स्वास्थ्य तथा जनसंख्या मन्त्रालय मार्फत प्राप्त स्वस्थ्य सामग्रीहरुको सूची
| Names of Medical Supplies | Remarks |
| 1. Vaccines
2. Oxygen plants 3. Oxygen Concentrators with filling option 4. Oxygen Cylinder 5. Liquid Oxygen Tank with Liquid oxygen 6. Ventilators 7. Antigen Kits 8. Package of Rt. PCR test kits Extraction kits (Manual and automated) 9. Full set PPES 10. B-PAP, C-PAP, High Flow nasal cannula 11. ICU negative pressure beds 12. ICU beds 13. Tocilizumab 14. Remdesivir 15. Pulse oximeter 16. Patient monitor 17. Virus transport medium 18. Gene experts’ machines with cartridge 19. Portable digital X-ray 20. Thermal guns (infrared thermometer) 21. Surgical mask 22. Gloves 23. N 95 mask 24. Gown (coverall protection) 25. Hand sanitizer (500 mL) 26. Face Shield/Safety Goggles 27. Heavy Duty Gloves 28. Shoe Cover 29. Bouffant/Surgical Cap 30. Gum Boot 31. Dead Body Wrapping Bag 32. Ambulance |
- Technical specification of Oxygen Concentrator with filling station and portable oxygen cylinders
| S.N. | Purchaser’s Specifications | Remarks |
| Oxygen Concentrator with filling station and portable oxygen cylinders | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 1 | Description of Function | |
| 1.1 | Oxygen concentrator produces oxygen from ambient air. The high purity oxygen thus obtained can be delivered to the patient directly through nasal cannula or can be filled into the cylinders for portable use via oxygen filling compressor. | |
| 2 | Operational Requirements | |
| 2.1 | Oxygen Concentrator with oxygen cylinders filling compressor and oxygen cylinders complete set. | |
| 3 | System Configuration | |
| 3.1 | Oxygen Concentrator with oxygen cylinders filling compressor and oxygen cylinders complete set. | |
| 4 | Technical Specifications | |
| I | Oxygen Concentrator | |
| 4.1 | Output flow: 9LPM | |
| 4.2 | Flow meter range: 1 to 9 L/min | |
| 4.3 | Output pressure: Approx. 60kPa. | |
| 4.4 | Should have high oxygen purity 87-96% across all flow rates. | |
| 4.5 | Should have at least three-step filtering of air-intake. Oxygen concentrator must be able to run with operating time 24hrs a day. | |
| 4.6 | Continuous monitoring, with visual and audible alert on for the following:
· Low output pressure · High output pressure · Low oxygen concentration · Power failure |
|
| 4.7 | Should have LED oxygen indicator for the following
· Green LED: >82% · Yellow LED: >70% · Red LED: <70% |
|
| 4.8 | Should have integrated hour meter to check the usage of the machine. | |
| 4.9 | Sound level produced: max 50dB(A). | |
| 4.10 | Should have 4 antistatic swivel casters, 2 with brakes and with integrated handle to allow for easy moving and positioning. | |
| 4.11 | Should be compatible with oxygen cylinders filling compressor and portable oxygen cylinders | |
| II | Oxygen cylinders filling compressor | |
| 4.12 | Oxygen filling compressor, connection tubing and portable oxygen cylinders must have interlocking fill fitting. | |
| 4.13 | Maximum cylinder fill pressure of 2000PSI | |
| 4.14 | Filling system should be compatible with oxygen concentrators of different flow.
Bidders to specify the model number, flow rate of compatible oxygen concentrator. |
|
| 4.15 | Oxygen compressor should fill oxygen cylinders only when the oxygen concentration of the inlet gas is more than 90% | |
| III | Oxygen Cylinder | |
| 4.16 | Oxygen cylinder should be with integrated conserver for delivering oxygen in both pulse mode as well as continuous mode | |
| 4.17 | Should be flow cylinder with integratedflow meter and a regulator | |
| 4.17 | Capacity : Approx.50-420ltrs | |
| 5 | Accessories, spares and consumables | |
| 5.1 | Accessories:
· 2 x Adult cannula, with 2m tubing. · 2 x Infant/Paediatric cannula, with 2m tubing. · 3 x Connector for above. · 2 x Humidifiers. · 4 x 50′ tubing. · 4 x tubing adapter kit. · 3 x Spare inlet-filters. · 3 x Spare bacterial-filters · Carrying bag for portable oxygen cylinder · Oxygen analyzer – 1Nos · Portable oxygen cylinder – different sizes
|
|
| 5.2 | All standard accessories/consumables/parts required for the proper operation of the above item shall be included in the offer. Bidders shall specify, in a separate Excel worksheet, the quantity and details of any items included in this offer which have not been specified in this Technical Specifications Form. | |
| 6 | Operating Environment | |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Climate, Temperature, Humidity, etc. | |
| 6.2 | Power supply: 220-240VAC, 50Hz fitted with appropriate plug. The power cable must be minimum 3 metres long.
Power consumption, approx.: 500 W. |
|
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | European CE (93/42 EEC Directives) and USFDA approved product certificate. | |
| 8 | User Training | |
| 8.1 | Must provide user training. | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2years after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During warranty period supplier must ensure corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | The supplier must accomplish proper installation and commissioning of equipment onsite. | |
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English. | |
| 12.2 | Service (Technical / Maintenance) manual in English. | |
| 12.3 | List of important spare parts and accessories with their part number and costing. | |
| 12.4 | Certificate of calibration and inspection from factory. | |
| Remarks |
- Technical Specification of Ventilator, ICU (Infant to Adult)
| S.N. | Purchaser’s Specifications | Bidder’s offer | |
| Ventilator, ICU (Infant to Adult) | |||
| Manufacturer | |||
| Brand | |||
| Type / Model | |||
| Country of Origin | |||
| 1 | Description of Function | ||
| 1.1 | The ventilator should be suitable for use in Adult and Pediatric patients in all critical care areas with selection between adult and pediatric modes or patient
hoses |
||
| 2 | Operational Requirements | ||
| 2.1 | Microprocessor Controlled ventilator with integrated facility for ventilation monitoring suitable for pediatric to adult ventilation. | ||
| 3 | System Configurations | ||
| 3.1 | ICU Ventilator for Infant to Adult, complete unit with all standard accessories. It should be Turbine based system with in-built nebulization | ||
| 4 | Technical Specifications | ||
| 4.1 | Should have medical oxygen and air high pressure input ports (>35 psi / 2.4 bar) provide a means to limit reverse gas flowrate (leakage). Each high-pressure input
ports should have a filter and water trap |
||
| 4.2 | Should have possibility for using external low-pressure oxygen as source | ||
| 4.3 | Colour touch screen of 10” or more. | ||
| 4.4 | Automatic compliance & leakage compensation for circuit and ET tube. | ||
| 4.5 | Display parameters:
· End tidal CO2 with capnography. · 3 Waves: Pressure & Time, Volume & Time and Flow &Time. · 3 Loops: P-V, F-V, P-F with facility of saving of 3 loops for reference. · FiO2. · Airway pressures (peak, plateau mean and PEEP) · Tidal volume (inspired and expired). · Minute volume (inspired and expired) · I:Eratio · RR (spontaneous and mechanical) · Status indicator for ventilator mode, battery life, patient data, alarm settings, clock etc · Display easily readable in low ambient light and sunlight. |
||
| 4.6 | Must have following settings for all age groups (pediatric to adult):
· Tidal Volume at least 20 to2000ml. · Pressure setting : approx. 0–40cmH2O · Respiratory rate: 10- 60 breaths per minute. · Internal PEEP range: 0-20cmH2Ominimum · FiO2:21-100% · I:E inverse ratio · I:E Ratio: 1:10 to4:1 · Inspiratory pause maneuver capability to measure plateau pressure; · Peak pressure limitation/pressure-cycling mechanism adjustable range of5 – 20 cmH2O above measured peak pressure |
||
| 4.7 | Alarms: should have audio visual alarms for | ||
| S.N. | Purchaser’s Specifications | Bidder’s offer |
| · High/low tidal volume (not achieved or exceeded);
· High/lowFiO2 · High/low inspiratory pressure and PEEP · Apnoea, · High/low respiratory rate; · Continuously high pressure/occlusion; · Breathing circuit disconnect · Low minute volume · Gas supply failure; · Power failure and low battery · self-diagnostics failure alarm |
||
| 4.8 | Should have following modes of ventilation:
· Volume control ventilation(VCV) · Pressure control ventilation(PCV) · Pressure support ventilation(PSV) · Non-Invasive ventilation (CPAP and BIPAP) · Pressure regulated volume control (PRVC) or equivalent · Synchronized intermittent mandatory ventilation(SIMV) |
|
| 4.9 | Shall have apnoea /backup ventilation | |
| 4.11 | Shall have automatic patient detection facility. | |
| 4.12 | Event log for errors traceability | |
| 4.13 | Trending facility for 72 hours with minimum 5 minutes resolution for recent 24 hours | |
| 4.14 | At least IP21 degree of protection to harmful ingress of water | |
| 4.15 | Shall have built-in rechargeable battery with battery operating mode with standard ventilation not less than 1 hour | |
| 4.16 | Total recharging time not greater than 6 hours | |
| 4.17 | RS 232C interface or equivalent for communications with networked devices. | |
| 5 | Accessories, spares and consumables | |
| 5.1 | Consumables
· Breathing circuits for adult and pediatric: double-limb with standard outlet/inlet connectors with 22mm outside diameter with double water traps: 10 nos each · Exhaled gas filter: 10nos · Heat moisture exchanger filters (HMEF): 10nos · Viral/Bacterial filters of minimum efficiency 99.97% of all 0.3microns particles; inspiratory and expiratory: 10 nos each · Non-invasive ventilation masks of medium and large sizes for both adult and pediatrics: 10nos · Filter paper for humidifier for 50uses · T-piece connector: 10nos |
|
| 5.2 | Reusable:
· Beathing circuits for paediatric and adult: reusable, autoclavable double- limb with standard outlet/inlet connecters with 22mm outside diameter with double water traps: 2each · Active humidifier with relevant connectors: 2nos · Expiratory housing with in-built bacteria filters; as well as the possibility to accommodate heat moisture exchanger(HMEs) · CO2 sensors: 1 no · Exhalation valve · Standards hoses and connectors for oxygen and medical air wall outlets |
| S.N. | Purchaser’s Specifications | Bidder’s offer |
| and cylinders
· Pressure regulators (from wall outlet to ventilator) to avoid damaging ventilator as required to operate: 1no · Reusable Masks (Medium, and Large) with textured dual flap silicone cushion flap for easy fit: 2each · Removable forehead support and pad to match the angle of patient’s forehead. · Silicone test lung adult and child size: 01 set each · Flow sensors: 1no · in-built nebulizer, autoclavable: 1no · O2 cell with O-ring:1no |
||
| 5.3 | Imported hinged arm holder for holding the circuit | |
| 5.4 | Non corrosive imported trolley with wheels & brakes and hinged arm: 01 no. | |
| 5.5 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer
(including items not specified above). |
|
| 6 | Operating Environment | |
| 6.1 | The system offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply,
Climate, Temperature, Humidity, etc. |
|
| 6.2 | Power supply: 220 – 240V AC, 50-60Hz fitted with appropriate plug. The power cable must be at least 3 metre in length. | |
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | CE (93/42 EEC Directives) and USFDA approved product certificate. | |
| 7.3 | Certified to be compliant with ANS/IEC60601.2.12-01 Medical Electrical Equipment—Part 2-12; Particular Requirements for the Safety of Lung
Ventilators—Critical Care Ventilators. |
|
| 8 | User Training | |
| 8.1 | Must provide user training (including how to use and maintain the equipment). | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2 years after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During the warranty period supplier must ensure preventive maintenance and corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | The bidder must arrange for the equipment to be installed and commissioned by certified or qualified personnel; any prerequisites for installation to be
communicated to the purchaser in advance, in detail. |
|
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English. | |
| 12.2 | Service (Technical / Maintenance) manual in English. | |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. | |
| 12.4 | Certificate of calibration and inspection from factory. |
- Antigen Kit
| S.N. | Parameter | Specification |
| Name of the manufacturer | ||
| Country of origin | ||
| 1 | IVD Method | Lateral Flow, immunochromatography based qualitative detection (visual Reading of bands without the aid of any devices) |
| 2 | Sample | Oropharyngeal swab/Nasopharyngeal swab/Nasal Swab |
| 3 | Target | SARS COV-2 Specific Antigen |
| 4 | Sensitivity | Above 80% |
| 5 | Specificity | 95% of above |
| 6 | Time | Whole process time of testing (The antigen extraction as well as run time) should not exceed 30 minutes |
| 7 | Additional Supplies | At least one swab stick for sample collection
Reagents and all consumables required for test |
| 8 | Storage Temperature | All of the supplies should have storage temperature between 2-300 C |
| 9 | Remaining Self-life | At least 6 months at the time of acceptance of goods |
| 10 | Certification | US FDA or USFDA (EUA) or WHO EUL or EU-CE |
- RNA extraction reagent for manual extraction
| Country of Origin | |
| Name of Manufacturer | |
| Brand Name | |
| Particulars | Requirements |
| Purpose | RNA extraction suitable for manual extraction of RNA from sputum, oropharyngeal swab, nasopharyngeal swab body fluids and serum/Plasma samples. |
| Description | Spin column based
Sample input: Up to 400 microliter Elution volume: More than 30 microliter with RNA ready for Real Time PCR Should not require heating step during extraction Extraction steps should not take more than thirty minutes. The number of collection tubes should be provided in sufficient number
|
| Other requirements | The manufacturer should be certified by WHO or USFDA or EUCE or should have USFDA/CDC emergency use authorization or WHO Emergency Use Listing |
RNA Extraction Kit Automated
| S.N. | Purchaser’s Specifications |
| B | RNA Extraction Kit Automated Compatible with (Nanjing Zhongkebio Medical Technology co Ltd., Brand name ZhongkeBio Type model ZK-96) |
| Manufacturer | |
| Brand | |
| Type / Model | |
| Country of Origin | |
| 1 | Description of Function |
| 1.1 | Extraction of Nucleic acid (RNA) with all accessories and consumables necessary for asked number of tests |
- PPE Set
Item No. 1 Bouffant Cap
| Name of Manufacturer | |
| Country of Origin | |
| Item type | Bouffant cap |
| Purpose | Protection from dirt |
| Item description | Single use disposable stretchable |
| Material used | Made of strong, light weight and breathable spun bonded polypropylene (SPP) fabric |
| Requirements | Dimensions
Relaxed 8” and stretched 21” for small and relaxed 8.5” and 24” in stretched condition |
| Color | Blue/white |
| Compliance/certification required | CE or USFDA |
Item No. 2: Particulate-filtering face piece respirator (N-95 or equivalent)
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Particulate-filtering face piece respirator(N-95 or equivalent) |
| Purpose | Protection of mouth from pathogenic microbes |
| Type | Face piece respirator |
| Purpose | Protection from the Corona virus while in contact with COVID 19 cases |
| Requirements | Should have performance equivalent to filter performance at least ≥95%, flow rate 85 to 95L/min
Good breathability with design that does not collapse against the mouth (e.g. duckbill, cup shaped) |
| Equivalent standards | N95/KN95/FFP2 |
| Compliance/certification required | At least WHO COVID specification for face respirator and/CE/USFDA requirements |
Item No. 3 : Medical/surgical mask
| Name of Manufacturer | |
| Country of Origin | |
| Item | Medical/surgical mask |
| Purpose | Protection from bio hazard |
| Medical/surgical mask, high fluid resistance, good breathability, internal and external faces should be clearly identified, structured design that does not collapse against the mouth (e.g. duckbill, cup shaped)
Fluid resistance at minimum 120 mmHg pressure. |
|
| Filtration efficiency | ASTM F2101, EN14683 annex B, or equivalent |
| Breathability | MIL–M-36945C, EN 14683 annex C, or equivalent |
| Compliance/certification required | EN 14683 Type IIR performance ASTM F2100 level 2 or level 3 or equivalent; based on ASTM F1862-07, ISO 22609, or equivalent |
Item No. 4: Face shields/visor
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Face shields/visor |
| Purpose | Protection of face including eye from microbial contamination |
| Material | Made of clear plastic and provides good visibility to both the wearer and the patient, |
| Requirements | Adjustable band to attach firmly around the head and fit snuggly against the forehead, Fog resistant (preferable), Completely cover the sides and length of the face, May be re-usable (made of robust material which can be cleaned and disinfected) or disposable. |
| Compliance/certification required | EU standard directive 86/686/EEC, EN 166/2002, ANSI/ISEA Z87.1-2010, or equivalent
|
Item No. 5 Goggles (reusable)
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Safety Goggles |
| Purpose | Use for biohazard (Virus) protection |
| Requirements | Good seal with the skin of the face, Flexible PVC frame to easily fit with all face contours with even pressure, Enclose eyes and the surrounding areas,
Accommodate wearers with prescription glasses, Clear plastic lens with fog and scratch resistant treatments, Adjustable band to secure firmly so as not to become loose during clinical activity, Indirect venting to avoid fogging, |
| Type | Reusable after decontamination |
| Compliance/certification required | EU standard directive 86/686/EEC, EN 166/2002, ANSI/ISEA Z87.1-2010, or equivalent |
Item No. 6: Goggles (disposable)
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Safety Goggles |
| Purpose | Use for biohazard (Virus) protection |
| Requirements | Good seal with the skin of the face, Flexible PVC frame to easily fit with all face contours with even pressure, Enclose eyes and the surrounding areas,
Accommodate wearers with prescription glasses, Clear plastic lens with fog and scratch resistant treatments, Adjustable band to secure firmly so as not to become loose during clinical activity, Indirect venting to avoid fogging, |
| Type | Disposable |
| Compliance/certification required | EU standard directive 86/686/EEC, EN 166/2002, ANSI/ISEA Z87.1-2010, or equivalent |
Item No. 7: Nitrile Gloves (Non-sterile)
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Gloves, non-sterile |
| Purpose | Protection of hand from microbial contamination |
| Description | Comfortable, super soft flexible powder free nitrile gloves provide added safety applications.
|
| Requirements | Designed with special nitrile formulation and fit like latex and allow full range of motion and excellent flexibility to minimize stress and fatigue.
powder-free, Cuff length preferably reach mid-forearm (e.g. minimum 280mm total length. Should not contain natural rubber latex |
| Size | Different size |
| Compliance/certification required | EU standard directive 93/42/EEC Class I, EN 455, EU standard directive 89/686/EEC Category III, EN 374 ANSI/ISEA 105-2011, ASTM D6319-10 or equivalent |
Item No. 8: Biohazard bag
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Biohazard bag |
| Purpose | Personnel protection from biohazard |
| Requirements | Disposal bag for bio-hazardous waste, 30x50cm, with “Biohazard” print, autoclavable polypropylene. Not less than micron thickness |
| Basic unit | One |
| Packing | Not more than 50 units per cartoon |
Item No. 9: Body bag (for dead body packing)
| Name of Manufacturer | |
| Country of Origin | |
| Item type | Body bag (for dead body packing) |
| Purpose | Infected dead body packing |
| Requirements | Made of linear enforced, U-shape zipper and 2 zipper pulls with tie ribs. Adult size 250x120cm Protector Body Bag specifications: 6 handles Impermeable, linear reinforced LLDPE, LDPE, EVA, PEVA, (avoid PVC), minimum thickness 400 microns; Should be able to hold 100-125 kilos (200-250 lbs), Should contain no chlorides: burning of chlorides pollute the environment and can cause damage to retort chambers.
Should be non-carcinogenic to health of funeral workers when used for cremations. At least 6 handles included in the body bag to allow burial team to hand carry it safely Heat-sealed: insure superior strength and safety, provide full containment of blood borne pathogens Cracking point of 25 – 32 degrees below zero |
| Shelf-life | Minimum 10 years |
| Color | White |
Item no. 10: Gown Level IV
| Name of Manufacturer | |
| Country of Origin | |
| Item name | Gown for COVID |
| Purpose | Virus protection barrier |
| Type | Blood borne pathogens penetration resistant: |
| Descriptions | Single use, fluid resistant, disposable, length mid-calf to cover the top of the boots, thumb/finger loops or elastic cuff to anchor sleeves in place. |
| Requirements | To be used in high risk situations which prevents all fluid penetration at least for up to 1 hour
Must have tested the barrier level barrier level performance |
| Color | Preferably light |
| Compliance/certification required | AAMI PB70 level 4 performance, or (EN 14126-B) and partial body protection ( EN 13034 or EN 14605), or equivalent |
Item No. 11: Reusable Gown (Coverall)
| Name of Manufacturer | |
| Country of Origin | |
| SN | Requirements |
| 1 | Heavy-duty apron Heavy-duty non-woven apron
|
| 2 | Straight apron with bib Fabric: 100% polyester with PVC coating, or 100% PVC, or 100% rubber, or other fluid-resistant material
|
| 3 | Waterproof, sewn strap for neck and back fastening
|
| 4 | Minimum basis weight: 300 g/m2 Covering size : approximately 70–90 cm width x 120–150 cm length |
10 . Technical specification of High flow nasal cannula therapy device (HFNC)
| S. N. | Purchaser’s Specifications | Bidder’s Remarks |
| Name of Bidder | ||
| High flow nasal cannula therapy device | ||
| Manufacturer | ||
| Brand | ||
| Type/Model | ||
| Country of Origin | ||
| 1 | Description of Functions | |
| 1.1 | High flow nasal cannula therapy device (HFNC)is a kind of oxygen therapy device that directly transports a certain oxygen concentration of air oxygen mixed with high flow gas to patients through a soft nasal cannula. | |
| 2 | Operational Requirements | |
| 2.1 | It shall operate from the mains supply/ central oxygen supply, inbuilt air source. | |
| 3 | Technical Specifications | |
| 3.1 | It should be single system for treating paediatric and adult patients. | |
| 3.2 | It should be complaint for use on patients in ICU, wards and emergency department oxygen therapy. | |
| 4.3 | It shall have LCD/LED display to monitor for temperature, flow rate, Therapy air Fio2, mode of operation and fault error. | |
| 4.4 | Inbuilt flow generator capable of delivering wide range of flows:2-25 litres in paediatric mode and 10-80 litres in adult mode. | |
| 4.5 | Inbuilt Air/O2 blending and Fio2 monitoring, facility to deliver wide range of oxygen concentration (Fio2) from 21 to 100%. | |
| 4.6 | It should have inbuilt Air source | |
| 4.7 | It should have integrated heated humidifier with temperature control range of 31°C to 37°C. | |
| 4.8 | It should have Visual and audible alarm indication for:
High/Low oxygen, temperature, power failure etc. |
|
| 4.9 | Should be supplied with heated wire patient breathing tube and nasal cannula of different sizes. | |
| 4.10 | Paediatric nasal cannula should be made of kink proof material with adhesive pads to stick on skin. | |
| 4.11 | It should commonly be used on tracheostomy patients and covid patients | |
| 4.12 | System shall come with appropriate trolley, basket/drawer and tubing holder set. | |
| 5 | Accessories, Spare Parts and Consumables | |
| 5.1 | All standard accessories/consumables/parts required for the proper operation of the above item shall be included in the offer. Bidders shall specify, in a separate Excel worksheet, the quantity and details of any items included in this offer which have not been specified in this Technical Specifications Forms. | |
| 5.2 | Each high flow nasal cannula device should have supply following Standard accessories
– Mobile trolley. – Tubing Holder Set – Servo control auto heated humidifier with accessories – Oxygen hose – Power cable – Nasal cannula for adult – 1 Pcs each. – Nasal cannula for pediatric –1 Pcs each – Tracheostomy set for adult-1pcs each – Heating circuit- 1 pcs each |
|
| 6 | Operating Environment | |
| 6.1 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. The power cable must be at least 3 metres in length. | |
| 7 | Standards & Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | European CE issued by a notified body registered in the European commission or USFDA approved product certificate. Self-declaration of CE will not valid. | |
| 7.3 | Document evidence shall be submitted for evaluation. | |
| 8 | User Training | |
| 8.1 | The Supplier shall conduct user training for this equipment to enable operators to use the equipment properly. The training shall include the use of all operational functions of the equipment, as well as routine checks and maintenance expected by users. | |
| 9 | Warranty | |
| 9.1 | The warranty period for this item shall be 2 years after acceptance of the Goods. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During the warranty period supplier must ensure planned preventive maintenance (PPM) along with corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | The bidder must arrange for the equipment to be installed and commissioned by certified or qualified personnel; any prerequisites for installation to be communicated to the purchaser in advance, in detail. | |
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English | |
| 12.2 | Service (Technical / Maintenance) manual in English | |
| 12.3 | Original catalog or e-copy | |
| 12.4 | Must submit valid manufacturer’s authorization letter | |
| 12.5 | Certificate of calibration and inspection from factory. | |
| Bidders must completely fill the Technical Specification Form (TSF). Only YES/NO/COMPLY should not be written. Page number in the catalog must be clearly mentioned and highlighted. Failure in doing so may lead to rejection of bid from technical committee. |
- Technical specification of ICU bed with Mattress
| S.N. | Purchaser’s Specification | Bidder’s Remarks |
| ICU Bed with Mattress | ||
| Name of Bidder | ||
| Manufacturer | ||
| Brand | ||
| Type/Model | ||
| Country of Origin | ||
| 1 | Description of Function | |
| 1.1 | ICU Beds are required in the Intensive Care for comfort of the patient and to facilitate comfortable transfer to and from emergency/OT/Wards etc. It is also required to carry out point of care procedures including radiological procedures at the bedside. | |
| 2 | Operational Requirements | |
| 2.1 | The system must b electrically operated five function and adjustable height and tilt. It must also have option for a radio translucent top for carrying out X-Ray at the Bedside. | |
| 3 | System Configuration | |
| 3.1 | Electrically operated Four section high pressure laminate board bed platform ICU bed with mattress and pillow | |
| 4 | Technical Specifications | |
| 4.1 | The bed must have an open-architecture design for quick and easy cleaning, helping to reduce the risk of infection. | |
| 4.2 | Must have retracting side rails to prevent patient entrapment and falls. | |
| 4.3 | Must have zero gaps for safe and easy patient transfers. | |
| 4.4 | Must have trend and reverse trend for emergency situations and comfort. | |
| 4.5 | Must have actuator control for movement with hand control (remote control) and Side rail embedded patient control. | |
| 4.6 | Must have back rest rising 0 to 75̊ | |
| 4.7 | Must have knee rising from 0 to 45 ̊. | |
| 4.8 | The under bed clearance approx 5.5”. | |
| 4.9 | Must have Trendelenburg 0 to 15 ̊ and reverseTrendelenburg0 to 15 ̊. | |
| 4.10 | Must have an gle indicator on side rail for trend and reverse trend. | |
| 4.11 | Must have central Brakes system accessible from all four corners of the bed. | |
| 4.12 | Must have dual sides Manual CPR and electric CPR. | |
| 4.13 | Shall have X-ray translucent backrest with cassette holder | |
| 4.14 | Shall have Nurse control pendent at foot board. | |
| 4.15 | Shall have Auto regress backrest and Auto-contour adjustment facility. | |
| 4.16 | Must have One step head board removal for rapid access to the patient’s head | |
| 4.17 | Four corners crash bumper, Pull-out linen shelf, One handed release split side rail and Total lock castors. | |
| 4.18 | Must have 4 positions IV Pole holder | |
| 4.19 | Must have battery backup facility for electric functionality. | |
| 4.20 | Must have IPX 4 protection and Ground line protection. | |
| 4.21 | It must have hook on bed frame on both sides for holding urine/
drainage bag (at least 4 nos.) |
|
| 4.22 | Dimensions of bed:
· Overall Length: Approx 220cm · Overall Width: Approx 105cm · Auto regress on backrest: Approx 10cm · Auto regress on leg: Approx 10 cm |
|
| 4.23 | Height: Approx.40 – 80cm | |
| 4.24 | The working load capacity of unit should be at least 250Kg. | |
| 4.25 | Mattress:
· Shall provide with one, four section mattress of suitable dimensions with washable cover of good quality. The mattress must be made of high density PU foam of 12cm thickness with Anti-Microbial agent incorporated into all components. · Mattress must be fully radiolucent for ease in performing X-rays Pillow: Shall provide suitable pillow with washable cover of good quality |
|
| 5 | Accessories, spares and consumables | |
| 5.1 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). | |
| 6 | Operating Environment | |
| 6.1 | The system offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 6.2 | Power supply: 110 – 230V AC, 50Hz, 60VA fitted with appropriate plug type. The power cable must be at least 3 metre in length | |
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate | |
| 8 | User Training | |
| 8.1 | User and maintenance training should be provided to the hospital personnel at the time of installation | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2 year after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | Standard warranty conditions are applicable. | |
| 11 | Installation and Commissioning | |
| 11.1 | Must supply preassembled unit, ready to use. | |
| 12 | Documentation | |
| 12.1 | User / instruction manual shall be provided in English. |
- Hand held Pulse Oximeter
| S.N. | Purchaser’s Specifications | |
| Hand Held Pulse Oximeter | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 1 | Description of Function | |
| 1.1 | A pulse Oxymeter is a medical device that indirectly measures the amount of oxygen in a patient’s blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photo plethysmography. | |
| 2 | Operational Requirements | |
| 2.1 | Suitable for all types of patient range, adult, paediatric and infant and shall operate on AC mains as well as from internal rechargeable battery. | |
| 3 | System Configuration | |
| 3.1 | Pulse Oxymeter, complete unit with all standard accessories. | |
| 4 | Technical Specifications | |
| 4.1 | It shall be portable unit. | |
| 4.2 | Display- LCD, backlight illuminated. | |
| 4.3 | Parameters and waveform displayed- SpO2, pulse rate, system status, plethysmogram, menus for user settings. | |
| 4.4 | SPO2 range: 70-100 %. | |
| 4.5 | Accuracy of SPO2: 3%. | |
| 4.6 | Pulse rate range must be 30-240bpm. | |
| 4.7 | Audio-visual alarms: High/low SpO2 and pulse rate, sensor off, sensor failure, low battery. | |
| 4.8 | Shall have alarm override facility. | |
| 4.9 | It must be suitable to operate in the presence of potentially flammable anaesthetic gases, and it shall not cause fire or explosion during operations. | |
| 4.10 | RS 232C interface for data communication. | |
| 4.11 | Inbuilt rechargeable battery and shall have battery back-up for at least 4 hours. Battery charger along with AC adaptor to be provided if integrated charger is not there. | |
| 5 | Accessories, spares and consumables | |
| 5.1 | Accessories:
· Reusable adult SpO2 sensor with cable: 02 nos. · Reusable paediatric SpO2 sensors: 01 no. · Reusable infant SpO2 sensor:01 no. |
|
| 5.2 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). | |
| 6 | Operating Environment | |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 6.2 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. The power cable must be at least 3 metre in length. | |
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate. | |
| 7.3 | Electrical safety conforms to standards for electrical safety IEC 60601-1 General requirement for Electrical safety of Medical Equipment. | |
| 8 | User Training | |
| 8.1 | Must provide user training (including how to use and maintain the equipment). | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2 years after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During warranty period supplier must ensure preventive maintenance and corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | Supplier must accomplish proper installation & commissioning of equipment onsite. | |
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English. | |
| 12.2 | Service (Technical / Maintenance) manual in English. | |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. | |
| 12.4 | Certificate of calibration and inspection from factory. | |
15.1 Spot-Check Pulse Oxymeter
| S.N. | Purchaser’s Specifications |
| Spot-Check Pulse Oxymeter | |
| Manufacturer | |
| Brand | |
| Type / Model | |
| Country of Origin | |
| 1 | Description of Function |
| 1.1 | For spot-check of percentage arterial oxygen saturation (SpO2, %) and pulse rate (HR, bpm) of all patient categories. Non-invasive monitor using a clip-on sensor placed on a finger or toe. |
| 2 | Operational Requirements |
| 2.1 | It shall be suitable for professional clinical use, all patient categories neonate, infant and adult. |
| 3 | System Configuration |
| 3.1 | Pulse Oxymeter, complete unit with all standard accessories. |
| 4 | Technical Specifications |
| 4.1 | Ultra compact pulse oxymeter integrated into finger/toe sensor clip. |
| 4.2 | It shall be of robust, shock resistant design, which allows use in demanding environments. |
| 4.3 | It shall accommodates finger/toe thicknesses 8 to 25mm. |
| 4.4 | Facility of spot-check of arterial blood oxygen saturation (SpO2) and heart rate (HR). |
| 4.5 | It shall have one button operation, auto-off when not in use for 10 seconds. |
| 4.6 | Clip with extended side flaps eliminates ambient light from the measurement. |
| 4.7 | Measuring range:
· SpO2 30 to 100% (minimum graduation 1%) · HR 20 to 320bpm (minimum graduation 1bpm) |
| 4.8 | Accuracy:
· SpO2 +/-2% in the range from 70 to 100% · HR +/-2% in the range from 30 to 250 bpm |
| 4.9 | Display: Easy readable display shows operational status, SpO2, HR, signal strength (bar graph) and battery status. |
| 4.10 | Alarm: Audio-visual alarm on operational status, SpO2<90%, sensor malfunction and loss of signal. |
| 5 | Accessories, spares and consumables |
| 5.1 | Accessories:
· 2 x spare set of two batteries 1.5V AAA/LR03 Alkaline. · 1 x Neck lanyard for carrying. · 1 x Strong protective carry bag. |
| 5.2 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). |
| 6 | Operating Environment |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. |
| 6.2 | Power supply: Shall work on two 1.5V AAA/LR03 batteries. |
| 7 | Standards and Safety Requirements |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate. |
| 8 | User Training |
| 8.1 | Must provide user training (including how to use and maintain the equipment). |
| 9 | Warranty |
| 9.1 | Comprehensive warranty for 1 year after acceptance. |
| 10 | Maintenance Service During Warranty Period |
| 10.1 | During warranty period supplier must ensure preventive maintenance and corrective/breakdown maintenance whenever required. |
| 11 | Installation and Commissioning |
| 11.1 | Supplier must accomplish proper commissioning of equipment onsite. |
| 12 | Documentation |
| 12.1 | User (Operating) manual in English. |
| 12.2 | Service (Technical / Maintenance) manual in English. |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. |
| 12.4 | Certificate of calibration and inspection from factory. |
- Technical specification of patient monitor 5 parameter
| S.N. | Purchaser’s Specifications | Bidder’s Remarks |
| 1 | Patient Monitor, 5 parameter | |
| Name of Bidder | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 2 | Description of Function | |
| 2.1 | It should be suitable for usage in Emergency, Operation Room and ICU Capable of monitoring ECG, SPO2, Non Invasive Blood Pressure (NIBP), Respiration Rate and Temperature. | |
| 3 | Operational Requirements | |
| 3.1 | It shall operate on AC power supply as well as built-in battery | |
| 4 | System Configuration | |
| 4.1 | Five parameter Patient Monitor, portable with complete accessories | |
| 5 | Technical Specifications | |
| 5.1 | Monitor must be able to monitor ECG, Respiration, SpO2, NIBP and Temperature as a standard parameter. | |
| 5.2 | At least 12” high resolution TFT display with LED backlight with touch screen. | |
| 5.3 | Display waveform: simultaneously display of at least 10 waveforms along with related numerical parameters on single screen. | |
| 5.4 | Monitor must have Lithium ion Battery. More than 3 hour battery Backup. | |
| 5.5 | Should have Adult, Pediatric and neonatal measurement mode. | |
| 5.6 | Shall have Protection system against defibrillator discharge. | |
| 5.7 | Shall have atleast 72-hour ECG waveform data storage and recall with more than 2000 hour data trends, graphics and tabular view. | |
| 5.8 | 2000 groups event, ARR and SpO2 storage | |
| 5.9 | The monitor should be able to configure automatically for new parameters as they are connected. | |
| 5.10 | Should have alarm indicators with different alarm tones and visible alarm lights indicators for different issues. | |
| 5.11 | The key volume, alarm volume and beat volume should be adjustable according to clinical practices and/or preferences. | |
| 5.1 | Shall have Integrated 3 channel thermal Printer to record the events. | |
| 5.13 | Connection and interface: Should have network capability to connect central monitoring system. | |
| 5.14 | Clinicians should be able to “freeze” applications at the bedside and have access to real-time ECG monitoring and other information at the same time. | |
| 6 | NIB | |
| 6.1 | Technique: Oscillometric Measurement mode: Manual , Automatic and STAT | |
| 6.2 | Measuring time: <30 seconds (typical adult cuff) | |
| 6.3 | Measuring range: Systolic pressure: 40mmHg~275mmHg Diastolic pressure: 10mmHg~210mmHg Mean arterial pressure: 20mmHg~230mmHg |
|
| 7 | SpO2 | |
| 7.1 | Transducer: Dual-wave length LED SpO2 measuring range: 0%~100% SpO2 measuring accuracy: 2% for range from 70% to 100% |
|
| 7.2 | PR measurin range: 0 to 250 bpm. Accuracy +/-2% | |
| 8 | ECG | |
| 8.1 | HR measuring range: 15bpm~350bpm HR measuring accuracy: ±1% or ±2bpm |
|
| 9 | TEMP | |
| 9.1 | Measuring range : 21.0°C~50.0°C Measuring accuracy: ±0.2°C for range from 25.0°C~45.0°C |
|
| 10 | RESP | |
| 10.1 | RR measuring range: 0rpm~120rpm RR measuring accuracy: ±5% or ±2rpm | |
| 13 | Accessories, spares and consumables | |
| 13.1 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. | |
| 13.2 | • NIBP reusable cuffs with hose of 3 various sizes (neonate, pediatric and adult) – 1 no. each. • Spo2 Probe with extension set, various size ( Neonate, Pediatric and Adult) – 1 no each .• ECG:- 3/5 lead ECG cable and wire- 1 set • TEMP:- Skin temperature probe- 1 set |
|
| 14 | Operating Environment | |
| 14.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 14.2 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. | |
| 15 | Standards and Safety Requirements | |
| 15.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 15.0 | Must Submit CE (93/42 EEC) Directive certificate and USFDA approved product certificate. | |
| 15.4 | Shall meet IEC 61010-2-081 safety requirements for electrical equipment. | |
| 16 | User Training | |
| 16.1 | Must provide user training (including how to use and maintain the equipment). | |
| 17 | Warranty | |
| 17.1 | Comprehensive warranty for 2 years. | |
| 17.2 | Maintenance Service During Warranty Period | |
| 12.3 | During the warranty period supplier must ensure corrective/breakdown maintenance whenever required. (written document) | |
| 18 | Installation and Commissioning | |
| 18.1 | The bidder must arrange for the equipment to be installed and commissioned by certified or qualified personnel; any prerequisites for installation to be communicated to the purchaser in advance, in detail. | |
| 19 | Documentation | |
| 19.1 | User (Operating) manual in English. | |
| 19.2 | Service (Technical / Maintenance) manual in English. | |
| 19.3 | Certificate of calibration and inspection from factory. |
16.1 Technical specification of patient monitor 7 parameter
| S.N. | Purchaser’s Specifications | Bidder’s Remarks |
| 1 | Patient Monitor, 7 parameter | |
| Name of Bidder | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 2 | Description of Function | |
| 2.1 | It should be suitable for usage in Emergency, Operation Room and ICU Capable of monitoring ECG, SPO2, Non Invasive Blood Pressure (NIBP), Respiration Rate, Etco2, 2IBP and Temperature. | |
| 3 | Operational Requirements | |
| 3.1 | It shall operate on AC power supply as well as built-in battery | |
| 4 | System Configuration | |
| 4.1 | Seven parameter Patient Monitor, portable with complete accessories | |
| 5 | Technical Specifications | |
| 5.1 | Monitor must be able to monitor ECG, Respiration, SpO2, NIBP, Temperature, 2IBP and EtCo2 as a standard parameter. | |
| 5.2 | At least 12” high resolution TFT display with LED backlight with touch screen. | |
| 5.3 | Display waveform: simultaneously display of at least 10 waveforms along with related numerical parameters on single screen. | |
| 5.4 | Monitor must have Lithium ion Battery. More than 3 hour battery Backup. | |
| 5.5 | Should have Adult, Pediatric and neonatal measurement mode. | |
| 5.6 | Shall have Protection system against defibrillator discharge. | |
| 5.7 | Shall have intelligent arrhythmia analysis and S-T segment measurement. | |
| 5.8 | Shall have at least 72-hour ECG waveform data storage and recall with more than 2000 hour data trends, graphics and tabular view. | |
| 5.9 | 1000 groups event, ARR and SpO2 storage | |
| 5.10 | Shall have various drug calculation including oxygenation calculation, Renal function calculation, ventilation calculation, medication calculation and hemodynamic calculation. | |
| 5.11 | The monitor should be able to configure automatically for new parameters as they are connected. | |
| 5.1 | Should have alarm indicators with different alarm tones and visible alarm lights indicators for different issues. | |
| 5.13 | The key volume, alarm volume and beat volume should be adjustable according to clinical practices and/or preferences. | |
| 5.14 | Shall have Integrated 3 channel thermal Printer to record the events. | |
| 5.15 | Connection and interface: Should have network capability to connect central monitoring system. | |
| 5.16 | Clinicians will be able to “freeze” applications at the bedside and have access to real-time ECG monitoring and other information at the same time. | |
| 6 | NIB | |
| 6.1 | Technique: Oscillometric Measurement mode: Manual , Automatic and STAT | |
| 6.2 | Measuring time: <30 seconds (typical adult cuff) | |
| 6.3 | Measuring range: Systolic pressure: 40mmHg~275mmHg Diastolic pressure: 10mmHg~210mmHg Mean arterial pressure: 20mmHg~230mmHg |
|
| 7 | SpO2 | |
| 7.1 | Transducer: Dual-wave length LED SpO2 measuring range: 0%~100% SpO2 measuring accuracy: 2% for range from 70% to 100% |
|
| 7.2 | PR measurin range: 0 to 250 bpm. Accuracy +/-2% | |
| 8 | ECG | |
| 8.1 | HR measuring range: 15bpm~350bpm HR measuring accuracy: ±1% or ±2bpm |
|
| 9 | TEMP | |
| 9.1 | Measuring range : 21.0°C~50.0°C Measuring accuracy: ±0.2°C for range from 25.0°C~45.0°C |
|
| 10 | RESP | |
| 10.1 | RR measuring range: 0rpm~120rpm RR measuring accuracy: ±5% or ±2rpm | |
| 11 | Etco2 | |
| 11.1 | Side Stream or main stream. | |
| 12 | IBP | |
| 12.1 | Dual channel IBP. | |
| 13 | Accessories, spares and consumables | |
| 13.1 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. | |
| 13.2 | • NIBP reusable cuffs with hose of 3 various sizes (neonate, children and adult) – 1 no. each. • Spo2 Probe with extension set, various size ( Neonate, Pedriac and Adult) – 1 no each .• ECG:- 3/5 lead ECG cable and wire- 1 set • TEMP:- Skin temperature probe- 1 set • IBP module:- 2 sets of cables with 4 sets of kits • Artema Side-stream EtCO2 module:- Side-stream EtCO2 kit- 1 set |
|
| 14 | Operating Environment | |
| 14.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 14.2 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. | |
| 15 | Standards and Safety Requirements | |
| 15.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 15.0 | Must Submit CE (93/42 EEC) Directive certificate and USFDA approved product certificate. | |
| 15.4 | Shall meet IEC 61010-2-081 safety requirements for electrical equipment. | |
| 16 | User Training | |
| 16.1 | Must provide user training (including how to use and maintain the equipment). | |
| 17 | Warranty | |
| 17.1 | Comprehensive warranty for 2 years. | |
| 17.2 | Maintenance Service During Warranty Period | |
| 12.3 | During the warranty period supplier must ensure corrective/breakdown maintenance whenever required. (written document) | |
| 18 | Installation and Commissioning | |
| 18.1 | The bidder must arrange for the equipment to be installed and commissioned by certified or qualified personnel; any prerequisites for installation to be communicated to the purchaser in advance, in detail. | |
| 19 | Documentation | |
| 19.1 | User (Operating) manual in English. | |
| 19.2 | Service (Technical / Maintenance) manual in English. | |
| 19.3 | Certificate of calibration and inspection from factory. |
- Infrared Thermometer
| S.N. | Purchaser’s Specifications |
| Name of Bidder | |
| Non Touch Infrared Sensor Thermometer | |
| Manufacturer | |
| Brand | |
| Type/Model | |
| Country of Origin | |
| 1 | Requirements |
| – Purpose: Non-contact temperature sensing of human body, ideal for individual screening
-Infrared sensor reads temperature approx 4-6 cm from the center of forehead -Should have option for temperature display in both ℃ and 0F – Measurement Range: At least measure 89.60F to 109.40F(32℃ -43℃) – Accuracy: not less than ±0.2℃ -Should have alarm setting for high temperature – Display type: LCD with backlight – Response Time: Not more than 5 Seconds, with beep – Power Supply: 3 Volt DC (battery operated) – Accessories: extra battery 1 pair -CE/USFDA certificate should be submitted – Warranty: minimum 2 years |
Technical specification BIPAP
| S.N. | Purchaser’s Specifications | Bidder’s Remarks |
| Name of Bidder | ||
| BIPAP (Bi-level Positive Airway Pressure) | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 1 | Description of Function | |
| 1.1 | BIPAP (Bi-level Positive Airway Pressure) incorporates the comfort of BiLevel technology to deliver comfortable therapy at higher prescription pressures. The goal is reducing the average pressure for the Patient. | |
| 2 | Operational Requirements | |
| 2.1 | Should have Real-time display – LCD display shows actual pressure, leak rate and patient breathing parameters such as breath rate, I/E ratio, minute volume and tidal volume, On board Filter Clean Reminder, etc. | |
| 2.2 | Should have Integrated heated humidification system without requiring a separate hose or power cord. | |
| 3 | System Configuration | |
| 3.1 | BIPAP (Bi-level Positive Airway Pressure) should be complete unit with all standard accessories. | |
| 4 | Technical Specifications | |
| 4.1 | The device should offer patented flow rounding technology, which further enhances comfort by allowing for adjustment of transitions in and out of ipap and epap. | |
| 4.2 | IPAP: approx. 3 to 25cmH2O. | |
| 4.3 | EPAP: approx. 3 to 25cmH2O. | |
| 4.4 | Breath rate: approx.0 to 30BPM with spontaneous for time mode. | |
| 4.5 | Timed inspiration: approx. 0.5 to 3.0s. | |
| 4.6 | Should have ramp function to lower the pressure at initial phase and slowly increase to allow pressure. | |
| 4.7 | Should have automatic leakage compensation | |
| 4.8 | Should have low noise level less than or equivalent to 30dBA. | |
| 4.9 | Should have customizable and the sensitivity of the trigger should be adjustable | |
| 4.10 | Should have operating mode of CPAP, Spontaneous, timed, PAC/PC (Pressure Assisted Control/Pressure Control) | |
| 4.11 | Should provide with carry bag | |
| 5 | Accessories, spares and consumables | |
| 5.1 | All standard accessories, consumables and parts required to operate the equipment to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). | |
| 6 | Operating Environment | |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 6.2 | Should have Auto Switching universal Power supply of: 100 – 240 VAC, 50Hzto 60Hz and must be operated from 12 V DC source. | |
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate. | |
| 7.3 | Electrical safety conforms to standards for electrical safety IEC 60601-1 General requirement for Electrical safety of Medical Equipment. | |
| 8 | User Training | |
| 8.1 | Must provide user training (including how to use and maintain the equipment). | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2 years after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During warranty period supplier must ensure corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | Supplier must accomplish proper commissioning of equipment onsite. | |
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English. | |
| 12.2 | Service (Technical / Maintenance) manual in English. | |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. | |
| 12.4 | Certificate of calibration and inspection from factory. |
