Kamdhenu University ECG Machine Tender Gujarat - 12-Lead, MDR 2017 Compliant, ISI/ISO Standards 2026

Tender Overview

Kamdhenu University in Gujarat invites bids for a 12-lead ECG Machine (V2), with a target value around ₹150,000.00. The procurement emphasizes comprehensive clinical features, including adult and pediatric lead acquisition, real-time colour display, and wireless data transfer. The scope covers installation, training, and a service framework with an approved Indian service center, plus mandatory MDR compliance and licensing. A key differentiator is the requirement for PDF report download and report preview before printing, alongside advanced interpretation software and safety standards compliance. This ECG system targets accurate rhythm analysis and edge-to-edge patient diagnostics in rural and campus clinics.

Technical Specifications & Requirements

• Product information includes multi-channel ECG with lead annotation, simultaneous lead acquisition, and pediatric capability.
• Must support 12 leads with interpretation and provide adult and pediatric ECG acquisition, with lead fail, lead reversal, and impedance checks indicators.
• Real-time, colour, backlit display with signal quality indication; ACQ time in seconds and digital sampling rate for pacemaker spike detection.
• Inbuilt printer with configurable report format; printer type, recorder speed, and paper count clearly defined; full-screen preview prior to print.
• Connectivity via wireless RF module and dedicated software to save/download ECG as PDF; latest interpretation software included.
• Power/Environment: standard battery provisions, with replacement of individual leads on the patient cable; operating temperature/humidity and power input details.
• Accessories: 12-lead ECG with interpretation, patient and limb electrodes, chest electrodes, power cable, clip electrodes, compatible trolley; English manuals (hard/soft copies).
• Certifications: MDR 2017 compliance, valid Medical Device license, manufacturing unit certification, test reports per MDR, safety standards compliance; principal manufacturer must have a direct service presence in India. Installation/training post-supply is required.

Terms, Conditions & Eligibility

• Option clause allows quantity variation up to ±25%, with extended delivery periods based on the original timeline.
• State-level MSE purchase preference applies to eligible Indian manufacturers with online Udyam verification; resellers/traders are not eligible for preference.
• Bid must include all certifications, licenses, and test reports at bid submission or with supply, as required by the buyer.
• Installation, demonstration, and operator training must be completed after delivery and before acceptance; comprehensive warranty can be chosen via bidding.
• Ensure direct service presence in India by the principal manufacturer; comply with all MDR obligations and clinical safety standards.