Spot-Check Pulse Oxymeter

S.N. Purchaser’s Specifications
  Spot-Check Pulse Oxymeter
  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.