Supply, installation and commissioning of Robot- Assisted Joint Replacement System

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-800014

NIT No. 14/2026-2027/ Robot Assisted/IGIMS/Store

A.: To be filled by the bidder and submitted along with the Technical Bid.

Sl. No. Terms & Conditions as per Bidding Document Page No. Remarks

1 Status of Bidder:

· Manufacturer or Authorized Agent of the Manufacturer

· Whether Public Undertaking, Public Ltd., Private Ltd. Company or Proprietary Firm/partnership firm

(Please attach Notary certified MANUFACTURER’S AUTHORISATION FORM as per FORMAT placed at Annexure – III)

2 Power of Attorney as per Annexure - V in favour of person to sign, submit and negotiate the bid.

3 Certificate towards market standing of minimum 05 years in the area of supply and or maintenance of bio-medical equipments.

4 Certificate for sole ownership / partnership

5 Statement of financial standing from bankers

6 Statements of turnover per year for last three successive years duly certified by the Chartered Accountants.

7 Notary certified User List (List of Govt.

/Semi Govt., Reputed Pvt. Hospital) where quoted model of the items has been supplied and installed.

8 Notary certified Supply order copy (Minimum 3nos. or more) issued by Govt./Semi Govt.//Reputed Pvt. Institutions/organization for the quoted items. ( same model)

9 Notary certified Performance certificate of the same supplied machine (of quoted make and Model) issued by Head of the deptt. or Institution after a minimum period of six months of installation

10 Prerequisite (if any) for installation of the Machine, if any, to be provided by the Institute.

11 Whether rates quoted are inclusive of all taxes or not.

12 Whether rates are quoted as per format mentioned in the Bidding Document or not.

13 Affidavit to the effect that the bidder is not

blacklisted by any Govt. agency or have no pending case either Civil or Criminal against them.

14 Affidavit, to the effect that the bidder is not supplying the quoted item(s) to any other Govt. / Pvt. Organizations / Institutions / Hospitals at the rate lower than the rate quoted against this tender.

15 Quality Assurance Certificate like ISI, ISO-9002, IP/BP, CE, FDA (US) or any other (please specify)

16 Bid Security amount deposited is enclosed or not. If yes, please mention the details.

17 Original Technical Catalogue of the quoted model

18 Certificate, to the effect that bidder will maintain the quoted item(s) during Warranty period of Three years including all spares, accessories, consumables etc.,

(Please mention the name of the item / items with price, which are not supplied by the bidder free of cost with frequency of replacement)

19 Certificate, to the effect that bidder has quoted its rate for Comprehensive Annual Maintenance Contract inclusive of labour, spares, consumables, accessories etc. on per year basis for a further period of seven years after expiry of warranty period of three years in the price bid.

(Please mention the name of the item / items with price, which are not supplied by the bidder free of cost with frequency of replacement during Comprehensive Annual Maintenance Contract period in the price bid)

20 Acceptance of all terms / conditions towards after sales / services as mentioned in the bidding document.( Clause No- 13 of “ Instruction to Bidder “ & clause no- 3, 4 and 5 of Condition of contract.)

21 Compliance Statement with relation to the technical specification as mentioned in the bidding document duly supported by the original catalogue. The bidder must quote specification in the compliance column Mere writing” Complied shall not be accepted.

22 Compliance Statement with relation to the terms & conditions as mentioned in the document.

23 PAN and copies of Income Tax Returns for the last three years.

24 Duly attested copy of GST registration certificate.

B: To be filled by the Bidder and submitted along with Price Bid

Sl. No. Terms & Conditions as per Bidding Document Page No. Remarks

1 Item wise price for the item(s) as mentioned in the Bidding Document and as per format attached as Annexure – I(a) or I (b)

2 Rate for Comprehensive Annual Maintenance Contract as per terms & conditions mentioned in the Bidding Document and as per format attached as Annexure - II

Note: If the above-tender details are not mentioned and required documents are not attached at appropriate places, the offer of the bidder(s) shall be summarily rejected. Hence, bidder(s) are advised to go through the bidding document carefully and tender be prepared with all the required documents to avoid rejection of offer.

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-800014

NIT No. 14/2026-2027/ Robot Assisted/IGIMS/Store

ELIGIBILITY CRITERIA Mentioned Page no.

1 Manufacturers or their authorized dealers/Indian subsidiaries/direct importers having a place of business in any of the States of India are eligible to participate in this tender.

2 The bidder and manufacturer of the equipment offered should be in the business of the supply and installation of same / similar equipment for the last five calendar years.

3 (a) The manufacturer should have completed at least 05( Five ) nos. installations of the quoted items in Govt. /Pvt. Institutions /Hospitals in India. The installations mentioned by the manufacturer in their offer must be functional and performance certificate for the same issued by the user concerned also be attached with the offer.

(b) The bids quoted as the authorized representative of the manufacturer meeting the above criteria 02 (a) should have also supplied and installed at least 03( Three) nos. installations of the quoted items in Govt. /Pvt. Institutions/ Hospitals in India in last five years from the last date of submission of tender. The installations mentioned by the authorized representative in their offer must be functional and performance certificate for the same issued by the user concerned also be attached with the offer.

4 The Bidder should be public undertaking /Autonomous Body /Public Ltd./Pvt. Ltd. Company or proprietary firm /Partnership Firm and should be in medical equipment business since last five years in India. The Bidders having manufacturing facility in their name in India for the majority of the items offered by them shall be given preference.

5 The Bidder (manufacturer or their authorized agent) should have had average annual financial turnover of Rs. 50 Lakh during the last three years ending s 31st March 2026.

6 Bidders who have the capability to attend repairs of these equipment within the time mentioned in this bidding document and who are willing to provide stand by equipment or replace the faulty equipment if the repair/down time extends beyond 72 hours from the time of reporting of the fault within the next 48 hours (total down time should not exceed 5 days in one instance). The bidders who have the capability to ensure the uptime mentioned in this document (Documentary proof shall be submitted on the after sales facilities and expertise of the bidder.)

7 Bidders are not offering the equipment of a firm /company that has

been blacklisted by Indira Gandhi Institute of Medical Sciences – Patna or blacklisted/debarred by any other State / Central Government's organization.

Note: Notwithstanding anything stated above, the Institute reserves the right to assess the Bidder’s capability and capacity to perform the contract satisfactorily before deciding on award of contract, should circumstances warrant such an assessment in the overall interest of the purchaser.

The Institute reserves the right to ask for a free demonstration of the quoted equipment at a pre determined place acceptable to the purchaser of technical acceptability as per the tender specification, before the opening of the price tender.

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-800014

NIT No. 14/2026-2027/ Robot Assisted/IGIMS/Store

TECHNICAL BID SHEET

EARNEST MONEY 2% of the Equipment

COST OF BOQ 5000

TENDER PROCESSING FEE 590

ADDRESS OF AGENCY

CONTACT NUMBER OF AGENCY

E-MAIL ID OF AGENCY

NAME OF WORK:- A

SI. NO. Specification for Supply, Installation & Commissioning of Robot- Assisted Joint Replacement System

Technical Specification

1. General Specification

1) The robotic system should have at least one of US-FDA / European CE (4 digit notified body) / BIS/ CDSCO-Class C / CDSCO approved certification.

2) Price should be in Indian currency.

3) Latest Make and Model should be mentioned

4) Required space and infrastrucre should be mentioned for installation of robotic joint replacement set.

The robotic-assisted joint replacement system should be a semi-active system allowing the surgeon to guide the robotic arm to perform both femoral and tibial bony preparation within the confines of haptic constraint pre-determined by surgical planning.

3. Capabilities / Range of procedures

The system must be capable of performing following surgical procedures:

(a) Primary Total Knee replacement

(b) Partial knee replacement

(c) Primary Total Hip replacement

(d) Patello- femoral Joint Replacement

4. Components of the System:-

The main Equipment should comprise of the following fully integrated sub-systems:

(a) Robotic arm controlling saw, drill and reamer for bony resections

(b) Guidance cart with computer, keyboard, mouse and monitor

(c) Camera cart interacting with trackers with Fibreoptic interconnections connecting the components

5. Accessories:- Following accessories should be included:

1. TKR Instrument Set

2. THR Instrument Set

3. PKR Instrument Set

6. Storage capacity:- 1 TB

The system shall have all software required to support all disciplines of surgery which is possible by the system under the control of the system.

8. Instrument & Trial implants set:-

The product must include complete conventional instrument and trial implants set for OEM-Specific implants for TKA, PKA & THA

9. Pre-operative support for each case:-

Clinical Specialist support for each robotic case

10. Pre-op planning:-

The system should be a CT image-based system using computer software to generate a virtual 3D-model of the patient-specific bony anatomy and allowing sufficient time to pre-operatively plan, including choosing implant size and orientation

11. Assessment before bony resection (dynamic joint balancing)

Real time medio lateral laxity assessment before bony resections.

The system should be able to predict the implant size in pre-op planning and joint balancing before resection.

12. Bony resection:-

Option for robotic-assisted resection using saw, burr & reamer.

Haptic field constraint feature to ensure that the robotic arm only allows removal of bone within 0.5 mm of the original surgical plan.

Stereotactic boundary must be available to prevent soft tissue injury.

The system should also allow for hybrid approach for bone resection if the surgeons chooses to do the same.

13. Assessment at the time of trial:-

Intra-op ligament assessment

14. Implantation &Final result:-

Intra-op ligament assessment

15. Patient records management:-

Post-op patient data

16. Technical support for each case:-

Product specialist with system: available intra-op for system support and assistance, evaluation of plan, placement of system and accessories, maintenance of system during and after each case.

17. Hardware upgradation:- If any

18. Software upgradation & Support:-

Free of cost of any software upgradation

19. Technical support Centres:-

The supplier must maintain a technical support centre in each of the consignee location. The Supplier shall furnish the names, complete postal address, Telephone/Mobile numbers, email address and FAX numbers of Technical support centers. The supplier shall ensure that all the Technical support centers are manned by fully competent and responsible Engineers and who are capable of attending the faults at the consignee’s sites, whenever needed.

20. Installation:-

Free on-site installation of equipment at consignee’s locations

21. Training at consignee location:-

Bidder has to arrange for onsite training in a phased manner for at least 15 working operating days. A set of OT staff such as nurses and OT technicians and biomedical staff shall be trained by the vendor for handling the system covering powering on, moving and positioning the system and observing the system for right function and errors it any etch. The training method and duration shall be outlined by the vendor. There may be multiple batches of OT staff required to be trained over a period of time.

22. Surgeon training:-

(a) The vendor should have a training center in India.

(b) 4 or moresurgeons nominated in a phased manner by the organization shall be trained and certified by the vendor for using the system to perform robot assisted surgeries. The duration of the training and the training method shall be as per International norms at an authorized training center.

(c) The Vendor shall arrange for training at an appropriate facility for surgeons from the centre where machine is installed for at least 7 days (off site) for the equipment by trained personnel for the seamless functioning of the entire system in a phased manner. All necessary training should be provided by the vendor or company by its own cost (including fooding, lodging and transportation.)

23. New Applications:-

System should be expandable to existing and future new applications add-ons

24. Buyback option:-

For future if any

25. Clinical Evidence:-

System should supported by Clinical evidence for Safety, Precision, and Accuracy of the procedures.

26. List of Consumables (Price should be quated speartly)

Trackers, robotic-arm drapes, pins, check points.

The vendor should provide a list of consumables available for the use of the system suitable for the capabilities of the system. The vendor must provide the quote of consumables complying with their system and the type of surgery. The complete range minimum to maximum must be put and its must be complying for next at least 10 years from the time of installation.

27. Warranty on Equipment:-

a. 3 years comprehensive onsite warranty of entire equipment (Spares and labour) and 7 years of CMC should be quoted.

Maintenance services during warranty and CMC directly by OEM Engineer not by channel partner.

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-800014

NIT No. 14/2026-2027/ Robot Assisted/IGIMS/Store

NAME OF WORK:- A

EARNEST MONEY 2% of the Equipment

COST OF BOQ 5000

TENDER PROCESSING FEE 590

LOCATED WITHIN INDIA.

ADDRESS OF AGENCY

CONTACT NUMBER OF AGENCY

EMAIL ID OF AGENCY

Scheduled Brief description of goods Make: Model: Country of origin Qty./Nos. Ex-factory/ Ex-warehouse/ Ex-Showroom/ off-the shelf (a) Excise duty (If any) % and value. (b) GST (If any) % and value (c) Pcaking and forwarding charge (d) Inland transportation, isurancer for a period inculing 3 months delivery, loading/unloading and incidental cost till consignee site. (e) Incidental services (Including installation and commissioning, supervision, demonstration and training) at the consignee site. (f) Unit Price( at consingee site basis (g) a+b+c+d+e+f Total unit price (at consignee site) Basis Rs. 4x5 (g)

TOTAL AMOUNT IN FIGURE

TOTAL AMOUNT IN WORDS

Note: Bidders are requested to submit price bid in above format otherwise the bid submitted will be regected.

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-800014

NIT No. 14/2026-2027/ Robot Assisted/IGIMS/Store

NAME OF WORK:- A

EARNEST MONEY 2% of the Equipment

COST OF BOQ 5000

TENDER PROCESSING FEE 590

COMPREHINSIVE ANNUAL MAINTENANCE CONTRACT PRICES SCHEDULE

ADDRESS OF AGENCY

CONTACT NUMBER OF AGENCY

E-MAIL ID OF AGENCY

S. No. Item Description 1st Yr. 2nd Yr. 3rd Yr. 4th Yr. 5th Yr. 6th Yr. 7th Yr. Total Comprehensive annual maintenance contract over a period of seven years after expiry of warranty period of three years from the date of successful installation. (a+b+c+d+e+f+g)

a b c d e f g h i

1 Name of the equipment Make: Model: Qty:

2 Name of the equipment Make: Model: Qty:

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5 Name of the equipment Make: Model: Qty:

6 Name of the equipment Make: Model: Qty:

7 Name of the equipment Make: Model: Qty:

8 Name of the equipment Make: Model: Qty:

9 Name of the equipment Make: Model: Qty:

10 Name of the equipment Make: Model: Qty:

11 Name of the equipment Make: Model: Qty:

12 Name of the equipment Make: Model: Qty:

13 Name of the equipment Make: Model: Qty:

14 Name of the equipment Make: Model: Qty:

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20 Name of the equipment Make: Model: Qty:

Scope of contrct (details as mentioned in the clause No. - 13 of "Instruction to Bidder" & Clauses No. 3,4 and 5 of Condition of Condition of Contract".)

a) The rate of Comprehensive Annual Maintenace Contract as mentioned above shoul cover the Complete system.

Complete System should include the basic unit and allied supporting components like UPS, stabilizer Computer System,

Printer, De-ionizer, dehumififer etc to be supplied by the bidder along with basic unit.

b) Preventifve maintenance visit: Four Maintenance visits at ragular interval for usual mintenance & supervision failing which

25% of the contract amount per visit would be deducted as penalty.

c) Break down maintenance visit: As & when requrd

d) Response Time: Within 48 Hours.

e) Uptime Guarantee: 95% of 365 days

f) The above-mentioned charges should includes labour charges for maifntenance and breakdown visits per year, spares,

accessories and all type of consumables requird for the maintenaed charges: it should be clearly mentiond with frequency of

replacement and with rate. The validity of rate of suchf items should also be mentioned vclearly. What will be the rate of

such item must be mentioned.

g) Payment of Comprehensive Annual Maintenance Contract would be made on half yearly basis after completion of work and

satisfctory working report . In no case, advance payment is to be considerd.