Equipment Specifications for Anesthesia Machines

UNSPSC Code: 42272501 ECRI Code: 10-134 1 Description of Function Sl 1.1 Name Anaesthesia Machine is used for delivering anaesthesia agents to the patients during surgery. The complete unit also monitors the vital signs and ventilates the patients.

2 Operational Requirements Sl 2.1 Name 1) Anaesthesia machine complete and integrated with Anaesthesia gas delivery system; Circle absorber system; Precision vaporizer for halothane, isoflurane/ Sevoflurane; Anaesthesia ventilator. Monitoring system to monitor Anaesthetic gases, ECG, EtCO2, FiO2 (Online O2 Analyzer), Pulse Oximeter and airway pressure, NIBP, IBP (No as required), rectal/&skin temperature. 2) Essential accessories to make the system complete and compatible with the existing system of gas outlets. Demonstration of the equipment as per specifications is a must.

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3 Technical Specifications Sl 3.1 Name Anaesthesia gas delivery system. 1. Should have provision for delivery of oxygen, nitrous oxide and medical air with pressure gauges. 2. Should have independent attachments for connecting central gas supply and pin indexed cylinders. Should have provision for attaching 1 cylinder each for O2 and N2O (Total 2 cylinders). 3. Flow Meter Cascade type of flow meter 2 for O2, 2 for N2O and 1 for Medical Air 4. Oxygen and Nitrous oxide should be linked either mechanically or pneumatically to ensure a minimum of 25% oxygen delivery at all times to avoid delivery of hypoxic mixture. 5. Should have audio-visual oxygen Failure warning System with Nitrous oxide cut off. 6. Should have back bar which is ISO pin type to attach vaporizer easily. 7. Should be supplied with necessary reusable and disposable breathing circuits (Bains, Jackson-Rees and closed circuit etc.,) 8. Should have top shelf to keep monitors and a tabletop to keep anaesthetic drugs, equipments etc. 9. The machine should possess battery back up for electrical components 10. Castor wheels should be durable and moisture resistant & Smooth. 11. The Anaesthesia machine frame should be made of rust proof material/Stainless steel. 12. Silicone cushion high quality, adult and Pediatrics face mask of four different sizes 2 each size

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Standard Circle Absorber System - Should have adjustable pressure limiting valve, breathing circuit pressure measuring device. - Should have a bag/ventilator selecting valve integrated onto the absorber. - Should be suitable to use low flow techniques - Facility to attach oxygen sensor. Should have CO2 absorbent chamber canister Precision Vaporizers (Temperature, pressure and flow compensated) for Halothane, Isoflurane and Sevoflurane. - Should be easy to mount and dismount from the back bar. - Vaporizers should have ISO pin type (Selectatec) mounting and vaporizer interlocking facility. - Should have a standard filling port with keyed filling device. - Should be designed for transport with liquid in vaporizer chamber with protection against tipping and shaking -Maintenance free vaporizer Ventilator (Integrated) - Should be a bag in bottle anaesthesia ventilator with standing (ascending/Piston) bellows. - Should be supplied with adult and pediatric bellows. - Should be able to set tidal volume, respiratory rate and I:E ratio - Ventilator should have audible alarms for ventilator failure, low oxygen supply pressure, inadequate volume delivery, disconnection alarm, and power supply failure. - Should have battery backup for min 30min Integrated Monitoring system Should provide facility to monitor a) Oxygen and Nitrous oxide and anaesthetic agent in the inspired mixture b) Inspired and end tidal carbon dioxide through side stream c) Oxygen saturation of the blood with both adult, paediatric/ neonates, probes & sensors (Reusable) d) Monitoring of ECG (5 leads), NIBP (inclusive of adult, paediatric & neonatal NIBP cuffs), IBP and CVP should be present Pressure transducers and necessary accessories as per requirement (preferably four reusable transducers with bracket and holder and 100nos disposable domes with pressure lines per monitor) e) Airway Pressure monitoring should be present f) Temperature Monitoring with 2 probes oesophageal / rectal and skin probe. g) Glare free TFT/LCD color monitors with large screen for easy visibility. h) Monitor should be accurate, precise and standard monitoring modes in modular type

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4 System Configuration Accessories, spares and consumables Sl 4.1 4.2 4.3 4.4 Name Anaesthesia Gas Delivery system -01 Circle absorber 01 Ventilator 01 Monitor 01

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Vaporiser Halothane -01 Vaporiser Savoflurane -01 Vaporiser Isoflurane -01 Accessories for above- 02 sets Should be supplied with negative pressure leak test equipment

5 Environmental factors Sl 5.1 5.2 5.3 5.4 Name The unit shall be capable of operating continuously in ambient temperature of 100C - 400C and relative humidity of 15-90% The unit shall be capable of being stored continuously in ambient temperature of 00C - 500C and relative humidity of 15-90% Shall meet IEC-60601-1-2: 2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Safe disposal system/port of waste anesthetic gases (AGSS Anesthetic Gas Scavenging System/Port) should be in place. Supplier will be held responsible if this is not ensured at the time of installation

6 Power Supply Sl 6.1 6.2 6.3 6.4 Name Power input to be 220-240VAC, 50Hz fitted with Indian plug Resettable over current breaker shall be fitted for protection Suitable Servo controlled Stabilizer/CVT UPS of suitable rating shall be supplied for minimum 1 hour backup for the entire system

7 Standards, Safety and Training Sl 7.1 7.2 7.3 7.4 Name Should be FDA or CE approved product Electrical safety conforms to standards for electrical safety IEC60601 / IS-13450 Manufacturer should have ISO certification for quality standards. Certified to be compliant with IEC 60601-2-13-Medical Electrical Equipments part 2-13:Particular requirements for the safety of Anaesthesia Workstations Should have local service facility .The service provider should have the necessary equipments recommended by the manufacturer to carry out preventive maintenance test as per guidelines provided in the service/maintenance manual. Comprehensive warranty for 5 years and provision of AMC for next 5 years.

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8 Documentation Sl 8.1 8.2 8.3 8.4 8.5 Name User manual in English Service manual in English List of important spare parts and accessories with their part number and costing. Certificate of calibration and inspection from factory. Log book with instruction for daily, weekly, monthly and quarterly maintenance checklist. The job description of the hospital technician and company service engineer should be clearly spelt out List of Equipments available for providing calibration and routine maintenance support as per manufacturer documentation in service / technical manual. Compliance Report to be submitted in a tabulated and point wise manner clearly mentioning the page/Para number of original catalogue/data sheet. Any point, if not substantiated with authenticated catalogue/manual, will not be considered. Must submit user list and performance report within last 5 years from major hospitals.

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