Biomedical Equipment for Indoor Section

Transcription

1 KASTURBA HEALTH SOCIETY'S MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, P.O. SEVAGRAM, WARDHA (DISTT.) MAHARASHTRA STATE Specifications Biomedical Equipment for Indoor Section 1) Mechanical Ventilator - 5 Nos. It is preferable that direct company (through it authorized agency) quotes for tender. No middleman is allowed Detail technical information supported by published data should be given. Technical data sheet must be provided. Submission of false compliance report will lead to disqualification of vendor. Demonstration of instruments should be done before or as soon quoted for tender (within 7 days). There are few changes from previous tender specifications. Those vendor who have quoted same model in previous tender, need to submit only compliance sheet and price bids. Centralized compressed based Mechanical Ventilator: 5 Units Ventilator for demonstration should be kept for at least 3 days for use. Software simulation or detail videos explaining each feature should be provided in demonstration. Those who fail to demonstrate ventilator within 7 days of quoting of tender will be disqualified. Selection will be done by fulfillment of specifications and maintenance cost. Department of Medicine should be contacted for any query about tender. Attach images of all accessories intended to be provided along with information about make and model. Features required in ventilators 1. Three ventilators for Medicine ICU: Adult ventilator with Volume control, Pressure control, SIMV, NIV (pressure support and pressure control), volume support (preferable), APRV/Bilevel, High flow oxygen therapy (preferable) and other optional modes as mentioned in detail specification should be present in one of the ventilator. 2. Two ventilators: One adult and one universal ventilator with Volume control, Pressure control, SIMV, NIV (pressure support and pressure control), volume support (optional), High flow oxygen therapy (preferable). Cost should be quoted in following parts for comparison 1. Cost of five ventilators with features as mentioned 2. Cost of accessories (except for high flow oxygen therapy, extra ventilator side arm and reusable flow sensor)

2 3. Cost of accessories for high flow oxygen therapy (vendor may quote it even if ventilator does not have high flow oxygen therapy mode) 4. Cost of extra five company supplied side arms 5. Cost of reusable flow sensor Final selection: It will be done by cost of five ventilators, cost of accessories (as quoted in point 2 above) and marks allotted to technical specifications (table B). Each 1 lakh cost will be converted into 20 points. Points gained in technical qualification are subtracted from points obtained after cost conversion. Consideration will be given separately to cost of accessories of high flow oxygen therapy and compatible ventilator arm and reusable flow sensor. Vendor who scores lowest will be given final order. A. Technical specifications: 1. Centralized compressor based ventilator: Do not quote compressor with ventilator 2. Brand of international repute with presence in market for at least 10 years (preferable) 3. Modes of ventilation: Volume control: VC with flow adaptation, VC without flow adaptation and VC with decelerating flow option is preferable Pressure control Pressure Regulated volume control SIMV (VC) +PS SIMV (PC) +PS, NIV (NIV PS and NIV PC modes) with maximum leakage compensation level 50L/min Pressure support including apnea backup ventilation. Volume support (preferable) APRV/BiLevel (volume guarantee) High Flow oxygen therapy ((Preferable) One ventilator for Medicine ICU with following preferable Option (Open lung tool, Automode, Adaptive support ventilation {closed loop} and proportional assist ventilation, FRC INview with PEEP inview) 4. Four ventilator for Adult use with preferable tidal volume 100 ml ml (in increments of 10 ml). 5. One ventilator with additional Neonatal use (universal) with tidal volume ml. 6. Display: At least 12.1" LCD TFT touch screen display (must) with intuitive menu with viewing area 246 x 184 mm approximately Facility of rotation and 45 tilt of display Ventilator settings can be made either via the touch screen, the main rotary dial, or a combination of both High-resolution pressure, flow and volume waveforms & loops, Clear graphic

3 presentation Upto 3 waveforms should be displayed simultaneously. Waveforms should be easily seen from distance for interpretation Graphic scale: auto and adjustable scale. Ventilator with option of adjustable graphic scale will be preferable. Machine should have the facility to show inlet pressure of oxygen & Compress Air. 360-degree visible alarm lamp (preferable) 7. Lung mechanics package including loops & respiratory parameters: resistance, static and dynamic compliance, P0.1, rapid Shallow Breathing Index, Work of Breathing, elastance, NIF 8. 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, P0.1, NIF 9. Special functions: Suction maneuver: Pre-suction oxygenation, automatic disconnection detection for suction, automatic reconnection detection and post suction oxygen enrichment phase. Manual inspiratory hold Expiratory hold Integrated medication nebulization 100% O2 P0.1 NIF 10. Automatic Disconnection detection and Reconnection detection 11. Diagnostic trend tools to ensure accurate time and detail recording for at least 24 hours after an event 12. Event log: storage and display of events with date and time stamp 13. Trended values: Breathing frequency, spontaneous breaths per min, peak airway pressure, mean airway pressure, pause airway pressure, end expiratory pressure, inspired tidal volume, Expired tidal volume, leak fraction in NIV, O2 concentration, spontaneous expiratory minute volume and optional values: static compliance, dynamic compliance, inspiratory resistance, expiratory resistance, elastance, P0.1, work of breathing, rapid shallow breathing index 14. System Check O2 /Air/Expiratory flow sensor test Expiratory/safety valve test O2 sensor test Leakage/compliance/circuit resistance measurement

4 Leakage, resistance and compliance are automatically compensated during ventilation 15. General ventilator specifications Installed over mobile cart for intra-hospital transfer (Supplied by company) with connection slot for heated humidifier. Ventilator side arm (imported and supplied by company) Internal battery support upto 60 min Low bias flow (2.0 LPM for adult) & high sensitivity at low volumes Gas delivery system: Microprocessor controlled valves and precise gas delivery by speed in sensing and regulation PEEP regulation: Microprocessor controlled valves. Peak gas flow >180 L/min Reusable flow sensor- for high sensitivity, accuracy, reliability & speed O2 Sensor: Non-consumable and maintenance-free O2 sensor will be preferable Autoclavable expiratory valve set O2 high pressure hose with coupling with each ventilator Air high pressure hose with coupling with each ventilator Air festo filter with each ventilator 16. Software: Free upgradation of software for lifetime of ventilator. 17. Vendor will have to inform about any updates in software every year. 18. Accessories: should meet the requirements of relevant BS, ISO and EN standards A. Disposable dual limb respiratory circuit kit: 20 per ventilator containing (total 100) Water traps Airway probe adapter at WYE piece HME filter catheter mount (with port for insertion of suction catheter for leak free suction procedure) B. Three Vibrating mesh nebulizer Unit (Aerogen) with AC-DC adapter with two extra reusable nebulizer chambers C. Extra 4 reusable flow sensor D. Inline MDI spacer device (e.g. OptiVent or ACE MDI holding chamber) for use in ventilator circuit: five per ventilator (total 40) E. HME Cum bacteria filter (Pure hygroscopic or combined hydrophobic hygroscopic) with at least 70% efficiency, providing at least 30 mg/l of water vapor: 20 per ventilator (total 100) F. Supply two heated wires for F &P MR 850 heated humidifier G. Autofill reusable humidification chamber (without heated humidifier): total 3 H. NIV non-vented masks with soft silicon cushion with headgear with nonbreakable clips: 2 small size and 4 medium size with each ventilator (total 15 small and 30 medium) I. Accessories of high flow oxygen therapy: o High flow nasal canula for oxygen therapy: 20 small and 20 medium size nasal cannula in total

5 J. Three airway probe adapters (where airway probe is inserted into circuit) with each unit K. Extra Company supplied ventilator side arm which are attachable to side rail of ventilator (will be ordered only if they are compatible): total Operational data Operating temperature: +10 to +40ºC, Relative humidity: 15 to 85% noncondensing, Atmospheric pressure: 660 to 1060 hpa, Lowest pressure in breathing system 400 cmh2o Certificates (Pre-market, sanitary; performance and safety standards (Specific to the device type); local &/or international: 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 20. Disinfection: Parts of the device that are designed to come into contact with the patient or the operator should be capable of easy disinfection 21. Requirement for sign-off: Certificate of calibration and inspection of parts from the manufacturer. Training of staff (Medical, nurses, technicians): Training of users on operation and basic maintenance for 2 weeks Advanced maintenance task required shall be documented 22. Maintenance and Service Response time should be less than 24hrs. Time to rectification should be less than 48hrs. If rectification time more than 48 hrs then standby unit to be provided. User & service manual should be provided (Soft copy & Hard copy). Operating & maintenance training should be given to BME. Calibration & quality testing certificate from manufacturer. Uptime guarantee should be 95%. Price list of the important spare parts with their parts number is must 23. Warranty: 2 years 24. To quote price of enabling neonatal mode with proximal flow sensor separately B. Scoring system for on technical features.

6 Features 1. Brand of international repute with presence in international ventilator market for at least 10 years 2. Four adult use ml tidal volume. Additional one Neonatal use (universal) in one ventilator ml tidal volume Volume control: VC (with flow adaptation), VC with decelerating flow, Pressure control, Pressure Regulated volume control, SIMV (VC) +PS, SIMV (PC) +PS, NIV (NIV PS and NIV PC/ST modes) with maximum leakage compensation level 50L/min Volume support 10 Marks allotted marks and additional 2.5 for neonatal mode 2.5 marks. Flow adaptation and decelerating flow gets additional 2.5 marks each NIV PS and NIV ST mode gets 2.5, NIV PC gets additional APRV/ Biphasic positive pressure ventilation (required in 3 ventilators) 5 7. Open lung tool, Automode, Adaptive support ventilation (closed loop), proportional assist ventilation and FRC INview with including 7.5 marks each PEEP INview in one of the adult ventilator for Medicine ICU 8. High Flow oxygen therapy (O2 therapy) Touch screen display 12.1 or 15 with at least 264 x 184 display area 2 marks for 15 screen 10. At least 3 waveforms displayed simultaneously and loops Adjustable graphics scale Extensive Lung mechanics package: resistance, static and dynamic compliance, P0.1, rapid Shallow Breathing Index, Work of 5 Breathing, elastance, NIF 13. Diagnostic trend tools for at least 24 hour and event log Automatic Disconnection detection and Reconnection detection in invasive and non-invasive mode Ventilator side arm supplied by company Non-consumable and maintenance-free O2 sensor Bias flow at the most 2.0 LPM for adult & high sensitivity at low volumes Reusable flow sensor- for high sensitivity, accuracy Corrective measures for past poor-quality services and products. At Subtract 2 if corrective least assurance has to be given in written before opening price measures are not taken bids. 20. Aerogen nebulizer (vibrating mesh nebulizer) with reusable nebulizer chamber Suction maneuver: Pre-suction oxygenation, automatic disconnection detection for suction, automatic reconnection detection and post suction oxygen enrichment phase 22. Ease of use (user experience), responsive touch screen and resolution of display 23. Any additional useful features provided for major and 1 for minor feature according to importance to user.

7 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. GST Registration Certificate 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

8 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 26/02/2018 up to 3.00 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) GST 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, GST, transportation, insurance will be paid by the buyer. c) MGIMS is holding a DSIR Certificate for Custom Duty concession and excise

9 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.

10 KASTURBA HEALTH SOCIETY'S MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, P.O. SEVAGRAM, WARDHA (DISTT.) Tender Notice 23 ( ) The Dean, Mahatma Gandhi Institute of Medical Sciences, Sevagram invites sealed tenders for the following items. The tenders in sealed envelope superscribed with name of the item and Department should be submitted in the office of The Dean, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra latest by 26/02/2018 up to 3.00 PM. The Technical Bids will be open on the next day i.e. 27/02/2018 at 3.00 pm in the Committee Room, Dean Office. The tender fees of Rs. 1,000/- (nonrefundable) is to be paid through RTGS/NEFT favoring Kasturba Health Society payable at Wardha. (Details are as mentioned below). Receipt of payment should be attached with tender documents (in Technical Bid). Tender forms also can be obtained by sending to or can be downloaded from the institute website ( The Dean reserves the right to reject any or all the tenders without assigning any reason. 1. Name of the Account - The Kasturba Health Society 2. Name of the Bank - Axis Bank Ltd., Wardha 3. Bank Address - Indira Market Road, Wardha Account Number IFSC Code - UTIB Branch Code Swift Code - AXISINBB MICR Code A) MCH, Melghat Project (2nd Call): 1) Electric Lawn Mower - 3, 2) Double Drum Vibratory Road Roller - 1 B) Anaesthesiology Department (2nd Call): 1) Medical Oxygen Generator - 1 C) Community Medicine Department (2nd Call): 1) Garbage Compactor Machine - 1 D) EMD Section (2nd Call): 1) Individual RO Systems for Hospital & College - 22 E) Biomedical Equipment for Indoor Section (2nd Call): 1) Mechanical Ventilator - 5 Nos. F) Indoor Section - MS Office (2nd Call): 1) Three Bucket Moping Systems - 90 Nos. DEAN