Catalogue values for Arthroscopy System (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | Arthroscopy System |
| Components of the Arthroscopy system to be from the same OEM | Arthroscope, Camera console, Light source & cable | |
| ARTHROSCOPE | Autoclavable Telescope | Yes |
| Number of Arthroscope | 2 | |
| Field of view | Wide angle | |
| Angle of view (degree) | 30°, 70° | |
| Usage | Knee, Shoulder, Elbow, Ankle, Hip, Wrist, Small Joints | |
| Diameter (mm) | 3.5 to 4 | |
| Length (cm) | 16 to 20 | |
| Fibre Optic light transmission incorporated | Yes | |
| Standard Ocular window for coupling camera head | Yes | |
| Arthroscope sheath, rotatable | Yes | |
| Sheath diameter and working Length compatible with scope | Yes | |
| Scratch resistant saphire lens on proximal and distal tip | Yes | |
| Rod lens systems for optimum brightness, contrast | Yes | |
| Two rotatable stopcocks | Yes | |
| Autoclavable stopcocks | Yes | |
| Semi sharp obturator compatible with arthroscopy sheath | Yes | |
| The surface of the arthroscope shall be free of pores, cracks, and remainders of tooling agents | Yes | |
| CAMERA CONSOLE SYSTEM | Camera processor | 2D |
| Video Camera type | 4K (3840x 2160) | |
| Zoom lens facility available | Yes | |
| The console interface is menu-driven with the facility for programmable individual surgeon preferences | Yes | |
| System has facility for numerous Display, Input & Output ports | Yes | |
| USB for Digital Recording | Yes | |
| Compatible Video output | Minimum 2 video output | |
| Progressive Scan technology | Yes | |
| Consistent use of 16:9 format for input & Output to guarantee genuine resolution | Yes | |
| Optimization of image quality & Digital Source sampling for maximizing hi-fidelity image transmission by image sensor | Yes | |
| Image sensor | CCD/CMOS | |
| Provision of near/close focus observation available | Yes | |
| The system automatically optimizes all settings, The system is ready-to-use as soon as it is connected to the camera control unit | Yes | |
| LIGHT SOURCE & CABLE | Light Source Type | LED Lamp |
| Lamp life | 20000 hours or more | |
| Colour temperature of light source (Approx) | 5500 K to 6500 K | |
| Minimum LED Lamp intensity | 1500 lumens or more | |
| High visual and photographic clarity for color retention due to high color temperature that corresponds to the brightness of sunlight | Yes | |
| Monitoring of lamp function | Yes | |
| Means of light intensity adjustment facility | Continuously adjustable from 0 to100% manually/automatically | |
| Fiber Optic cables autoclavable | Yes | |
| Minimum Thickness of Fiber Optic Cable (mm) | 3.5 mm | |
| Minimum Length of Fiber Optic Cable (cm) | 230 cm | |
| Provision of backlit front panel indicator | Yes | |
| DISPLAY MONITOR | Monitor view | 2D |
| Medical grade monitor is compatible with Camera system | Yes | |
| Monitor resolution | 4K (3840x 2160) | |
| Monitor Display | LED/Backlit LED | |
| Size of Monitor (inch) | 26 to 30 | |
| Minimum Video input ports as per monitor resolution | 2 | |
| Versatile Multi-Format Signal support | Yes | |
| Monitor is Drip water protected with dust proof housing | Yes | |
| Monitor has the aspect ratio | 16:9 | |
| Item should be from same OEM make | No (Item to be sourced from reputed OEM with OEM warranty support ) | |
| DATA MANAGEMENT SYSTEM | The system is compact and provided with medical grade recording device | Yes |
| Type of recording system | 2D | |
| Provision for digital storage of still images, video sequences, and audio files format available | 4K | |
| System is sterile, ergonomic operation via touch screen, camera head buttons / foot switch | Yes | |
| System has full featured Graphical User Interface DICOM capability | Yes | |
| Provision of Portable memory and USB slot for still image recording available | Yes | |
| Automatic creation of standard report possible | Yes | |
| Minimum internal memory | 1 TB | |
| Live streaming facility | Yes | |
| Should be from same OEM make | No (Item to be sourced from reputed OEM with OEM warranty support ) | |
| MOBILE VIDEO TROLLEY | Video trolley is of Shockproof powder-coated, good quality rust free material and is able to take the load of all equipment with accessories | Yes |
| Video trolley has the provision of mounting positions for central-monitor- mount, articulation-monitor-arm, cable winding aid, Fluid bag holder and tubing clamp etc | Yes | |
| Video trolly rides in 4 antistatic dual wheels, with atleast 2 lockable castors | Yes | |
| One camera head mount on Video cart | Yes | |
| Channel inside the stand is to avoid hanging of the cables | Yes | |
| Integrated power board to provide connection to all units | Yes | |
| Minimum 4 shelves (including one extendable shelf, one with handle and drawer with lock) | Yes | |
| Inbuilt arm for monitor | Yes | |
| Video cart is provided with power column with 10x cables and equipotential bonding cable | Yes | |
| One adjustable swivel arm for monitor to mount either on left or onright side for touch screen | Yes | |
| Trolley should be from same OEM make | No (Item to be sourced from reputed OEM with OEM warranty support ) | |
| STANDARD ACCESSORIES | Camera Head (Nos.) | 1 |
| Optical fiber light cable (Nos.) | 1 | |
| All the accessories provided are compatible with the Arthroscope and authorization certificate for compatibility by the parent company/supplier of the Arthroscope provided | Yes | |
| ELECTRICAL REQUIREMENTS | Input Power Supply | 220-240V AC, 50 HZ |
| CERTIFICATIONS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| Certification for manufacturing unit | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes | |
| Conformity to standards for safety | IEC/EN 60601-1 or equivalent BIS Standard | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes | |
| WARRANTY | Warranty in Years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 3, 5 Or higher |
| MISCELLANEOUS REQUIREMENTS | OEM/Reseller shall ensure uninterrupted availability of all spares, consumables for atleast 10 years | Yes |
| Availability of toll free facility for technical support maintened by OEM or authorized agencies | Yes | |
| User/Technical/Maintenance manuals to be provided in English in hard and soft copy | Yes | |
| Details of equipments and procedures required for local calibration and routine maintenance to be provided and advanced maintenance task documentation also to be furnished | Yes | |
| Supplier to perform installation, safety and operation checks before handover | Yes | |
| Training of users in operation and basic maintenance shall be provided | Yes | |
| Contact details of manufacturer, supplier and local service agent to be provided | Yes | |
| Certificate of calibration from the manufacturer | Yes | |
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