| S.N. | Purchaser’s Specifications | |
| Hand Held Pulse Oximeter | ||
| Manufacturer | ||
| Brand | ||
| Type / Model | ||
| Country of Origin | ||
| 1 | Description of Function | |
| 1.1 | A pulse Oxymeter is a medical device that indirectly measures the amount of oxygen in a patient’s blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photoplethysmography. | |
| 2 | Operational Requirements | |
| 2.1 | Suitable for all types of patient range,adult, paediatric and infant and shall operate on AC mains as well as from internal rechargeable battery. | |
| 3 | System Configuration | |
| 3.1 | Pulse Oxymeter, complete unit with all standard accessories. | |
| 4 | Technical Specifications | |
| 4.1 | It shall be portable unit. | |
| 4.2 | Display- LCD, backlight illuminated. | |
| 4.3 | Parameters and waveform displayed- SpO2, pulse rate, system status, plethysmogram, menus for user settings. | |
| 4.4 | SPO2 range: 70-100 %. | |
| 4.5 | Accuracy of SPO2: 3%. | |
| 4.6 | Pulse rate range must be 30-240bpm. | |
| 4.7 | Audio-visual alarms: High/low SpO2 and pulse rate, sensor off, sensor failure, low battery. | |
| 4.8 | Shall have alarm override facility. | |
| 4.9 | It must be suitable to operate in the presence of potentially flammable anaesthetic gases, and it shall not cause fire or explosion during operations. | |
| 4.10 | RS 232C interface for data communication. | |
| 4.11 | Inbuilt rechargeable battery and shall have battery back-up for at least 4 hours. Battery charger along with AC adaptor to be provided if integrated charger is not there. | |
| 5 | Accessories, spares and consumables | |
| 5.1 | Accessories:
· Reusable adult SpO2 sensor with cable: 02 nos. · Reusable paediatric SpO2 sensors: 01 no. · Reusable infant SpO2 sensor:01 no. |
|
| 5.2 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). | |
| 6 | Operating Environment | |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. | |
| 6.2 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. The power cable must be at least 3 metre in length. | |
| 7 | Standards and Safety Requirements | |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND | |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate. | |
| 7.3 | Electrical safety conforms to standards for electrical safety IEC 60601-1 General requirement for Electrical safety of Medical Equipment. | |
| 8 | User Training | |
| 8.1 | Must provide user training (including how to use and maintain the equipment). | |
| 9 | Warranty | |
| 9.1 | Comprehensive warranty for 2 years after acceptance. | |
| 10 | Maintenance Service During Warranty Period | |
| 10.1 | During warranty period supplier must ensure preventive maintenance and corrective/breakdown maintenance whenever required. | |
| 11 | Installation and Commissioning | |
| 11.1 | Supplier must accomplish proper installation & commissioning of equipment onsite. | |
| 12 | Documentation | |
| 12.1 | User (Operating) manual in English. | |
| 12.2 | Service (Technical / Maintenance) manual in English. | |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. | |
| 12.4 | Certificate of calibration and inspection from factory. | |
Spot-Check Pulse Oxymeter
| S.N. | Purchaser’s Specifications |
| Spot-Check Pulse Oxymeter | |
| Manufacturer | |
| Brand | |
| Type / Model | |
| Country of Origin | |
| 1 | Description of Function |
| 1.1 | For spot-check of percentage arterial oxygen saturation (SpO2, %) and pulse rate (HR, bpm) of all patient categories. Non-invasive monitor using a clip-on sensor placed on a finger or toe. |
| 2 | Operational Requirements |
| 2.1 | It shall be suitable for professional clinical use, all patient categories neonate, infant and adult. |
| 3 | System Configuration |
| 3.1 | Pulse Oxymeter, complete unit with all standard accessories. |
| 4 | Technical Specifications |
| 4.1 | Ultra compact pulse oxymeter integrated into finger/toe sensor clip. |
| 4.2 | It shall be of robust, shock resistant design, which allows use in demanding environments. |
| 4.3 | It shall accommodates finger/toe thicknesses 8 to 25mm. |
| 4.4 | Facility of spot-check of arterial blood oxygen saturation (SpO2) and heart rate (HR). |
| 4.5 | It shall have one button operation, auto-off when not in use for 10 seconds. |
| 4.6 | Clip with extended side flaps eliminates ambient light from the measurement. |
| 4.7 | Measuring range:
· SpO2 30 to 100% (minimum graduation 1%) · HR 20 to 320bpm (minimum graduation 1bpm) |
| 4.8 | Accuracy:
· SpO2 +/-2% in the range from 70 to 100% · HR +/-2% in the range from 30 to 250 bpm |
| 4.9 | Display: Easy readable display shows operational status, SpO2, HR, signal strength (bar graph) and battery status. |
| 4.10 | Alarm: Audio-visual alarm on operational status, SpO2<90%, sensor malfunction and loss of signal. |
| 5 | Accessories, spares and consumables |
| 5.1 | Accessories:
· 2 x spare set of two batteries 1.5V AAA/LR03 Alkaline. · 1 x Neck lanyard for carrying. · 1 x Strong protective carry bag. |
| 5.2 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above). |
| 6 | Operating Environment |
| 6.1 | The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc. |
| 6.2 | Power supply: Shall work on two 1.5V AAA/LR03 batteries. |
| 7 | Standards and Safety Requirements |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND |
| 7.2 | CE (93/42 EEC Directives) or USFDA approved product certificate. |
| 8 | User Training |
| 8.1 | Must provide user training (including how to use and maintain the equipment). |
| 9 | Warranty |
| 9.1 | Comprehensive warranty for 1 year after acceptance. |
| 10 | Maintenance Service During Warranty Period |
| 10.1 | During warranty period supplier must ensure preventive maintenance and corrective/breakdown maintenance whenever required. |
| 11 | Installation and Commissioning |
| 11.1 | Supplier must accomplish proper commissioning of equipment onsite. |
| 12 | Documentation |
| 12.1 | User (Operating) manual in English. |
| 12.2 | Service (Technical / Maintenance) manual in English. |
| 12.3 | List of important spare parts and accessories with their part numbers and costing. |
| 12.4 | Certificate of calibration and inspection from factory. |