RequiredExperience with Government
RequiredAnnual Turnover
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate
RequiredOEM Annual Turnover Acute Care Monitoring Units And Related Products-patient Monitors ( 6 ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) NEW SET Type of Monitor Preconfigured/Non Modular * Functional Requirements: Operates from mains voltage or from internal rechargeable battery Operator can set audio visual alarm levels for Yes * 1/7 low or high levels of each parameter independently Allows display of single
Required3 lead ECG or simultaneous display of at least 5 waves ECG selected from up to 12 points Display to be digital of all active parameters and trace display for at least three selectable parameters Clinical Purpose: Designed to continuously measure and display multiple vital physiological parameters of adults
Requirednewborn and premature infants
Requiredespecially those under critical care YES * Continuous display on screen of neonatal or infant ECG
Requiredrespiration and heart rates
Requiredinvasive/non-invasive blood pressure
Requiredbody temperature and SpO2 Yes * Patient monitor offered with option to monitor parameter(s): IBP EtCO2
RequiredIBP
RequiredCardiac Output Number of leads for ECG 12 12 Screen Size 15 17.0
Required15.0 Weight 7 * ECG patient connectors that are sterilisable and reusable are acceptable though reusable cables that attach to disposable connection patches are preferred Multichannel (up to 12 leads) ECG measurement and selectable display of upto 5 leads at a time Temperature probe to be reusable
Requiredexternal skin contact type; Yes * 2/7 Temperature range at least 30 to 40 deg C
Requiredminimum gradation (1/10) deg C/Heart rate measurement range to be at least 30 to 250 bpm
Requiredwith accuracy better than ± 5 bpm and minimum gradation 1 bpm/SpO2 measurement range at least 40-70 % and 70 to 99 %
Requiredwith accuracy better than ± 1% for 40-70 range and better than ± 3% for 70-99 range and minimum gradation 1%/Blood pressure monitoring range at least 30 to 300 mmHg
Requiredminimum gradation 1 mmHg Respiration rate measurement range at least 0 to 100 bpm
Requiredminimum gradation 1 bpm/Trend display of each parameter over at least previous 24 hours to be selectable ECG patient connectors that are sterilisable and reusable are acceptable though reusable cables that attach to disposable connection patches are preferred Multichannel (up to 12 leads) ECG measurement and selectable display of upto 5 leads at a time Temperature probe to be reusable
Requiredexternal skin contact type; Temperature range at least 30 to 40 deg C
Requiredminimum gradation (1/10) deg C/Heart rate measurement range to be at least 30 to 250 bpm
Requiredwith accuracy better than ± 5 bpm and minimum gradation 1 bpm/SpO2 measurement range at Yes * 3/7 least 40-70 % and 70 to 99 %
Requiredwith accuracy better than ± 1% for 40-70 range and better than ± 3% for 70-99 range and minimum gradation 1%/Blood pressure monitoring range at least 30 to 300 mmHg
Requiredminimum gradation 1 mmHg Respiration rate measurement range at least 0 to 100 bpm
Requiredminimum gradation 1 bpm/Trend display of each parameter over at least previous 24 hours to be selectable/TFT Screen User Interface Through touch Screen Through touch Screen Audio Visual alarms high and low levels for each parameter (operator variable settings)
Requiredsensor/wire probe disconnected
Requiredlow battery * Case is to be hard and splash proof/Display must allow easy viewing in all ambient light levels/Cable connectors to be designed so as fit correct socket only Yes * Noise (in dB) < 50 * Heat Dissipation: Should maitain nominal Temp and the heat should be disbursed through adequate arrangement * Mobility & Portability mobile and portable in protective case supplied for clean storage and safe transport. * Power supply 220 volt
Required50 Hz AC 220 volt
Required50 Hz AC Mains cable to be at least 3m length YES * Accessories & Spare Parts: pairs of ECG cable 5 sets of ECG connection electrodes 1 unit each of reusable SPO2 pairs of ECG cable 5 sets of ECG connection electrodes 1 unit each of reusable SPO2 4/7 probe(Adult/Paediatric) 1 unit of SPO2 probe(Neo natal) 2 units of NIBP cuffs for adult 2 units of NIBP cuffs for Paediatric 1 unit each of skin and rectal Temperature probe probe(Adult/Paediatric) 1 unit of SPO2 probe(Neo natal) 2 units of NIBP cuffs for adult 2 units of NIBP cuffs for Paediatric 1 unit each of skin and rectal Temperature probe Operating condition: apable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances * Should be FDA CE/BIS approved product US FDA
RequiredEuropean CE
RequiredBIS US FDA
RequiredEuropean CE
RequiredBIS - Electrical safety conforms to standards for electrical safety IEC-60601-1/- Shall meet IEC-60601-1-2 (General requirements for safety - electromagnetic compatibility)/-Also conforms to IEC 60601-2- 27 (Particular requirements for the safety of electrocardiographic monitoring equipment) - Manufacturer supplier should have ISO certificate for quality standard/- Shall meet IEC 60601-2-49 multi function patient monitoring equipment standard requirement Yes * Seller to perform supply
Requiredinstallation
Requiredsafety & operation checks and training before handover of the product [Training of users in operation and basic maintenance shall be provided] Yes * Warranty Comprehensive warranty of 3 years with free servicing ( * 5/7 min 3/year) during warranty Operating manuals
Requiredservice manuals
Requiredother manuals/documents Advanced maintenance tasks required shall be documented User
Requiredtechnical and maintenance manuals to be supplied in English language. List to be provided of equipment and procedures required for local calibration and routine maintenance List to be provided of important spares and accessories
Requiredwith their part numbers. Certificate of calibration and inspection to be provided. * Recommendations or warnings Any recommendations for best use and supplimentary warning for safety to be declared * Details of Item and test reports Availability of Test Report from Central Govt/NABL/ILAC/Any OPCW accredited lab to prove conformity to specification YES * Test report (if indicated as available) to be furnished to buyer on demand YES * Test report No & date QS1160944649036 * Name and address of the Lab: TUV SUD PRODUCTSERVICE GMBH RIDLERSTR65
Required0-80339 MONCHEN
RequiredGERMANY * * Bold specifications are the golden parameters.