TSN:113103 Approved Date:01.
2013
Endoscope, ENT
S.N. Purchaser’s Specifications
Endoscope, ENT
Manufacturer
Brand
Type / Model
Country of Origin
1 Description of Function
1.1 ENT Endoscopes are used for the diagnosis and observation of the otolaryngological area
including the vocal cords, nasal cavity, and eardrum.
2 Operational Requirements
2.1 Straight forward Telescope, Cold Light fountain, Fibre optic light, compatible camera and LCD
Monitor.
3 System Configuration
3.1 ENT Endoscope complete unit and with complete accessories.
4 Technical Specifications
4.1 Endoscope:
Straight forward Telescope 0 ° 1.9 mm 10cm length. 1 no.
Straight forward Telescope 30 ° 1.9 mm 10cm length. 1 no.
Straight forward Telescope 0 ° 4 mm 6 cm length. 1 no.
Straight forward Telescope 30 ° 4 mm 6 cm length. 1 no.
Pneumatic adapter for Oto- Endoscope.
Shall come with all the attachments.
4.2 Cold light fountain 150 watt halogen bulb.
4.3 Fibreoptic light 2.5 mm diameter and 1.5 meter in length.
4.4 Compatible camera and LCD monitor of 14”or more for image display.
4.5 Sialendoscopy:
Miniature straight forward Telescope 0’, semi –rigid, diameter 1mm, length 16cm, with
remote eyepiece and light connection, LUER lock adaptor, fibre optic light transmission
incorporated, including protective tube.
Examination Sheath, diameter 1.3 mm. working length 16cm, with blunt obturators, with
lateral LUER lock adaptor for irrigation, for use with miniature endoscope.
Operation Sheath, oval, 1.3 and 1.3 mm. working length 16 cm, with working channel
1.15 mm and telescope channel 1.15 mm, with 2 or 3 obturators, with lateral LUER lock
adaptor for irrigation.
Grasping forceps double action jaws, flexible, diameter 1mm, working length 19 cm.
Biopsy Forceps double action jaws, flexible, diameter 1mm, working length 19 cm.
Stone Extractor, diameter 0.6 mm. basket with 6 wires, sterile, single use.
Balloon Catheter, diameter 0.7mm, sterile, single use, package of 10.
Compatible light source.
5 Accessories, spares and consumables
5.1 Accessories:
Endoscopy Coupler
Endoscopy trolley
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 system offered shall be designed 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
S.N. Purchaser’s Specifications
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 Shall meet IEC-60601-1-2:2001General Requirements of Safety for Electromagnetic
Compatibility or must comply with 89/366/EEC; EMC directive
7.4 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 from acceptance.
10 Maintenance Service During Warranty Period
10.1 During the warranty period supplier must ensure planned preventive maintenance (PPM)
corrective/breakdown maintenance whenever required.
11 Installation and Commissioning
11.1 The bidder must arrange for the equipment to be installed and commissioned by certified or
qualified personnel; any prerequisites for installation to be communicated to the purchaser in
advance, in detail.
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 number and costing.
12.4 Certificate of calibration and inspection from factory.
