Revised Draft Amendment-5 AIS-125 (Part-2): Medical Equipment for Road Ambulances (1.53 Mb)

Date of hosting on ARAI website: 20th June 2005 Last date for comments: 27th June 2025 Revised Draft Amendment 1 (---/) To AIS-125 (Part 2): Medical Equipment for Road Ambulances 1.0 Add following Tables 12 and 13 after Table 11 Table 12 List of medical equipment’s for Neonatal Ambulance. Sr.No. Category Equipment Qty 1. Medical Neonatal Transport Incubator with Accessories 1 Equipment 2. Transport Ventilators with Accessories 1 3. Portable Infant Resuscitator - T- Piece with 1 Accessories 4. Defibrillator Pediatric with Accessories 1 5. Suction Device Electrical with Accessories 1 6. Self-Inflating Neonatal Resuscitation Kit with 1 Bag Valve Mask with Accessories & Disposables 7. Cardiac Monitor with Accessories 1 8. Pulse Oximeter - Line Powered 1 9. Non-Invasive Blood Pressure (NIBP) Monitors 1 10. Infusion Pumps with Accessories 2 11. Syringe Pumps with Accessories 2 12. Portable Warmer with Accessories 1 13. Blood Glucometer with Disposables 1 14. Bilirubinometer with Accessories 1 Page 1 of 16615. Neonatal Stethoscope 1 16. Direct Ophthalmoscope 1 17. Thermometer Digital 1 18. Neonatal Weighing Scale 1 19. Other Thermal Mattress / Gel Pads 1 Essentials 20. (Accessories, Medical Grade Refrigerator / Vaccine Cold 1 Disposables, Storage Box Temperature 2-8 Degrees C Kits) controlled, 50ml CDSCO Approved 21. Umbilical Catheterization Kit 2 22. Infant Intraosseous (IO) access complete kits 1 23. Oxygen Hood 1 24. Sterile Gloves & Gowns 6 + 6 25. Oxygen Supply System 1 26. Feeding Tubes 10 27. Chest Drainage Kits 24, 30 & 32, 1 each 28. Hand Sanitizers & Antiseptic Solutions 1 Each 29. Documentation & Medical Charts 1 Set 30. Endotracheal Tubes (ETTs) 2 each of 8.5, 8, 7.5, 7, 6.5, 6, 5.5, 5, 4, 3 sizes 31. Neonatal catheters 2 32. Umbilical vein catheters 2 33. Child Spine Board 1 34. Emergency Child Restraint System 1 35. Vein Finder 1 36. Emergency response Drugs & Food Set Supplements as directed 33. Oxygen Supply Portable lightweight aluminium cylinder with 1 Cylinders pin index mechanism 4.5 litres water capacity Page 2 of 166NEONATAL TRANSPORT INCUBATOR WITH ACCESSORIES 1.0 USE 1.1 Clinical purpose Designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Visual and audible alarms for: (specific to this type of (i) Patient and air high/low temperature alarm. device) (ii) Air circulation / probe / system / power failure larm. 2. Heater power indicator 3. Air velocity: minimum 0.30m/sec 4. Oxygen input flow rate 5 to15 liters/min or oxygen concentration range 25 to 70%. 5. Maximum CO2 concentration inside incubator 0.2%. 6. Internal noise level < 60 dB. 7. Mode of operation should be properly displayed. 8. Green indicator light should be provided for its ready to be in normal use. 9. Infants straps should be provided to restrict the baby movement. 10. Skin temperature probe should be small in size not more than 10mm diameter and 4mm in height to fix the probe firmly on the infant. Baby contact material should be biocompatible as per ISO 10993 standard requirement. 11. Infant bed should be drawable. Mattress foam density should be minimum 25kg. /cm3 and infant bed mattress cover should be biocompatible material. 12. Examination light should be provided for inspection. 13. Should have heater power indicator. 14. Warmup time 30-40 minutes and shall not differ by more than 20%. 15. Shall be equipped with a thermal cut-out. It shall be so arranged that the heater is disconnected and an auditory and visual warning is given at an incubator temperature which does not exceed 40 deg. C. 16. Should have elbow operate-able ports and head access door. 17. It should not topple over at 10 deg. inclined plane. 18. Patient skin temperature range: 35 deg. C to 37.5 deg. C. over ride up-to 38 deg. C. Page 3 of 16619. Air temperature range: 30 deg. C to 39 deg. C; Temperature resolution ±0.1 deg. C; Temperature accuracy ± 0.2 deg. C. 2.2 Settings Patient skin temperature range: 35 deg. C to 37.5 deg. C. over ride up to 38 deg. C. Air temperature range: 30 deg. C to 39 deg. C. 2.3 User's interface Display allows easy viewing in all ambient light levels 2.4 Software and/or In built standard of communication 2.5 Others 1. Temperature on the baby mattress should not exceed 40 deg. C and 43 deg. for other materials 2. Uniformity of temperature on the horizontal mattress shall not exceed1.5 deg. C and in tilted mattress not exceed 2 deg. C. 3. The overshoot temperature shall not exceed 2 deg. C. 4. The stability of temperature during steady temperature shall not differ from the average temperature by more than 1 deg. C. 3. PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Baby bed should be at-least 60X30cm and the canopy should be at-least 80X40 cm. 3.2 Weight (lbs, kg) not exceeding 40kg. (without cylinders). 3.3 Configuration Oxygen port with tubing, also mount for oxygen cylinder of 5 litters size. Accommodates shelves, suction unit and I/V poles. Double-walled cabinet with at least two hand ports. Should have collapsible trolley with lockable castors. Mounted on mobile base, lowest height setting of which is at least 80 cm high. Minimum castor diameter 12cm. At least two castors must be fitted with brake facility. Castors must be made of conductive material such as Static dissipative Polyurethane and rotate (swivel) freely around the vertical axis. The canopy and infant bed should be crevice free for Page 4 of 166ease of cleaning. 3.4 Noise (in dBA) <60dBA; Alarm Audible sound level should be at-least 65dBA at 3meter distance from the device. 3.5 heat dissipation Should maintain up-to 37 deg. temp. 3.6 Mobility, portability Yes, on castors 4.0 ENERGY SOURCE (Electricity, UPS, Solar, Gas, Water, CO ) 2 4.1 Voltage (value, AC or DC, 220VAC ± 10% , 50 Hz mono-phase or tri-phase) 4.2 Battery operated Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit. Electrical protection by resettable over-current breakers or replaceable fuses, fitted in both live and neutral lines. Battery backup of 2 hours for equipment operation. The battery should be protected from overcharging. 4.3 Tolerance (to variations, Voltage corrector / stabilizer to allow operation at ± shutdowns) 10% of rated voltage. 4.4 Protection Internal, replaceable, rechargeable battery allows operation for at least two hours in the event of power failure 4.5 Power consumption 4.6 Other energy supplies Mains cable to be at least 3m length 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Page 5 of 1665.1 Accessories (Mandatory) With washable and removable straps and binders Light Weight Collapsible Aluminium Stretcher - 1 No Oxygen Cylinder Compatible - 1 Small + 1 Large along with pressure Valves Air Cylinder Compatible - 1 No IV Pole Compatible - 1No Foam Bed with Straps - 1 No Air Filters - 1 Set Flexible Examination LED Lamp - 1 No Power Cord: 1 No Cylinder Star Knobs: 1 Each 5.2 Spare parts (main ones) Two extra sets of all sensors 5.3 Consumables / reagents Two extra sets of filters, two extra set of fuses ( if (open, closed system) replaceable fuses used) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS 6.1 Atmosphere / Ambiance Operating condition: (air conditioning, – Capable of operating continuously in ambient humidity, dust ...) temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. – an ambient air velocity is less than 0.3 m/s. 6.2 User's care, Cleaning, Unit layout to enable easy cleaning and sterilization of Disinfection & Sterility all surfaces, with no unreachable fluid traps.The case is issues to be cleanable with alcohol or chlorine wipes 6.3 Others 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, 1) Product should be FDA (US) /CE (EU) from sanitary, ..); Performance authorized third party/ BIS approved and CDSCO and safety standards & ISO 13485 (specific to the device 2) Relevant IEC-60601-Part 1 & 2, certificates by a type); Local and/or notified agency international 8.0 TRAINING AND INSTALLATION 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 Certificate of Calibration and inspection from the factory. Page 6 of 1668.3 Training of staff (medical, Training of users in operation and basic maintenance paramedical, technicians) shall be provided 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years excluding battery and consumables 9.2 Maintenance tasks Advanced maintenance tasks required shall be documented 9.3 Service contract clauses, Local clinical staff to affirm completion of installation including prices 10.0 DOCUMENTATION 10.1 Operating manuals, User, technical and maintenance manuals to be supplied service manuals, other in English language. manuals Certificate of calibration and inspection to be provided. List to be provided of equipment and procedures required for local calibration and routine maintenance List to be provided of important spares and accessories, with their part numbers and cost. 10.0 Other accompanying User/Technical/Maintenance manuals to be supplied in documents English TRANSPORT VENTILATOR 1.0 USE 1.1 Clinical purpose To provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. 1.2 Used by clinical department/ ward Emergency /Critical Care 2.0 TECHNICAL CHARACTERISTICS Page 7 of 1662.1 Technical characteristics (specific to this 1. Mountable transport ventilator type of device) (Neonate/Paediatric). 2. Invasive Modes (CMV and SIMV) and Non-invasive Mode (CPAP). 3. Pressure controlled - Pressure up to 15mmHg. 4. Respiration Rate up to 40. 5. There should be two FiO2 setting range between 21% and 100%. Setting 100% FiO2 should be mandatory. 6. PEEP 0-20 cm of water. 7. Trigger sensitivity - Pressure. 8. The associated cylinder (to be supplied along with the machines) should be such that it could be locally filled. 9. Oxygen Cylinder connector (to be supplied along with the machines) should be compatible with ventilator. 10. Audio and visual alarm for disconnection and high pressure. 11. The device should be capable of operation in various environments such as Emergency, Ambulance, Aircraft, Hospital and MRI. 12. The device should be MRI conditioned up to 3 Tesla, 430 G/cm. 2.3 User's interface Automatic 2.4 Software and/or standard of inbuilt communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS Page 8 of 1663.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) <8kgs 3.3 Configuration NA 3.4 Noise (in dBA), heat dissipation Should have audio visual alarm for disconnection and high pressure. 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements 220 to 240V, 50 Hz; electricity and battery driven; should be compatible with ambulance power supply system with other life saving equipments running parallel in the ambulance. 4.2 Battery operated with atleast 6 hours battery backup 4.3 Tolerance (to variations, shutdowns) ± 10% of input 4.4 Protection OVP, earth leakage protection. 4.5 Power consumption <140Watt 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares full face mask - 1 No 3 Sets of reusable breathing circuit of silicone material(2 for pediatiric and 2 for neonates) with exhalation valves carry bag - 1 No ventilator connecting tubes Test Lung - 1 No Clamp for fixing ventilator in Trolley - 1No 5.3 Consumables / reagents (open, closed Battery, Leakage adapter. system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, Capable of being stored continuously humidity, dust ...) in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg Page 9 of 166C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & The unit should be cleanable with Sterility issues alcohol and/or other chemical agents. 7.0 STANDARDS AND SAFETY 7.1 Certifications 1) Product should be FDA (US) /CE (EU) from autorized third party/ BIS approved and CDSCO & ISO 13485 2) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency IEC-60601-1-2; ISO 15001-2010 (Anestheric & respiratory equipment- compatibility with oxygen). Certificate of approval for transport ventilator. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, electrical sockets; Oxygen supply. quality, tolerance 8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before handover. Local clinical staff to affirm completion of installation. 8.3 Training of staff (medical, paramedical, Training of users in operation and technicians) basic maintenance shall be provided. Advanced maintenance tasks required shall be documented. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule. 9.3 Service contract clauses, including prices warranty of three year with free servicing ( min. 3) during warranty. Page 10 of 1669.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other User and maintenance manuals to be manuals supplied in English language. Certificate of calibration and inspection to be provided. List to be provided of equipment and procedures required for local calibration and routine maintenance. List to be provided of important spares and accessories, with their part numbers and cost. Contact details of manufacturer, supplier and local service agent to be provided. 10.2 Other accompanying documents User/Technical/Maintenance manuals to be supplied in English. Page 11 of 166INFANT RESUSCITATOR – T PIECE 1.0 USE 1.1 Clinical purpose The infant resuscitator is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment. 2.0 TECHNICAL CHARACTERISTICS 2.1 Manometer -20 to 80 cm H O (mbar) 2 2.2 Inlet 2.3 1. Inlet flow range 0 to 15 LPM 2.4 2. Inlet pressure range 3 to 6 bar 2.5 Maximum Pressure Relief. Factory setting is 40 cm H O 2 2.6 Peak Inspiratory Pressure (PIP) 2 – 40 cm H O at 8 L/min 2 2.7 Positive End Expiratory Pressure (PEEP) At 6 L/min PEEP = 2 to 5 cm H O 2 At 8 L/min PEEP = 2 to 6 cm H O 2 At 10 L/min PEEP = 2 to 8 cm H O 2 2.8 Mounting Free standing with handle for transport or IV pole mounting 2.9 Dimension (L x W x H) 170 x 110 x 180 mm (approx) 2.10 Weight 2.5 Kg 2.11 Operating Temperature 10 to 40 degree C 2.12 Operating Humidity up to 90% RH non-condensing 2.13 Storage /Transportation Temperature 10 to 60 degree C 2.14 Storage Humidity up to 90% RH non-condensing The equipment should have dual air supply provision in such a way that it can be connected to centralized gas supply and flow meter as well. Page 12 of 1662.15 There should be a provision to measure the pressure at the Patient end. 2.16 Should be easy to mount anywhere. 2.17 Accessories Disposable T-piece resuscitation circuit: 5 Nos. Reusable T-Piece Resusitation Circuit - 3 Nos 0 Size Mask - 2 No 1 Size Mask - 2 No Oxygen Tube - 1 No 2.18 Certifications 1) Product should be FDA (US) /CE (EU) from autorized third party/ BIS approved and CDSCO & ISO 13485 2) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency IEC-60601-1-2 2.19 Training of staff (medical, paramedical, Training of users in operation and technicians) basic maintenance shall be provided. Advanced maintenance tasks required shall be documented. 2.0 WARRANTY AND MAINTENANCE 2.1 Warranty 3 years 2.1 Maintenance tasks maintenance manual detailing complete maintaining schedule. 2.1 Service contract clauses, including prices warranty of three year with free servicing ( min. 3) during warranty. 2.1 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached. 3.0 DOCUMENTATION Page 13 of 1663.1 Operating manuals, service manuals, other User and maintenance manuals to manuals be supplied in English language. Certificate of calibration and inspection to be provided. List to be provided of equipment and procedures required for local calibration and routine maintenance. 3.2 List to be provided of important spares and accessories, with their part numbers and cost. Contact details of manufacturer, supplier and local service agent to be provided. 3.3 Other accompanying documents User/Technical/Maintenance manuals to be supplied in English. Page 14 of 166DEFIBRILLATOR 1.0 USE 1.1 Clinical purpose Defibrillation is a common treatment for life-threatening cardiac dysrhythmias, ventricular fibrillation and pulseless ventricular tachycardia. Defibrillation consists of delivering a therapeutic dose of electrical energy to the heart with a device. 1.2 Used by clinical department/ ward NICU and PICU 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type of 1) The Defibrillator should have device) biphasic technology having energy selection of 1-200 Joules. 2) The machine should have facility for ECG monitoring, defibrillation, transcutaneous pacing, defibrillation and synchronized cardioversion with CPR feedback to measure chest compression rate and depth in real time and visual on screen feedback. 3) Machine must be with sweep rate 25mm/sec, 50mm/sec. 4) It should be capable of monitoring ECG though ECG cables, electrodes & paddles. 5) Machine should have 24 hour trend storage facility. 6) The machine should have defibrillator facility for neonatal and pediatric patients. 7) The machine should have ECG waveform display with provision for synchronization. 8) The machine should be compact, portable with built in rechargeable Page 15 of 166battery & light weight. 9) The machine should have inbuilt auto & manual recorder for printing ECG trace & stored information. 10) The machine should have user selectable alarms setting. 11) The machine should work on mains (without battery) and on battery as well. 12) The machine should have AED feature as inbuilt with manual override for manual operations. 2.2 User's interface Manual/Automatic 2.3 Software and/or standard of 1)Inbuilt software. communication(where ever required) 2)Convenient and quick USB interface. 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) Max 10kg 3.3 Configuration Should have audio visual alarm for battery low. 3.4 Noise (in dBA) <60db 3.5 Heat dissipation 1) Should maintain nominal Temp of the control unit and the heat should be disbursed through an cooling mechanism. 3.6 Mobility, portability Portable 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements Input voltage 220 VAC +_10%, 50Hz; 4.2 Battery operated 1) Battery powered, silenceable alarm for power failure. 2) Battery charger to be integral to mains power supply, and to charge battery during mains power Page 16 of 166operation of unit. 3) Internal, replaceable, rechargeable battery allows operation for a minimum of two hour in the event of power failure. 4.3 Tolerance (to variations, shutdowns) Voltage corrector / stabilizer to allow operation at ± 15% of local rated voltage. Use of SMPS to correct voltage. 4.4 Protection 1) Electrical protection, resettable over current breakers or replaceable fuses (fitted in both live and neutral lines). 2) Leakage 4.5 Power consumption NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional); 1) Machine must be supplied with Spare parts (main ones); Consumables / reagents ECG cable, Battery, Paddle (Adult (open, closed system) integrated with paediatric). 2) 3 No. Reusable CPR feedback sensor. 3) 300 gel sheet or pads for monitoring and defibrillation. 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, 1) Operating condition: Capable of humidity, dust ...) operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90% in ideal circumstances. 2) Storage condition: Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Sterility 1) Disinfection: Parts of the Device issues that are designed to come into contact with the patient or the operator should either be capable of easy disinfection or be protected by a single use/disposable cover. 7.0 STANDARDS AND SAFETY Page 17 of 1667.1 Certificates (pre-market, sanitary, ..); 1) Product should be FDA (US) /CE Performance and safety standards (specific to (EU) from authorized third party or the device type); Local and/or international BIS and manufacturer to be CDSO & ISO 13485 certified 2) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, 1) Availability of 5 amp/15amp quality, tolerance socket. 2) Safety and operation check before handover. 8.2 Requirements for sign-off 1) Supplier to perform installation, safety and operation checks before handover. 2) Local clinical staff to affirm completion of installation. 8.3 Training of staff (medical, paramedical, 1) Training of users on operation and technicians) basic maintenance. 2) Advanced maintenance tasks required shall be documented. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks 1) Maintenance manual detailing. 2) Complete maintenance schedule. 9.3 Service contract clauses, including prices 1) The spare, accessories & consumables price list required for maintenance and repairs in future after guarantee / warranty period should be attached. 2) Free servicing during warranty period. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Should provide 2 sets(hardcopy) of:- manuals 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. Page 18 of 1663) Certificate of calibration from the manufacturer. 10.2 Recommendations for maintenance List of important spares and accessories, with their part numbers and cost. Page 19 of 166SUCTION MACHINE 1.0 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 department/ ward NICU & PICU 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type of 0 to - 760 mm Hg ± 10 regulable, 1/2 device) HP; single phase 1440 RPM motor; flutter free vacuum control knob, ; Wide mouthed 2 x 2 LITRE (light weight, unbreakable and clear) with self sealing bungs and mechanical over flow safety device. 2.2 Settings Manual 2.3 User's interface Manual 2.4 Software and/or standard of communication NA (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Max: 43 x 30 x 68 cms 3.2 Weight (lbs, kg) Max: 27Kg 3.3 Configuration NA 3.4 Noise (in dBA) 50 dB A ± 3 3.5 heat dissipation Should maintain upto 36.5 deg temp and the heat disbursed through a exhaust fan 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (Electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements 220 V, 50 Hz, 2 ± 0.5 Amps, 370 watts for AC 4.2 Battery operated NA Page 20 of 1664.3 Tolerance (to variations, shutdowns) Voltage corrector/stabilizer to allow operation at ± 30% of local rated voltage. Use of SMPS to correct voltage. 4.4 Protection Electrical protection by resettable overcurrent breakers or replaceable fuses, fitted in both live and neutral lines. 4.5 Power consumption should run with other lifesaving equipment’s running parallelly. 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares Suction Jar & its cap - 600ml - 1 No suctions tube tips a vacuum gauge two sets of moisture & microbial filters and control knob. Neonatal Suction Catheters - 2 No 5.2 Consumables/reagents (open, closed system) Suction Silicone Tubing:8 mm ID x 2 mtr. (PVC) - 2 Nos 2x2 lt. jar (one set extra) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Capable of being stored continuously humidity, dust...) in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Sterility Complete unit to be easily washable issues and sterilizable using alcohol and other chemical agents. 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA/CE and BIS/ISO 13485:2003; IEC 60601-1-8; IEC 60601-1-SER-Ed 1.0-2011; IEC/TRF 60601-1-8-Ed 4.0- 2010 8.0 TRAINING AND INSTALLATION Page 21 of 1668.1 Pre-installation requirements: nature, values, Availability of 15 amp socket, safety quality, tolerance and operation checks before handover. 8.2 Requirements for sign-off Certificate of Calibration and inspection from the factory. 8.3 Training of staff (medical, paramedical, Training of users in operation and technicians) OPTIONAL (Depending upon basic maintenance shall be provided. scope of work order) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule. 9.3 Service contract clauses, including prices Local clinical staff/authorized officer on behalf of purchaser to affirm completion of installation. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Advanced maintenance tasks required manuals shall be documented. User, technical and maintenance manuals to be supplied in English/Hindi language along with machine diagrams. List to be provided of equipment and procedures required for local calibration and routine maintenance. 10.2 Other accompanying documents List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. Page 22 of 166SELF-INFLATING NEONATAL RESUSCITATION KIT WITH BAG VALVE MASK 1.0 USE 1.1 Clinical purpose To provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through manual pulmonar-driven pressure cycle functions. 1.2 Used by clinical department/ ward It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Manual resuscitator with transparent face-mask. 2. Child models (750ml, 500ml and 280ml bag capacity). 3. Standard 15/22 mm Swivel connector allows connections to all common masks Endotracheal Tubes both for adults and infants. 4. Provision to give supplemented oxygen-by-oxygen reservoir providing 100% oxygen. 5. Non-re breathing valve enabling the patient to inspire oxygen from the reservoir bag. 6. Should be suitable for single hand operate. 7. Should be easy to dissemble for cleaning and disinfection. 8. Should have pressure release valve at 40cm H O. 2 9. Should have silicone oxygen tube 2m length. 10 It should be up-to 40 times autoclavable including bag and washers. 11. The bag should be of silicone material. 12. Self Inflating Resuscitator bag should be of medical grade silicone rubber. 13. The reservoir should be a PVC bag Page 23 of 166of 600ml capacity for 260ml & 500ml bag capacity and 1000ml for 750ml bag capacity. 2.2 Settings NA 2.3 User's interface manual 2.4 Software and/or standard of NA communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) handheld 3.2 Weight (lbs, kg) light enough to be operated by hand/palm for long duration. 3.3 Configuration NA 3.4 Noise (in dBA), heat dissipation NA 3.5 Mobility, portability handheld 3.6 Others 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA Page 24 of 1665.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Silicon bellow Non Rebreathing Valve 2 meter oxygen tube, Guedel Airway Warm Towel - 2 No Sterile Gloves - 6 No Suction Bulb - 1 No Resuscitation Mask - 2 No 5.2 Spare parts (main ones) Oxygen Reservoir bag 5.3 Consumables / reagents (open, closed system) Neonatal Mask of 3 sizes viz 0, 1 and 2 - 1 No each 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS 6.1 Atmosphere / Ambiance (air conditioning, Operating condition: humidity, dust ...) – Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. – an ambient air velocity is less than 0.3 m/s. 6.2 User's care, Cleaning, Disinfection & Sterility Complete unit to be easily washable issues and sterilizable using both alcohol and chlorine agents. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); ISO 13485;Manufacturer / supplier Performance and safety standards (specific to the should have ISO certificate for quality device type); Local and/or international standard. Should be FDA (US) / CE (EU) approved product or BIS certified Should meet ISO 10651-4 standard requirement 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform installation, safety quality, tolerance and operation checks before handover. 8.2 Requirements for sign-off Certificate of Calibration and inspection from the factory. 8.3 Training of staff (medical, paramedical, Training of users in operation and Page 25 of 166technicians) basic maintenance shall be provided 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 year. 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices Page 26 of 166CARDIAC MONITOR 1.0 USE 1.1 Clinical purpose Designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. 1.2 Used by clinical department/ ward NICU and PICU 1.3 Overview of functional requirements Operates from mains voltage or from internal rechargeable battery. Operator can set audio visual alarm levels for low or high levels of each parameter independently. Allows display of single, 3 lead ECG or simultaneous display of at least 5 waves ECG selected from up to 12 points. Display to be digital of all active parameters and trace display for at least three selectable parameters. Continuous display on screen of neonatal or infant ECG, respiration and heart rates, invasive/non-invasive blood pressure, body temperature and SpO2. 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type 1. Should have facility for printing of device) ECG at 25mm/sec and 50mm/sec speed. 2. Should have facility for charging from both 12V DC & 220V AC. 3a. Should be supplied with. i. Pulse oximeter probe. ii. ECG cable -12 lead. iii. Temperature probe. iv. NIBP (non-invasive blood pressure) probe All probes should be supplied in 2 pairs, should be re-usable and should include adult, pediatric & neonatal size cuff/leads. The material of the probe should be such that it is non- breakable. 3. Capable of saving data for min 24 Page 27 of 166hrs. 4. Rates for consumables should be offered in price bid. 5. Optional item to be quoted : invasive blood pressure- monitoring module complete with reusable transducer. 2.2 Settings User operated 1mV ECG test marker function required. 2.3 User’s interface Manual (touch screen or remote operated not mandatory). 2.4 Software and/or standard of communication Audio Visual alarms required: high and low levels for each parameter (operator variable settings), sensor/wire/probe disconnected, low battery. 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Screen size minimum: 10”. 3.2 Weight (lbs, kg) <6kg. 3.3 Configuration Case is to be hard and splash proof. Display must allow easy viewing in all ambient light levels. Cable connectors to be designed so as fit correct socket only. 3.4 Noise (in dBA) <50 dB; Lead disconnection Alarm > 65 dB. 3.5 heat dissipation Should maitain nominal Temp and the heat should be disbursed through a exhaust cooling fan. 3.6 Mobility, portability Supplied in protective case for clean storage and safe transport. 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Voltage (value, AC or DC, monophase or 220 to 240V, 50 Hz. triphase) Page 28 of 1664.2 Battery operated Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit.Battery powered, silenceable alarm for power failure.Internal, replaceable, rechargeable battery allows operation for at least one hour in the event of power failure. Battery backup of minimum 100 minutes. 4.3 Tolerance (to variations, shutdowns) Voltage corrector/stabilizer to allow operation at ± 30% of local rated voltage. 4.4 Protection Electrical protection provided by fuses in both live and neutral supply lines. 4.5 Power consumption <120Watt. 4.6 Other energy supplies Mains cable. 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares 2 pairs, 12 lead ECG cable. 2 packs of 100 disposable ECG connection electrodes pediatric / Neonatal. Two sets of reusable SpO2 probes ncluding adult, pediatric & neonatal probes. Two sets of NIBP cuffs of each size. Two external skin temperature probes. 5.2 Consumables/reagents (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Capable of being stored continuously humidity, dust ...) in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User’s care, Cleaning, Disinfection & Sterility Complete unit to be easily washable issues and sterilizable using alcohol and other chemical agents. 7.0 STANDARDS AND SAFETY Page 29 of 1667.1 Certifications FDA/CE and BIS/ISO 13485:2003; ; IEC-60601-1-2:2007; IEC 60601-1-8- 2006; IEC 60601-1-SER-Ed 1.0-2011; IEC/TRF 60601-1-8 Ed4.0-2010; ISO 13485; ISO 80601-2-56-2009 (Thermometer); ISO 80601-2-61-2011 (SpO2) 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform installation, safety quality, tolerance and operation checks before handover. 8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before handover Local clinical staff to affirm completion of installation. 8.3 Training of staff (medical, paramedical, Training of users in operation and technicians) basic maintenance shall be provided. 8.4 Others 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices Warranty of 3 years with free servicing (min. 3/year) during warranty 9.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee/warranty period should be attached 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Advanced maintenance tasks required manuals shall be documented User, technical and maintenance manuals to be supplied in English language. List to be provided of equipment and procedures required for local calibration and routine maintenance Page 30 of 16610.2 Other accompanying documents List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. Page 31 of 166PULSE OXIMETER – LINE POWERED 1.0 USE 1.1 Clinical purpose Measurement and display of haemoglobin oxygen saturation (SpO2). 1.2 Used by clinical department/ ward All 1.3 Overview of functional requirements Continuously displays patient oxygen saturation in real time using an external probe on the skin. Contains adjustable alarms to alert when either saturation or heart rate is low. Reusable, sterilisable probes are robust and easily connected and disconnected. Operates from mains voltage or from internal rechargeable battery. 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type a) SpO2 measurement range at least of device) 40-70 and 70 to 99 %, minimum gradation 1%. b) Accuracy of SpO2 better than ± 1% for range 40-70 and better than ± 3% for range 70-99. c) Pulse rate range at least 30 to 240 bpm, minimum gradation 1 bpm. d) Accuracy of pulse rate better than ± 5 bpm. e) Signal strength or quality to be visually displayed. f ) Audiovisual alarms required: high and low SpO2 and pulse rate (operator variable settings), sensor disconnected, sensor failure, low battery. g) TFT Screen. h) Plethysmograph (may be in form of bar) display is mandatory. 2.2 Settings Should have minimum 24 hrs trend memory for SpO2 & PR. 2.3 User’s interface Easily accessible touch button to operate the machine. Page 32 of 1662.4 Software and/or standard of communication in built. 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) should be less than 5kg 3.3 Configuration Case is to be hard and splashproof. Display must allow easy viewing in all ambient light levels. Supplied in protective case for clean storage and safe transport. 3.4 Noise (in dBA) <50dBA 3.5 heat dissipation Dispersed through exhaust. 3.6 Mobility, portability Mobile 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Voltage (value, AC or DC, monophase or 220 to 240V, 50 Hz triphase) 4.2 Battery operated Internal, replaceable, rechargeable battery allows operation for at least four hours in the event of power failure. Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit. 4.3 Tolerance (to variations, shutdowns) Voltage corrector/stabilizer/UPS to allow operation at ± 30% of local rated voltage. 4.4 Protection Electrical protection by resettable circuit breakers in both live and neutral supply lines, Alarms should include Power failure. 4.5 Power consumption 50-100 W. 4.6 Other energy supplies Mains supply cable to be at least 3m in length. 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Page 33 of 1665.1 Accessories (mandatory, standard, optional) Two reusable probes each for adult, paediatric and infant use, Y Probes with clips for infant use and Forehead SpO2 sensors for detection of low saturation levels (less than 70%)/flex probe with provision of fixation. 5.2 Spare parts (main ones) Two sets of spare fuses (if non- resettable fuses used). 5.3 Consumables/reagents (open, closed system) NA 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Operating condition: humidity, dust ...) – Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. 6.2 User’s care, Cleaning, Disinfection & Sterility Cleanable with alcohol or chlorine issues wipes 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..), Should be FDA/CE approved product Performance and safety standards (specific to ISO 80601-2-61-2011: Medical the device type);Local and/or international Electrical equipment- part 2-61: Particular requirements for the basic safety snd essential performance of pulse oxymeter. Electrical safety conforms to standards for electrical safety IEC-60601-1, EMC safety confirms to IEC 60601-1-2 standard requirement. Manufacturer/supplier should have ISO 13485 certificate for quality standard. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Electrical sockets quality, tolerance 8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before handover. Local clinical staff to affirm completion of installation. Page 34 of 1668.3 Training of staff (medical, paramedical, Training of users in operation and basic technicians) maintenance shall be provided Advanced maintenance tasks required shall be documented. 8.4 Others 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule. 9.3 Service contract clauses, including prices Warranty of three year with free servicing (min. 3) during warranty. 9.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee/warranty period should be attached. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other User and maintenance manuals to be manuals supplied in English language. Certificate of calibration and inspection to be provided. List to be provided of equipment and procedures required for local calibration and routine maintenance List to be provided of important spares and accessories, with their part numbers and cost. Contact details of manufacturer, supplier and local service agent to be provided. 10.2 Other accompanying documents User/Technical/Maintenance manuals to be supplied in English. Page 35 of 166NON-INVASIVE BLOOD PRESSURE MONITOR 1.0 USE 1.1 Clinical purpose To measure non-invasive blood pressure. 1.2 Used by clinical department/ ward All 1.4 Overview of functional requirements 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type Corrosion resistant shock proof body, of device) chrome plated metal/stainless steel pressure control valve, scale 0-300 mm hg. Air release at closed lap with maximum 4mmHg/Minute. Manual setting of deflation possible upto 2/3mm Hg/sec. From 260mmHg. To 15mm Hg in a maxium deflation time of 10 seconds. Gauge’s background in white colour. Graduated scale for ever/2mmhg, every 10 units and every 20 units. Nylon straps cuff with pouch, latex bulb with completely chromium plated valve with regulation of vent-hole air by screw valve. 2.2 Settings The cuff is inflated just to fit in the limb for which an inflation bulb is used to control the air pressure within the cuff. 2.3 User’s interface Manual 2.4 Software and/or standard of NA communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) The rubber tubes used should have an internal diameter of 3 ± 0.5mm and the external diameter should not be less than 8mm; The dial mano meter with minimum diameter of 160 mm. Page 36 of 1663.2 Weight (lbs, kg) NA 3.3 Configuration NA 3.4 Noise (in dBA), heat dissipation NA 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Adult arm cuffs of size medium & large and paediatric & Neonatal size 1 each inflation bulb Tubing 5.2 Spare parts (main ones) Dial mano meter 5.3 Consumables/reagents (open, closed system) NA 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Capable of being stored continuously humidity, dust ...) in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User’s care, Cleaning, Disinfection & Sterility NA issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); ISO 13485; Performance and safety standards (specific to the device type); Local and/or international Page 37 of 1668.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform safety and quality, tolerance operation checks before handover. 8.2 Requirements for sign-off Certificate of inspection from the factory. 8.3 Training of staff (medical, paramedical, Training of users in operation and technicians) basic maintenance shall be provided. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule. 9.3 Service contract clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Should be supplied in English. manuals Page 38 of 166INFUSION PUMP 1.0 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 Used by clinical department/ ward NICU and PICU 1.3 Overview of functional requirements Alarms indicate if any error situations occur. The drive arm infuses the medication at a steady, programmed rate. 2.0 TECHNICAL CHARACTERISTICS 2.1 Clinical performances Should accept all internationally produced/marketed bottle and should be able to detect it automatically, Should support the Bolus supply of drug on press of single button, as per need and should be able to preset different range of Bolus supply. Preferably the unit should be of Bottom/side loaded to avoid accidental spilling of drugs and damage to the machine. 2.2 Technical characteristics (specific to this 1. Flow rate programmable range at least type of device) 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 Page 39 of 166on. 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 . 2.3 Settings Single loadable 2.4 User's interface Automatic 2.5 Software and/or standard of communication Inbuilt 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) NA 3.3 Configuration Tamper-resistant case made of impact resistant material. Securely mountable on tabletop, IV stand or bed fitting. 3.4 Noise (in dBA) Noise free 3.5 heat dissipation 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Voltage (value, AC or DC, monophase or 220V ± 10%, 50 Hz triphase) 4.2 Battery operated Internal rechargeable battery having a minimum of 2 hours backup 4.3 Tolerance (to variations, shutdowns) ± 10% 4.4 Protection Battery powered alarm for power failure or disconnection 4.5 Power consumption NA 4.6 Other energy supplies NA Page 40 of 1665.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Clamp for mounting pump on IV stand IV Set - 3 Nos 5.2 Spare parts (main ones) NA 5.3 Consumables/reagents (open, closed system) NA 5.4 Others 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Operating condition: humidity, dust...) – Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. 6.2 User's care, Cleaning, Disinfection & Capable of cleaning with alcohol or Sterility issues chlorine wipes 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); 1) FDA (US)/CE (EU) from autorized Performance and safety standards (specific third party and BIS/ISO 13485. to the device type) 2) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform installation, safety quality, tolerance and operation checks before handover. 8.2 Requirements for sign-off As per requirement 8.3 Training of staff (medical, paramedical, Training of users in operation and basic technicians) maintenance shall be provided. 8.4 Others 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Advanced maintenance and calibration tasks required shall be documented Page 41 of 1669.3 Service contract clauses, including prices 1) The spare, accessories & consulables price list required for maintenance and repairs in future after guarantee/warranty period should be attached; 2) Free servicing during warranty period; 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Should provide 2 sets (hardcopy) of:- manuals 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 manufacture; 10.2 Other accompanying documents List of important spares and accessories, with their part numbers and cost; Page 42 of 166SYRINGE PUMP 1.0 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 department/ ward NICU/PICU 2.0 TECHNICAL CHARACTERISTICS 2.1 Clinical performances Should accept all internationally produced/marketed syringes and should be able to detect it automatically, Should support the Bolus supply of drug on press of single button, as per need and should be able to preset different range of Bolus supply. Preferably the unit should be of Bottom / side loaded to avoid accidental spilling of drugs and damage to the machine. 2.2 Technical characteristics (specific to this 1. Flow rate programmable range at least type of device) 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. 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. Page 43 of 16612. 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. 2.3 Settings Single loadable with one syringe of minimum 20ml. 2.4 User's interface Automatic 2.5 Software and/or standard of communication Inbuilt 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) NA 3.3 Configuration Tamper-resistant case made of impact resistant material. Securely mountable on tabletop, IV stand or bed fitting. 3.4 Noise (in dBA) Noise free 3.5 heat dissipation 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Voltage (value, AC or DC, monophase or 220 to 240V, 50 Hz triphase) 4.2 Battery operated Internal rechargeable battery having at 4 to 6 hours backup for 10ml/hr flow rate with 50ml syringe. 4.3 Tolerance (to variations, shutdowns) 10% 4.4 Protection Battery powered alarm for power failure or disconnection. Page 44 of 1664.5 Power consumption 25W 4.6 Other energy supplies Na 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Clamp for mounting pump on IV stand PMO Line - 4 Nos 5.2 Spare parts (main ones) - 5.3 Consumables / reagents (open, closed Battery, syringe holder system) 5.4 Others 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, Operating condition: humidity, dust ...) – Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. 6.2 User's care, Cleaning, Disinfection & Capable of cleaning with alcohol or Sterility issues chlorine wipes. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); CE or FDA certified. Performance and safety standards Manufacturer / supplier should have ISO (specific to the device type) 13485 certificate for quality standard. Electrical safety conforms to standards for electrical safety IEC-60601-1, class II. Shall meet IEC 60601-1-2 EMC standard requirements. Certified to IEC-60601-2-24: Particular requirements for the safety of infusion pumps and controllers. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform installation, safety quality, tolerance and operation checks before handover. 8.2 Requirements for sign-off As per requirement 8.3 Training of staff (medical, paramedical, Training of users in operation and basic technicians) maintenance shall be provided. Page 45 of 1668.4 Others 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 year 9.2 Maintenance tasks Advanced maintenance and calibration tasks required shall be documented. 9.3 Service contract clauses, including prices Local clinical staff to affirm completion of installation. 9.4 Others 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other User, technical and maintenance manuals manuals to be supplied in english language. List to be provided of equipment and procedures required for local calibration and routine maintenance. 10.2 Other accompanying documents List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. Page 46 of 166PORTABLE WARMER 1.0 USE 1.1 Specially designed to support/reinforce the new-born during transport, which is bacteria resistant, skin safe, and easy to clean. (Preferably size should be between 520mm x 250mm to 600mm x 300mm) 2.0 TECHNICAL CHARACTERISTICS 2.1 Baby should be comfortable and safe away from electricity, hard surfaces or projections. 2.2 Baby wrap should be reusable and easy to sanitize using disinfectants or soap wash. 2.3 Weight of all components should be less than 5kg. Weight of baby-carrying and warming components should be less than 2 kg to allow transport and usage. 2.4 Should consist of Phase Change Material that maintain temperature at 37degC for atleast 4 hours. Size should be between 380mm x 220mm to 400mm x 250mm. (PCM should be certified nontoxic and non-hazardous. Also should ensure safety even in case of accidental damage to product) 2.5 There should be a precision heating mechanism to prevent overheating of warm pack. 2.6 Operating Conditions: Power consumption should be max 15 Watts in ready mode 3.0 ACCESSORIES 3.1 Accu Temp heater - 1 No 3.2 Warm pack - 2 No 3.3 Baby wrap - 2 3.4 Power cord Page 47 of 166BLOOD GLUCOSE MONITOR 1.0 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 Used by clinical department/ ward All 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this Should have reading range/linearity from type of device) 30 to 600 mg/dl; Should have a maximum reading time of less than 10 seconds; Should use a minimum blood sample less than 1.5µl; Should have a minimum memory of 50 tests; accuracy +/-10% and reproducibility +/-5%; Packing of strips should be such that there are not more than 50 strips/pack. The strips should be readily avalibale throughout the country; 2.2 Settings Should have automatic code detection facility , display of sugar in Mg/dl and NOT in mili moles. 2.3 User's interface LCD display 2.4 Software and/or standard of inbulit; .Should have facility to ensure communication (where ever required) accuracy of measurements. 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Handheld device 3.2 Weight (lbs, kg) Handheld device 3.3 Configuration Electrochemical/colorimetric/color sensing technology. 3.4 Noise (in dBA), heat dissipation NA 3.5 Mobility, portability Handheld 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements Battery powered 4.2 Battery operated 3-volt lithium coin cell battery or 2 x (AAA) Alkaline Batteries. Page 48 of 1664.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spare parts NA 5.2 Consumables/reagents (open, closed Glucose strips(able to use capillary blood system) samples) with availabilty in local market, shelf life of strips should be 12 months, the cost of strips for the next five years should be declared (for cost comparison)- with use of two strips/ day. 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere/Ambiance (air conditioning, Capable of being stored continuously in humidity, dust...) ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & The unit should be cleanable with alcohol. Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); Product should be US FDA or CE (EU) or Performance and safety standards (specific BIS certified and manufacturer should be to the device type); Local and/or CDSO & ISO 13485 certified. international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, NA values, quality, tolerance 8.2 Requirements for sign-off NA 8.3 Training of staff (medical, paramedical, Required technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 2 years; shelf life of minimum 12 months for strips from the date of manufacture; strips should work minimum 3 months from opening of pack. 9.2 Maintenance tasks Should require no routine maintenance. Page 49 of 1669.3 Service contract clauses, including prices Should have life time replacement offer. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Required manuals 10.3 Recommendations for maintenance To Be provided during installation Page 50 of 166BILIRUBINOMETER 1.0 USE 1.1 Clinical purpose Determining the concentration of bilirubin in the blood or other clinical specimen, most commonly to rapidly assess hyperbilirubinemia in neonates. 1.2 Used by clinical department/ ward NICU/PICU 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this 1) Sample volume of < 100 µL required, type of device) automatic calibration facility. 2) Total bilirubin concentration measurable (at least) in range of 0 to 30 mg/dl. 3) Time for total concentration measurement: ≤ 5 seconds. 4) Should have filters: 455 and 575 nm (± 2%). 5) Should have error rate less than 5%. 6) Should have resolution- 0.1 mg/dl. 7) Automatic correction for Hemoglobin. 8) Measuring cell: Direct Hematocrit capillary readings. 9) heparinized hematocrit glass capillary. 2.2 Settings Method to recalibrate / save current calibration, set sample size. 2.3 User's interface Manual interface. Backlit display with easy viewing in all ambient light levels. 2.4 Software and/or standard of Inbuilt software. communication(where ever required) Convenient and quick USB interface. 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Approx. 110 x 150 x 200 mm. 3.2 Weight (lbs, kg) 5 kg - 15 kgs 3.3 Configuration (Ex : Compact, modular, to be fixed to walls, ceiling, etc). 3.4 Noise (in dBA) <60dB Page 51 of 1663.5 Heat dissipation Heat Dissipation: Should maintain nominal temp and the heat should be disbursed through an cooling mechanism. 3.6 Mobility, portability Easy and safe transport to be possible by hand, stable when tabletop mounted; 4.0 ENERGY SOURCE (Electricity, Ups, Solar, Gas, Water, CO ) 2 4.1 Power Requirements 220VAC ± 10%, 50 Hz; 4.2 Battery operated Yes (optional) 4.3 Tolerance (to variations, shutdowns) Voltage corrector / stabilizer to allow operation at ± 10% of local rated voltage. 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies Length of mains power cable should be at least 3 meters. 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Hard and splash-proof case to be supplied. 5.2 Spare parts (main ones) 1) Spare/replaceable fuses - 2 sets. 2) Reagents and capillary tubes sufficient for minimum 100 tests. 3) Reagents and consumables per test should be declared. 5.3 Consumables / reagents (open, closed 1) Capillary tubes, haemofluorometric system) reagents (e.g., aqueous cyanide salt with stabilizers, if applicable). 2) Price of all Consumables to be mentioned. 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, 1) Operating condition: humidity, dust ...) Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90% in ideal circumstances. 2) Storage condition: Capable of being stored continuously in ambient temperature of 0 to 50 deg C and Page 52 of 166relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Disinfection: Parts of the Device that are Sterility issues designed to come into contact with the patient or the operator should either be capable of easy disinfection or be protected by a single use/disposable cover. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); 1) Should be CE (EU)/FDA (US) / BIS Performance and safety standards (specific approved product. to the device type);Local and/or 2) Manufacturer / supplier should have ISO international 13485 certificate for quality standard and CDSCO approved 3) Should have IEC 61010 certificate. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Availability of 5Amps electrical socket. quality, tolerance 8.2 Requirements for sign-off 1) Supplier to perform installation, safety and operation checks before handover. 2) Local clinical staff to affirm completion of installation. 8.3 Training of staff (medical, paramedical, 1) Training of users on operation and basic technicians) maintenance. 2) Advanced maintenance tasks required shall be documented. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks 1) Maintenance manual detailing. 2) Complete maintenance schedule. 9.3 Service contract clauses, including prices 1) The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached. 2) Free servicing ( min. 2/year) during Page 53 of 166warranty period. NEONATAL STETHOSCOPE 1.0 USE 1.1 A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users’ ears. Designed specifically to detect higher frequencies which are produced by newborns and infants. 2.0 TECHNICAL SPECIFICATIONS 2.1 Double cup chest piece with one diaphragm and one bell cup in zinc alloy. 2.2 Diaphragm Ø: 23 mm; bell Ø: 18 mm. 2.3 Tube treated rubber, PVC, crack resistant. 2.4 Tube impervious to outside noises, guaranteeing full transmission of sound, good auditive quality. 2.5 Tube diameter: outer Ø: 8-10mm, inner Ø: 4.2mm. Tube maximum length 60cm. 2.6 Sensitivity from 3.2dB to 26dB in a range from 50 to 1000Hz for cardiology. 2.7 Sensitivity 8.1dB in a range from 600 Hz to 1,500Hz for pneumology. 2.8 Arms: stainless steel with flexible spring. 2.9 Removable plastic earpieces. 3.0 Latex-free. 3.1 Designed for frequent and easy disassembly and disinfection with hospital-grade products. 4.0 SUPPLIED WITH 4.1 Instructions for assembly, use and maintenance in English. 4.2 1 x spare diaphragm. 4.3 1 x set spare earpieces. Page 54 of 1665.0 ESTIMATED LIFE SPAN Five years. 6.0 WARRANTY Two years. 7.0 ENVIRONMENTAL CONDITIONS Storage conditions: 0 - 50°C / 85% RH. Operating conditions: 10 - 40°C / 85% RH. 8.0 STANDARDS Product should be US FDA or CE (EU) or BIS certified and manufacturer should be CDSO & ISO 13485 certified. Page 55 of 166DIRECT OPHTHALMOSCOPE 1.0 USE 1.1 Clinical purpose Direct ophthalmoscope is a hand-held and battery powered device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye. 1.2 Used by clinical department/ ward NICU & PICU 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type 1) Should have on/off button for of device) illumination and battery operated; 2) Should have rotating knob to control the intensity of the ophthalmoscope and should be used with filters that eliminate UV radiation (<400nm) and, whenever possible, filters that eliminate short- wavelength blue light (<420nm); 3) Should have the range of +20 to -20 in single dioptre steps to ensure easy examination of all ocular structures; 4) Should have apertures shape: Large spot, small spot, slit, central net, and red free; 2.2 User's interface Manual 2.3 Software and/or standard of communication NA (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Max: 50mm x 50mm x 250mm. 3.2 Weight (lbs, kg) NA 3.3 Configuration NA 3.4 Noise (in dBA) NA 3.5 Heat dissipation NA 3.6 Mobility, portability Handheld device 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 Page 56 of 1664.1 Power Requirements NA 4.2 Battery operated Yes 4.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional); 1) Replacement bulb/illumination Spare parts (main ones); source -2 Nos. Consumables/reagents (open, closed system) 2) Storage case (rigid and steady). 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS 6.1 Atmosphere/Ambiance (air conditioning, 1) Operating condition: Capable of humidity, dust...) operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90% in ideal circumstances. 2) Storage condition: Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Sterility Disinfection: Parts of the Device that are issues designed to come into contact with the patient or the operator should either be capable of easy disinfection or be protected by a single use/disposable cover. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); 1) Should have IEC 60601-1/IEC Performance and safety standards (specific to 60601-1-2/CE (EU) certificate; the device type); Local and/or international 2) Optical radiation hazards with ophthalmoscopes: ISO 10942 or ISO 15004; 3) Manufacturer/supplier should have ISO 13485 certificate for quality standard; 8.0 TRAINING AND INSTALLATION Page 57 of 1668.1 Pre-installation requirements: nature, values, NA quality, tolerance 8.2 Requirements for sign-off Certificate of calibration and inspection from the manufacturer. 8.3 Training of staff (medical, paramedical, 1) Training of users on operation and technicians) basic maintenance; 2) Advanced maintenance tasks required shall be documented. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years including bulb. 9.2 Maintenance tasks 1) Maintenance manual detailing; 2) Complete maintenance schedule; 9.3 Service contract clauses, including prices 1) The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee/warranty period should be attached; 2) Free servicing (min. 2/year) during warranty period; 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Should provide 2 sets (hardcopy) of: manuals 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 and inspection; 10.2 Other accompanying documents List of important spares and accessories, with their part numbers and cost; 11.0 NOTES 11.1 Service Support Contact details (Hierarchy Contact details of manufacturer, supplier Wise; including a toll free/landline number) and local service agent to be provided; Any Contract (AMC/CMC/add-hoc) to be declared by the manufacturer; 11.2 Recommendations or warnings Any warning signs would be adequately Page 58 of 166displayed . DIGITAL THERMOMETER 1.0 USE 1.1 Clinical purpose To measure body temperature 1.2 Used by clinical department/ ward All 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type 1. Range of temperature measurement of device) 32 deg C- 42 deg C (89.60F-109.40F). 2. Can be calibrated in both centigrade and Fahrenheit, but if only one option is available, then Fahrenheit is preferable. 3. Buzzer signal function. 4. Takes 60-90 seconds to measure temperature. 5. Can be used in the armpit/axilla, orally and rectally. 6. Accuracy of temperature ± 0.1deg C and ± 0.2 F. 2.2 User's interface LCD display 2.3 Software and/or standard of communication inbuilt (wherever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) NA 3.3 Configuration NA 3.4 Noise (in dBA) NA 3.5 Heat dissipation NA 3.6 Mobility, portability Portable Page 59 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements As per device 4.2 Battery operated yes 4.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption As per device 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) NA 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents (open, closed system) Batteries 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, Capable of being stored continuously in humidity, dust ...) ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Sterility Complete unit to be easily washable and issues sterilizable using both alcohol and chlorine agents. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); ISO:13485 Manufacturer Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform operation checks quality, tolerance before handover. 8.2 Requirements for sign-off Certificate of inspection from the factory. 8.3 Training of staff (medical, paramedical, NA technicians) Page 60 of 1669.0 WARRANTY AND MAINTENANCE 9.1 Warranty One yaer 9.2 Maintenance tasks NA 9.3 Service contract clauses, including prices NA 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other Required manuals Page 61 of 166BABY WEIGHING SCALE 1.0 USE 1.1 Clinical purpose To measure body mass of the neonate 1.2 Used by clinical department/ ward NICU/SNCU 1.3 Overview of functional requirements 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this 1. Tabletop, light and portable. type of device) 2. Built in rechargeable battery. 3. Easy to clean baby tray (acrylic). 4. Zero weight adjustment facility. 5. Quick, clear digital read outs. 6. Measurement does not change with position of baby on the pan. 7. Provision to measure the height of the baby in its laying position. 8. Accuracy: 5g, resolution: 1g, limit: 10gm to 15kg. 2.2 Settings Auto setting to 0.00 once a the machine is switched on or when no external weight has been put on. 2.3 User's interface LCD/LED display 2.4 Software and/or standard of In built communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Base: 300mm x 265mm x 85mm ± 20%, Pan: 510mm x 300mm x 85mm (minimum). 3.2 Weight (lbs, kg) NA 3.3 Configuration N.A. 3.4 Noise (in dBA) N.A. 3.5 heat dissipation NA 3.6 Mobility, portability portable Page 62 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO ) 2 4.1 Power Requirements 230 V AC, 4.2 Battery operated 4XAA battery(rechargable) or equivalent; one hour backup. 4.3 Tolerance (to variations, shutdowns) NA 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) NA 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents (open, closed NA system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, Operating condition: humidity, dust ...) – Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. – An ambient air velocity less than 0.3 m/s. 6.2 User's care, Cleaning, Disinfection & Complete unit to be easily washed and Sterility issues disinfected using both alcohol and chlorine agents. 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); The Scale should be as per BIS Performance and safety standards (specific specifications. The scale should have ISI to the device type); Local and/or mark ie IS: 2489 Or CE/FDA certified. international Should have model approval from Legal Metrology Dept., Govt. of India. 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, NA Page 63 of 166quality, tolerance 8.2 Requirements for sign-off NA 8.3 Training of staff (medical, paramedical, NA technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty one year 9.2 Maintenance tasks Calibration schedule to be provided. 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other NA manuals 10.2 Other accompanying documents NA 10.3 Recommendations for maintenance Cautionary Note: Do not press the weighing pan with your hand. It could damage the load cell system in the weighing machine Other Essentials (Accessories, Disposables, Kits) to be quoted from genuine standard manufacturer with relevant ISO 13485 & CDSCO approvals and with standard one-year warranty. The products supplied are mandatory to be compatible with neonatal and child use. The specifications must be furnished along with brochure marked with model number for technical evaluation and approval. At any given point of time the buyer will request for demo of the equipment. Page 64 of 166Table 13 List of medical equipment’s for Multi stretcher Ambulance. S. Equipments Quantity No. 1 Defibrillator with AED Pacing 1 2 ECG Machine 1 Transport Ventilator Universal (Adult, 3 1 Pediatric & Neonatal) 4 Syringe Pump 1 5 Infusion Pump 1 Suction Machine Electrical, Foot Operated 6 1 Each & hand operated 7 Cardiac Monitor 1 8 Laryngoscope 1 9 BP Instrument Aneroid 1 Medical 10 Equipment Stethoscope 1 11 Portable handheld Glucometer 1 12 Foetal Doppler 1 13 Nebulizer (Electric) 1 14 Double Head Immobilizers 1 15 Spine Board & Immobilization Devices. 3 16 Cervical collar 3 17 Pneumatic Splints 1 18 Scoop Stretcher 2 Resuscitation Kit with Bag Valve Mask - 19 3 Neonatal & Child Page 65 of 166Resuscitation Kit with Bag Valve Mask - 20 3 Adult Oxygen Cylinders (B & D Type) and 21 3 Each Regulator 22 Autoloader Stretchers on Trolley 3 23 Canvas Foldable Stretcher 2 24 Flowmeter with Humidifier bottle 3 25 IV Stand Detachable 3 26 Intraosseous (IO) Infusion System 2 27 Foldable wheelchairs with hand break 2 (A) Intra Venous Cut Down Set and (C) 28 1 Suture Kit 29 Biohazard Disposal Kits 1 Other Essentials 30 Body Bags (for disaster response) 1 (Accessories, Disposables, Kits) 31 Extra PPE Kits (for paramedics) 1 Basic First Aid Kit – Bandages, 32 1 antiseptics, gauze, tape 33 Safety Restraints 3 34 Supraglottic device (LMA) all sizes Burn Treatment Kit – Cooling dressings & 35 1 ointments Patient Lifting Devices – Hydraulic 36 1 stretcher loading 37 Blankets and Sheets 2 each 38 Multiple Stretcher Mounts 3 Sets Fabrication Requirements 39 Medical Cabinet 2 40 Oxygen Cylinder Holder 1 Mounts for all medical equipment based on 41 1 design Page 66 of 16642 IV Hanger 3 43 Suction Canister Holder 1 44 Patient Seat 1 45 Communication Devices 1 46 Navigation and Lighting Equipment 1 Electronic Patient Care Record (ePCR) 47 1 System Global Positioning System (GPS) and 48 1 Navigation System 49 Ambulance Power Lift or Winch System 1 50 Patient Identification Tags Set 51 Storage Compartments At least 4 Automated External Defibrillator GENERAL 1.0 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 Page 67 of 1662.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Defibrillator should be bi-phasic and with AED Pacing characteristics (specific to this type 2. Should work on Automated external defibrillation mode. of device) Manual selection maximum up to 150J to 200J 3. Should be capable of doing synchronized cardioversion 4. Can be operated from mains as well as battery 5. Should defibrillate through pads 6. Should have charging time of less than 10 seconds for maximum energy with charging indicator 7. Should have two inbuilt batteries capable of usage for at least 120 minutes and/or 30 discharge 8. Detailed audio-visual message guide responder through use of the defibrillator 9. Color Coding for different buttons 2.2 Settings Automatic 2.3 User's interface Should have display- LCD 2.4 Software and/or Inbuilt standard of communication (wherever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Compact 3.2 Weight (lbs, kg) <5kg 3.3 Configuration 3.4 Noise (in dBA), heat Audio Visual message in case pads not applied properly dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE 4.1 Power Requirements 220 to 240V, 50 Hz Page 68 of 1664.2 Battery operated Should have a battery capable of usage for at least 120 minutes and/or 30 discharge 4.3 Tolerance (to ± 10% of input AC variations, shutdowns) 4.4 Protection Electrical protection by resettable overcurrent breakers or replaceable fuses, fitted in both live and neutral lines 4.5 Power consumption - 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares 2 nos of patient cable, 2 sets each adult and pediatric pads 5.3 Consumables / - reagents (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of 0 Ambiance (air to 50 deg C and relative humidity of 15 to 90%. Capable of conditioning, operating continuously in ambient humidity, dust...) temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA (US) /CE (EU) and BIS/ISO 13485:2003; IEC-60601-1-2 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform installation, safety and operation checks requirements: nature, before handover. values, quality, tolerance 8.2 Requirements for Certificate of Calibration and inspection from the factory. sign-off 8.3 Training of staff NA (medical, paramedical, Page 69 of 166technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance manual detailing complete maintaining schedule Maintenance tasks 9.3 Service contract Local clinical staff to affirm completion of installation clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in english language. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with their documents part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES 11.1 Service Support Contact details of manufacturer, supplier and local service agent to Contact details be provided (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or List to be provided of important spares and accessories, with their warnings part numbers and cost. Certificate of calibration and inspection to be provided. 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade ECG Machine -12 Channel GENERAL 1.0 USE 1.1 Clinical purpose Continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to Page 70 of 166the patient. Used by clinical 1.2 ALL department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Simultaneous 12 Channel ECG recording with 12 lead characteristics simultaneous acquisition (specific to this type of device) 2. Should have a digital display of 12 channel ECG and should have three modes(Automatic, Manual and rhythm). 3. Heart rate measurement range to be at least 30 to 250 bpm, with accuracy better than ± 5 bpm. Heart rate trend display of at least previous 24 hours. 4. Arrhythmia detection facility required; minimum gradation of 1 bpm. 2.2 User's interface Manual 2.3 Settings Audiovisual alarms required: high and low heart rate (operator variable settings), cardiac arrhythmia, sensor/wire disconnected, low battery. Software and/ or standard of 2.4 In built communication(where ver required 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions(metric) NA 3.2 Weight (lbs, kg) less than 5 kgs 3.3 Configuration Case is to be hard and splashproof. 3.4 Noise (in dBA) <50 dB Heat Dissipation: Should maintain nominal Temp and the heat 3.5 Heat dissipation should be 3.6 Mobility, portability Supplied in protective case for clean storage and safe transport. 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ….) Page 71 of 1664.1 Power requirements 220 to 240V, 50 Hz 4.2 Battery operated Battery powered, silenceable alarm for power failure. Voltage corrector/stabilizer to allow operation at ±30% of local 4.3 Protection rated 4.4 Power consumption To be specified by vendor. 4.5 Other energy supplies Mains cable to be at least 3m length. 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Accessories, 5.1 12 lead ECG cable. (mandatory, standard, 5.2 Spare parts(main ones) Two sets of spare fuses (if non-resettable fuses used) Consumables/reagents( 5.3 5 tubes electrode gel (if required) open, closed 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS 6.1 Atmosphere/Ambience 1. Operating Condition: Capable of operating continuously in (air conditioning, ambient temperature of 5 to 50 deg C and relative humidity of 15 humidity, dust …) to 90% in ideal circumstances. 6.2 User's care, Cleaning, 1. Disinfection: Parts of the Device that are designed to come Disinfection & Sterility into contact with the patient or the operator should either be issues capable of easy disinfection or be protected by a single use/disposable cover. 2. Sterilization not required. 7.0 STANDARDS AND SAFETY 1. Should be FDA/European CE/BIS approved product. 2. Manufacturer should have ISO 13485 certification for quality Certificates (pre- standards. market, sanitary ...); Performance and 3. Electrical safety conforms to the standards for electrical safety 7.1 safety standards IEC 60601-1-General requirements (or equivalent BIS Standard) (specific to the device type); Local and/or 4. History of adverse events and actions (Recall/Filed safety international correction etc) taken by manufacturer on the product should be made available to procurer. Such information (as and when happen) after commission of product should be continued to be provided to purchaser till manufacturing of same type product is Page 72 of 166curtailed. 8.0 TRAINING AND INSTALLATION Pre- installation 8.1 Availability of 5 Amp/15 Amp. Electrical Socket. requirements: Requirements for sign- Supplier to perform installation, safety and operation checks before 8.2 off handover. Training of staff Training of users in operation and basic maintenance shall be 8.3 (medical, paramedical, provided. 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years, including all spares and calibration. 10.0 DOCUMENTATION 10.1 Operating manuals, Should provide 2 sets(hard copy and soft copy) of: set manuals, other manuals 1. User, technical and maintenance manuals should be supplied in English/Hindi/Regional language along with machine diagrams. 2. List of equipment and procedures required for local calibration and routine maintenance. 3. Service and operation manuals (original and copy) to be provided. 4. Advanced maintenance tasks documentation. 5. Certificate of calibration and inspection. 6. Satisfactory certificate for any existing installation from government hospital. 10.2 Other accompanying List of essential spares and accessories, with their part number documents and cost; Transport Ventilator (Adult & Pediatrics) Version no. : 2.0 Page 73 of 166Date: 2016 Done by : (name / institution) Dte. GHS NAME AND CODING GMDN name Transport pneumatic high-frequency ventilator GMDN code(s) CT2175 GENERAL 1.0 USE 1.1 Clinical purpose To provide automated, alveolar ventilatory support for patients during inter - hospital or intra - hospital transport, and in emergency situations. 1.2 Used by clinical Emergency /Critical Care department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Mountable transport Ventilator (Adult & Pediatrics) (specific to this type of device) 2. Invasive Modes (CMV and SIMV) and Non-Invasive Mode (CPAP) 3. Tidal Volume: 50 - 1500 ml 4. Respiration Rate upto 30 bpm 5. Apnoeic Ventilation: 10 - 60 seconds with alarm 6. There should be two FiO2 settings ranging from 21% to 100%. Setting of 100% FiO2 is mandatory. 7. PEEP 0 - 20 cm of water 8. Trigger Sensitivity – Pressure 9. Flow Range: 1 - 120 Lts/min 10. The associated cylinder(to be supplied along with the machines) should be such that it could be locally filled. 11. Oxygen Cylinder connector (to be supplied along with the machines) should be compatible with ventilator Page 74 of 16612. Audio visual alarm for disconnection and high pressure 2.2 User's interface Automatic Software and/or standard 2.3 of communication (where inbuilt ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) <8kgs 3.3 Configuration NA Noise (in dBA), heat 3.4 <60dB; Alarm > 65dB dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements 220 to 240V, 50 Hz; electricity and battery driven 4.2 Battery operated Atleast 6 hours battery backup Tolerance (to variations, 4.3 ± 10% of input shutdowns) 4.4 Protection OVP, earth leakage protection 4.5 Power consumption <140Watt 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Full face mask, 4 reusable breathing circuit of silicone material (2 for 5.1 Accessories & Spares adults and 2 for pediatrics), carry bag, filters Consumables / reagents 5.2 battery, leakage adapter (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS Page 75 of 1666.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 to (air conditioning, 50 deg C and relative humidity of 15 to 90%. humidity, dust...) Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Sterility The unit should be cleanable with alcohol issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA (US) /CE (EU) and BIS/ISO 13485:2003; IEC-60601-1-2; ISO 15001-2010 (Anesthetic & respiratory equipment- compatibility with oxygen) Certificate of approval for transport ventilator 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, electrical sockets; Oxygen supply values, quality, tolerance 8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before handover Local clinical staff to affirm completion of installation Training of staff (medical, Training of users in operation and basic maintenance shall be 8.3 paramedical, technicians) provided Advanced maintenance tasks required shall be documented 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, warranty of three year with free servicing ( min. 3) during warranty including prices 9.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached 10.0 DOCUMENTATION Page 76 of 16610.1 Operating manuals, User and maintenance manuals to be supplied in English language. service manuals, other Certificate of calibration and inspection to be provided. manuals List to be provided of equipment and procedures required for local calibration and routine maintenance List to be provided of important spares and accessories, with their part numbers and cost. Contact details of manufacturer, supplier and local service agent to be provided 10.2 Other accompanying User/Technical/Maintenance manuals to be supplied in English documents 11.0 NOTES 11.1 Service Support Contact Contact details of manufacturer, supplier and local service agent to be details (Hierarchy Wise; provided including a toll free/landline number) 11.2 Recommendations or Any warning signs would be adequately displayed warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Transport Ventilator (neonatal & Pediatrics) GENERAL 1.0 USE 1.1 Clinical purpose To provide automated, alveolar ventilatory support for patients during inter - hospital or intra - hospital transport, and in emergency Page 77 of 166situations. 1.2 Used by clinical Emergency /Critical Care department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Mountable transport ventilator (Neonate/Pediatric) (specific to this type of device) 2. Invasive Modes (CMV and SIMV) and Non-invasive Mode (CPAP) 3. Pressure controlled - Pressure upto 15mmHg 4. Respiration Rate upto 40/ mins 5. There should be two FiO2 setting range between 21% and 100%. Setting 100% FiO2 should be mandatory 6. PEEP 0-20 cm of water 7. Trigger sensitivity - Pressure 8. The associated cylinder(to be supplied along with the machines) should be such that it could be locally filled 9. Oxygen Cylinder connector(to be supplied along with the machines) should be compatible with ventilator. 10. Audio and visual alarm for disconnection and high pressure 2.2 User's interface Automatic 2.3 Software and/or standard inbuilt of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) <8kgs 3.3 Configuration NA Noise (in dBA), heat 3.4 Should have audio visual alarm for disconnection and high pressure dissipation Page 78 of 1663.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements 220 to 240V, 50 Hz; electricity and battery driven 4.2 Battery operated with at least 6 hours battery backup 4.3 Tolerance (to variations, ± 10% of input shutdowns) 4.4 Protection OVP, earth leakage protection 4.5 Power consumption <140Watt 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares full face mask, 4 reusable breathing circuit of silicone material(2 for pediatiric and 2 for neonates), carry bag, ventilator connecting tubes 5.2 Consumables / reagents battery, leakage adapter (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 to (air conditioning, 50 deg C and relative humidity of 15 to 90%. humidity, dust Capable of operating continuously in ambient temperature of 10 to 40 ...) deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA (US) /CE (EU) and BIS/ISO 13485:2003; IEC-60601-1-2; ISO 15001-2010 (Anesthetic & respiratory equipment- compatibility with oxygen) Certificate of approval for transport ventilator 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation electrical sockets; Oxygen supply requirements: nature, values, quality, tolerance 8.2 Requirements for sign-off Supplier to perform installation, safety and operation checks before Page 79 of 166handover Local clinical staff to affirm completion of installation 8.3 Training of staff (medical, Training of users in operation and basic maintenance shall be paramedical, technicians) provided Advanced maintenance tasks required shall be documented 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, warranty of three year with free servicing ( min. 3) during warranty including prices 9.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached 10.0 DOCUMENTATION 10.1 Operating manuals, User and maintenance manuals to be supplied in English language. service manuals, other Certificate of calibration and inspection to be provided. manuals List to be provided of equipment and procedures required for local calibration and routine maintenance List to be provided of important spares and accessories, with their part numbers and cost. Contact details of manufacturer, supplier and local service agent to be provided 10.2 Other accompanying User/Technical/Maintenance manuals to be supplied in English documents 11.0 NOTES 11.1 Service Support Contact Contact details of manufacturer, supplier and local service agent to be details (Hierarchy Wise; provided including a toll free/landline number) 11.2 Recommendations or Any warning signs would be adequately displayed warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 80 of 166Syringe Pump GENERAL 1.0 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 Intensive care unit (ICU), radiology department, orthopaedics, Page 81 of 166department/ward emergencies, ...) 1.3 Overview of functional A syringe containing medication is securely mounted on the drive requirements arm. Alarms indicate if any error situations occur. The drive arm infuses the medication at a steady, programmed rate. TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Flow rate programmable range at least from 1 to 100 ml/hr, in (specific to this type of steps of 0.1 ml/hr; with bolus rate from 200 to 999 ml/hr in device) steps of 1 ml/hr 2. Saves last infusion rate even when the AC power is switched off 3. Bolus rate should be programmable, with infused volume display. 4. Must work on commonly available 5, 10, 20 and 50 ml syringes 5. Accuracy of ±2% or better. 6. Maximum pressure generated ≤ 20 psi 7. Automatic detection of syringe size and proper fixing. Must provide alarm for wrong loading of syringe viii. Anti-bolus system to reduce pressure on sudden release of occlusion. 8. Pause infusion facility required 9. Self-check carried out on powering on 10. 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 alarm, drive disengaged alarm, syringe loading error alarm 11. Should be front loading with wall mounting facility 12. waterproof surface 2.2 Settings NA 2.3 User's interface Automatic 2.4 Inbuilt Software and/or standard Page 82 of 166of communication 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) max spec: 120 x 100 x 40mm 3.2 Weight (lbs, kg) <500gm 3.3 Configuration Tamper-resistant case made of impact resistant material Securely mountable on tabletop, IV stand or bed fitting proof water 3.4 Noise (in dBA) <50 dB 3.5 heat dissipation NA 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Voltage (value, AC or DC, 220 to 240V, 50 Hz monophase or triphase) 4.2 Battery operated Internal rechargeable battery having at least 5 hours backup for 10ml/hr flow rate with 50ml syringe 4.3 Tolerance (to variations, Voltage corrector / stabilizer to allow operation at ± 30% of local shutdowns) rated voltage. 4.4 Protection Battery powered alarm for power failure or disconnection; Electrical protection provided by fuses in both live and neutral supply lines; 4.5 Power consumption Should easily run in an ambulance with other life saving equipments 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares Clamp for mounting pump on IV stand 5.2 Consumables / reagents Battery, syringe holder (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 to (air conditioning, 50 deg C and relative humidity of 15 to 90%. humidity, dust ..) Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. Page 83 of 166Enclosure to protect against water ingress; 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA (US) /CE (EU) and BIS/ISO 13485:2003; IEC-60601-1 including particular requirements for the safety of infusion pumps and controllers; 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform installation, safety and operation checks before requirements: nature, handover. values, quality, tolerance 8.2 Requirements for sign-off As per requirement 8.3 Training of staff (medical, Training of users in operation and basic maintenance shall be paramedical, technicians) provided 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Advanced maintenance and calibration tasks required shall be documented 9.3 Service contract clauses, Local clinical staff to affirm completion of installation including prices 10.0 DOCUMENTATION 10.1 Operating manuals, User, technical and maintenance manuals to be supplied in english service manuals, other language. manuals List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with their documents part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES 11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided Page 84 of 16611.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Suction pump portable electric GENERAL 1.0 USE 1.1 Clinical purpose To aspirate fluids, secretions, or other foreign materials from Page 85 of 166a patient's airway by means of suction. 1.2 Used by clinical department/ward All TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to 0 to - 760 mm Hg ± 10 regulable, 1/2 HP; single phase 1440 this type of device) RPM motor; flutter free vacuum control knob,; Wide mouthed 2 x 2 LITRE (light weight, unbreakable and clear) with self sealing bungs and mechanical over flow safety device. 2.2 Settings Manual 2.3 User's interface Manual 2.4 Software and/or standard of NA communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Max: 43 x 30 x 68 cms 3.2 Weight (lbs, kg) Max: 2.7Kg (with jar) 3.3 Configuration NA 3.4 Noise (in dBA) 50 dB A ± 3 3.5 heat dissipation Should maintain upto 36.5 deg temp and the heat disbursed through an exhaust fan 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements 220 V, 50 Hz, 2 ± 0.5 Amps, 370 watts for AC and DC compatible with ambulance power supply with other life saving equipments running 4.2 Battery operated NA Page 86 of 1664.3 Tolerance (to variations, shutdowns) Voltage corrector / stabilizer to allow operation at ± 30% of local rated voltage. Use of SMPS to correct voltage 4.4 Protection Electrical protection by resettable over current breakers or replaceable fuses, fitted in both live and neutral lines 4.5 Power consumption should run with other life saving equipments running parallelly in the vehicle 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares collection container & its cap, suctions tube tips, a vacuum gauge, two sets of moisture & microbial filters and control knob 5.2 Consumables / reagents (open, closed SiliconeTubing:8 mm ID x 2 mtr (PVC), 2x2 lt jar ( one set system) extra) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air Capable of being stored continuously in ambient conditioning, humidity, dust...) temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Disinfection & Complete unit to be easily washable and sterilizable using Sterility issues alcohol and chemical agents. 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA(US) /CE(EU) and BIS/ISO 13485:2003; IEC 60601-1 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, Availability of 15-amp socket, safety and operation checks values, quality, tolerance before handover. Compatible with ambulance electrical systems 8.2 Requirements for sign-off Certificate of Calibration and inspection from the factory. 8.3 Training of staff (medical, Training of users in operation and basic maintenance shall paramedical, technicians) be provided OPTIONAL (Depending upon scope Page 87 of 166of work order) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including Local clinical staff / authorized officer on behalf of prices purchaser to affirm completion of installation 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, Advanced maintenance tasks required shall be documented other manuals in English and/or Hindi User, technical and maintenance manuals to be supplied in English/Hindi language along with machine diagrams. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying documents List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES 11.1 Service Support Contact details Any Contract (AMC/MC/ad-hoc) to be declared by the (Hierchy Wise; including a toll manufacturer free/landline number) 11.2 Recommendations or warnings Any recommendations for best use and supplementary warning for safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Suction Pump, foot operated Page 88 of 166GENERAL USE TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 0 to - 600 mmHg +-10mm regulable, flutter free, vacuum control knob (specific to this type of device) 2.2 Settings Manual 2.3 User's interface Manual 2.4 Software and/or standard of NA communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) 2.5kg max 3.3 Configuration NA 3.4 Noise (in dBA) NA 3.5 heat dissipation NA 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ................ ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Page 89 of 1665.1 Accessories & spare parts collection bottles, clear unbreakable jar (one set extra) 5.2 Consumables / reagents (open, silicon tubing - two sets closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air Capable of being stored continuously in ambient conditioning, humidity, dust ...) temperature of 0 to 50 deg C and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Complete unit to be easily washable and sterilizable using both alcohol and chemical agents. Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA(US)/CE (EU) and BIS/ISO 13485:2003; ISO 10079-2-2014 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: NA nature, values, quality, tolerance 8.2 Requirements for sign-off NA 8.3 Training of staff (medical, Training of users in operation and basic maintenance paramedical, technicians) shall be provided OPTIONAL (Depending upon scope of work order) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including Local clinical staff / authorized officer on behalf of prices purchaser to affirm completion of installation 10.0 DOCUMENTATION Page 90 of 16610.1 Operating manuals, service Advanced maintenance tasks required shall be manuals, other manuals documented User, technical and maintenance manuals to be supplied in English/Hindi language along with machine diagrams. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying documents List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES 11.1 Service Support Contact details NA (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or warnings Any recommendations for best use and supplementary warning for safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Suction Pump, hand operated GENERAL 1.0 USE Page 91 of 1661.1 Clinical purpose to aspirate fluids, secretions, or other foreign materials from a patient's airway by means of suction. TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 0 to - 600 mmHg +-10mm regulable, flutter free, vacuum control (specific to this type of knob device) 2.2 Settings Manual 2.3 User's interface Manual 2.4 Software and/or NA standard of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) 2.5kg max 3.3 Configuration NA 3.4 Noise (in dBA) NA 3.5 heat dissipation NA 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA Page 92 of 1664.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & spare collection bottles, clear unbreakable jar (one set extra) parts 5.2 Consumables / reagents silicon tubing- two sets (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 (air conditioning, to 50 deg C and relative humidity of 15 to 90%. Capable of humidity, dust operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. ...) 6.2 User's care, Cleaning, Complete unit to be easily washable and sterilizable using both Disinfection & Sterility alcohol and chemical agents. issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA(US)/CE(EU) and BIS/ISO 13485:2003; ISO 10079-2-2014 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for sign- NA off 8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) OPTIONAL (Depending upon scope of work order) 9.0 WARRANTY AND MAINTENANCE Page 93 of 1669.1 Warranty 3 years 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, Local clinical staff / authorized officer on behalf of purchaser to affirm completion of installation including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in English/ Hindi language along with machine diagrams. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to documents be provided. 11.0 NOTES 11.1 Service Support Contact NA details (Hierchy Wise; including a toll free/landline number) 11.2 Recommendations or Any recommendations for best use and supplementary warning for safety should be declared warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Monitor GENERAL Page 94 of 1661.0 USE 1.1 Clinical purpose Designed to continuously measure and display multiple vital physiological parameters 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Should have facility for printing ECG at 25mm/sec and 50mm/sec speed. 1. characteristics (specific to this type of device) 1. Should have facility for charging from both 12V DC & 220V AC. 2. Should be supplied with a. Pulse oximeter probe (adult and paediatric) b. ECG cable -12 lead c. Temperature probe d. NIBP (non-invasive blood pressure) cuffs 3. All probes should be supplied in 2 pairs, should be re-usable and should include adult, pediatric & neonatal size cuff/leads. The material of the probe should be such that it is non-breakable 4. Capable of saving data for minimum of 24 hrs 5. Prices for consumables should be offered in financial bid 6. The monitor should have facility for transmission of data from ambulance to a receiving station (desirable and NOT Mandatory, to be quoted separately) 7. Material of probe should be non-biodegradable 8. Should also have wall mounting facility available 2.2 Settings User operated 1mV ECG test marker function required 2.3 User's interface Manual 2.4 Software and/or Audio Visual alarms required: high and low levels for each parameter standard of (operator variable settings), sensor / wire / probe disconnected, low Page 95 of 166communication battery 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Screen size minimum: 10" or more 3.2 Weight (lbs, kg) <6kg. 3.3 Configuration Case is to be hard and splash proof. Display must allow easy viewing in all ambient light levels.Cable connectors to be designed so as fit correct socket only 3.4 Noise (in dBA) <50 dB; Lead disconnection Alarm > 65 dB 3.5 heat dissipation Should maitain nominal Temp and the heat should be disbursed through a exhaust cooling fan 3.6 Mobility, portability Supplied in protective case for clean storage and safe transport 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ................ ) 4.1 Voltage (value, AC or 220 to 240V, 50 Hz DC, monophase or triphase) 4.2 Battery operated Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit. Battery powered, silenceable alarm for power failure. Internal, replaceable, rechargeable battery allows operation for at least one hour in the event of power failure. 4.3 Tolerance (to variations, Voltage corrector / stabilizer to allow operation at ± 30% of local rated shutdowns) voltage. 4.4 Protection Electrical protection provided by fuses in both live and neutral supply lines 4.5 Power consumption <120Watt Compatible with electrical system of the ambulance; should be able to perform with other life saving equipments running 4.6 Other energy supplies Mains cable 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES Page 96 of 1662 pairs, 12 lead ECG cable. 2 packs of 100 disposable ECG connection electrodes. Two sets of reusable SpO2 probes including adult, paediatric 5.1 Accessories & Spares & neonatal probes. two sets of NIBP cuffs of each size(adult, paediatric and neonatal).Two external skin temperature probes 5.2 Consumables / reagents (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 to 50 (air conditioning, deg C and relative humidity of 15 to 90%. Capable of operating humidity, dust ...) continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA (US) (EU) and BIS/ISO 13485:2003; /CE IEC-60601-1-2; ISO 80601-2-56-2009 (Thermometer); ISO 80601-2- 61-2011 (SpO2) 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform installation, safety and operation checks before requirements: nature, handover. values, quality, tolerance 8.2 Requirements for sign- Supplier to perform installation, safety and operation checks before off handover Local clinical staff to affirm completion of installation 8.3 Training of staff Training of users in operation and basic maintenance shall be provided. (medical, paramedical, technicians) 8.4 Others 9.0 WARRANTY AND MAINTENANCE Page 97 of 1669.1 Warranty 3 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, warranty of 3 years with free servicing ( min. 3/year) during warranty including prices 9.4 Others The spare price list of all spares and accessories (including minor) required for maintenance and repairs in future after guarantee / warranty period should be attached 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in English language. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be documents provided. 11.0 NOTES 11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided 11.2 Recommendations or Any warning signs would be adequately displayed warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Laryngoscope GENERAL Page 98 of 1661.0 USE 1.1 Clinical purpose For viewing vocal folds and glottis. Surgical and mechanical ventilation/intubation 1.2 Used by clinical O.T/ ICU / NICU/ Casualty department/ward 1.3 Overview of functional A light source on or via the blade illuminates the larynx to allow requirements viewing and tube passage. The unit is handheld with internal batteries and has interchangeable, rigid blades of different sizes. TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Laryngoscope should be reusable using the latest LED technology. The characteristics main body of the handle should incorporate an excellent grip even (specific to this type of wearing a glove. The unit should allow the blade (macintosh) to be device) inserted easily & should provide a positive locking mechanism when moved in to the closed position. 2.2 Settings NA 2.3 User's interface Manual 2.4 Software and/or NA standard of communication (wherever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) Light weight (upto 500 gms including blade, handle and battery) 3.3 Configuration Handheld unit, single piece when in use; External material to be of rust proof metal, On/off switch to be robust and easy to use; macintosh blades to be surgical grade stainless steel; Supplied in protective, enclosable case; 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes Page 99 of 1663.6 Others storage box should be provided 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 .....................) 4.1 Power Requirements Battery 4.2 Battery operated Internal batteries rechargeable Battery charger , Battery compartment (if reusable’s) to be sealed against liquid ingress, yet easily opened. 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption 3V lithium battery; 2nos. 4.6 Other energy supplies 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories Batteries, blades of all sizes 0,1,2,3,4,5 (mandatory, standard, optional) 5.2 Spare parts (main Handle ones) 5.3 Consumables / 3LED should be given as spare reagents (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of 0 to 50 Ambiance (air deg C and relative humidity of 15 to 90%. conditioning, humidity, dust ...) Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. Liquid splash resistant Blades should be autoclavable 6.2 User's care, Cleaning, Complete unit to be easily washable and sterilizable using both alcohol Disinfection & and chemical agents. Page 100 of 166Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates US FDA/European CE and BIS/ISO 13485 7.2 Local and/or Manufacturer / supplier should have ISO certificate for quality standard. international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for NA sign-off 8.3 Training of staff NA (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years ; LED upto 6 months 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, User, technical and maintenance manuals to be supplied in English service language along with machine diagrams. List to be provided for manuals, other procedures required for routine maintenance manuals 10.2 Other accompanying NA documents 11.0 NOTES 11.1 Service Support NA Contact details Page 101 of 166(Hierchy Wise; including a toll free/landline number) 11.2 Recommendations or Any recommendations for best use and supplementary warning for warnings safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade BP Instrument Aneroid GENERAL Page 102 of 1661.0 USE 1.1 Clinical purpose to measure noninvasive blood pressure 1.2 Used by clinical All department/ward 1.3 Overview of functional requirements TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Scale 0-300 mm hg. characteristics (specific to this type of device) Air release at closed lap with maximum 4mmHg/Minute. Manual setting of deflation possible upto 2/3mm Hg/sec. From 260mmHg. To 15mm Hg in a maximum deflation time of 10 seconds. Gauge’s background in white colour. Graduated scale for ever/ 2mmhg, every 10 units and every 20 units. Nylon straps cuff with pouch, latex bulb with completely chromium plated valve with regulation of vent-hole air by screw valve. Additional provision of panel dial with standard size (diameter) of the dial 2.2 Settings The cuff is inflated just to fit in the limb for which an inflation bulb is used to control the air pressure within the cuff. 2.3 User's interface manual 2.4 Software and/or NA standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) The rubber tubes used should have an internal diameter of 3 ± 0.5mm and the external diameter should not be less than 8mm; The dial mano meter with minimum diameter of 160 mm 3.2 Weight (lbs, kg) NA Page 103 of 1663.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories one extra pair of adult( both medium & large size of adult) and (mandatory, paediatric arm cuffs size, inflation bulb and tubing(one extra pair) standard, optional) 5.2 Spare parts (main dial manometer ones) NA 5.3 Consumables / reagents (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of 0 to Ambiance (air 50 deg C and relative humidity of 15 to 90%. Capable of operating conditioning, humidity, continuously in ambient temperature of 10 to 40 deg C and relative dust ...) humidity of 15 to 90%. Page 104 of 1666.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre- ISO 13485 certified company and the instrument should have ISI market, sanitary, ..); mark. The parts shall be made of natural or artificial rubber. Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform safety and operation checks before handover. requirements: nature, values, quality, tolerance 8.2 Requirements for sign- Certificate of inspection from the factory. off 8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, User, technical and maintenance manuals to be supplied in english service manuals, other language along with machine diagrams. manuals List to be provided for procedures required for routine maintenance 10.2 Other accompanying documents Page 105 of 16611.0 NOTES 11.1 Service Support NA Contact details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or Any recommendations for best use and supplementary warning for warnings safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Stethoscope GENERAL 1.0 USE Page 106 of 1661.1 Clinical purpose listening to sounds from the heart, lungs, and/or gastrointestinal tract 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Stethoscope should amplify sounds below 100Hz and attenuate characteristics (specific sounds above 200Hz. to this type of device) 2. Designed to transmit low frequency sounds in the range of 30- 1000Hz. 3. Provide amplifications of between 10 to 15 dB, with the best performance in the frequency range of human auscultation sounds (30 Hz) 4. Ear pieces made of soft gel or rubber. High quality flexible diaphragm made of plastic or epoxy fibreglass compound, capable of good contact with skin. Tube made of thick PVC or latex rubber. Dual head (with bell) made of stainless steel (aluminium not acceptable). No air leakage between examiner's air and diaphragm of the stethoscope. 5. Good performance and characteristics in the following areas: Loudness- the perceived amplitude of the sound a. clarity- the ability to distinguish diagnostic cardiac sounds b. such as vulvular clicks c. Ergonomics- the ease of use. 6. Elimination of noise artifacts or external noise interference. 2.2 Settings NA 2.3 User's interface manual 2.4 Software and/or NA standard of communication (where ever required) 2.5 Others NA Page 107 of 1663.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Diaphragm approx: 20 mm, length between 54.1cm to 78.7 cm. 3.2 Weight (lbs, kg) 70gm to 240gm 3.3 Configuration NA 3.4 Noise (in dBA) NA 3.5 heat dissipation NA 3.6 Mobility, portability Portable 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories& Spares 1 x spare set of earpiece, 1 x spare diaphram, 5.2 Consumables / reagents NA (open, closed system) 5.3 Others NA 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of 0 (air conditioning, to 50 deg C humidity, dust ...) and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative Page 108 of 166humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 6.3 Others NA 7.0 STANDARDS AND SAFETY 7.1 Certifications by ISO 9001 certified manufacturer and the device should comply to IS 3391 standards 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for sign- NA off 8.3 Training of staff NA (medical, paramedical, technicians) 8.4 Others NA 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 year 9.2 Maintenance tasks NA 9.3 Service contract clauses, NA including prices 9.4 Others NA 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA Page 109 of 166documents 10.3 Recommendations for NA maintenance 10.4 Others NA 11.0 NOTES 11.1 Service Support NA Contact details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Portable hand-held Glucometer GENERAL Page 110 of 1661.0 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 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Should have reading range/linearity from 30 to 600 mg/dl; Should characteristics (specific have a maximum reading time of less than 10 seconds; Should use to this type of device) a minimum blood sample less than 1.5µl; Should have a minimum memory of 50 tests; accuracy +/- 10% and reproducibility +/-5%; Packing of strips should be such that there are not more than 50 strips/pack. The strips should be readily available throughout the country 2.2 Settings Should have automatic code detection facility , display of sugar in Mg/dl and NOT in millimoles. 2.3 User's interface LCD display 2.4 Software and/or inbuilt; .Should have facility to ensure accuracy of measurements standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) handheld device 3.2 Weight (lbs, kg) handheld device 3.3 Configuration Should use electrochemical technology 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability handheld Page 111 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2................. ) 4.1 Power Requirements Battery powered 4.2 Battery operated 3-volt lithium coin cell battery or 2 x (AAA) Alkaline Batteries 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spare parts NA 5.2 Consumables / reagents glucose strips(able to use capillary blood samples) with (open, closed system) availability in local market, shelf life of strips should be 12 months, the cost of strips for the next five years should be declared (for cost comparison) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air Capable of being stored continuously in ambient temperature of 0 conditioning, humidity, dust to 50 deg C ...) and relative humidity of 15 to 90%. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, FDA US) /CE(EU) and BIS/ISO 13485:2003; ISO 15197: 2013 sanitary, ..); Performance and compliant safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION Page 112 of 1668.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for sign-off NA 8.3 Training of staff (medical, required paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 2 years; shelf life of minimum 12 months for strips from the date of manufacture; strips should work minimum 3 months from opening of pack 9.2 Maintenance tasks Should require no routine maintenance 9.3 Service contract clauses, Should have life time replacement offer including prices 10.0 DOCUMENTATION 10.1 Operating manuals, service Required manuals, other manuals 10.2 Recommendations for To be provided during installation maintenance 11.0 NOTES 11.1 Service Support Contact Should provide complete contact details of sales and service details (Hierarchy Wise; departments. including a toll free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 113 of 166Fetal doppler GENERAL 1.0 USE 1.1 Clinical purpose to non-invasively detect foetal heart beats from the surface of the pregnant women's abdomen. 1.2 Used by clinical Emergency/Gynae deptt. department/ward 1.3 Overview of functional requirements TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics Water proof probes of 2MHz, 3MHz and 5 MHz frequency, (specific to this type of Ultra sound Intensity device) ‹10mw/cm2, Auto Shut Off Facility to save Battery Power, Built-in Speaker, Volume Control Facility and Audio Output for Ear Phone, Heart Rate Range should be from 50 to 210 bpm with accuracy of + /-2%, Should be Water Proof Body 2.2 Settings setting of ultrasound intensity 2.3 User's interface LCD/LED display 2.4 Software and/or standard inbuilt of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) handheld 3.2 Weight (lbs, kg) 500 gm 3.3 Configuration Page 114 of 1663.4 Noise (in dBA), Noise: <60dBA 3.5 heat dissipation 3.6 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 .............. ) 4.1 Power Requirements Rechargeable battery 4.2 Battery operated Rechargeable battery 4.3 Tolerance (to variations, ± 10% of input AC shutdowns) 4.4 Protection Electrical protection by resettable overcurrent breakers or replaceable fuses, fitted in both live and neutral lines 4.5 Power consumption 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, Doppler probe, rechargeable battery, battery charger standard, optional) 5.2 Spare parts (main ones) 5.3 Consumables / reagents Rechargeable battery (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of (air conditioning, 0 to 50 deg C and relative humidity of 15 to 90%. Capable of humidity, dust ...) operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY Page 115 of 1667.1 Certificates (pre- US FDA/European CE and BIS/ISO 13485 market, sanitary, ..) Performance and safety standards (specific to the 7.2 device type) Shall meet IEC-60601- part 1 and 2 7.3 Local and/or NA international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform installation, safety and operation checks requirements: nature, before handover. values, quality, tolerance 8.2 Requirements for sign- Certificate of Calibration and inspection from the factory. off 8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty three years (including probe and battery) 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, Local clinical staff to affirm completion of installation including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in english language. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with documents their part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES Page 116 of 16611.1 Service Support Contact details (Hierarchy Wise; including a toll AMC/CAMC Details to be provided free/landline number) 11.2 Recommendations or List to be provided of important spares and accessories, with warnings their part numbers and cost. Certificate of calibration and inspection to be provided. 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 117 of 166Nebulizer (Electric) GENERAL 1.0 USE 1.1 Clinical purpose Designed to generate aerosolized medication/fluids (finely dispersed airborne droplets in a liquid phase) intended to be inhaled by a patient with a respiratory disorder. 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical medicine cup capacity of minimum 5 ml characteristics (specific to this type of device) 2.2 Settings manual 2.3 User's interface manual 2.4 Software and/or NA standard of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) should be compact 3.2 Weight (lbs, kg) <2kg. 3.3 Configuration 3.4 Noise (in dBA), heat <60dBA dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) Page 118 of 1664.1 Power Requirements 220 V AC + 10%, 50Hz power supply; 5A plug 4.2 Battery operated NA 4.3 Tolerance (to ± 10% of input AC variations, shutdowns) 4.4 Protection Electrical protection by resettable overcurrent breakers or replaceable fuses, fitted in both live and neutral lines 4.5 Power consumption Should be compatible with ambulances power sources with other equipment’s running 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares With necessary accessories- nebulisation mask(both adult and paediatric size), PVC tubing for nebulizer (two pair extra); cable cord 5.2 Consumables / reagents Aerosol/medicinal solutions (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of 0 Ambiance (air to 50 deg C and relative humidity of 15 to 90%. Capable of conditioning, humidity, operating continuously in ambient temperature of 10 to 40 deg C dust ...) and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, The unit should be cleanable with alcohol Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre- FDA (US)/CE (EU) and BIS/ISO 13485:2003; ISO 27427-2013; market, sanitary, ..) IEC-60601-1 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform installation, safety and operation checks requirements: nature, before handover. values, quality, tolerance Page 119 of 1668.2 Requirements for sign- Certificate of Calibration and inspection from the factory. off 8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 Years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract Local clinical staff to affirm completion of installation clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in english language. List to be provided of equipment and procedures required for local calibration and routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with their documents part numbers and cost. Certificate of calibration and inspection to be provided. 11.0 NOTES 11.1 Service Support Contact details of manufacturer, supplier and local service agent Contact details to be provided (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to warnings be provided. 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 120 of 166Double Head Immobilizers GENERAL 1.0 USE 1.1 Clinical purpose used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. 1.2 Used by clinical Emergency department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Should be of two adult sizes (large and medium) and one (specific to this type of paediatric size. device) 2. Should be with padded belts for the fixing. 3. It should be covered by a liquid proof material. 4. Should be high density plastic material 2.2 Settings NA 2.3 User's interface Manual 2.4 Software and/or NA standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) standard 3.2 Weight (lbs, kg) standard 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes Page 121 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, NA standard, optional) 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance NA (air conditioning, humidity, dust ...) 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, ISO 9001 manufacturer sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION Page 122 of 1668.1 Pre-installation Supplier to perform safety and operation checks before handover. requirements: nature, values, quality, tolerance 8.2 Requirements for sign- off 8.3 Training of staff (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 year 9.2 Maintenance tasks NA 9.3 Service contract clauses, NA including prices 9.4 Others 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 10.4 Others 11.0 NOTES 11.1 Service Support Contact NA details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 123 of 166Spinal Board GENERAL 1.0 USE 1.1 Clinical purpose It is placed under a patient to ensure spinal immobilization when a spinal injury is suspected. 1.2 Used by clinical Emergency/Trauma Care department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Should be in plastic material of high strength and waterproof. 1. characteristics (specific to this type of device) 2. It should be supplied with 3 belts with rapid unhooking buckle in all three belts. Should have radio transparency to make radiologic 3. examinations/x-rays without removing the patient from the board. 2.3 Settings NA 2.4 User's interface Manual 2.5 Software and/or NA standard of communication (wherever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Length: 180 - 190cm; Breadth: 40 - 48cm ; Height: 5 to 7cm 3.2 Weight (lbs, kg) Weight: <8 kg; load: upto 120kgs. 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes Page 124 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories NA (mandatory, standard, optional) 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / NA Ambiance (air conditioning, humidity, dust ...) 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre- ISO 9001; FDA/CE market, sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION Page 125 of 1668.1 Pre-installation Supplier to perform safety and operation checks before requirements: nature, handover. values, quality, tolerance 8.2 Requirements for sign- off 8.3 Training of staff (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 year 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 9.4 Others 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 10.4 Others 11.0 NOTES 11.1 Service Support NA Contact details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or NA Page 126 of 166warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 127 of 166Cervical Collar GENERAL 1.0 USE 1.1 Clinical purpose used to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains 1.2 Used by clinical Trauma care; musculo-skeletal support department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. Should be adjustable to 4 different sizes. (specific to this type of device) 2. Should be pre-moulded chin support, locking dips and rear ventilation panel, enlarged trachea opening 3. Should be high-density polyethylene and foam padding with one piece design enables efficient storage where space is limited. 4. Should be X-ray lucent and easy to clean and disinfect. 2.2 Settings Size adjustment 2.3 User's interface Manual 2.4 Software and/or standard NA of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) NA 3.2 Weight (lbs, kg) As light as possible 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability NA Page 128 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, NA standard, optional) 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance NA (air conditioning, humidity, dust ...) 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, ISO 9001 sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform safety and operation checks before requirements: nature, Page 129 of 166values, quality, tolerance handover. 8.2 Requirements for sign- off 8.3 Training of staff (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 years 9.2 Maintenance tasks NA 9.3 Service contract clauses, NA including prices 9.4 Others 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 10.4 Others 11.0 NOTES 11.1 Service Support Contact details (Hierarchy Wise; including a toll NA free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 130 of 166Pneumatic Splints GENERAL 1.0 USE 1.1 Clinical purpose To immobilize the limb for transport to a hospital 1.2 Used by clinical Emergency Services department/ward 1.3 Overview of functional requirements TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. 1.X-ray should be possible through the splints (Radio- characteristics transparency); (specific to this type of device) 2. Inflatory tubes' extension with dosing damp makes dosing easy and quick after inflation; 3. Fixing of splint is by zipper or belt; 4. Distal end left open to expose toes; 5. Should be washable and reusable 6. Weather Proof 7. Material: Neoprene rubber 2.2 Settings Fixing of splint is by zipper or belt 2.3 User's interface Manual 2.4 Software and/or NA standard of communication(where ver required) 3.0 PHYSICAL CHARACTERISTICS Page 131 of 1663.1 Dimensions (metric) set of 6 adult sizes with carrying case:1.Hand & Wrist 2.Half arm 3.Full arm 4. Foot and ankle 5. Half leg 6. Full leg 3.2 Weight (lbs, kg) Light 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ............ ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional) Inflatory tubes' extension 5.2 Spare parts (main NA ones) 5.3 Consumables / NA reagents (open, closed system) 5.4 Others NA 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of Ambiance (air 0 to 50 deg C and relative humidity of 15 to 90%. Capable of conditioning, operating continuously in ambient temperature of 10 to 40 deg C humidity, dust ...) and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Should be washable and reusable Disinfection & Sterility issues Page 132 of 1666.3 Others Should be washable and reusable 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre- ISO 9001 certified manufacturer market, sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for sign- NA off 8.3 Training of staff NA (medical, paramedical, technicians) 8.4 Others NA 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 year 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 9.4 Others NA 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA Page 133 of 166documents 10.3 Recommendations for NA maintenance 10.4 Others NA 11.0 NOTES 11.1 Service Support Contact details (Hierarchy Wise; NA including a toll free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 134 of 166Stretcher Scoop GENERAL 1.0 USE 1.1 Clinical purpose It is most frequently used to lift supine patients from the ground, either due to unconsciousness or in order to maintain stability in the case of trauma, especially spinal injury, where it is used as an intermediate step between the ground and a restraining device such as a long spine board or vacuum mattress. 1.2 Used by clinical Emergency department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. The equipment shall be lightweight aluminium stretcher, (specific to this type of which folds into two and separates for application and device) removal, locking adjustable length with latches - with nylon - straps 2. Narrow foot end frame for handling in confined areas 2.3 Settings NA 2.4 User's interface manual 2.5 Software and/or standard NA of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Length: 160 to 200 cms; Width: 42 cm (Minimum); 3.2 Weight (lbs, kg) Weight: < 10 kg; Load capacity -120 kg (Min) 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes Page 135 of 1664.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ........................... ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, NA standard, optional) 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance NA (air conditioning, humidity, dust ...) 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications ISO 13485/BIS and European CE/US FDA 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform safety and operation checks before handover. requirements: nature, values, quality, tolerance 8.2 Requirements for sign- Certificate of inspection from the factory. off Page 136 of 1668.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 5 years 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in english language along with machine diagrams. List to be provided for procedures required for routine maintenance 10.2 Other accompanying List to be provided of important spares and accessories, with documents their part numbers and cost. 11.0 NOTES 11.1 Service Support Contact NA details (Hierchy Wise; including a toll free/landline number) 11.2 Recommendations or Any recommendations for best use and supplimentary warning warnings for safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 137 of 166Bag and Mask Ventilation device (Child & Neonatal) GENERAL 1.0 USE 1.1 Clinical purpose to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through manual pulmonary- driven pressure cycle functions. 1.2 Used by clinical It is used in ambulances, intensive care units (ICU), during department/ward internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Easy Grip manual resuscitator with transparent face-mask; characteristics 2. Child models (500 to 250ml bag capacity); 3. Standard 15-22 mm Swivel connector allows connections to all common masks Endotracheal Tubes; 4. Provision to give supplemented oxygen-by-oxygen reservoir providing 100% oxygen; 5. Non-re breathing valve enabling the patient to inspire oxygen from the reservoir bag. 6. 6. Device should be made of silicon except reservoir 2.2 Settings Manual 2.3 User's interface Manual 2.4 Software and/or NA standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) handheld 3.2 Weight (lbs, kg) light enough to be operated by hand/palm for long duration Page 138 of 1663.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability handheld 3.6 Others 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ............. ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares silicon bellow, Non Re - breathing Valve 5.2 Consumables / reagents Mask (0,1,2 sizes; 3 sets), Oxygen Reservoir bag, 1 meter oxygen (open, closed system) tube, Guedel Airway(0,1,2 sizes; 3 sets) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of Ambiance (air 0 to 50 deg C conditioning, humidity, dust and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and ...) relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Complete unit to be easily washable and sterilizable using both Disinfection & Sterility alcohol and other chemical agents. issues 7.0 STANDARDS AND SAFETY 7.1 Certifications FDA(US)/CE(EU) and BIS/ISO 13485:2003 Page 139 of 1668.0 TRAINING AND INSTALLATION 8.1 Pre-installation Bag for storage should be supplied requirements: nature, values, quality, tolerance 8.2 Requirements for sign- Certificate of Calibration and inspection from the factory. off 8.3 Training of staff NA (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 Year 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 11.0 NOTES 11.1 Service Support NA Contact details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendatios or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 140 of 166Bag and Mask Ventilation Device (Adult) GENERAL 1.0 USE 1.1 Clinical purpose to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through manual pulmonary- driven pressure cycle functions. 1.2 Used by clinical It is used in ambulances, intensive care units (ICU), during department/ward internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Easy Grip manual resuscitator with transparent face-mask; characteristics 2. Adult models (1500 to 2000ml bag capacity); 3. Standard 15-22 mm Swivel connector allows connections to all common masks & Endotracheal Tubes; 4. Provision to give supplemented oxygen-by-oxygen reservoir providing 100% oxygen; 5. Non-re breathing valve enabling the patient to inspire oxygen from the reservoir bag; 6. Unit should be of medical grade silicon material (mask) excluding reservoir 2.2 Settings manual 2.3 User's interface manual Software and/or NA standard of 2.4 communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Handheld Page 141 of 1663.2 Weight (lbs, kg) light enough to be operated by hand/palm for long duration 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability handheld 3.6 Others 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ............. ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares Silicon bellow, Non-Re-breathing Valve, Consumables / reagents Adult Mask - 3,4,5 size (3 nos. of each size), 1-meter oxygen (open, closed system) tube, Guedel Airway- 3,4,5 size (3nos. each), Oxygen Reservoir 5.2 bag 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of Ambiance (air 0 to 50 deg C and relative humidity of 15 to 90%.Capable of conditioning, humidity, operating continuously in ambient temperature of 10 to 40 deg dust ...) C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, Complete unit to be easily washable and sterilizable using both alcohol and any other chemical agents. Disinfection & Sterility issues Page 142 of 1667.0 STANDARDS AND SAFETY 7.1 Certifications FDA(US)/CE(EU) and BIS/ISO 13485:2003 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Bag for storage requirements: nature, values, quality, tolerance 8.2 Requirements for sign- NA off 8.3 Training of staff NA (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 Year 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 11.0 NOTES 11.1 Service Support Contact details (Hierarchy Wise; NA including a toll free/landline number) Page 143 of 16611.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 144 of 166Oxygen cylinder “B” Type GENERAL 1.0 USE 1.1 Clinical purpose A container designed as a refillable cylinder used to hold compressed medical oxygen (O2) under safe conditions at high pressure; O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes. 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Colour coded, light weight molybdenum steel oxygen characteristics (specific cylinder for providing oxygen therapy of total capacity of 4 to this type of device) cu M. 2. Mounted with pressure reducer and flow-meter provision of capacity upto 15 Litres per minutes and outlet for secretion aspiration. 3. Should have membrane pressure regulator with manometer complete with flow meter (0-15 litres /minute) and 4. Humidifier bottle. 5. The cylinder should be seamless 2.2 Settings flowmeter as specified earlier 2.3 User's interface manual 2.4 Software and/or NA standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) to contain capacity of 4 cu M Page 145 of 1663.2 Weight (lbs, kg) NA 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes; for Ambulances - to be supplied bare without trolley 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ............. ) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares humidifier, key and flow meter 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of Ambiance (air 0 to 50 deg C conditioning, humidity, dust ...) and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 Certificates (pre-market, sanitary, ..) 7.1 Certifications Cylinder should have ISI mark and ISO certificate for quality standard or BIS equivalent; IS 3224. Cylinder should have explosive safety certificate and should be provided along with each cylinder Page 146 of 166during installation 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation NA requirements: nature, values, quality, tolerance 8.2 Requirements for sign- Certificate of Calibration, NFPA Certificate and inspection from off the factory. 8.3 Training of staff Training of users in operation (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 10 years 9.2 Maintenance tasks NA 9.3 Service contract NA clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 11.0 NOTES 11.1 Service Support NA Contact details (Hierchy Wise; including a toll free/landline number) Page 147 of 16611.2 Recommendations or Colour Codes to be displayed on the cylinders warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Page 148 of 166Oxygen cylinder “D” Type GENERAL 1.0 USE 1.1 Clinical purpose A container designed as a refillable cylinder used to hold compressed medical oxygen (O2) under safe conditions at high pressure; O2 is used as an essential life support gas, for anesthesia, and for therapeutic purposes. 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics 1. It should be a standard „D' type molybdenum steel (specific to this type of device) cylinder. 2. The capacity should be of approx 7 cu mt. at pressure of 1800 – 2000lbs/square inch. 3. A pressure regulator/flow meter capable of reducing the pressure to appropriate level to run either a ventilator or provide oxygen therapy. 4. Should be seamless 2.2 Settings NA 2.3 User's interface manual 2.4 Software and/or standard of NA communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) The capacity should be of 5000 to 6000 Liters at pressure of 1800 – 2000 lbs/square inch 3.2 Weight (lbs, kg) NA 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability NA 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ...... ) 1/14.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares Cylinder key 5.3 Consumables / reagents (open, NA closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air Capable of being stored continuously in ambient conditioning, humidity, dust ...) temperature of 0 to 50 deg C and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 Certificates (pre-market, sanitary, ..) 7.1 Certifications Cylinder should have ISI mark and ISO certificate for quality standard or BIS equivalent; IS 3224, and NFPA certificate. Cylinder should have explosive safety certificate and should be provided along with each cylinder during installation 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: NA nature, values, quality, tolerance 8.2 Requirements for sign-off Certificate of Calibration, NFPA certificate and inspection from the factory. 8.3 Training of staff (medical, Training of users in operation paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 10 years9.2 Maintenance tasks NA 9.3 Service contract clauses, NA including prices 10.0 DOCUMENTATION 10.1 Operating manuals, service NA manuals, other manuals 10.2 Other accompanying NA documents 10.3 Recommendations for maintenance NA 11.0 NOTES 11.1 Service Support Contact NA details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or warnings Colour Codes to be displayed on the cylinders 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees CentigradeTrolley Stretcher- with back tilt facility and collapsible wheels (Autoloader) GENERAL 1.0 USE 1.1 Clinical purpose It is designed for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Automatic loading stretcher cum trolley. characteristics (specific to this type 2. Built with anodized aluminum lightweight / stainless steel. of device) 3. Adjustable back rest 0 dg -90 dg which allows to fix the back rest safety in any position. 4. Side protections completely overturn able with easy locking safety belts flap type. 5. Safety lever for the legs positioned near the unlocking device allowing thus the release operation for the loading, keeping the hands on the stretcher. 6. Vertical legs protected by nylon wedges. 6. Automatic centering device mounted on rotating wheels. This system automatically blocks the back wheels in the central position during the loading of the stretcher on the ambulance without having turn the wheels manually. 7. Stand for automatic loading stretcher with locking facility for quick fixing system with handle to mount the stand in very position on the stretcher. 8. One number of IV pole of adjustable height should be provided. 9. Head end of the trolley should be easily identifiable 2.2 Settings NA 2.3 User's interface NA 2.4 Software and/or NA standard of communication (where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Length; 190-210 cm; Width: 50-60cm; Height: 80-85cm;wheel/bearing size: 6 to 8 inch 3.2 Weight (lbs, kg) Weight 35-45 kg; Loading Capacity: up to 180 kgs 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability yes on castors(functional for minimum of 3 years; suitable for rough use) compatible with rails of the ambulance 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy NA supplies 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories Stand for loading stretcher- removable (mandatory, standard, optional) 5.2 Spare parts (main Castors, Safety lever; anti static mattress (at least 2.5" thick, stain ones) proof, suitable for rough use, tear resistant, high density material) with 3 years warranty 5.3 Consumables / NA reagents (open, closed system) 5.4 Others 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Capable of being stored continuously in ambient temperature of 0 to Ambiance (air 50 deg C and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative conditioning, humidity of 15 to 90%. humidity, dust ...)6.2 User's care, NA Cleaning, Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre- FDA(US)/CE(EU) and BIS/ISO 13485:2003 market, sanitary, ..)Performance and safety standards (specific to the device type);Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, Supplier to perform safety and operation checks before handover. quality, tolerance 8.2 Requirements for Certificate of inspection from the factory. sign-off 8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, provided paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 3 years 9.2 Maintenance tasks maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices 10.0 DOCUMENTATION Required- along with diagrammatic maintenance manual 10.1 Operating manuals, service manuals, other manuals 11.0 NOTES11.1 Service Support should provide complete contact details of sales and service Contact details departments. (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations Any warning should be displayed or warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees CentigradeCanvas Stretcher folding GENERAL 1.0 USE 1.1 Clinical purpose It is designed for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles 1.2 Used by clinical ALL department/ward 1.4 Overview of functional requirements TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical 1. Should be lightweight stretcher frame characteristics (specific to this type 2. Should be easy to carry. of device) 3. Should be rugged. 4. Should be compact & foldable. 5. Should have automatic locking, which does not fold in automatically. 6. Canvas used should be High strength light weight material. 2.2 Settings NA 2.3 User's interface NA 2.4 Software and/or NA standard of communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Length: 200-210 cm; Width: 50-60cm; Height: 15-20cm from the base level 3.2 Weight (lbs, kg) less than 6 kg 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to NA variations, shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, None standard, optional) 5.2 Spare parts (main ones) None 5.3 Consumables / reagents None (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance Capable of being stored continuously in ambient temperature of (air conditioning, 0 to 50 deg C and relative humidity of 15 to 90%. Capable of humidity, dust...) operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%. 6.2 User's care, Cleaning, NA Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, ISO 13485 sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation Supplier to perform safety and operation checks before requirements: nature, handover. values, quality, tolerance 8.2 Requirements for sign- Certificate of inspection from the factory. off8.3 Training of staff Training of users in operation and basic maintenance shall be (medical, paramedical, provided technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty 1 years 9.2 Maintenance tasks Maintenance manual detailing complete maintaining schedule 9.3 Service contract clauses, including prices 10.0 DOCUMENTATION 10.1 Operating manuals, Advanced maintenance tasks required shall be documented service manuals, other manuals User, technical and maintenance manuals to be supplied in English language along with machine diagrams. List to be provided for procedures required for routine maintenance 10.2 Other accompanying documents 11.0 NOTES 11.1 Service Support Contact NA details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or Any recommendations for best use and supplementary warning warnings for safety should be declared 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees CentigradeFlowmeter with Humidifier bottle GENERAL 1.0 USE 1.1 Clinical purpose flow meter unit is used for regulation and accurate measuring of flow of gasses 1.2 Used by clinical All department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical Flowmeter: chromium plated brass body, metering tube and cover characteristics made of polycarbonate body, flow adjustment by needle valve (specific to this type equipped with inlet filter - 100 um, flow rate 0-15 litres per minute, of device) flush flow 60 litres per minute, flow read by the centre of the ball, inlet pressure 60psi; Humidifier bottle: lid made of ABS plastic, Jar made of unbreakable Poly carbonate, valve pressure brass chromium plated, it should be steam autoclaved/gas sterilized. Inlet probe compatible with Oxygen system of the ambulance 2.3 Settings to manage flow of oxygen through the knob from 0 to 15 LPM 2.4 User's interface Manual 2.5 Software and/or standard NA of communication (wherever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) for 200ml 3.2 Weight (lbs, kg) as per standard 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes 4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ) 4.1 Power Requirements NA 4.2 Battery operated NA4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories & Spares Stainless steel or brass chromium needle valve and outlet flow control valve 5.3 Consumables / reagents Crack resistant transparent tube of 1.5 MT. length (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance NA (air conditioning, humidity, dust ...) 6.2 User's care, Complete unit to be easily washable and sterilizable using alcohol Cleaning, and other chemical agents Disinfection & Sterility issues 7.0 STANDARDS AND SAFETY 7.1 Certifications complies with NFPA standard ; 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation availability of oxygen outlet points requirements: nature, values, quality, tolerance 8.2 Requirements for sign-off NA 8.3 Training of staff (medical, NA paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty One year 9.2 Maintenance tasks Complete unit to be easily washable and sterilizable using both alcohol and chemical agents. 9.3 Service contract clauses, NA including prices10.0 DOCUMENTATION 10.1 Operating manuals, NA service manuals, other manuals 10.2 Other NA accompanying documents 10.3 Recommendations NA for maintenance 11.0 NOTES 11.1 Service Support Contact NA details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations NA or warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade (A) Intra Venous Cut Down Set S.No Description of items Qty Technical Specifications 1 Forceps, Artery, curved, 145mm 3 Material: Stainless Steel Rusting Prevention Procedure: Passivated 2 Forceps, Artery, straight, 145mm 3 Ultrasonic Cleaned: Yes 3 Forceps, dissecting, straight, ½ teeth 1 Dull Polished: Yes 145mm Tests Performed: Boil test, performance 4 Forceps, dissecting, straight, Plain 1 test, shape test 180mm Packing: Individually packed QC Passed: 5 Hook, skin, Gilles, 180mm 1 Yes 6 Handle for surgical blade No. 3 2 7 Needle Holder, mayo, 150mm 1 8 Scissors, ligature, Spenser, 115mm 1 9 Instruments Container, S.S. with cover 1 10 Bowl 1 11 Sponge holding instrument 1 12 Suture, Nylon 3-0 213 Suture, Nylon 5-0 2 (B) Dressing Kit S.No Description of items Qty Technical Specifications 1 Mayo Scissors 14cm Straight TC 1 Material: Stainless Steel Rusting Prevention Procedure: Passivated 2 Dissecting Scissors 14cm Sharp/blunt 1 Ultrasonic Cleaned: Yes 3 Lister Bandage Scissors 15cm 1 Dull Polished: Yes 4 Spenser Stitch Scissors 11cm 1 Tests Performed: Boil test, performance test, shape test 5 Forester sponge forceps 25.5cm 1 Packing: Individually packed QC Passed: 6 Dressing forceps 16cm 2 Yes 7 Dressing Forceps 1:2 16cm 2 8 Kelly Forceps 14cm Straight 1 9 Adson forceps 12cm 1 10 Lotion Bowl 04 Oz 1 11 Kidney dish 08” 1 (C) Suture Kit S.No Description of items Qty Technical Specifications 1 Container for storage and sterilization 1 Material: Stainless Steel of suturing set Rusting Prevention Procedure: Passivated Ultrasonic Cleaned: Yes 2 Lancet Handle 1 Dull Polished: Yes 3 Scissors straight Standard 13-15cm 1 Tests Performed: Boil test, performance 4 Scissors Curved (Baby 1 test, shape test Metzenbaum)13-15cm Packing: Individually packed QC Passed: 5 Forceps Straight 1 Yes 6 Needle holder small stout 1 7 Forceps Hem. Curved 14cm 2 8 Dressing, Gauge, sterile, 2”X2” Pkg./2 1 9 Dressing, Gauge, sterile, 4”X4” Pkg./2 1 10 Antiseptic Wipe 10 11 Suture, Nylon 3-0 112 Suture, Nylon 5-0 2 13 Povidone Iodine, ¾ oz 2First Aid Box GENERAL 1.0 USE 1.1 Clinical purpose Transport of medical equipment, devices and supplies to places where vehicles cannot get sufficiently close to the patient. 1.2 Used by clinical Trauma care; musculo-skeletal support department/ward TECHNICAL 2.0 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics The bag should be possible to carry via a shoulder strap and (specific to this type of also by handles and as a back pack to suit the convenience of device) the user. It should be resistant to wear and tear. It should be waterproof. There should be space for multiple colour coded pouches which should be possible to arrange as relevant to Airway, Breathing, Circulation, Disability management and carrying essential Injectable medicine vials or fluid. It should not have less than 4 external pockets and not less than 5 detachable colour coded compartments / pouches with transparent windows to enable user to see the contents without opening them. The bags should also have space to safely store used needles, blades etc. 2.3 Settings NA 2.4 User's interface NA 2.5 Software and/or standard of NA communication(where ever required) 3.0 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric) Pre-packed kits as convenient as long as it contains the specified first aid items. 3.2 Weight (lbs, kg) Less than 3kg, should sustain minimum 10kg. wt. equipment, medicines and accessories 3.3 Configuration NA 3.4 Noise (in dBA), heat NA dissipation 3.5 Mobility, portability Yes4.0 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2) 4.1 Power Requirements NA 4.2 Battery operated NA 4.3 Tolerance (to variations, NA shutdowns) 4.4 Protection NA 4.5 Power consumption NA 4.6 Other energy supplies NA 5.0 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, NA standard, optional) 5.2 Spare parts (main ones) NA 5.3 Consumables / reagents NA (open, closed system) 6.0 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, humidity, dust ...) NA 6.2 User's care, Cleaning, Disinfection & Sterility NA issues 7.0 STANDARDS AND SAFETY 7.1 Certificates (pre-market, ISO 9001 supplier sanitary, ..); Performance and safety standards (specific to the device type); Local and/or international 8.0 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, quality, tolerance Supplier to perform safety and operation checks before handover.8.2 Requirements for sign- off 8.3 Training of staff (medical, paramedical, technicians) 9.0 WARRANTY AND MAINTENANCE 9.1 Warranty NA 9.2 Maintenance tasks NA 9.3 Service contract clauses, NA including prices 9.4 Others 10.0 DOCUMENTATION 10.1 Operating manuals, service manuals, other manuals NA 10.2 Other accompanying NA documents 10.3 Recommendations for NA maintenance 11.0 NOTES 11.1 Service Support Contact NA details (Hierarchy Wise; including a toll free/landline number) 11.2 Recommendations or NA warnings 11.3 Temperature Range Should be able to operate between – 32 degrees Centigrade to + 52 degrees Centigrade Other Essentials (Accessories, Disposables, Kits) to be quoted from genuine standard manufacturers with relevant ISO 13485 & CDSCO approvals and with standard one-year warranty. The products supplied are mandatory to be compatible with emergency adult, pediatric /neonatal use as applicable. The specifications must be furnished along with a brochure marked with model number for technical evaluation and approval. At any given point of time the buyer will request for demo of the equipment.