Department of Medicine

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1 KASTURBA HEALTH SOCIETY'S MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, P.O. SEVAGRAM, WARDHA (DISTT.) MAHARASHTRA STATE Specifications Department of Medicine Tender to be quoted by only authorized distributor/dealer of company. No middleman is allowed. Detail technical information supported by published data should be given. Technical date sheet must be provided. Demonstration of instruments should be done as soon quoted for tender (Preferably within 7 days). Submission of false compliance report will lead to disqualification of vendor. FDA and BIS/CE certificate should be provided. 1. Non-Invasive Portable Ventilator with NIV Masks 2 Units For hospital use Modes: S/T, PAC (Pressure assist control), CPAP, S (spontaneous), T (timed), and Volume targeted mode (optional) Pressure range: IPAP 4-30 cm of H2O, EPAP 2-25 cm of H2O Respiratory rate 5-40 bpm Tidal volume: ml Peak flow 150 L/min at 20 cm H20 Flow accuracy ± 5 lit/min or 20% measured value whichever is greater Leak accuracy: ±12 L/min or 20% of reading, whichever is greater, 0 to 60 L/min Inspiratory time: Ti min (0.1-Ti max), Ti max sec Rise time setting: Five setting Ramp function setting: 10 to 60 min, off Alarms: High leak, Low minute ventilation, apnea, High pressure, low pressure, highrespiratory rate, low respiratory rate, circuit disconnected Alarm volume settings: Low (nominal 54 dba), Medium

2 (nominal 60 dba), High (nominal 73 dba) Internal battery backup time: minimum of 2 hours Expiratory (leak) port extra 4 leak ports to be provided with each noninvasive ventilator NIV mask: Full face non-vented mask of different sizes (S, M and L) with non-breakable attachment clips. Cushion made up of soft silicon. Optional Attachable headgear. Quantity of NIV mask required: Small - 2, Medium - 3 (total 5 with each NIV machine) Autoclavable standard tubing for NIV 3 per NIV machine Without heated humidifier electromagnetic compatibility requirements (EMC) according to IEC List price of different parts must be quoted Brand of international repute 2. High Flow Oxygen Therapy System (3 for Medicine Dept. & 1 for Anaesthesiology Dept.) A. High flow air oxygen blender with high flowmeter with pole mount bracket with air and oxygen hose (hose connector should be as per our site) with Air Inlet Filter/Water Trap/Festo filter Oxygen concentration range 21%-100% High flow air oxygen blender with outlet flow range: 2-100LPM with inlet pressures at 50 PSIG (4 BAR) Pressure Drop: Less than 6 PSIG ( PSIG (3.4 BAR) sensor supply pressure and 10LPM flow rate FiO2 accuracy: ±3% of full scale Number of output ports: 1-2 Flowmeter of 0-70 lit per min Gas supply pressure: at a pressure of 30 to 75 PSIG (2.0 to 5.2 BAR). Optional ability to monitor outcoming oxygen concentration (FIO2) IV pole and Pole mount bracket Air and oxygen hose (hose connector should be as per our site) with Air Inlet Filter/Water Trap/ Festo filter B. Respiratory circuit for high flow oxygen therapy with nasal cannula with adapter for inlet in heated humidifier: 6

3 Any one of following options o Heated wire circuit is preferable option. o Single limb respiratory circuit with manually added heated wire (provide one extra) o Non-heated wire single limb respiratory circuit with water trap (to demonstrate feasibility). High flow nasal cannula and High Flow Tracheostomy Adapter should be provided Should integrate with Fisher and Paykel heated humidifier system MR850 Provide two inlet adapters for heated humidifier per respiratory circuit Adapter for airway probe included: twoper circuit List price of different parts must be quoted 3. Mobile Surgical LED Spot Light 1 No. For surgical procedures in ICU Illumination lux or more Sterile handle Colour rendering index: Colour temperature: around 5000 With protective fire resistant ESG safety glass for scratch proof Allows fast disinfection process Protects UV and IR rays Improve light penetration With special European design for ventilation of heat Body is made of high quality fire resistant polymer Size of light field: 30 cm Led Life: >50000 Hrs Focusing adjustable IEC 60601

4 4. Hemodialysis Machine with facility of SLED 2 Units General 1. The hemodialysis unit shall be microprocessor control and capable of providing the following features: - Acetate & bicarbonate dialysis Volumetric ultrafiltration Sodium & UF profilings Upgradeable to link up with central monitoring & data collection system. Built in Online Clearance Monitoring for real time clearance survelliance and Urea clearance measurement (OCM) 2. Graphical User Interface Keyboard function keys are provided. An enlarged and high-resolution color screen for dialysis data display: - High resolution LCD color display. Its brightness is adjustable adaptively to the illumination of the environment. The keyboard function keys and LCD color display can provide an immediate overview of the machine status for treatment supervision. A number of treatment parameters can be shown upon different pop-up menu: - Cumulative graphical display of treatment data and physiological trends including sodium and ultrafiltration profiles 3. Safety Feature Closed system design: The equipment has a close balancing system to ensure that the inflow of fresh dialysate is always equal to the outflow of spent dialysate. Volumetric ultrafiltration: The rate of ultrafiltration is determined entirely by the UF pump, which attached to the closed balancing system. Volumetric concentrate dilution: The dialysate is mixed with a fixed-volume proportioning system to avoid risks associated with intake of incorrect concentrates. Startup test: The equipment performs a self-test before treatment to ensure system functions. Self-test during treatment: The equipment performs a selftest during treatment automatically in a fixed time slot not less than 15 minutes to ensure the integrity of closed system.

5 Performance Requirements I. Blood Circuit a) Blood Pump Flow rate range: ml/min for haemodialysis in 5 ml/min increment Accuracy: ± 10% Effective blood flow rate calculated and displayed on the front panel in a real-time basis during dialysis automatically. It is easy and safe to thread with bloodline diameter from 2 mm up to 10 mm. Automatic set up and priming facility available. An emergency hand crank is provided for returning blood to patient when electrical power is lost. Direction of rotation is visually indicated. b) Heparin Pump Infusion rate: ml/hr in 1 ml/hr increment Accuracy: ± 5% Positive and negative extracorporeal circuit pressure will not affect the infusion rate. Stop Time: Heparinization stop time (before end of treatment) 0 9 hr 59min user-adjustable in 1 min increment. c) Pressure Monitoring and Alarms Venous pressure monitoring Range: -60 to +520 mmhg. Accuracy: ± 10 mmhg Venous pressure alarm Adjustable high & low alarm limits Alarm Limit can spread and be reset automatically on adjustment of blood flow Arterial pressure monitoring Range: -300 to +280 mmhg. Accuracy: ± 10 mmhg Arterial pressure alarm Adjustable high & low alarm limits Alarm Limit can spread and be reset automatically on adjustment of blood flow

6 Air Detection Alarm shall be activated for air bubbles and micro-bubbles over the entire blood flow range. The tenderer shall state the sensitivity of the detection mechanism in terms of air bubble size at particular blood flow rate. On detection of excessive air on the venous line, the blood pump shall be stopped and the venous return line shall be clamped at a point below the air detector. Ultrasonic sensor shall be used for preventing being affected by ambient light. II. Dialysis Circuit a) Treatment Facilities Acetate dialysis Bicarbonate dialysis Variable sodium and bicarbonate olumetric Ultrafiltration Sodium and UF profiles b) Dialysate Flow Rate 0, 300, 500, 800 ml/min, user-selectable Accuracy: ± 10% c) Temperature control and alarms Control range: 35.0 to 39.0 degree C in 0.5 degree C increment Alarm limits: 33.5 to 40.0 degree C d) Conductivity Control and Alarms The dialysate conductivity shall be adjusted by setting the sodium concentration For acetate dialysis, sodium concentration shall be adjustable from 125 to 150 mmol/l. in 1 mmol/l increment For bicarbonate dialysis, sodium concentration shall be adjustable from 125 to 150 mmol/l and bicarbonate concentration shall be adjustable of ±8 mmol/l from the original mixing concentration. Conductivity measurement Range: 12.8 to 15.7 ms/cm. Accuracy: ± 0.1 ms/cm e) Blood Leak Detection Alarm shall be activated for blood loss rate not greater than 0.5 ml/min into dialysate at max. dialysate flow of hematocrit about 20-25%.

7 Photo detector shall be used. Different types of alarms shall be shown to differentiate a true blood leakincident or dirtiness. f) Volumetric Ultrafiltration Control Control range: 0 to 4L/hr given by the set values of UF volume and treatment time Accuracy: ± 1%. UF volume: 0 to 9.99L adjustable in 1 ml increment Treatment time: adjustable up to 9 hr 59 min. in 1 min increment TMP monitoring: -60 to +520 mmhg. Isolated ultrafiltration process shall be provided. g) On-line preparation of bicarbonate dialysis fluid through dry bicarbonate powder cartridge facility. h) It should have Ultrapure Dialysate Fluid Filter Disinfection and Cleaning: Both chemical and heat disinfections can be performed at 83 degcelcius One-touch fully automatic operation including: pre-rinse, chemical-intake for combined disinfection & decalcification, post-chemical mandatory rinse, and automatic power-off; without extra end-user handling during the whole disinfection process. Dialysis Parameter Display The equipment digitally displays the below parameters: - Arterial pressure Venous pressure Blood flow rate Dialysate conductivity TMP UF volume UF rate Remaining treatment time Heparin infusion rate Alarm information in text format Online Clearance Monitoring Built-in device for measurement and monitor of effective urea clearance (K), dialysis dose (Kt/V), and plasma sodium (Na) automatically during treatment The measurement of effective urea clearance (K), dialysis dose (Kt/V) and plasma sodium (Na) shall be performed in noninvasive, real-time mode without additional disposable

8 required during treatment Measuring accuracy Clearance measurement accuracy: +/-5% (standard deviation) Kt/V determination accuracy: +/-9% (standard deviation) Blood Pressure Monitoring: Built-in blood pressure monitoring for measuring the patient noninvasive blood pressure and pulse rate automatically. Battery Backup The equipment able to operate and monitor the extracorporeal circuit without interruption for at least 30 min. in case of AC power failure by backup battery. Equipment should be supplied with suitable servo stabilizer. Other features Machine should have facility for Acetate, Bicarbonate, sequential dialysis (Isolated UF) The blood pump should run even in the absence of water or dialysate flow Machine should have two bacterial filters (pyrogen filter) one at water inlet & one before water going to dialyzer Should have Na, & UF profiling dialysate temperature selected over a suitable range variable conductivity settling should have variable dialysate flow over wide range Should have facility to show trends curve of all parameter for min. Heparin pump- syringe based should be available Ultra filtration rate: - 0 to 4 liters (Max)/Hr. Treatment parameter should be displayed by machine at the time of operation Should have accurate UF control by flow measurement technique/volumetric system facilities like blood volume sensor, Bicarb. Select technique & online clearance Should have integrated heat (80 degree Celsius) & Chemical disinfection facility Automatic self test& auto ON/OFF facility Safety Feature- Closed system design. The equipment has a close balancing system to ensure that the inflow of fresh dialysate is always equal to the outflow of spent dialysate. Blood pump rate over a wide range adaptable to standard A-V blood lines Touch Screen Ability to monitor pulse rate & Blood Pressure with graphic & tabulated trends.

9 Cumulative graphical display of treatment data and physiological trends including sodium and ultra-filtration profiles. Color display can provide an immediate overview of the machine status for treatment supervision. Startup test- The equipment performs a self-test before treatment to ensure system functions. Self-test during treatment- The equipment performs a self-test during treatment automatically in a fixed time slots not less than 15 minutes to ensure the integrity of closed system. The unit shall be capable of being stored continuously in ambient temperature of 0-50 deg. C & relative humidity of 15-90% The unit shall be capable of operating continuously in ambient temperature deg. C & relative humidity of 15-90% All Consumable required for installation & Standardization of system to be included in quoted cost. Servo controlled stabilizer 3kVA one & bacterial filter-2 set extra should be provided and cost to be included in quoted cost Company should have a service center at Nagpur with posting of one trained Engineer permanently. Company should undertake operating & maintenance training of Dialysis technician Company should submit certificates by various health regulatory authorities (FDA/CE approved), certifying machine s fitness for use and quality assurance. Should have inbuilt function for Single needle dialysis. It should have Ultrapure Dialysate Fluid Filter. Safety Feature- Closed system design. The equipment has a close balancing system to ensure that the inflow of fresh dialysate is always equal to the outflow of spent dialysate. Online Clearance Monitoring: Built-in device for measurement and monitor of effective urea clearance (K), dialysis dose (Kt/V), and plasma sodium (Na) automatically during treatment. The measurement of effective urea clearance (K), dialysis dose (Kt/V) and plasma sodium (Na) shall be performed in non-invasive, real-time mode without additional disposable required during treatment Should have air bubble detector & blood leak sensor. Should have in built quality for 3 phase chemical disinfection. Should have in built facility for thermal disinfection. Should have computer Interface for further up gradation.

10 Lifetime free upgradation of software. Service and spare parts Response time should be less than 24 hours and time to rectification should be less than 48hrs. If rectification time more than 48 hrs then standby unit to be provided. In case of delay in response time more than 24 hours, 5% of amount deposited will be deducted. 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. 5. High Flow Air Oxygen Mixer (1 for Medicine Dept. & 1 for Anaesthesiology Dept.) Precise mixing of medical grade air and oxygen through two separate gas flowmeters controlled by two separate flow control knobs Medical air flowmeter: 0-50LPM Oxygen flowmeter: 0-50LPM Medical Air Flow Adjustment Valve: Manual flow adjustment of air Optimal Working Pressure: 50 PSIG Relative Humidity Range: 0-95% non-condensing O2 Concentration Adjustment Range: % Optional mixed gas analysis port and oxygen concentration analyser Air and oxygen hose (hose connector should be as per our site) with Air Inlet Filter/Water Trap/ Festo filter Chart with description of the required air/oxygen flow ratesrequired to attain a desired FiO2 should be provided IV pole clamp

11 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. & id X Signature with Company Seal

12 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 27/11/2017 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.

13 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 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.

14 KASTURBA HEALTH SOCIETY'S MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, P.O. SEVAGRAM, WARDHA (DISTT.) Tender Notice 14 ( ) 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 27/11/2017 up to 3.00 PM. The Technical Bids will be open on the next day i.e. 28/11/2017 at 3.00 pm in the Committee Room, Dean Office. The tender fees of Rs. 1,000/- (nonrefundable) is to be paid by enclosing D.D. favoring Kasturba Health Society, Sevagram payable at Sevagram / Wardha. Tender forms will be available in the office of the Dean (Central Purchase Section) on working days between am and 4.00 pm. Tender forms also can be obtained by sending to centralstore@mgims.ac.in or can be downloaded from the institute website ( The Dean reserves the right to reject any or all the tenders without assigning any reason. A) Medicine Department: (2 nd Call) 1) Non-Invasive portable Ventilator with NIV masks, 2) High Flow Oxygen Therapy System ) Mobile Surgical LED Spot Light, 4) Hemodialysis Machine with facility of SLED, 5) High Flow Air Oxygen Mixer B) Community Medicine Department (3 rd Call): 1) Four Wheeler Vehicle (Mahindra Bolero ZLX BSIV) C) MCH, Melghat Project (3 rd Call): 1) Four Wheeler Vehicle (Tata Sumo Gold CX PS BS4) against buyback of old Tata Grande 2) Four Wheeler Vehicle (Maruti Suzuki OMNI) D) Orthopaedics Department (3 rd Call): 1) Kyphoplaty kit (Disposable) E) HIS Department: 1) 10 KVA Online UPS (2 nd Call), 2) Storage of High Capacity, 3) Number Plate Identification Cameras, 4) Night Vision Cameras, 5) Outdoor Shied F) Microbiology Department: 1) ELISA Microplate Reader, 2) ELISA Microplate Washer, 3) Cold Room G Obstetrics and Gynaecology Department: 1) Latest highest quality HD Endo Camera, 2) Cold LED Light source, 3) Fibre Optical Cable, 4) HD Hysterescopy Set, 5) French Semi Rigid Hand instruments Items, 6) High Definition Monitor DEAN

For Department of CSSD

Kasturba Health Society's Mahatma Gandhi Institute of Medical Sciences, P.O. Sevagram, District - Wardha MAHARASHTRA - 442 102 For Department of CSSD SUPPLY OF MEDICAL GASES (Refilling) Sr No Name of Gas