Department of Paediatrics

Transcription

1 KASTURBA HEALTH SOCIETY'S MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, P.O. SEVAGRAM, WARDHA (DISTT.) MAHARASHTRA STATE Specifications for Equipment Department of Paediatrics 1. A) Ventilator 1 Unit Technical specification for Ventilator (Qty-1) is given below:- Modes of ventilation: Volume control: VC with flow adaptation, VC without flow adaptation and VC with decelerating flow options Pressure control Pressure Regulated volume control SIMV (VC) +PS SIMV (PC) +PS, NIV (NIV PS and NIV PC modes) with leak compensation Pressure support including Apnoea backup ventilation. For Neonatal cum Pediatric use (2 ml ml) Display: 12.1" LCD TFT screen display with intuitive menu High-resolution pressure, flow and volume waveforms & loops, upto 3 waveforms should be displayed simultaneously. Extensive lung mechanics package including loops & respiratory parameters Display following monitoring values: Breathing frequency, Spontaneous breaths per minute, Peak Airway Pressure, Mean Airway Pressure, Pause Airway Pressure, End Expiratory Pressure, Inspired Tidal Volume, Expired Tidal Volume, Inspired Minute Volume, Expired Minute Volume, Leakage fraction in NIV (%), Ti/Ttot, I:E ratio, Total PEEP, oxygen Concentration (measured), MVe sp / MVe, Spontaneous Exp. Minute Volume (MVe sp), End Expiratory Flow, Static Compliance, Dynamic Compliance, Inspiratory Resistance, Expiratory Resistance, Elastance

2 Reusable ultrasonic flow sensor- for unmatched sensitivity, accuracy, reliability & speed Low bias flow (2.0 LPM) - for lowest in class O2 consumption & highest sensitivity at low volumes +Auto patient circuit compensation. O2 Sensor: Should be permanent Accessories Installed over mobile cart for intra-hospital transfer Expiratory Cassette: Should supply two sets Silicon tube: Should supply 5 sets. (Compatible with MR850 Humidifier) Vibrating mesh nebulizer Unit with AC-DC adapter: 2 (It should be compatible with Silicon Patient Circuit) HME Cum bacteria filter (Pure hygroscopic or combined hydrophobic hygroscopic, Should have at least 70% efficiency, providing at least 30 mg/l of water vapour):- supply 100 no. Test Lung (Adult)-1 Heated humidifier: MR850 humidifier including chamber with all accessories required for operating in invasive and non-invasive mode. Heater wire: Two Support Arm should be imported. O2 high pressure hose with coupling Air high pressure hose with coupling Air festo filter (As per Japanese technology) Atmosphere/Ambiance (air conditioning, humidity, dust):- Operating condition: Operating temperature: +10 to +40ºC, Relative humidity: 15 to 85% non-condensing, Atmospheric pressure: 660 to 1060 hpa, Lowest pressure in breathing system 400 cmh2o User care, Cleaning, Disinfection & sterility issues:- Disinfection: Parts of the device 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. Certificates (Pre-market, sanitary; performance and safety standards (Specific to the device type); local &/or international:- Should be FDA/European CE/BIS approved product. Manufacturer and supplier should have ISO certification for the quality standards Electrical safety conforms to the standards for electrical safety IEC60601 general requirement Shall meet internationally recognized for electromagnetic compatibility (EMI/EMC) for electrometrical equipment: Certified to be complaint with IEC , IEC safety. Requirement for sign-off:- Certificate of calibration and inspection of parts from the manufacturer. Training of staff (Medical, paramedical, technicians):- Training of users on operation and basic maintenance for 2 weeks Advanced maintenance task required shall be documented

3 Warranty:- Warranty should be 2 years & 3 years AMC free. However, the AMC / CMC to be quoted for next 5 years after the warranty, which will be considered for evaluation purpose of the bidder to Qualify as Lowest among them. Service contract Clauses, including prices:- 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. Operating manuals, service manuals, other manuals:- Should provide 2 sets (Hard copy and soft copy) of: User, technical and maintenance manuals to be supplied in English language along with machine diagram List of equipment and procedures required for local calibration and routine maintenance. Service and operation manual to be provided Advanced maintenance tasks documentation Certificate of calibration and inspection. The Installation base list of the quoted model to be submitted by the bidder. Other accompanying documents:- List of essential spare and accessories with their part number and cost. Recommendations or warnings:- Any warning signs would be adequately displayed. 1. B) Ventilator (Dedicated Neonatal Ventilator) 1 Unit Technical specification for Ventilator (Qty-1) is given below:- Modes of ventilation: Pressure control Pressure Regulated volume control SIMV (VC) +PS SIMV (PC) +PS, NIV (NIV PS and NIV PC modes) with leak compensation Pressure support including Apnoea backup ventilation. For Neonatal cum Pediatric use (2 ml- 100 ml) Display: 12.1" LCD TFT screen display with intuitive menu High-resolution pressure, flow and volume waveforms & loops, upto 3 waveforms should be displayed simultaneously. Extensive lung mechanics package including loops & respiratory parameters

4 Display following monitoring values: Breathing frequency, Spontaneous breaths per minute, Peak Airway Pressure, Mean Airway Pressure, Pause Airway Pressure, End Expiratory Pressure, Inspired Tidal Volume, Expired Tidal Volume, Inspired Minute Volume, Expired Minute Volume, Leakage fraction in NIV (%), Ti/Ttot, I:E ratio, Total PEEP, oxygen Concentration (measured), MVe sp / MVe, Spontaneous Exp. Minute Volume (MVe sp), End Expiratory Flow, Static Compliance, Dynamic Compliance, Inspiratory Resistance, Expiratory Resistance, Elastance Reusable ultrasonic flow sensor- for unmatched sensitivity, accuracy, reliability & speed Low bias flow (2.0 LPM) - for lowest in class O2 consumption & highest sensitivity at low volumes +Auto patient circuit compensation. O2 Sensor: Should be permanent Accessories Installed over mobile cart for intra-hospital transfer Expiratory Cassette: Should supply two sets Silicon tube: Should supply 5 sets. (Compatible with MR850 Humidifier) Vibrating mesh nebulizer Unit with AC-DC adapter: 2 (It should be compatible with Silicon Patient Circuit) HME Cum bacteria filter (Pure hygroscopic or combined hydrophobic hygroscopic, Should have at least 70% efficiency, providing at least 30 mg/l of water vapour):- supply 100 no. Test Lung (Adult)-1 Heated humidifier: MR850 humidifier including chamber with all accessories required for operating in invasive and non-invasive mode. Heater wire: Two Support Arm should be imported. O2 high pressure hose with coupling Air high pressure hose with coupling Air festo filter (As per Japanese technology) Atmosphere/Ambiance (air conditioning, humidity, dust):- Operating condition: Operating temperature: +10 to +40ºC, Relative humidity: 15 to 85% non-condensing, Atmospheric pressure: 660 to 1060 hpa, Lowest pressure in breathing system 400 cmh2o User care, Cleaning, Disinfection & sterility issues:- Disinfection: Parts of the device 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. Certificates (Pre-market, sanitary; performance and safety standards (Specific to the device type); local &/or international:- Should be FDA/European CE/BIS approved product. Manufacturer and supplier should have ISO certification for the quality standards Electrical safety conforms to the standards for electrical safety IEC60601 general requirement Shall meet internationally recognized for electromagnetic compatibility (EMI/EMC) for electrometrical equipment: Certified to be complaint with IEC , IEC safety.

5 Requirement for sign-off:- Certificate of calibration and inspection of parts from the manufacturer. Training of staff (Medical, paramedical, technicians):- Training of users on operation and basic maintenance for 2 weeks Advanced maintenance task required shall be documented Warranty:- Warranty should be 2 years & 3 years AMC free. However, the AMC / CMC to be quoted for next 5 years after the warranty, which will be considered for evaluation purpose of the bidder to Qualify as Lowest among them. Service contract Clauses, including prices:- 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. Operating manuals, service manuals, other manuals:- Should provide 2 sets (Hard copy and soft copy) of: User, technical and maintenance manuals to be supplied in English language along with machine diagram List of equipment and procedures required for local calibration and routine maintenance. Service and operation manual to be provided Advanced maintenance tasks documentation Certificate of calibration and inspection. The Installation base list of the quoted model to be submitted by the bidder. Other accompanying documents:- List of essential spare and accessories with their part number and cost. Recommendations or warnings:- Any warning signs would be adequately displayed. *****

6 Check List (to be submitted with Technical Bid) The Vendor should submit following documents (duly attested) with Technical Bid (Please give Annexure No. for submitted Documents as mentioned below) Name of Company: Sr. No. Name of the Document Documents Submitted (Yes / No) Annexure No. Reason (for non submitted documents) 1. FDA / BIS Approval I 2. CE Certification II 3. ISO Certification (ISO 9001 & ISO 13485) III 4. VAT Registration & CST Registration IV 5. Manufacturing Certificate of Manufacturer Company V 6. Authorized Distributor Certificate (Current Year's) VI 7. Last 3 years Tax Assessment & Turn Over Certificates VII 8. User List (wherever Equipments / Instruments supplied & installed) VIII 9. PAN Card IX 10. Contact Person Name with Mobile No. X Signature with Company Seal

7 Kasturba Health Society's Mahatma Gandhi Institute of Medical Sciences Sevagram, Wardha (Dist), Maharashtra Terms and Conditions for the tenders Any non compliance of the following will amount to disqualification of the tender 1. Sealed tender should be addressed to the DEAN, Mahatma Gandhi Institute of Medical Sciences, Sevagram, (P.O.) Wardha (Dist), Maharashtra Tender should be submitted on or before 12/12/2016 up to 1.00 P.M. Tender received after the last date will not be accepted. Separate tenders are to be submitted for each instrument. Mention on the envelope "Tender for. (instrument name) of the Dept...(Dept name)". 3. Tender should be in two separate envelopes one for Technical Bid and other for Price Bid 4. The technical bid must contain the following (duly attested) along with Check List: a) Detailed technical specifications of equipment quoted (Catalogue / illustrated literature) and options / other model. b) A soft copy (CD) in Microsoft Word / Excel Format showing compliance with our given Technical Specifications (i.e. Compliance chart). c) Authorized dealer certificate (Current year's) from the Principal of manufacturing company for supply and service d) List of users / institutional installations / Govt. supply orders / Reputed private hospitals and copy of Manufacturing License from the manufacturer. e) Income Tax and annual returns of Last three years f) FDA Approval Certificate for the equipment / item & FDA Registration of the manufacturer. g) VAT & CST Registration Certificate h) PAN Card copy i) Country of Origin of the equipment j) If you are registered firm under Micro, Small Enterprises (MSEs), please submit a copy of the Registration Certificate. 6. For equipment to be imported the prices should to be quoted in both a) Foreign Currency - CIF Mumbai and also b) INR Delivery at Sevagram including all taxes and levies Note: a) FOR CIF prices, the duty, transportation from Mumbai port to Sevagram, insurance will be borne by the buyer. b) FOR INR prices-- no excise duty, sales tax, VAT, transportation, insurance will be paid by the buyer.

8 c) MGIMS is holding a DSIR Certificate for Custom Duty concession and excise duty exemption. d) For ease of computation you may furnish the import duty structure of your equipment and classification HSN code no of custom tariff. Import License and IEC code should also be submitted. e) Kindly quote the prices strictly as per the scope of the supply written in the tender without offering your special features and accessories prices. f) You have to provide Performance Bank Guarantee covering the Warranty period g) Penalty clause for delay in supplying will be applicable. 7. Payment terms: a) For CIF: L/C will be opened by the buyer on the condition of payment on successful installation of the equipment. b) For INR quote: Payment will be against successful installation of the equipment c) No advances are given with Purchase Order (PO). 8. Delivery period from date of Purchase Order (PO) to be written clearly in days. Penalty clause can be levied on case to case basis. Installation of the equipment should be free and to the satisfaction of the buyer. 9. Service and Guarantee conditions: a) Equipment will be under guarantee of two years from the date of installation. On case to case basis Performance Bank Guarantee may be sought. b) Mention the charges and terms of AMC & CMC (Labour + Part) applicable from 3rd year onwards. c) Mention about the nearest facility/office where service personnel are available. d) Mention about the facility for training of personnel safety and quality standards. 10. Dean M.G.I.M.S. reserves the right to reject all or any tender without assigning any reason. *****