Dexa Machine (Bone Mass Densitometry)

Model Name:

Year of Introduction :

Probable end of support :

Should utilize a narrow-angle fan beam and direct digital detector to provide precise results in all skeletal sites, and enables clinicians to properly monitor the therapy of their patients.

Should provide precise body composition results, such as fat mass and lean mass, at any part of the human body.

Should run on lowest exposure area (narrow fan beam) where system optimizes the scan area.

Should be based on Computer Assisted Densitometry (CAD) where system automatically identifies potential acquisition.

System with shorter distance of X Ray travel above table preferred to reduce scattered dose.

High definition, direct-digital detector with staggered array detector with high resolution preferred.

To reduce distortion the low and high power X Rays are to be preferred to be generated from same pulse.

Multi view image reconstruction preferred over single sweep to reduce distance to detector impact.

Should be based on Intuitive and ergonomic graphical user interface on latest WINDOWS 10 Platform

should have Advanced Cyber Security Features like IPV6, Improved Encryption, Audit Trails, Secure DICOM

Should have the following Analysis & reporting: • ScanCheck • Custom region of interest analysis • Composer reporting tools Along with bone scan The system should be capable for visceral fat analysis , total body fat analysis and measure lean mass body fat composition .

Should have the following Connectivity protocols: • HIPAA secure view • DICOM interface

Should have the following Clinical applications: • AP spine • Femur • DualFemur • Forearm/supine forearm • Total body BMD1 • Dual-energy Vertebral Assessment (DVA) (lateral and AP)

Should have the following Workflow features: • Previous scan image comparison • OneScan measurement • OneVision • Automatic metal detection • QuickView measurement (10sec) • Image preview

• Scanner size should be 110" x 50" x 49" minimum • Scanner weight should not be more than 365 kg • Patient table top height to be around 25” and preferably adjustable • Maximum patient weight supported should be above 200 kg • Active scan area should be minimum of - 198cm x 66cm

Detector specifications: Detector should be direct-digital detector.

Software features should be :

• Intuitive and ergonomic graphical user interface based on WINDOWS 10 Professional

•Daily Quality Assurance with complete testing, evaluations and trend graphs

• Advanced patient management (Multi criteria search, several directories..)

• Scan repositioning from the computer with visual control

• Image Parameters, ROI and Automated Point Typing • AutoAnalysis

• Custom analysis for a more flexible use

• Graphical Reference comparison including WHO criteria (if applicable)

• Complete set of regional Reference Data and also Custom Reference

• Results: BMD, BMC, Area, T-score, Z-score, % YoungAdult and % AgeMatched, and standardized BMD

• Patient’s Trend with automated change calculation

• Advanced printing management with several report types

• Multimedia Online Help

• Previous exam results importation from any DEXA Manufacturers

• Interpretation and printing format defined by the user

System should provided with Compatible Computer System and Printer

System should include TBS software

Application Software to be Included:

• AP Spine Provides an estimate of bone mineral density for the lumbar spine. BMD Lumbar spine acquisition in 30 seconds (< 1%CV, Typical Values). Automated scoliosis adaptation.

• Femur Provides an estimate of bone mineral density for the proximal femur. BMD Single femur acquisition in 30 seconds (< 1%CV, Typical Values).

• DualFemur Dualfemur measures quickly and automatically both right and left femora without repositioning the patient. Each femur BMD and average of both femora is provided in a combined easy-to-read report with patient trending capability.

• DVA (Includes: LVA, APVA, Lateral BMD) Should Performs both LVA and APVA in one scan for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights. Lateral Spine measurement and analysis provides an estimate of bone mineral density for the lumbar spine.

• Forearm Should Measures radius and ulna, providing additional clinical information on BMD for the distal forearm. This option allows forearm BMD measurements of different ROI (Radius 33%, Radius UD, Total Radius). Measurement can be taken in both sitting or supine position.

• Non-seated Forearm Allows a non-seated position for forearm measurement.

• Total Body BMD Total Body measurement and analysis provides an estimate of bone mineral density for the entire body as well as regional results. This feature is only available with Full Size tables.

• FRAX Fracture Risk Tool FRAX 10-Year Fracture Risk provides an estimate of 10-year probability of hip fracture and 10-year probability of an osteoporotic fracture for men and postmenopausal women ages 40-90 years.

• Orthopedic Knee Orthopedic Knee measurement and analysis provides an estimate of the bone mineral density around knee implants pre- and post-surgery.

• Orthopedic Hip Allows the accurate measurement of the Bone Mineral Density and Bone Mineral Content around the implant. For a hip implant, the standard 7 Gruen zones or the 19 extended Gruen zones are automatically positioned or customized regions of interest (ROI’s) that can be customized and copied to another scanned image. Prosthesis, metal fastenings, and other artifacts are automatically excluded from the analyzed region.

• Advanced Hip Analysis Advanced Hip Assessment software allows the accurate measurement of the Hip Axis Length (HAL) in mm, the upper neck femoral BMD for better prediction of femoral neck fracture risk & Femur strength Index (FSI) using Cross Sectional Area (CSA), Cross Sectional Moment of Inertia (CSMI) for an improved patient fracture risk evaluation. Provided with HAL reference data.

• Spine Geometry The Dual Energy Vertebral Assessment (DVA) has been enhanced to add a spine geometry analysis calculation, providing lateral and anterior views of the spine with soft tissue equalization to assess spinal curvature using Cobb angle. Measurements displayed in separate reports that accompany either of the existing LVA or APVA analysis reports.

• Hand Allows a complete acquisition of the hand with an automated TOTAL ROI and customs analysis.

Total Body Composition This feature provides BMC, lean and fat tissue composition results in grams and %fat for a total body measurement. Total and segmental ROI are available as well as dedicated Android and Gynoid ROI. The Patient BMI is plotted on a graph with the WHO criteria for Obesity. Color Fat Mapping. Flexible trend graph is also provided for an easier patient follow up. Total Body Composition is only available in full size tables.

Should be capable of Advanced Body Comp

Color Coding (lean, fat, bone distribution) Body Composition images, Resting Metabolic Rate calculated from Fat Free Mass or manual entry, Relative Skeletal Muscle Index, ability to enter total body water (TBW), intra-cellular water (ICW), extra-cellular water (ECW), New Body Composition composer style sheets, Image trending, Possibility to modify the Body composition reference graph colors and breaks - The tools are designed to help patients understand how diet, lifestyle and exercise programs impact overall health and human performance.

Should be capable of feature estimates the VAT (Visceral Adipose Tissue) and SAT (Subcutaneous Adipose Tissue) mass, volume and area within the android region. The values can be displayed in user-defined statistical formats and trends.

Should be capable of General-purpose business reporting tools for your practice. Includes multiple templates to make the creation of reports with conditions simple and easy. Allows complete and flexible sort of patients using simple, user-defined queries.

DXA measurement information, results, comparison and trending graphs, and images in a single report and allows the user to input their recommendation/evaluation of a patient’s results based upon the analysis results.

Should be capable of Enableing multiple measurements in one exam, eliminating keystrokes and improving throughput for customers that routinely perform multiple measurements on each patient.

Should be capable to perform an AP Spine and Dual Femur exam without repositioning patient and saving time.

Should run on SQL Server Database

Should be capable of future upgrade to HL7 Allows communicating worklist from the HIS (Hospital Information System) directly and automatically with the scanner. HIS must be pre-equipped with HL7 protocol.

Should be capable of future upgrade to Multi-user Database (1-40) which Allows connecting to the networking for full data SQL from remote workstations.

Should be capable of future upgrade to TeleDensitometry for providing digital paperless reports for reading or referring physicians by e-mail or fax.

System should provide with Compatible UPS system

Should be CE/FDA/BIS/ICMED approved.

AERB approval/ NOC is mandatory.

Should perform yearly calibration/Validation and preventive maintenance (4nos) during warranty & if entered into AMC(includes unlimited breakdown calls,calibration) /CMC (which will include spare replacement, consumable spares,breakdown calls,calibration) Testing & measuring equipment used should be traceable to SI units through National/international standards( As per NABL norms). To submit SOPs for PMS at the time of installation/commissioning. QA/QC should be included in warranty as well as in CMC without any additional cost.

Vendor to provide UPS with adequate capacity, if required for the quoted equipment. If not required, vendor to mention the same.

Vendor to submit the technical data sheet, brochure etc as a tender document with reference to the quoted make & model. Please mention the reference page no., quoted model name/number against each item etc in these documents against each technical specifications in the compliance.

Please specify list of consumables/consumable Spares( i.e.spares need to be replaced at regular intervals, maybe quarterly/half yearly/yearly such as annual maintenance kit etc.)

Please specify pre installation requirements [electrical, HVAC, Compressed air ( please specify required air pressure), water requirement (RO/DI/Distilled water with its pressure, flow rate per hour) ; if any of the above is essential]

Please specify footprint size & weight.

Demo of the quoted model , will be required if so desired by the user, after the opening of the technical bid and prior to opening of financial bid. This is for technical evaluation. All technical specifications mentioned above to be mandatorily shown in the demo unit.

Please visit the site to check whether quoted model can be accomodated in the available space.

Operational training to be provided onsite to all departmental staff and primary level maintenance training to be provided to inhouse Biomedical Engineers.

User/Installation list: A list of installations of the quoted model with the address and contact numbers to be provided.

Vendor should provide the user manual and service manual copy during the installation of the equipment.

Please specify power consumption.

Local Service Support: Should have local office and/ or service support/service engineer for attending the breakdown calls.

Response Time: Should not be more than 12 hrs from lodging a breakdown complaint on toll free or by email.

Warranty - 2 years

CMC- cost per annum will be considered for all bidders for 8 years after warranty

Warranty and CMC should include : a) 4 preventive maintenance/ year and unlimited breakdown calls along with spares.b) All bought out items quoted along with the main system (local/non-local) and UPS should be covered. c) Yearly calibration/Validation; Testing and measuring equipment used should be traceable to SI units through National/ International standards (as per NABL/NABH norms). d) PM kit if any. No extra cost will be payable for service kit/PM kit/Maintenance kit, it should be covered under warranty as well as CMC. e) All upgrades/update, no seperate licence fees will be payable. f) QA/QC in warranty as well as in CMC without any additional cost.

Back to back assurance to be taken by the supplier from OEM to supply spares for minimum 10 years and to be submitted.

Penalty Clause: