of -10 to 60 deg C and relative humidity
upto 90%.

Disinfection &
Sterility issues
safety standards (specific to 3. Should comply with USFDA/European CE standards in
the device type); Local and/or case of non-availability of BIS standards.
tolerance
8.3 Training of staff (medical, User training should be provided.
10. DOCUMENTATION
10.1 Operating manuals, service User, technical and maintenance manuals should be
manuals, other manuals supplied along with machine diagrams
Documents
11. NOTES
11.1 Other information Contact details of manufacturer and supplier should be
provided.
11.2 Recommendations NA
or Warnings
Stethoscope
Version no.: 02
NAME AND CODING
GMDN name Stethoscopes, Mechanical
GMDN code(s) 13755
GENERAL
1. USE
1.1 Clinical purpose Listening to sounds from the heart, lungs, and/or
gastrointestinal tract.
1.2 Used by clinical All
department/ward
2.1 Technical 1. Should have single lumen binaural.
characteristics(specific 2. Latex free Polyvinyl chloride (PVC) stethoscope
to this type of device) tubing, soft and should not harden/crack.
3. Tube should be impervious to outside noises.
4. Earpieces (02) should be with soft sealing ear tips and
easy to stay fixed in ears.
5. Earpiece material: Soft PVC/Silicone preferably.
6. Should have good quality and highly sensitive
fixed/floating diaphragm.
7. Dual head: Cup/ bell for low frequency sounds,
sensitive membrane for skin contact.
of communication (where
ever required)
3.1 Dimensions (metric) Tube length – 55 cm minimum
4. ENERGY SOURCE
4.3 Protection NA
5.1 Accessories& Spares 1 x spare set of earpiece, 1 x spare diaphragm.
Consumables / reagents
6.1 Atmosphere / Ambiance NA
(air conditioning,
humidity, dust ...)
6.2 User's care, Cleaning, NA
Issues
8.2 Requirements for sign- NA
off
8.3 Training of staff (medical, NA
9.1 Warranty 1 year
10. DOCUMENTATION
10.1 Operating manuals, NA
service manuals, other
manuals
documents
10.3 Recommendations for NA
maintenance
11. NOTES
11.1 Service Support Contact NA
details (Hierchy Wise;
including a toll free/ landli
number)
warnings
(ICU BED- MECHANICAL, HANDLE OPERATED)
Version no.: 01
Done By: HCT/NHSRC
NAME AND CODING
GMDN Name Hydraulic Hospital Bed
GMDN Code 34871
GENERAL
1. USE
ICU beds are special hospital beds designed for ICUs totake
1.1 Clinical Purposes care of critical patients. ICU beds facilitates comfortable transfer
to and fro and has a provision of bedside diagnostic including
X-ray investigations. Thus, they provide safety, comfort and
convenience to the patients and caregivers alike.
Used by clinical ICU (Intensive Care Unit)

1.2 department/ward
TECHNICAL
Technical 1. Should have 4 sections and sectional mattress with
Characteristics perforated top.
2. Should have 4 separate mechanical operating
function (Screw Lever mechanism) for Height
adjustment (Hi- Low), Back rest, Knee rest and
Trendelenburg/Reverse Trendelenburg.
3. Should have PPE head and foot board fixed/
detachable on the bed frame; 4 PPE side boards with
2.1 360-degree swivel mechanism/push button
mechanism for operation.
4. Should have four section lying surface, three made
of robust materials and having microbe free material &
joined by corrosion resistant joineries.
5. The bed frame should be made of stainless-steel SS
(304) with epoxy coating and should be easy to
disinfect and maintain.
6. The bed should be radiolucent for using portable X-
rays and supporting accessories like attaching urine
bags and bed pans.
7. Should have indicator for correct height to operate
Trendelenburg/Reverse Trendelenburg.
8. Clearance between Bed Base frame and Floor surfaceshould
be having adjustable range in mm: 120-150 mm.
9. Should have Back Rest angular movement in range from 0-
70o (degree) and Knee rest angular movementin range from 0-
45o (degree).
10.Should have Ergonomically designed detachable
plastic/Stainless steel handles having outward locking
mechanism. Handles are self-locking with a knob with aNylon
grip.
11. Should have a therapeutic Weight bearing up to 150-200 Kg.
12. Should have heavy duty roller casters made up of
Stainless Steel (304) ball bearing/ABS/Polyester with dual
locking arrangement.
13. High density foam mattress washable and detachable
in 4 parts.
2.2 User's Interface Manual
Software and/ or NA
standard of
2.3 communication
(wherever required)
3. PHYSICAL CHARACTERISTIC
3.1 Dimensions (in cm) NA
3.2 Weight To be specified by the Manufacturer/Supplier;

3.3 Noise NA
3.5 Mobility/Portability Should be easily movable with minimal physical effort.
4. ENERGY SOURCE
4.1 Power inputs NA

Battery backup NA
4.3
5. ACCESSORIES. SPARE PARTS AND CONSUMABLES
Accessories,(mandat 1. Should be provided with Saline Stand made of StainlessSteel
5.1 ory, Standard, SS (304) grade.
operational); 2. Telescopic Saline Stand with two hooks with a provisionto fix
Spare parts (main on all four corners of the beds and also in the middle of the bed
on either side.
ones)
Consumable/reagent 3. Mattress with cross sectional thickness of (100mm-
s (open, closed 250mm) with rexin cover as per the specs specified in
Section (2.1)
system)
4. Oxygen Cylinder holder should be provided
detachable handles of plastic/SS (304) material/ABSwith a Nylon
grip.

Atmosphere NA
6.1 /Ambiance (air

conditioning,
humidity, dust ...)
User’s care, Easy to clean and disinfect.

6.2 Cleaning,
Disinfection &
Sterility issues

Performance and 3. Should comply with USFDA/European CE standards incase of
safety standards non-availability of BIS standards.
7.1 (specific to the 4. Should conform to ISO 13485 quality standards.
device type); Local

Pre-installation NA
8.1 values,
quality, tolerance
Requirements for Supplier to perform safety and operation check before hand over.
8.2
sign-off
Training of staff Training of User on operation and basic maintenance.
(medical,
8.3 paramedical,
technicians)

Warranty 3 years including all spare parts and accessories.
9.1
10. DOCUMENTATION
manuals, service 1. User, technical and maintenance manuals should be supplied
manuals, other in English/Hindi language along with machine diagrams.
provided.
10.1
government hospital
10.2 Other accompanying List of essential spares and accessories with their part number
documents and cost.
11. NOTES
Service Support Contact details of manufacturer and supplier to be provided.
Contact details
(Hierarchy Wise;
including a toll
11.1 free/landline
number)
warnings
Multipara Monitor
Version no. : 02
NAME AND CODING
GMDN name Patient Monitors/Monitoring Systems.
GMDN code(s) CT1444
GENERAL
1. USE
1.1 Clinical purpose Designed to continuously measure and display
multiple vital physiological parameters of patients,
especially those under critical care.
1.2 Clinical department/ward All Departments
TECHNICAL
2.1 Technical characteristics 1. Multichannel (up to 12 leads) ECG measurement
and selectable display of upto 5 leads at a time.
2. Temperature probe to be reusable, external skin
contact type. Temperature range at least 30 to 40 deg
C, minimum gradation 0.1 deg C.
3. Heart rate measurement range to be at least 30 to
250 bpm, with accuracy better than ± 5 bpm and
minimum gradation 1 bpm.
4. SpO2 measurement range at least 40-70 % and 70
to 99 %, with accuracy better than ± 1% for 40-70 range
and better than ± 3% for 70-99 range and minimum
gradation 1%.
5. Blood pressure monitoring range at least 30 to 300
mmHg, minimum gradation 1 mmHg.
6. Respiration rate measurement range at least 0 to 100
bpm, minimum gradation 1 bpm.
7. Trend display of each parameter over at least
previous 24 hours to be selectable.
8. LCD screen for displaying all parameters.
9. Audio Visual alarms required: high and low levels for
each parameter (operator variable settings), sensor /
wire / probe disconnected, low battery.
2.2 User's interface LCD display
communication
3.1 Dimensions (metric) Screen size minimum: 8”X6”.
3.3 Noise (in dBA) <50dB.
3.4 heat dissipation Should maintain nominal temperature and the heat
should be disbursed through an exhaust cooling fan
4. ENERGY SOURCE

4.3 Protection Electrical protection provided by fuses in both live and
neutral supply lines
4.4 Power consumption To be specified by manufacturer
5.1 Accessories (mandatory, 2 pairs, 12 lead ECG cable. 5 sets of ECG connection
standard, optional) electrodes (if reusable type). 5 lead ECG cable. Two
reusable SpO2 probes for infant use. Two reusable
neonatal cuffs. Two external skin temperature probes.
Consumables/reagents Two sets of spare fuses (if non-resettable fuses used).
(open, closed system) 5 tubes electrode gel (if required).
6.1 Atmosphere/Ambiance (air Operating condition: – Capable of operating
conditioning, humidity, dust continuously in ambient temperature of -10 to 60
...) deg C and relative humidity of upto 90%.

Disinfection &
Sterility issues
andsafety standards 3. Should comply with USFDA/European CE
(specific to the device standards incase of non-availability of BIS
type); Local and/or standards.
requirements: electrical accessories as per Indian standard set-up.
nature,
hand over.

each quarter.
10. DOCUMENTATION
10.1 Operating manuals, service 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 language along with
machine diagrams.
2. Service and operation manuals (original and Copy)
to be provided.
3. Satisfactory certificate for any existing installation
from government hospital
10.2 Other accompanying List of essential spares and accessories, with their par
Documents number and cost.
11. NOTES

OT TABLE
Version no.: 02
Done by: (name / institution) HCT/NHSRC
NAME AND CODING
GMDN name Operation table
GMDN code NA
GENERAL
1 USE
1.1 Clinical purpose An operating table, sometimes called operating room
table, is the table on which the patient lies during a
surgical operation. This surgical equipment is usually
found inside the surgery room of a hospital.
1.2 Used by clinical Operation theatre
department/ward
TECHNICAL
2 TECHNICAL CHARACTERISTICS
2.1 Technical characteristics 1) Should have OT Table type base made of high
(specific tothis type of quality304 stainless steel with double table, split
device) leg type and can take x ray photography.
2) Should have imported Y type sealing ring with
good sealing performance and durability.
3) Should have a Rotary brake device which is
easy for moving operating table.
4) Base is stainless steel.
5) Leg board is separated & dischargeable.
6) Inclining forward ≥30°
7) Inclining backward ≥25°
8) Inclining leftward≥20°
9) Inclining rightward≥20°
10) Back board folding upward ≥45˚ Fold downward ≥90°
11) Headboard folding upward ≥80°Folding downward
≥10°
12) Leg board Folding downward ≥90°.
13) Fold outward ≥90°.
14) Waist board elevation ≥120°.
15) The table top must be made of durable radiolucent
Bakelite material capable of withstanding exposure
to frequent C-Arm imaging, without diminishing the
Image clarity
standard of
communication
(wherever required)
3.5 Mobility, portability NA
4 ENERGY SOURCE
4.3 Protection NA
5 ACCESSORIES, SPARE PARTS, CONSUMABLES
5.1 Accessories 1) Shoulder support (1 pair)
(mandatory, standard, 2) Waist Support (1 pair)
optional); Spare parts 3) Arm rest (1 pair)
(main ones); 4) Leg holder (1 pair)
Consumables / reagents 5) Screen Frame (1 Piece)
(open, closed system) 6) Foot Plate (1 Pair)
BIDDING / PROCUREMENT TERMS /
DONATION REQUIREMENTS
6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS
6.1 Atmosphere / Ambiance Capable of operating continuously in ambient temperature
(air conditioning, of -10 to 60 deg C and relative humidity of upto 90% in
humidity, dust ...) ideal circumstances.
6.2 User’s care, Cleaning, To be specified by manufacturer.

Disinfection &Sterility
issues
7 STANDARDS AND SAFETY
sanitary, 2. Should comply with BIS standards.
..); Performance and 3. Should comply with USFDA/European CE standards
safety standards in case of non-availability of BIS standards.
type); Local and/or 5. Should conform to IEC 60601-1 General requirements
international of electrical safety standards.
8 TRAINING AND INSTALLATION

requirements: nature, accessories as per Indian standard set-up.
values, quality,
tolerance
hand over.
8.3 Training of staff (medical, Training of users on operation and basic maintenance;
9 WARRANTY AND MAINTENANCE
10 DOCUMENTATION
10.1 Operating manuals, Should provide 2 sets (hardcopy and soft-copy) of:-
service manuals, 1) User, technical and maintenance manuals to
othermanuals be supplied in English/Hindi language along
with machine diagrams.
2) Service and operation manuals (original and copy)
to be provided.
3) Advanced maintenance tasks documentation.
documents numbers and cost;
11 NOTES
11.1 Service Support Contact details of manufacturer, supplier and
Contact details local service agent to be provided.
(Hierarchy Wise;
including a toll
11.2 Recommendations or Any warning signs would be adequately displayed
warnings
OT LIGHT (SHADOWLESS LAMP CEILING TYPE MAJOR)
Version no.: 02
NAME AND CODING
GMDN name Shadowless lamp ceiling type major
GMDN code(s) NA
GENERAL
1. USE
1.1 Clinical purpose Luminescence shadow less lamp adopts light sources
different positions for focus to eliminate shadows of
different parts of medical workers.
1.2 Clinical department/ward Operation Theater
TECHNICAL
2.1 Technical characteristics 1) Double dome
2) Intensity Control in 9 steps for individual domes
3) Height Adjustment :600mm
4) Action Radius :1850mm
5) Possible Movements: Radial, Angular & Axial
6) Colour Temperature :4500K and above
7) LED technology: minimum 40,000 hours lamp life
8) Intensity, brightness, contrast and power switch to be
made available on handle/wall-check.
9) Focal distance(d1+d2) =0.8 to 1.2 m
10) Temperature rises on the keep of surgeries to be less
than 10°
11) CR± approx. 95 or more
12) 360° rotation for both arms
2.3 Software and/or standard of NA
communication
3.4 heat dissipation Heat Dissipation: Should maintain nominal temperature
and the heat should be disbursed through an cooling
mechanism
3.5 Mobility, portability Stationary

4.3 Protection NA
standard, optional)
upto 90%.
6.2 User's care, Cleaning, Easy to clean and maintain.

Disinfection &
Sterility issues
sanitary, ..); Performance and
safety standards (specific to
the device type); Local and/or 3. Should comply with USFDA/European CE standards
international incase of non-availability of BIS standards.
5. Should conform to IEC 60601-1 General requirements
of electrical safety standards.
nature, values, quality, accessories as per Indian standard set-up.
tolerance
8.2 Requirements forsign-off Supplier to perform installation, safety and operation
paramedical, technicians) should be provided

10. DOCUMENTATION
10.1 Manuals Should provide 2 sets (hardcopy and soft-copy) of:-
1) User, technical and maintenance manuals to be supplied
in English/ Hindi language along with machine diagrams.
11. NOTES
11.1 Other information Contact details of manufacturer, supplier and local service
11.2 Recommendations Any warning signs should be adequately displayed

or Warnings
ANAESTHESIA WORKSTATION
Version no.: 02
Done by:(Name/Institution) HCT/NHSRC
NAME AND CODING
UMDNS name
UMDNS code(s)
GENERAL
1 USE
1.1 Clinical purpose Devices that continuously or intermittently administer a mixture
of gases (e.g., oxygen, nitrous oxide, the vapor of a volatile liquid
such as halogenated hydrocarbon), varying the proportion of
gases in order to control an individual’s level of consciousness.
These devices are also designed to facilitate spontaneous,
controlled, or assisted ventilation with these gas mixtures. An
anesthesia unit is typically comprised of four basic subunits: a
gas supply and controlcircuit, breathing and ventilation circuit, a
scavenging system to help prevent the escape of exhaled gases,
and a set of function and breathing circuit monitors (e.g.,
inspired oxygen concentration, breathing circuit integrity).
1.2 Used by clinical Operation Theatre

department/ward
TECHNICAL
2 TECHNICAL SPECIFICATIONS
2.1 Technical Flow Management:
characteristics 1. Should be compact, ergonomic and easy to use.
(Specific to thistype of 2. Machine should provide electronic gas mixing.
device)
3. Multi color TFT display of at least 15”size, with virtual
meters forO2, N2O or Air.
4. Dual flow sensing capability at inhalation and exhalation
ports.
5. Should have backup02control which provides an
independentfresh gas source and flow meter control in
case of electronic failure.
6. Gas regulators (flow control valves) shall be of
modulardesign/ graphic display.
7. All pipeline connections should have diameter-
indexed safety systems (DISSs) or another means of
preventing connection of dangerous gases.
8. System should permit connection of atleast two
yokes, one dedicated to 02 cylinder to meet clinical
needs during failure ofpipeline supply. All cylinder
yokes (regardless of the gas forwhich they are
intended) should include pin-index safety systems to
prevent connection of dangerous gases.
9. Hypoxic guard to ensure minimum 25% 02 across all
02-N2O mixtures and Oxygen failure warning.
Breathing System:
1. Latex free fully autoclavable/ disposable with
minimal flowof 250 ml of 02.
2. Sensor should not require daily maintenance.
3. Bag to vent switch shall be bi stable and
automaticallybegins mechanical ventilation in
the ventilator position.
4. Adjustable pressure limiting valve shall be flow and
pressure compensated.
Vaporizers:
1. Provision to mount following selectable vaporizers
such asDesflurane, halothane, isoflurane,
sevoflurane with interlocking facility to allow use of
only one vaporizer at a time.
2. All the vaporizers should be temperature,
pressure andflow compensated vaporizers and
maintenance free.
Ventilation:
1. The workstation should have an integrated anesthesia
ventilator system.
2. It should have the following Ventilation modes
Manual/spontaneous, VCV, PCV, SIMV or pressure
support,advanced modes.
3. Tidal volume: A control adjusts the volume of
individualbreaths within range of 20-1,500 cc.
4. Minute volume: A control adjusts the total
inspiratory volume- per-minute delivery from the
bellows shall be >20L/min.
5. The respiratory frequency can be set within
range of 5-60 breaths per minute.
6. Inspiratory flow: The flow range of gas that the
ventilatoris capable of delivering to the patient
shall be 0-180 L/min.
7. Pressure limit shall be adjustable and <70
preferred cmH2O. Unit should have PEEP of 0-
20 cm H2O.
8. The workstation should be capable of delivery of
low flow anesthesia.
Anesthesia Monitoring Specifications:
1. Monitoring of vital parameters: ECG, NIBP,
SPO2, andInvasive Blood Pressure.
2. Twin temperature measurement with skin
and coretemperature
probes — Two sets with each monitor.
3. Automatic identification and measurement of
anestheticagents EtCO2, 02, and N2O and MAC
value. FiO2 measurement.
3. Facility to store snapshots during critical
events forwaveform review at a later stage.
4. Audio visual and graded alarming system.
Display of Ventilator:
Mode of ventilation to be displayed, Respiratory
rate, flow,pressure also to be displayed.
2.2 User Interface Manual
2.3 Software and/ or Inbuilt
standard of
ever Required)
3 PHYSICAL CHARACTERICSTICS
3.3 Noise (in dBA) Noise pressure level: <60 dbA.
3.4 Heat dissipation Should maintain nominal temperature and the heat should
be disbursed through a cooling mechanism.
4. ENERGY SOURCE
4.1 Power 220 +/- 10% VAC, 50 Hz
4.2 Battery operated Yes, at least 30 minutes back up.
4.3 Protection Stabilizer to be provided for protection.
4.4 Power To be specified by service provider.
consumption
5. ACCESSORIES, SPARE PARTS AND CONSUMABLES
5.1 Accessories, 1. Circle absorber — 01 No.
2. Vaporizer Halothene — 01 No.
standard, 3. Vaporizer Desflurane — 01 No.
optional); Spare 4. Vaporizer isoflurane — 01 No.
parts (main ones);
5. Vaporizer sevoflurane — 01 No.
Consumables/re-
agents (open, 6. Adult and Pediatric autoclavable silicone breathing
closed system) circuits —2each.
7. Reusable IBP cable -04.
8. Humidifiers — 1 No
9. Disposable transducer — 100
10. Temperature Probe Skin reusable — 02.
12. Temperature core reusable -04 (02-Adults, 02-
paediatrics)
13. Depth of anesthesia sensors — 50
14. Accessories for neuromuscular transmission monitor -
01 set.
15. Standard accessories to make all parameters working -
01 set.
16. Disposable adult and pediatric circuit — 50 each.
17. HME Filters — 1000 nos
18. Vital parameter accessories (ECG Leads — 5
sets, NIBPCuffs all sizes) -01 set.
19. Spo2 probes both adult and pediatric 2in no should be
suppliedwith each machine.
20. EtCo2 sampling line and connector should be supplied 25
no each with apparatus.
6.1 Atmosphere/Ambience Capable of operating continuously in ambient
(air temperature of -10to 60 deg C and relative humidity of
conditioning, humidity, up to 90% in ideal circumstances.
dust. ..)
6.2 User’s care, To be specified by manufacturer.
Cleaning,
Disinfection &
Sterility issues
7 STANDARDS AND SAFETY
market, sanitary,..); 2. Should comply with BIS standards.
Performance andsafety 3. Should comply with USFDA/European CE standards
standards (specific to incase ofnon-availability of BIS standards.
the device type); Local 4. Should conform to ISO 13485 quality standards.
and/or 5. Should conform to IEC 60601-1 General
International requirements ofelectrical safety standards.
8 TRAINING AND INSTALLATION
8.1 Pre- installation To be specified by manufacturer and compatible
requirements: electricalaccessories as per Indian standard set-
nature, values, quality, up
tolerance
8.2 Requirements forsign- Supplier to perform safety and operation check before
off hand over.
8.3 Training of staff Training of users in operation and basic
(medical, paramedical, maintenance shallbe provided.
technicians)

quarter
10 DOCUMENTATION
manuals, 1. User, technical and maintenance manuals should be
set manuals, other suppliedin English/Hindi/ Regional language along
manuals with machine diagrams.
2. Service and operation manuals (original and
Copy) to beprovided.
4. Satisfactory certificate for any existing
installationfrom government hospital.
11 NOTES
11.1 Service Support Contact Contact details of manufacturer, supplier and local
details (Hierarchy Wise; service agentto be provided.
including a toll
free/landline
number)
Warnings
SURGICAL DIATHERMY (ELECTROSURGICAL UNIT)
Version no.: 02
Done by: (name. Institution) HCT/NHSRC
NAME AND CODING
UMDNS name Electrosurgical Unit
UMDNS code(s) NA
GENERAL
1. USE
1.1 Clinical purpose Diathermy uses an electric current to produce heat deep
inside a targeted tissue. It can reach areas as deep as
two inches from the skin’s surface.
The diathermy machine does not apply heat directly to
the body. Instead, the current from the machine allows
the body to generate heat from within the targeted
tissue
1.2 Used by clinical OT
department/ward
TECHNICAL
2. TECHNICAL CHARACTERICSTICS
2.1 Technical characteristics 1) Facility for Monopolar, Bipolar and underwater cutting.
(Specific to this type of 2) Monopolar cutting and coagulation
device) 3) Micro-processor-based technology
4) Monopolar cut in minimum 3 modes
5) Bipolar coagulation in 3 or more modes (forced
coagulation, spray coagulation and soft coagulation)
6) Blending of cutting and coagulation -in minimum 2
levels
7) Automatic cut-off technology with self check on every
start.
8) Foot and hand switch
9) Auto monitoring and display of set parameters
10) Touch-controlled interface to set parameters
11) 4 or more programmable memory
12) Simultaneous use of Monopolar and Bipolar
Coagulation.
13) Output Power of 300 Watt(Minimum)
14) Monopolar Cutting and Coagulation power adjustable
from 0-300 Watt
15) Bipolar Coagulation power adjustable from 0-50 W,
Micro Power Range- 0.1-to-9.9-Watt increment of 0.1
Watt, Macro Power range from 1-50 Watt increment of 1
Watt
16) Audio-Visual Alarm for disconnection of Neutral Plate
2.3 Software and/ or standard of Inbuilt
ever required)
3. PHYSICAL CHARACTERICSTICS
3.3 Noise (in dBA) Noise pressure level: <60 dbA.

4. ENERGY SOURCE
4.1 Power 220 +/- 10% VAC, 50 Hz
4.3 Protection NA
4.4 Power consumption To be specified by Manufacturer
5.1 Accessories, 1) Power cord :1pc
standard, optional); Spare 2) Electrode lever:1pc
parts (main ones);
Consumables/reagents 3) Electrode:2sets
4) Collective electric bulb: 2pcs switch
5) Trolley: Foot switch
6) Reusable electrode handle
withcutting/coagulation switch
7) Disposable REM plate
8) Cable for electrode handle
9) Neutral plate for adults and pediatric
6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS
6.1 Atmosphere/Ambience (air Capable of operating continuously in ambient
conditioning, humidity, temperature of -10 to 60 deg C and relative humidity of
dust…) upto 90% in ideal circumstances.
6.2 User’s care, Cleaning, To be specified by manufacturer

issues
sanitary,..); Performance and 2. Should comply with BIS standards.
the device type); Local and/or 4. Should conform to ISO 13485 quality standards.
international 5. Should conform to IEC 60601-1 General
requirementsof electrical safety standards.
8. TRAINING AND MAINTENANCE
8.1 Pre- installation To be specified by manufacturer and compatible electrical
Training of staff (medical, Training of users in operation and basic
8.3 paramedical, technicians) maintenanceshall be provided.
• Preventive Maintenance visits at least once
ineach quarter
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
shouldbe supplied in English/Hindi/ Regional
language along with machine diagrams.
2) Advanced maintenance tasks documentation.
3) Satisfactory certificate for any
existinginstallation from government
hospital.
10.2 Other accompanying List of essential spares and accessories, with their
documents partnumber and cost;
11. NOTES
11.1 Service Support Contact details of manufacturer, supplier and local
Contact details service agent to be provided;

warnings
BLOOD WARMER
Version no.: 01
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERAL
1. Use
1.1 Clinical purpose A blood warmer is used to warm blood or other fluids,
minimizing the risk of hypothermia.
1.2 Used by clinical Emergency, ICU
department/ ward
TECHNICAL
2.1 Technical characteristics 1. Should be able to warm blood at a temperature
(specific to this type of range of 37˚C – 40˚C with control knob.
device)
2. Should be able to maintain or warm blood/fluid
at a flow rate of 2.5 L/min.
3. It should have digital temperature display of
fluid.
4. Should use inbuilt water tank /dry heat
technology / counter current heat exchanger
technology to warm the infused fluid/blood.
5. Should be able to attach to IV set.
6. Should have a digital display of temperature.
7. Audio visual alarms for disconnections and over
temperature must be present.
8. Should be compatible for both adult and
Paediatric patients.
2.3 User's interface NA

of communication
(wherever required)

3.3 Noise (in dba) NA
4. Energy source
4.3 Protection NA
5.1 Accessories (mandatory, At least 80 disposable tubing set for adults and 20 for
standard, optional) pediatrics should be supplied.
6.1 Atmosphere / ambiance (air Capable of operating continuously in ambient
conditioning, humidity, dust temperature of -10 to 60 deg C and relative humidity of
...) upto 90% in ideal circumstances.
6.2 User's care, cleaning, Easy to clean and maintain
issues
sanitary, ..); performance 2. Should comply with BIS standards.
and safety standards 3. Should comply with USFDA/European CE
(specific to the device type); standards in case of non-availability of BIS
local and/or international standards.

requirements: nature, electrical accessories as per Indian standard set-up
hand over
each quarter.
10. Documentation
manuals, other manuals 1. User, technical and maintenance manuals should be
supplied in English/Hindi language along with machine
diagrams.
to be provided.
documents number and cost.
11. Notes
11.1 Service support contact Contact details of manufacturer, supplier and local
details (hierchy Wise; service agent to be provided.
including a toll free/landline
number)
11.2 Recommendations and Any warning sign should be adequately displayed.
Warnings
RADIANT WARMER
Version no. : 02
NAME AND
CODING
GMDN name
GMDN code(s)
GENERAL
1. USE
1.1 Clinical purpose Infant Radiant warmer is an electrically powered
device with a radiant heating source intended to
maintain the thermal balance of an infant by direct
radiant of energy in the infrared region of the
electromagnetic spectrum.
1.2 Used by clinical Neonatal ICU/ SNCU
department/ ward
TECHNICAL
2.1 Technical characteristics 1. It should be microcontroller chip based radiant
(specific to this type of warmer with manual and servo options.
device) 2. It should have the facility to display skin set, skin
observed temperature in degree C and heat power
separately.
3. Should have user friendly touch panel control.
4. It should have ceramic or quartz infrared or calrod
heater.
5. It should have audiovisual alarm facility for
overheating beyond set temperature range.
6. It should have an alarm facility for patient
temperature less than or greater than the required
temperature i.e.above or below the set range.
Machine should sense the skin probe failure and cut
off the heater.
7. The warmer head should be rotatable in different
direction, so as to allow taking X-ray.
8. It should have an alarm for probe failure, power
failure, system failure and heater failure.
9. Observation light of 90-to-100-foot candles or
1000Lux (color temperature range 3700K to
5100K) should be provided for inspection.
10. Battery backup for Power failure indication during
power fail.
11. The desired temperature range from 25 to 40
degree C and settable temperature can be from
32 to 38 degC.
12.The resolution should be 0.1 degree C and accuracy
should be 0.2 °C.
13 Should have a facility to lock the keyboard to avoid
unwanted user modification of the set parameters.
14. The height of the warmer should be adjustable for
different types of bed.
15. It should have separate bassinet trolley, bed should be
tiltable and have provision for x-ray cassette holder,
Mattress foam density should be minimum 25 kg/cm3,
transparent collapsible side walls easily detachable for
cleaning. Mattress size should be minimum 20"X30".
16. Should have a Feather Touch operation with large
digital display and comprehensive alarms. Control
Panel should be liquid proof and allow easy and
hygienic disinfection.
17. Manual Mode can adjust Heater Output 10 -100 %,
with 10% increment, an auditory and visual alarm
shall be given at least every 15 min.
18. In manual mode, heater cut off / switch off, if the
maximum irradiance at any point of the mattress area
exceeds a total irradiance level of 10 mW/ cm2
(between 10 to 30 minutes).
19. Bed should be about 80 - 100 cms from the Floor and
80-90cms from the heat source.
20. Should have lockable castor wheels.
21. Green indicator light shall be provided to indicate
that warmer is ready for normal use.
22. Markings on the bassinet and X-Ray cassette
holder is mandatory to enable proper positioning
of the baby while doing the X-Ray.
23. The size of the drop-down sides should be such that it
is 5" above the mattress surface and should be at
least 6mm thick; clear and transparent.
24. If there is more than 60% heater output for 10
minutes it should cutoff with alarm.
25. For the purpose of cable management there should be
at least two number of tubing ports (edges covered by
silicon rings) on the side walls. The height of the side
walls should be minimum 110mm over the mattress.
26.X-Ray cassette tray should be at least 750X350mm
and should adopt up to 20mm thick X-Ray cassette.
27. The bay bed should be crevice free for ease of cleaning,
infection control.
28. The mattress used should be of biocompatible material.
29. Thermistor based skin temperature probe should be
small in size not more than 10mm diameter and 3-4mm thick
to fix the probe firmly on the infant. Baby contact material
should be biocompatible as per ISO 10993 standard
requirement. It should be insulated on one side and have
well conducting non-rusting, non-reacting metallic surface
on the other side. Probe wire should bepliable, thin and soft.
The attachment site of the probe with the wire should also
be pliable and non-stiff.
2.2 Settings 1. Should have Manual mode and Baby (Servo) mode
settings.
2. Mode of operation should be clearly displayed.
3. In servo mode baby set temperature should be 32 to 38
deg C.
2.3 User's interface Manual and Servo controlled temperature regulation.
2.4 Software and/or LED Display and inbuilt software; Interruption and
standard of restoration of the power supply does not change the preset
communication (where values.
ever required)
2.5 Others 1. Device shall not overbalance when placed in any
transport position of normal use on a 10° inclined plane
from the horizontal plane.
2. Transformers of device shall be protected against
overheating in the event of short circuit or overload of any
output winding.
3. Patient leakage current should be less than 100 µA in
normal condition.
4. Temperature on the baby mattress should not exceed
43 deg C when the warmer is operating under steady
temperature condition.
5. Temperature of HEATER GUARDS should not exceed
85 °C in normal use.
6. The Temperature differences on the mattress shall not
exceed 2 °C.

3.4 Noise (in dBA) Sound level of the alarm shall not exceed 80 dBA
3.5 Heat dissipation Should maintain nominal temperature and the heat
disbursed through a exhaust fan, so that effect of UV light
is not disturbed.
4. ENERGY SOURCE
Accessories Should have standard IV pole (sturdy; on rusting;
5.1 (mandatory, medical grade stainless steel; adjustable to a max
standard, optional) height of 6 feet from the ground level), monitor tray
Spare parts (main (12X10 inches;270 deg swivel; fixed at level of warmer
ones) display) and storage trays.
Consumables / Skin temperature probes,
reagents (open, Thermal reflector to fix the skin probe on baby.
closed system)
6.1 Atmosphere / Capable of operating continuously in ambient temperature
Ambiance (air of -10 to 60 deg C and relative humidity of upto 90% in
conditioning, humidity, ideal circumstances.
dust ...)
issues
7.1 Performance and 1. Should be CDSCO approved.
safety standards 2. Should comply with BIS standards.
(specific to the device 3. Should comply with USFDA/European CE standards
type); Certificates (pre- incase of non-availability of BIS standards.
market, sanitary, ...); 5. Should conform to IEC 60601-1 General requirements of
Local and/or electrical safety standards
international
values, quality,
tolerance
8.3 Training of staff Training of users in operation and basic maintenance shall
(medical, be provided.
paramedical,
technicians)
quarter
10. DOCUMENTATION
servicemanuals, other 1. User, technical and maintenance manuals should
manuals be supplied in English/Hindi language along with machine
diagrams.
2. List of equipment and procedures required for local
calibration and routine maintenance.
from government hospital.
documents number and cost
11. NOTES
details (Hierchy Wise; agent to be provided.
including a toll
free/landlinenumber)
11.2 Recommendations Any warning/ precautions to be declared
orwarnings
Hemodialysis Machine
Version no.: 01
NAME AND CODING
GMDN name
GMDN code(s)
GENERAL
1. Use
1.1 Clinical purpose Hemodialysis machine is used in dialysis procedure that filters a
patient blood to remove excess water and waste products when
the kidney is damaged, dysfunctional or missing.
1.2 Used by clinical Dialysis Services
department/ ward
TECHNICAL
2.1 Technical 1. The hemodialysis machine should have a blood pump to
characteristics achieve a unidirectional flow up to 400ml/min.
(specific to this type of
device) 2. It should have a heparin pump, arterial line and venous line
pressure monitors and functional air bubble detector.
3. Mixing proportion of unit with bicarbonate dialysis facility
4. Dialysate delivery should be from 300 to 500 ml/min or more.
5. It should have a conductivity meter and functional blood

leak detector.
6. Dialysate temperature regulator with temperature of 35 to 39

deg C.
7. Built-in device for measurement and monitor of effective urea

clearance (K) and dialysis dose (Kt/V) automatically during
treatment.
7. Volumetric UF control
8. Safety devices functioning alarms, venous blood camp
9. Dialysate filter
Desirable Features:
1. Online blood volume monitor
2. Online urea clearance

3. Sodium profiling of dialysate
4. Single needle dialysis facility
5. Hemodiafiltration
6. Optical detector
2.2 User's interface LCD display

standard of
communication
(wherever required)

4.2 Battery operated UPS with at least 2-hour battery backup
4.3 Protection NA
5.1 Accessories All consumables required for installation and standardization of
(mandatory, standard, system to be given free of cost.
optional); Spare parts
(main ones);
6.1 Atmosphere / ambiance Capable of operating continuously in ambient temperature of -10
(air conditioning, to 60 deg C and relative humidity of upto 90% in ideal
6.2 User's care, cleaning, To be specified by manufacturer.
issues
sanitary, ..); 2. Should comply with BIS standards.
performance and safety 3. Should comply with USFDA/European CE standards incase of
the device type); local 4. Should conform to ISO 13485 quality standards.
and/or international 5. Should conform to IEC 60601-1 General requirements of
values, quality,
tolerance
8.2 Requirements for sign- Supplier to perform safety and operation check before hand over
off
(medical, paramedical, provided.
technicians)
10. Documentation
service manuals, other 1. User, technical and maintenance manuals should be supplied in
provided.
10.2 Other accompanying List of essential spares and accessories, with their part number
documents and cost.
11. Notes
contact details (hierchy be provided.
Wise; including a toll
warnings
DIALYZER REPROCESSOR
Version no. : 01
Done by : (name. Institution) HCT/NHSRC
NAME AND CODING
GMDN name
GMDN code(s)
GENERAL
1. USE
Clinical purpose Dialyzer preprocessor is a system which cleans the
1.1 dialyzer for reuse on the same patient after completion
of one dialysis cycle.
1.2 Used by clinical Dialysis Unit
department/ward
TECHNICAL
Technical • Fully automatic reprocessing and disinfecting
characteristics cycles.
(specific to this type of • Should be able to clean both high flux and low
device) flux dialyzers and hemodialysis filters.
• Should be safe for cellulose based and synthetic
membranes.
• Should be compatible with sterilant available in
open market.
• High standardization in cleaning, fiber bundle
2.1
volume measuring, leak testing and chemical
disinfecting
• Should have LCD Screen and menu guided
operations.
• Water requirements - flow 3 litres/ minute and
pressure 35-50 psi.
• It should have regulators and pressure gauges
to monitor pressures.
• Safety Alarms, Audible & Visible Alarms.
Software and/ or NA
2.3 standard of
communication
(wherever required)
3.5 Mobility, portability Fixed

4. ENERGY SOURCE
4.1 Power requirements 220+/-10% V, 50/60 Hz
4.2 Battery operated Yes, with battery backup

4.3 Protection NA
Accessories, NA
(mandatory, standard,
optional);
5.1 Spare parts (main
ones);
Atmosphere/Ambience Capable of operating continuously in ambient
6.1 (air conditioning, temperature of -10 to 60 deg C and relative humidity of
humidity, dust …) upto 90% in ideal circumstances.
User's care, Cleaning, To be specified by manufacturer.

6.2 Disinfection & Sterility
issues
market, sanitary,); 2. Should comply with BIS standards.
Performance and 3. Should comply with USFDA/European CE standards
7.1 safety standards incase of non-availability of BIS standards.
type); Local and/or 5. Should conform to IEC 60601-1 General
international requirements of electrical safety standards
Pre- installation To be specified by manufacturer and compatible
8.1 requirements: electrical accessories as per Indian standard set-up.
tolerance
8.2 Requirements for sign- Supplier to perform safety and operation checks before
off hand over.
Training of staff Training of users in operation and basic maintenance
8.3 (medical, paramedical, shall be provided.
technicians)
Warranty • 03 years
9.1 • Preventive Maintenance visits at least once in
each quarter
10. DOCUMENTATION
Operating manuals, Should provide 2 sets (hard copy and soft copy) of:
set manuals, other User manuals should be supplied in English/Hindi
10.1 manuals language along with machine diagrams.
Other accompanying NA
10.2 documents
11. Notes
Service Support Contact details of manufacturer and supplier should be
Contact details provided.
11.1 (Hierarchy Wise;
including a toll
11.2 Recommendations or Any warning sign should be displayed adequately.
warnings
CPAP
Version no.: 02
NAME AND CODING
GMDN name
GMDN code(s)
GENERAL
1. Use
1.1 Clinical purpose It is used to deliver air or a mixture of air and oxygen (O2) at
high flow rates through tubing to a nasal or oral-nasal mask
which is affixed to the patient's face. CPAP units are
commonly used to treat patients with obstructive sleep apnea
(OSA) or sleep apnea/hypopnea syndrome (SAHS).
1.2 Used by clinical NICU & PICU
department/ ward
TECHNICAL
2.1 Technical 1) Device should be able to deliver CPAP of 1 to 10 cmH2O
characteristics increments of 1cm, using an underwater bubble system.
(specific to this type of
device) 2) The device should have an in-built air oxygen blender to
deliver FiO2 21% to 100% (+/- 2 %) with an adjustable flow in
the range of 0 -15 L/min (+/-0.5 L/min).
3) Should have a heated wire servo-controlled humidifier with

display temperature near patient end of the circuit; to be
supplied with 2 reusable infant water chamber.
4) Should be supplied with 2 reusable heated wire silicone

tubing circuit for infant/Newborn.
5) Should be able to deliver CPAP using available patient

interfaces nasal prongs/nasopharyngeal prongs.
6) For devices based on underwater bubble systems the water

chamber should be reusable; to be supplied with 2 reusable
water chamber.
7) Should be provided pressure release valve at 15cmH2O to

17cm H2O.
2.2 User's interface 1. For a flow driving system a pressure display is required
2. Audio visual alarm for low pressure, high pressure, power
failure and low O2.
standard of
communication
(wherever required)

3.3 Noise (in dba) Noiseless
4.2 Battery operated Minimum 6 hours battery back up
4.3 Protection NA
5.1 Accessories 1) Each device should be provided with 30 nasal prongs (At
(mandatory, standard, least three sizes suitable for neonates weighing <1000grms,
optional); Spare parts
1000-1500grms & >1500grms)
(main ones);
Consumables / 2) Air and O2 hose of 3m length each along with the appropriate
reagents (open, closed socket
system)
6.1 Atmosphere / ambiance Capable of operating continuously in ambient temperature of
(air conditioning, -10 to 60 deg C and relative humidity of upto 90% in ideal
6.2 User's care, cleaning, To be specified by manufacturer
issues
7.1 Certificates (pre- • Should be BIS and CDSCO approved.
market, sanitary, ..); • Should conform USFDA/ European CE, in case of non-
performance and safety availability of BIS Standards.
standards (specific to • Should conform to ISO 13485 quality standards.
the device type); local • Should conform to IEC 60601-1-General requirements
and/or international of Electrical Safety Standards

values, quality,
tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand
sign-off over.
(Medical, provided.
paramedical,
technicians)
10. Documentation
service manuals, 1. User, technical and maintenance manuals should be
other manuals supplied in English/Hindi language along with machine
diagrams.
provided.
government hospital
documents
11. Notes
11.1 Service support Contact details of manufacturer, supplier and local service
contact details agent to be provided.
(hierchy Wise;
including a toll
warnings
BI-LEVEL POSITIVE AIRWAY PRESSURE (BiPAP) UNIT (ADULT/PEDIATRIC)
Version no.: 01
Done By: HCT/NHSRC
NAME AND CODING
GMDN Name Bi-Level Positive Airway Pressure Unit (BiPAP Unit)
GMDN Code 60712
GENERAL
1. USE
A BiPAP (bi-level positive airway pressure), device is a form of non-
invasive ventilation (NIV) therapy used to facilitate breathing. This
helps in providing positive pressure ventilation both in inspiration and
expiration phase. The machine is connected with a tube to the face
1.1 Clinical Purpose mask worn over nose & mouth by the patient.
BiPAP is helpful in a variety of clinical conditions that make breathing
difficult, such as chronic obstructive pulmonary disorder (COPD,
obstructive sleep apnoea, obesity hypoventilation syndrome
(Pickwickian Syndrome), Amyotrophic Lateral
Sclerosis (ALS), Muscular dystrophy.
1.2 Used by clinical ICU, PICU, Emergency, HDU, General Ward
department/ward
TECHNICAL
Technical 1. Should have Real-time display – LCD display shows actual
Characteristics pressure, leak rate and patient breathing parameters such
as breath rate, I/E ratio, minute volume and tidal volume,
On board Filter Clean Reminder, etc
2. BIPAP (Bi-level Positive Airway Pressure) should be a
complete unit with al standard accessories.
3. The device should allow adjustment of transitions in and out
of IPAP and EPAP
4. IPAP: approx. 3 to 25 cm H2O, EPAP: approx. 3 to 25 cm
H2O
5. Breath rate: approx.0 to 30 BPM with spontaneous for
2.1 time mode or manual override
6. Timed inspiration: approx. 0.5 to 3.0s
7. Should have ramp function to lower the pressure at
initial phase and slowly increase to allow pressure.
8. Should have automatic leakage compensation.
9. Should have customizable and the sensitivity of the
trigger should be adjustable.
10. Should have operating mode of CPAP, Spontaneous,
timed, PAC/PC (Pressure Assisted Control/Pressure
Control).
11. Should provide with carry bag.
User's Interface Display easily readable in low ambient light and sunlight:
a. Inspiratory and Expiratory pressure.
b. Inspiratory and Expiratory time.
2.2 c. FiO2%.
d. Mean Airway Pressure (MAP).
e. Air leak%.
3.1 Dimensions (in cm) NA
3.2 Weight Should be light weight.
3.3 Noise Less than 35dbA at mid pressure range. Alarm: 65dbA
3.4 Heat Dissipation Should not get heated when operated.
Mobility/Portability Should be a lightweight portable, reliable and sturdy equipment with
3.5 mechanical strength to withstand rough handling.
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 .........)
Power input 220 +/- 10% VAC, 50 Hz
Automatic switch from AC power electric-line mode to battery
4.1 operating mode and vice versa.

4.3 Battery backup At-least one hour battery backup.
5. ACCESSORIES. SPARE PARTS AND CONSUMABLE
Accessories, 1. Reusable nasal mask for adult and pediatric use with tubing;
(mandatory, withstands high level disinfection and sterilization.
Standard, 2. Humidifier accessory, if not integrated in-built.
5.1 operational), 3. Connectors for air and oxygen outlets.
Spare parts (main 4. Mains power cable to have length ≥2.
ones) 5. Inlet bacteria filter, if applicable and Expiratory filters high
Consumable/reagent efficiency.
s (open, closed
system)
Atmosphere Capable of operating continuously in ambient temperature of -10 to
6.1 /Ambiance (air 60 deg C and relative humidity of upto 90% in ideal circumstances.
conditioning,
humidity, dust ...)
User’s care, To be specified by manufacturer
6.2 Cleaning,
Disinfection &
Sterility
Issues
Performance and 3. Should comply with USFDA/European CE standards incase
7.1 safety standards of non-availability of BIS standards.
type); Local 5. Should conform to IEC 60601-1 General requirements of
and/or international electrical safety standards.

Pre-installation
8.1 requirements: To be specified by manufacturer and compatible electrical
nature, values, accessories as per Indian standard set-up
quality,
tolerance
Requirements for Supplier to perform installation and safety and operations check for
8.2 sign-off the device before handover.
Training of staff Training of users in operation and basic maintenance shall be

8.3 (medical, provided.
paramedical,
technicians)
Warranty • 03 years
9.1
10. DOCUMENTATION
Operating manuals, Supplier should provide 2 sets(hardcopy) of: -
service manuals, other 1. User, technical, maintenance and service manuals to be
10.1 manuals supplied along with machine diagrams.
2. List of equipment and procedures required for local calibration
and routine maintenance.
Other accompanying NA
10.2 documents
11. NOTES
Service Support Contact details of manufacturer, supplier and local service
Contact details. agent to beprovided.
(Hierarchy Wise;
including a toll
11.1 free/landline number)
11.2 Recommendations or Any warning signs would be adequately displayed.
warnings
TABLE FOR OBSTETRIC LABOUR (LDR)
Version no.: 02
Done By: HCT/NHSRC
NAME AND CODING
GMDN Name Birthing Bed/Table, Powered
GMDN Code 15732
GENERAL
1. USE
Clinical Purpose Table for Obstetric labour (LDR) is specifically designed to
1.1
support the mother during all stages of giving birth that includes
labour, delivery and recovery.
The bed should convert quickly from a practical labour bed to a

delivery platform and back to a comfortable recovery bed. At
anystage, it can be rapidly adjusted to any positions to cater for
emergency situations.
1.2 Used by clinical Labour Room Complex (As per Labour room standard Guideline)
department/ward
TECHNICAL
1. The LDR bed should be electro-mechanically controlled.
2.1 Technical
Characteristics
2. It should have three sections and seamless joint in each part
with minimal gap between sectional mattresses and the seat-
(Specific to this type
section should have a large perineal cut.
of device)
3. Mattresses cover should be non-slippery, washable and
waterproof.
4. The foam density of the mattresses should be of
minimum 60 kg/m3 and thickness of minimum 3-4
inches.
5. The mattress should be fixed with high grade adhesive
velcro tape for proper fixing on the bed top.
6. Removable SS (304)/ABS head and leg bows with padded
panel.
7.The unit should have provision for trendelenburg and reverse
trendelenburg positions (minimum 15 degree or more) and
reclinable adjustable back rest angle of 60 degree or more. All
positions should be achievable by both mechanically and
electronically.
8. Should have control device for back and height
adjustments through remote control as well as manually
operable.
9. Pre-fitted SS-304 grade adjustable/collapsible side rails.
10. Push grip handle (grab bars) with soft cushion padding on
both sides of the bed.
11. Should have foot support for nursing staff.
12. Frame should be of epoxy powder coated steel.
13. Should be easy to clean, sterilize (especially blood stains) and
maintain.
14. Should have catheter bag holder which can be attached on
either side of bed.
15. Should have infusion rods (made of SS-304 grade) which
have adjustable heights, quick release and attachable to
all corners of the bed.
16. Should have retractable foot section (section can be
telescoped under) so as to convert bed into table.
17. To and fro motion of the leg section should be very smooth.
18. Should be able to hold minimum 150 Kg of load.
19. Caster: Should have minimum 100mm or more heavy duty
roller wheels with ball bearing and with central & directional
locking mechanism.
20. Should have rectangular sliding/detachable SS-304 tray at
perineal part of table.
2.2 Electro-mechanical.
User's Interface
3.1 Dimensions (in mm) Overall approximate size 1880 -2160 mm (L) * 900 - 1010 mm
(W) * 550 mm to 880 mm (H) (With option of manual adjustable
height of the bed)
3.2 Weight To be specified by the Manufacturer/Supplier
3.3 Noise Less than 50 db.
3.5 Mobility/Portability Area Specified above (Labour room)
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2)
4.1 Power input 220-240V AC,50 Hz fitted with Indian plug
4.2 Battery backup 1. Battery backup of minimum 30 minutes operation time
with inbuilt battery charger shall be provided. The handset
shall have indications for power onand battery charge.
2. Should have facility to operate manually in case of power
failure.
4.3 Power consumption To be specified by the Manufacturer/Supplier
5.1 Accessories, 1. All consumables required for installation and
(mandatory,Standard, standardization of the systemshould be provided free of
operational); Spare cost.
parts (main ones) 2. Minimum 60 mm thick kg/m3 high density foam
Consumable/reagents mattress washable andwaterproof and detachable in
(open, closed system) three parts.
3. Should be provided with extra one pair of leg rest.
4. Should be provided with minimum four infusion rods
(SS 304) with hookfor hanging IV fluids.
6.1 Atmosphere Capable of operating continuously in ambient temperature of -10
/Ambiance(air to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust ...)
6.2 User’s care, Parts of the Device that are designed to come into contact with
Cleaning, the patient or the operator should be compatible with medical
Disinfection & grade disinfectant solution.
Sterility
Issues
market, 2. Should comply with BIS standards.
sanitary,..);Performa
nceand safety 4. Should conform to ISO 13485 quality standards.
standards (specific 5. Should conform to IEC 60601-1 General requirements of
to the device electrical safety standards
type);Local and/or
international
nature,values,
quality, tolerance
8.2 Requirements for Supplier to perform safety and operation check before hand over.
sign-off
8.3 Training of staff 1. Hands on training to be provided to healthcare professionals
(medical,paramedical, on using the equipment, day to daymaintenance/cleaning.
technicians) 2. Hand on training for in-house (Biomedical engineers)for
preventive and Corrective maintenance.
9.1 Warranty 03 years all spares parts, battery and other accessories.
10. DOCUMENTATION
10.1 Operating Should provide 2 sets (hardcopy and soft-copy) of: -
manuals, service 1. User, technical and maintenance manuals to be supplied
manuals, other in English/Regional language along with machine
manuals diagrams.
2. List of equipment and procedures required for local
calibration and routinemaintenance.
3. Service and operation manuals (original and copy) to be
provided.
5. Certificate of calibration and inspection
10.2 Other accompanying ISO Certification on quality of stainless steel used;
documents
11. NOTES
11.1 Service Support 1. Contact details of manufacturer, supplier and local service
Contactdetails agent to be provided.
(Hierarchy Wise; 2. Manufacturer/ Supplier of medical services should provide price
including a toll quote for spare part of medical device or supply items, against
free/landline number) requisition/Purchase order from Biomedical
engineers/technicians.
11.2 Recommendations Any warning sign needs to be clearly mentioned.

and Warnings
Foetal Doppler / Fetoscope
Version 02
institution)
NAME AND CODING
GMDN name Foetal Doppler System
GMDN code(s) 34040
GENERAL
1. USE
1.1 Clinical purpose It is used to noninvasively detect foetal heart beats using
Ultrasound/Doppler technology. The heart beats are typically
conveyed audibly via the measuring/display unit and attached probe
which is applied to the surface of the pregnant woman's abdomen.
1.2 Used by clinical Midwifery Led Care Unit/Obstetric/ANC Clinic
department/ward
TECHNICAL
2.1 Technical • It should measure fetal heart rate (FHR) accurately.
characteristics
(specific to • It should have backlit digital display.
this type of
• The probe should be highly sensible to pick up FHR.
device)
• The probe should be waterproof.
• Probe (transducer) with 2-5 MHz frequency attached
via a cable.
• It should give indication for low battery.
• It should have built-in-speaker with volume adjustment.
• Built-in rechargeable Li-on battery with minimum back
up of 6-8 Hrs.
2.2 User's interface Backlit digital display

standard of
communication(
wherever
required)
3.1 Dimensions NA
(metric)
3.3 Noise (in dBA), Noise: <60dBA
3.5 Mobility, Portable, Handheld device
portability
4. ENERGY SOURCE
4.1 Power 220 +- 10% VAC, 50 Hz
Requirements
4.2 Battery operated Built-in rechargeable Li-on battery with minimum backup of 6-8
Hrs.
4.3 Power To be specified by manufacturer

Consumption
5.1 Accessories Doppler probe, battery charger, Gel for application of probe.
(mandatory,
standard,
optional);
Spare parts
(main ones);
Consumables /
reagents
(open, closed
system)
conditioning,
humidity, dust
...)
Cleaning,
Disinfection
& Sterility
issues
(pre-market, 2. Should comply with BIS standards.
sanitary, ..); 3. Should comply with USFDA/European CE standards incase of
Performance non-availability of BIS standards.
and safety 4. Should conform to ISO 13485 quality standards.
standards 5. Should conform to IEC 60601-1 General requirements of
(specific to the electrical safety standards
device type);
Local and/or
international
requirements:
nature, values,
quality,
tolerance
8.2 Requirementsfor Supplier to perform installation, safety and operation check before
sign-off hand over.
(medical, provided.
paramedical,
technicians)
9.1 Warranty Three years
Preventive Maintenance visits at least once in each quarter.
10. Documentation
manuals, set 1. User, technical and maintenance manuals should be supplied in
10.1 manuals, other English/Hindi language along with machine diagrams.
provided.
Other List of essential spares and accessories, with their part number and
10.2 accompanying cost.
documents
11. Notes
Service Support Contact details of manufacturer, supplier and local service agent to
Contact details be provided.
11.1 (Hierarchy Wise;
including a toll
free/landline
number)
Recommendations Any warning sign should be adequately displayed.
11.2 or warnings
PULSE OXIMETER-FINGER TIP
Version no. : 02
NAME AND
CODING
GMDN name Pulse oximeter
GMDN code(s) 45607
GENERAL
1. USE
1.1 Clinical purpose It is used for the transcutaneous measurement and display of
haemoglobin oxygen saturation (SpO2). The signals are
produced by light-emitting diodes (LEDs) and received by a
photodetector. The device displays the SpO2 values and may
also measure/display pulse rate.
1.2 Used by clinical All Departments
department/ ward
TECHNICAL
2.1 Technical characteristics • Should measure SpO2 and pulse rate for adults and
(specific to this type of children, for all skin pigmentations.
device) • SpO2 detection range to include: 70–100%.
• SpO2 resolution: 1% or less.
• SpO2 accuracy should be within ± 3%.
• Pulse rate detection range to include: 30–240 beats per
minute (bpm)
• Pulse rate resolution: 1 bpm or less.
• Pulse rate accuracy: within ± 3 bpm.
• Digital display for SpO2, pulse rate, sensor error or
disconnect and low battery status.
• Suitable for detection in low perfusion conditions.

of communication
4.3 Protection
NA
5.1 Accessories & Spares NA
parts; Consumables /
reagents (open, closed
system)
6.1 Atmosphere/Ambiance Capable of operating continuously in ambient temperature of -
(air conditioning, humidity, 10 to 60 deg C and relative humidity upto 90% in ideal
dust ...) circumstances.
6.2 User’s care, Cleaning, Easy to clean
issues
sanitary, ..), 2. Should comply with BIS standards.
Performance and safety 3. Should comply with USFDA/European CE standards incase of
the device type);Local 4. Should conform to ISO 13485 quality standards


(medical,
paramedical,
technicians)
10. DOCUMENTATION
10.1 Operating manuals, User manuals to be provided in English/Hindi language along
service manuals, other with machine diagram.
manuals
documents
11. NOTES
11.1 Other information NA
warnings
Multipara Monitor with Central System
Version no. : 01
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERAL
1. USE
1.1 Clinical purpose Designed to continuously measure and display
multiple vital physiological parameters of patients,
especially those under critical care.
Central monitors display various parameters, from
bedside monitors connected to same including ECG,
respiratory rate, NIBP and IBP, body temperature,
SpO2, SvO2, cardiac output, ETCO2, intracranial
pressure, and airway gas concentrations. They include
computing capabilities and additional displays to
observe trend information.
1.2 Clinical department/ward Intensive Care Unit (ICU)
TECHNICAL
2.1 Technical characteristics 1. Should have modular Multi parameter monitor with
TFT/LED/LCD/touch screen display with more than 15
inches with at least 8 wave forms and upgradable up
to 14 waveforms & 22 parameter numeric on single
display.
2. The waveforms should be user selectable.
3. Monitor should have in built Lithium-ion type
battery for 2 Hour continuous operation.
4. Should have keys for quick access to main
functions.
5. Should be able to monitor ECG (3,5,12 leads),
SPO2, NIBP, 2 IBP, Respiration Rate, 2 temp,
ETCO2, for adult, pediatric and neonatal patients as
standard and Anesthesia gas monitoring.
6. Monitor must have facility for at least 2 IBP
measurements simultaneously. Also should have
SPV/PPV monitoring facility.
7. 5 Lead ECG monitoring with full range of lethal
arrhythmia recognition capability and ST analysis up to
12 leads and 72hour trend facility.
8. Respiration, Apnea alarm, Prioritized audio-visual
alarms and snapshot facility.
9. Transport module with display and battery backup
of at least 1 hour.
10. Pulse Oxymeter (SPO2) with Plethysmogragh &
PuIse strength indicator WithVariable pitch with
change inSpO2(low perfusion motion tolerance
technology).
11. Side-stream Capnography with display of CO2
wave form & digital values (ETCO2, FiCO2, RR).
12. Monitor should have provisions for automatic
identification and measurement of anesthesia agents,
CO2, 02, N2O and facility to measure at least S
volatile agents with automatic detection.
13. Should be upgradable to monitor cardiac output
(Thermo dilution/ PICCO), BIS/DA and NMT.
14. It should have provision for automatic identification
and measurement and anesthetic agents, Co2, 02,
N2O and facility to measure MAC.
15. The display setting should have at least 10 user
defined setups variable as per applications for flexible
use of the monitor in various clinical environments
such as in OT, PACU, ICU, ER, NICU.
16. Monitor should have networking options with
bidirectional & bed to bed communication.
Central Monitoring Station:
1. Central station should have minimum 22” color
display.
2. Should be supplied with network Laser printer &
printing of review/trend data from central station & any
bedside monitor connected in network should be
possible.
3. It should have facility to view minimum last 120
hours stored information such as vital signs, alarm
status, arrhythmia recall with ECG, trended
parameters, patient data etc. for any selected bed
from the central station.
4. It Should have facility to store and display full
disclosure of waveforms for 120 hours.
5. Should have default alarm limits and customizable
parameter settings.
6. Should have two-way communication with bedside
monitor, alarm settings should be possible from central
station.
7. All monitors including central station should have
similar user interface for easy usage among all
clinicians.
2.2 User's interface Digital display
communication
3.5 Mobility, portability -
4. ENERGY SOURCE

4.3 Protection Electrical protection provided by fuses in both live and
neutral supply lines
5.1 Accessories (mandatory, Each monitor should be supplied with following
standard, optional) accessories:
a) 5 lead ECG/Respiration cable
b) NIBP Cuff Adult, Pediatric & Neonate
c) SpO2 Sensor Adult
(open, closed system) d) SpO2 sensor Pediatric
e) SpO2 sensor disposable for infants/neonates
f) Mainstream ETCO2 cable
g) Invasive & noninvasive Adaptor for ETCO2
h) IBP Cable
i) IBP transducers
j) Rectal Temp Probe

Disinfection &
Sterility issues
nature,
hand over.

each quarter.
10. DOCUMENTATION
manuals, other manuals 1. 1. User, technical and maintenance manuals should
machine diagrams.
to be provided.
11. NOTES

Digital Infrared Thermometer
Version no. : 01
NAME AND CODING
GMDN name -
GMDN code -
GENERAL
1. USE
1.1 Clinical purpose Infrared (IR) thermometers allows to measure temperature
quickly, at a distance, and without touching the object.
1.2 Used by clinical All Departments

department/ward
TECHNICAL
2.1 Technical 1. It should be non-contact type Infrared digital
characteristics thermometer.
(specific to this type 2. It should measure and display temperature in both
of device) units-degree Celsius and degree Fahrenheit.
3. Measuring range: 32 deg C (89.6 deg F) or lower to 43
deg C (109.4 deg F) or higher.
4. Accuracy of measurement: 0.2 deg C/Fahrenheit or
better.
5. Measuring distance should be atleast 5cm.
7. It should have LCD display.
8. It should have auto shut down feature when not in use,
audio/visual alarm facility.
2.2 Settings NA
2.3 User’s interface Digital display
Noise (in dBA), heat NA
3.4 dissipation
4. ENERGY SOURCE
4.3 Protection NA
5.1 Accessories NA
(mandatory,
standard, optional)
Spare parts (main
ones)
Consumables /
reagents (open,
closed system)
6.1 Atmosphere / Capable of operating continuously in ambient temperature of
Ambiance (air -10 to 60 deg C and relative humidity of upto 90% in ideal
humidity, dust ...)
6.2 User’s care, Easy to clean.
Cleaning,
Disinfection &
Sterility issues
values, quality,
tolerance
8.2 Requirements for sign- NA
off
technicians)
10. DOCUMENTATION
service manuals, User, technical and maintenance manuals should be
other manuals supplied in English/Hindi language along with
machine diagrams.
documents
11. NOTES
11.1 Service Support Contact details of manufacturer and supplier should be
Contact details provided..
(Hierchy Wise;
landline number)
11.2 Recommendations or Any recommendations for best use should be declared.

warnings
Continuous Renal Replacement Therapy Machine
Version no. : 01
NAME AND CODING
GMDN name -
GMDN code(s) -
GENERAL
1. USE
1.1 Clinical purpose CRRT is used to provide atleast 24 hours continuous
(nonstop) dialysis therapy used to support patients
with kidney failure Patient Category Pediatrics and
adults.
1.2 Clinical department/ward Nephrology Department
TECHNICAL
2.1 Technical characteristics 1. The Machine should be of latest technology with
microprocessor-controlled user interactive menu with
operating and malfunction removal instructions on
display screen
2. The system should have four pumps, one each for
Blood, Dialysate, Replacement fluid and
Effluent/filtrate.
3. The system shall be capable of providing the
following therapies: -
• Slow Continuous Ultrafiltration (SCUF)
• Continuous Venovenous Hemofiltration
(CVVH)
• High-volume Continuous Venovenous
Hemofiltration (HVCVVH)
• Continuous Venovenous Hemodiafiltration
(CVVHDF)
• Continuous Venovenous Hemodialysis
(CVVHD)
• Hemoperfusion (HP)
• Therapeutic Plasma Exchange (TPE)
4. It should have a clear touch screen LCD/TFT
Monitor.
5. Blood pump speed of approximately 10-450 ml/min.
6. It should have close blood circuit to prevent air to
blood interface.
7. System should have short preparation and priming
program and should be ready to start treatment within
10-20 minutes.
8. Should have arterial pressure range: (-) 250 mmHg
+/- 50 mmHg
9. Should have venous pressure range:(+)350 mmHg
+/- 50 mmHg.
10. Should have Pre Filter-Pressure: 50mmHg to -500
mmHg
11. Should have Effluent Pressure: 350 mmHg+/- 50
mmHg
12. Should have Programmable Substitution solution
flow rate: 100-8000 mL/Hr
13. Should have Dialysate Flow rate: 0-4500 mL/Hr.
14. Should have Effluent Flow Rate: 0-10000 mL/Hr.
15. Should have integrated heparin pump with flow
rate of 0.5 ml-5 mL/Hr. Bolus facility range 0.5mL5mL.
16. Should have capability of changing therapies.
17. Should have three weighing scales to control the
system with balancing accuracy of less than 1 % of
total turnover in normal conditions and weighing
capacity of at least 0-20 kg.
18. Should have integrated Fluid/Blood warmer for
blood/dialysate warming.
19. Should have Ultrasonic air bubble detector and
Blood leak Detector.
20. Should have Alarm in case of blood leak, air in
line, pressure limit violation, empty dialysate/
replacement bag, full effluent bag and advisory alarms
in case of excessive TMP and filter clotting.
21. Should have a 30 min Battery back up for blood
pump.
22. Should have an RS 232 Port for Data transfer and
interface.
2.2 User's interface Digital display
communication
4. ENERGY SOURCE

4.3 Protection NA

5.1 Accessories (mandatory, Should be supplied with 10 Nos. of essential
standard, optional) accessories such as blood line set, haemofilters
and ultra filtrate bags at no extra cost.

Disinfection &
Sterility issues
nature,
hand over.

each quarter.
10. DOCUMENTATION
manuals, other manuals 1. User, technical and maintenance manuals should
machine diagrams.
to be provided.
11. NOTES


Critical Care Block - Equipment Technical Specification

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TECHNICAL SPECIFICATION OF

MEDICAL EQUIPMENT FOR

HEALTHCARE TECHNOLOGY DIVISION, NHSRC

GMDN Code 34870

Used by clinical ICU (Intensive Care Unit)

10. Should have a therapeutic Weight bearing up to 150-200 Kg

3.1 Dimensions (in cm) 1. Length: 2100-2300 mm

4.2 Power consumption To be specified by Manufacturer/Supplier;

5. ACCESSORIES. SPARE PARTS AND CONSUMABLE

6. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS

User’s care, Easy to clean and disinfect.

7. STANDARDS & SAFETY

8. TRAINING AND INSTALLATION

9. WARRANTY AND MAINTENANCE

11.2 Recommendations or Any warning sign should be adequately displayed.

2.3 Software and/or In-built

8. TRAINING AND INSTALLATION

4.2 Battery operated Internal rechargeable battery having a minimum of 2 hours

6.2 User's care, Cleaning, Easy to clean and maintain.

9. WARRANTY AND MAINTENANCE

11.2 Recommendations Any warning signs should be adequately displayed

1.2 Used by clinical Emergency department, Operation Theatre, Ambulance,

2.2 User's interface Manual

10.2 Other accompanying NA

7. STANDARDS AND SAFETY

8. TRAINING AND INSTALLATION

8.2 Requirements for Supplier to perform installation, safety and operation

11.2 Recommendations or Any warning sign would be adequately displayed.

6.2 User's care, Cleaning, To be specified by manufacturer

7. STANDARDS AND SAFETY

3) Heart rate measurement range to be at least 30 bpm

4) Heart rate trend display of at least previous 24 hours.

5) Arrhythmia detection facility required; minimum

2.3 User's interface Manual

2.3 Software and/or In-built

1. High frequency X-Ray generator having frequency of 20 KHz or

2. Power output of generator should be 20 KW Radiography KV

1. A very compact, Soft touch Control panel having following

2. Machine ON/OFF switch, Digital display of KV & mAs, KV

3. Bucky selection switch.

4. Self-diagnostic programme with indicators for earth fault

2. Anode heat storage capacity of tube should be more than 140

2.3 Software and/or In-built

3.1 Dimensions (metric) NA

3.5 Mobility, portability Mobile

8. Training and Installation

2. Phased array transducers required.

3. Following transducers are to be supplied:

• A-2.0-5.0 MHz Multi frequency Convex Transducer-One.

4. Transesophageal Echocardiogram - TEE scanning capability.

5. Penetration depth of at least 30 cm.

6. Digital and caliper measurement functions required for both

7. Alphanumeric annotation to be possible.

8. Measurement accuracy to be better than 2% over 10cm distance.

9. Doppler display to indicate blood flow both numerically and in

12. Equipment dynamic range, at least, 180 dB.

2.2 User's interface Patient Communication system: An integrated intercom and

2.2 User's interface LCD/Graphical Display

4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 )