Robotic Surgery System

TATA MEMORIAL CENTRE Annexure A

CENTRAL PURCHASE UNIT

Department :- OT RSS, ACTREC

Technical Specification of :- " Robotic Surgical System-1 Qty "

Intended Use: To perform minimally invasive robot assisted surgeries for malignant & benign tumors.

Sr. No. Name of the Vendor :

A Technical Specifications / Scope of supply Compliance Remarks (to provide details)

B Name of the Manufacturer :

C Country of Origin:

D Model Name / Model No. of the Equipment (If the equipment is a combination of more than one equipment then list down the model no. pertaining to each): Make:

E Year of Introduction Internationally

F Year of Introduction in India

G Please quote the latest state of the art model which meets the tender specifications. The offer should be complete in all respect for the intended use. The equipment should be completely new along with the supporting equipment and accessories

H Technical Specifications/Scope of supply

I Part A- "Robotic Surgical System -01 QTY " , complete as per below mentioned configuration and specifications:

J Features and specifications required:

1 The system should be capable of performing minimally invasive robot assisted operative procedures in General Surgery, Gastro intestinal, Urology, Gynaecology, Thoracic, Colorectal, and Head & Neck for non cancer and cancer surgeries. CDSCO/USFDA approval mandatory for all indications mentioned above.

2 The Main Equipment should comprise of the following fully integrated subsystems.

i Surgeon’s console/ Command Center:-

a) With Master controls and an integrated true High- Definition Full HD 3D display or immersive console.

b) The robotic surgery system should have an immersive console or open console with 3D 4K display to enable multiple surgeons/observers to view and learn robotic surgery.

ii Vision cart containing camera, image processing units and integrated true high- definition Full HD 3D display monitor 32 inches for interaction or 2D HD 21 inches display

iii Surgical Cart :-

a) The equipment should have minimum of 4 arms for camera and instruments on single boom.

3 System should be provided with integrated inbuilt simulator with the Surgeon Console to practice & enhance surgical skills of new & existing robotic surgeons on procedure specific simulation and it should be provided with the system.

4 Equipment should support 8mm/9mm instruments for performing various robotic surgeries with minimum of 7 degrees of freedom.

5 High-quality Three-Dimensional View of the field of operation is to be provided by the Vision system through its endoscope or with glasses.

6 The surgeon should be able to magnify the images with his own controls.

7 Rigid Camera and view to be controlled by Surgeon Cart

8 The surgeon console should have the capability to control inbuilt /external energy sources from the integrated foot switch

9 Provide 8mm endoscopes of 0 degree (Qty: 2 Nos.) and 30 degrees (Qty: 2 Nos.)

10 The system should have a near-infrared guidance through visualization of injectable fluorescence dye with suitable endoscope, illuminator and camera.

11 Instruments to be used with the system should be able to provide surgeons with natural dexterity and a range of motion equal to the human hand. It should have laser beam assisted docking mechanism. Such instruments should be able to offer a wide range of tips suitable for performing procedures for benign and oncology surgeries across multiple disciplines. These Instruments shall offer Seven degrees of motion mimicking the dexterity of human hand.

12 When clutch is disengaged , the instrument should not have any involuntary movements.Adequate safety features to prevent inadvertent movements of the surgeon affecting the instruments should be available.

13 The masters at the surgeon’s console should be capable of translating the natural hand and wrist movements in to corresponding precise and scaled movements to the instruments and camera attached to the surgical cart arms minimizing fatigue. Such movements of the instrument tips shall replicate the experience of open surgery.

14 There should have facility for scaling of surgeon hand movements to corresponding smaller instrument tip movements. The surgeons hand movements shall be replicated at the instrument tip after filtering tremors if any in real time.

15 The system should perform self-checks to provide safety during usage online.

16 The system should be supplied with energy source for mono polar and bipolar cautery and also upgradable to newer/advanced energy devices.

17 System be supplied with external CO2 insufflator.

18 Should have ability to change instruments during surgery safely with proper guidance.

19 Features to provide ability for the assistants in the operating room to see and communicate with the surgeon through AV mode and telestration or open console to facilitate easy communication between surgeon and operating room staff.

20 Ability to adjust the surgeons view ports and console to suit individual comfort and ergonomics should be available.

21 System should be compatible for external sources like CT/MRI/USG Robotic images in the console field of vision during surgery.

22 The system should have docking mechanism for the better stability of the instruments while performing the surgery.

23 The sub systems shall be easily movable within the OR. If wheels are used there should be features to lock the wheel to prevent movements.

24 The system shall provide high defination video output suitable for connecting to external devices such as recorders and additional video monitors.

25 System shall have features for emergency release of the robotic instruments from the surgery.

26 The system should have the capability of in-built battery back up for arms in case of emergency/power failure.

27 The application should facilitate two-way audio and video communication with live access to endoscopic view of the operative field

28 3 D Goggles:- 08 Qty should be provided with system as a standard , not applicable for immersive console which does not required 3D goggles

K OTHER REQUIREMENTS

1 Surgeon Training

All the surgeons of TMC nominated by HOD, Surgical oncology, ACTREC must be trained (Minimum of 15 surgeons ) on dry lab, wet lab and case observation. The duration of the training and the training method shall be as per international norms at an authorised training centre. Also there should be onsite & offsite training.

2 OT staff training

Vendor should have atleast one service engineer and application engineer located in Mumbai to provide support on need basis throughout the life of the equipment.

3 Sterilisation :- The equipment available at ACTREC CSSD for cleaning & sterilisation of instruments are mentioned below : (Kindly specify if any other Cleaning & sterilisation equipment are required other than below mentioned equipment.)

i Steam Sterilizer :- Make - Getinge , Model - GSs87H

ii Sealing Machine :- Make - Havo , Model - HM850

iii Drying Cabinet :- Make - Getinge , Model - S-363

iv Drying Cabinet :- Make - Axyos , Model - Model 123

v Washer Disinfector :- Make - Getinge , Model - S-8666

vi Ultrasonic cleaner :- Make - TRANS-O-SONIC , Model - D-1000/1H

vii Sonicleane :- Make - Getinge , Model - R3000L

viii Plasma Sterilizer :- Make - ASP , Model - ST-100NX

ix ETO - Make - 3M , Model - Steri-vac GS8

3.1 Vendor should evaluate the existing infrastructure for cleaning and sterilization of the robotic system consumables and provide necessary recommendations, incase if anything is required more than the existing facility.

L Part B: Consumables to be quoted as per the below mentioned list in the financial bid. [Note: The approximate number of surgeries performed in a year is 200 ]

1 The vendor shall provide a list of instruments, consumables and accessories available for the use of system for benign and cancer surgeries suitable for the capabilities of the system: If any of the consumables/ accessories already available with the vendor are not quoted in the tender and are required in the procedures for the departments mentioned in point No. J1 must be provided free of cost

2 Provide the list of proprietory consumables if any for the quoted equipment along with the technical bid (Not to include price as it may lead to disqualification) If no list is provided, it implies that there are no proprietory consumables.

3 The bidder to visit the site to ensure that the size of the available Operating rooms is adequate for docking/parking the equipment and has enough space for OR personnel to operate comfortably. Also If additional equipment which is required for the functionality of this equipment like UPS must also be included in the scope of this tender.

4 Vendor to quote for following Consumables( or equivalent in case if the name mentioned is proprietary ) and price should be mentioned in the price bid and should not be mentioned in technical bid. The prices quoted below it must be freezed for 2 years without any escalation.

a) Arm Drapes- 1 No.

b) Coloumn Drapes - 1 No.

c) Fenestrated Bipolar Forcep : - 1 No.

d) Prograsp Forceps :- 1 No.

e) Maryland Bipolar Forceps :- 1 No.

f) Monopolar Curved Scissor :- 1 No.

g) Large HEM -O - LOCK Applier :- 1 No.

h) Robotic / Laparoscopic Stapler Relod 60 Green Cartidge :- 1 No.

i) Robotic / Laparoscopic Stapler Relod 45 Green Cartidge :- 1 No.

j) Robotic / Laparoscopic Stapler Relod 60 Blue Cartidge:- 1 No.

k) Cautery Tip Cover :- 1 No.

l) Large Needle Driver :- 1 No.

m) Medium - Large Clip Applier -1 No.

n) Small Clip Applier :-1 No.

o) Permanent Cautery Spatula/Hook :- 1 No.

p) Cadiere Forceps :- 1 No.

q) Monopolar Cords - 1 No.

r) Bipolar Cords :- 1 No.

s) Vessel Sealer - 1 No.

t) Blunt Obturator - 1 No.

u) 8 MM Reducer - 1 No.

v) Long Cannula 15 Cm for Tors - 1 No.

M Mandatory Terms & Conditions

1 The vendor may visit the site of installation for detailed comprehensive survey to ensure availability of all the pre-requisites and conditions required for full functioning and maintenance of the equipment

2 Standard accessories (Which comes along with the machine, pricing of which is part of the equipment)

3 Available UPS system in the OT is be assessed and bid accordingly.

4 Periodic Calibration

5 Regulatory Approvals, If any. Details with copies of approvals.

6 Safety requirements: It should follow International / national safety requirement. Please specify certification with certifying agency and country with copies of certificate.

7 CDSCO Class C certification should be mandatory for the quoted model. Please mention if the equipment is additionally certified by USFDA/ European CE from EU notified body,

8 User's list: A list of installations with the address and contact numbers to be provided. (User list should be for the quoted model.)

9 Input power supply requirements: 240 V AC ± 10 %, 50 Hz, single phase. Specify if any other power supply requirement is recommended.

10 Manufacturer should have its authorised service provider's office located in Mumbai or Navi Mumbai area having adequate strength of service personnel trained on servicing and maintenance of the quoted model. Bidders who do not qualify this criteria shall not be considered. Bidder should provide address of the authorized service centre and details of number of personnel with training credentials.

11 Installation, Commissioning, testing and Training

12 Unpacking and Shifting the consignment to the installation site is to be included in the scope of supply. Bidder/manufacturer/authorized service provider should take responsibility to lift/shift the consignment from unloading site to the installation site . Unloading site shall be "Stores Department, KS Building, ACTREC Campus". If needed, Bidder has to arrange for labourers at no charge to ACTREC. (Before submitting the quotation, bidders may visit ACTREC to know unloading site and installation site)

13 Warranty and after sales support

14 Warranty: 2 years comprehensive-on site- Factory warranty- for entire equipment. All third party and bought out items, accessories, attachment, software etc. integrated with the system should also be covered the with factory warranty from respective manufacturers. The vendor should perform minimum 4 nos. of preventive maintenance services/ year, all breakdown visits and QA/QC as per prescribed protocol during the warranty period. The warranty and CMC should includes all software updates and upgrades along with required hardware at no cost to ACTREC-TMC .

15 CMC -: Vendor to quote the CMC charges for 8 years post warranty. All third party and bought out items, accessories, attachment, software etc. integrated with the system should also be covered under CMC. The vendor should perform 4 nos. of preventive maintenance services/ year, all breakdown visits and QA/QC as per prescribed protocol during the warranty and CMC period.

16 Uptime guarantee during warranty period and CMC at minimum of 95%: During the contract period minimum uptime guarantee to be provided by the bidder is 95%. The OT is functional from Monday to Saturday from 8:00 AM to 8:00 PM. The number of Days OT will be functional in a year is 300 days. The minimum uptime guarantee is for 285 days (95% of 300 functional days). Further preventive maintenance will have to done during off days or non- working hours, otherwise it will be included in downtime calculation.

17 Downtime penalty clause: While calculating the 95% guaranteed uptime i.e. all features as per specifications in purchase order should be functional for uptime. The supplier / agent shall be required to pay a penalty for every day 0.1% of the invoice value per day upto a maximum of 10% of the total value of the equipment.

18 Important terms to be noted by the bidders:

19 Read the above scope of supply carefully and quote accordingly. Incomplete and /or partially complete offers are liable to be rejected.

20 Manufacturer/bidder should clearly indicate typical life span / Life expectancy of the quoted equipment.

21 Mention typical site requirements for the installation.

22 Item/Equipment quoted should not be a second hand/refurbished/on verge of obsolescence/outdated model. Similarly, after award of contract, the item supplied should be a newly manufactured item and not the old item already manufactured and stocked for more than 6 months.

23 After opening of the Technical bid (Part-1), Physical demonstration of the quoted model may have to be shown / arranged by the bidder, if requested by the Institute. Physical demonstration may be shown at one of the end user’s site/Principle company’s application lab/manufacturing site located in Mumbai/Navi Mumbai/Thane cities. If there are no installations of the quoted model in Mumbai/Navi Mumbai/Thane cities, then the quoted model may have to be brought in at ACTREC for demo purpose within 10 days from the date of request.

24 Compliance column may be filled with relevant data, figures, range etc. as applicable. Do not just mention "YES / NO / Complied ".

25 Declaration by the bidder

26 We have quoted for all the items meeting the description/scope of supply in the Financial bid as per prescribed format of the Tender documents and we agree that Partial/incomplete offers are liable for rejection.

27 L1 Calculation:

28 L1 will be based on cost of the entire system with 2 years warranty, 8 years CMC cost and cost of consumables (single use/ multiple use) as per quantity mentioned in Part-B) including accessories and other support equipment at landing cost at ACTREC.

TATA MEMORIAL CENTRE Annexure A1

CENTRAL PURCHASE UNIT

Department : Surgery, HBCH&RC Visakhapatnam

Technical Specification of :- Robotic Surgical System , Qty 1 No."

Intended use: To perform minimally invasive robot assisted surgeries for malignant and benign tumors.

Sr. No. Technical Specifications / Scope of supply Compliance Remarks

1) Mention "Complied /Not Complied" 2) Highlight any deviations. 3) Mention part number/Catalogue number of the relevant item quoted. (to provide details)

I Name of the Manufacturer :

II Country of Origin:

III Model Name / Model No. of the Equipment (If the equipment is a combination of more than one equipment then list down the model no. pertaining to each):

IV Year of Introduction Internationally:

V Year of Introduction in India:

VI Year of probable end of support :

VII Please quote the model which includes latest state of the art equipment and meets the basic minimum specifications. The quoted model should be latest introduced with end of support not before 10 years from the date of installation at TMC.

A Main equipment

1 The equipment must be capable of performing minimally invasive robot assisted operative procedures in General Surgery, GI, Urology, Gynaecology, Cardiac, Thoracic, HPB, Colorectal, ENT and Paediatric surgery for benign and cancer surgeries, supported by high level clinical evidence (Level I/II/III) published in peer reviewed reputed international journals.

2 Surgeon’s console :

a The system should be with master controls and have an immersive console or open console with an integrated High-Definition display.

b The surgeon should be able to magnify the images with his/her own controls.

c The masters at the surgeon’s console should be capable of translating the natural hand and wrist movements in to corresponding precise and scaled movements to the instruments and camera attached to the surgical cart arms minimising fatigue. Such movements of the instrument tips shall replicate the experience of open surgery.

d There should be facility for scaling of surgeon hand movements to corresponding smaller instrument tip movements. The surgeons hand movements shall be replicated at the instrument tip after filtering tremors if any in real time.

e System should be capable for Integration with the Second Surgeon Console which provides the ability to switch surgeon console control from one console to the other real time during surgery.

f System should be capable for Integration of Skill Simulator with the Surgeon Console with supplied model of robotic system to practice & enhance surgical skills of new & existing robotic surgeons with the help of basic as well as advance procedure simulation, mimicking an actual operating environment.

g Ability to adjust the surgeons view ports and console to suit individual comfort and ergonomics should be available.

h Ability to enable the surgeon to view two additional video sources from other medical systems with compatible video sources.

i Should have the capability to control inbuilt energy sources from the integrated foot switch.

a Should have single boom-mounted arms with multi-position set up joints for instruments and camera.

b The operational unit should contain four robotic arms that perform the surgery directly on the patient.

c Should have 4 slim arms and should support 6–8 mm instruments with a minimum of 7 degrees of freedom.

d Surgical Cart with 4 universal arms enabling 8mm instrument/camera port and 12 mm stapler port, rotating boom structure with a targeting laser

e System should be capable to use Single Site instrumentations (optional).

f Flexibility to place endoscope in any robotic arm without the need for change in surgical port size.

g The system should perform self-checks to provide safety during usage.

h Ability to change instruments during surgery safely with proper guidance should be in built.

i Should provide the flexibility to place scope in any one of the surgical arms during the procedure.

j When clutch is disengaged, the instrument should not have any involuntary movements.

k It should have laser beam assisted docking mechanism.

a Should have immersive 3D-HD vision with up to 10x–15x magnification.

b Should contain camera, image processing units and integrated high-definition display monitor for interaction

c Capability for Real-time near-infrared guidance with endoscope through injectable fluorescence dye, offering total autonomy to the surgeon to control the vision system

d Camera should provide high resolution images of the operative field along with perception of depth of field.

e The system should have built in energy source for mono polar, bipolar cautery and Vessel Sealing, also have ability to use external energy source of at least one compatible model for emergency use.

f Features to provide ability for the assistants in the OR to see and communicate with the surgeon through monitor and telestration.

5 While the robotic arms shall be operated by sterile persons the vision system and surgeons console shall be non-sterile are in the Operating room.

6 Adequate safety features to prevent inadvertent movements of the surgeon affecting the instruments shall be available.

7 The sub systems shall be easily movable within the OR. If wheels are used there should be features to lock the wheel to prevent movements.

8 The system shall provide video output suitable for connecting to external devices such as recorders and additional video monitors.

9 System should be capable for viewing images from external sources like CT/MRI/USG robotic images in the console field of vision during surgery.

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

11 System shall have features for emergency release of the robotic instruments from the surgery

12 System should provide capability to conduct advance surgical steps like stapling with the help of fully wristed robotic staplers with 120° cone of articulation, real time feedback on tissue compression and controlled directly from Surgeon’s console

13 System should provide capability to conduct advance surgical steps vessel sealing with the help of fully wristed robotic vessel sealer with 60° articulation, controlled directly from Surgeon’s console

14 System should have the capability to connect through a dedicated mobile application synced to the surgeon console to provide surgery data in the form of procedure type, operative time, instruments choreography and benchmarking of instrument usage and operative time per procedure with other surgeons

15 The system should have the capability of in-built battery back up for arms in case of emergency or power failure.

16 The application should facilitate two-way audio and video communication with live access to endoscopic view of the operative field.

17 Should provide video recording device with the following features:

a Standard high-definition (HD) at 1080 x 720 pixels

b Recorders must support 2D/3D stereoscopic video streams.

c 30 frames per second (fps) to match the system's output

d External hard disk: 2 TB

19 Should provide CO2 insufflator with the following features :

a Should have intracavitary pressure(mmHg): High Flow: 1-30, Pediatrics: 1-15

b Should have flow (l/min): High Flow: 1-50, Pediatrics: 0.1-15

c Should have hose heating capability

d Should be supplied with pressure regulator,trolley for the cylinder and the hose for connection.

20 Should provide UPS and the necessary components (eg: rack)as per the equipment requirement.

21 Sterilisation : The equipment available at HBCH&RC Visakhapatnam CSSD for cleaning & sterilisation of instruments are mentioned below: (Kindly specifiy if any othe cleaning & sterilisation equipment are required other than below mentioned equipment and if yes then the same should be included in the scope of supply)

a Steam Steriliser: Make: BMT Medical Technology , Model: Sterivap SL 6618-2

b Drying cabinet: Make: Hybrid Biomedical Equipment & Allied Technologies, Model: HYDC 300

c Plasma Steriliser: Make: Steris , Model: VPro Max2

d ETO Steriliser: Make: 3M , Model: Sterivac GS8

e Washer Disinfector: Make: Tuttnauer, Model: Tiva 10-2V

f Sealing machine: Make: Hawo, Model: HM850DC

g Ultrasonic Cleaner: Make: Ralsonics , Model: RUTTC-750

22 Vendor should evaluate the existing infrastructure for cleaning and sterilization of the robotic system consumables and provide necessary recommendations, incase if anything is required more than the existing facility.

23 Optional Items : Should be included in the scope of supply if required by end user.

a Surgeon console for dual console configuration

B Instruments, Accessories and Consumables

1 Instruments to be used with the system should be able to provide surgeons with natural dexterity and a range of motion equal to the human hand.

2 The vendor should provide a list of instruments, consumables and accessories available for the use of system for benign and cancer surgeries suitable for the capabilities of the system. If any of the consumables/accessories already available with the vendor are not quoted in the tender and are required in the procedures for the departments mentioned in the point A1, the same must be provided free of cost.

3 Vendor should quote for all the instruments, consumables and accessories required for the surgeries mentioned as per point A1.

4 Should provide 8mm endoscopes of 0 degree (2 nos) and 30 degree (2 nos).

5 Should provide sterilization trays for instruments and telescopes.

6 Should include all standard accessories (which comes along with the machine, pricing of which is part of the equipment)

7 Instruments and accessories for approximately 500 cases over a period of 3 years should be provided based on the user requirement.

C General Terms:

1 System should be CE/FDA/BIS/ICMED approved.

2 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.

3 Equipment certification: Certificates need to be furnished.

a The robotic system should have CDSCO approval (Class C for the Robotic Surgery system and B/C for instruments and accessories as per the categorization) and documents should be submitted.

b Should submit CE/FDA/BIS/ICMED approval certification.

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

5 Response Time: Should not be more than 06 hrs from lodging a breakdown complaint on toll free or by email.

All accessories and consumables required for the training sessions should be provided by the vendor without any additional cost.

a Surgeon Training

a.1 Six surgeons nominated in a phased manner by the Institution Head 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 authorised training centre.

a.2 The training roadmap/schedule to be provided as part of the technical document

a.3 The training simulator, software, etc. should be arranged by the OEM for the training.

b OT staff training

b.1 A set of OT Staff should 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 if any etc. 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.

b.2 The training roadmap/schedule to be provided as part of the technical document

c Biomedical Engineer training

c.1 Primary level equipment maintenance training to be provided to Biomedical Engineers.

d The Vendor should be capable of providing the onsite proctor support as and when required during the cases/procedures at the Institution.

7 Precommissioning and site readiness

a The vendor may visit the site of installation for the detailed comprehensive survey to ensure availability of all the pre-requisites and conditions required for the full functioning and maintenance of the equipment.

b Any extra requirements for installation of equipment should be mentioned during negotiation otherwise handing over fully functional machine will be the responsibility of the vendor.

8 Safety requirements

a It should follow International/National safety requirements.

b Service, System and Schematic manuals.

10 Standard Spare Parts

a Provide the list of standard spare parts supplied with the machine,if any.

11 Installation Requirements: Please mention the following items.

a Physical Dimensions and Weights

The physical dimensions and weight should be specified

b Electrical Requirements:

Please specify the electrical requirements

c Air Conditioning :

c.1 Temperature

c.2 Relative Humidity

c.3 Air changes (To specify no. per hour)

c.4 Any other specific requirements regarding AC vents etc (please specify)

a Unpacking and shifting the consignment to the installation site is to be included in the vendor's scope of supply. Bidder/manufacturer/authorized service provider should take responsibility to lift /shift the consignment from unloading site to the installation site. Unloading site shall be Stores department, HBCH&RC Visakhapatnam. If needed ,bidder has to arrange for the labours at no charge toHBCH&RC Visakhapatnam.(Before submitting the quotation,bidders may visit HBCH&RC Visakhapatnam to know unloading and installation site.

13 WARRANTY & CMC

a Warranty: 5 years comprehensive-on-site- factory warranty for the entire equipment system. All third-party and bought-out items, accessories, attachments, software, UPS, etc. integrated with the system should also be covered by 5 years factory warranty from respective manufacturers. The vendor should perform 4 nos. of preventive maintenance services/ year and all breakdown visits during the warranty period.

14 Post Warranty CMC

a CMC: Quote for 5 years CMC cost after warranty in Financial Bid. It will include 4 preventive maintenance/per year and all breakdown visits. CMC will cover the entire system including the equipment, hardware, software, UPS, third-party supplies, and all bought-out items used in the system. CMC should include upgrades and/or update costs; no separate software license fees will be payable.CMC should include UPS battery replacement as per OEM recommendations.

15 Delivery Schedule: Please specify

16 Other Information

a No. of similar models: India (enclose list of institutions)

b Details of Installations: (i) Date of Purchase Order, (ii) Date of Installation, (iii) Date of Commissioning (iv) Current Operational Status of the Machines. Contact details of the End user needs to be provided.

c Nos. of Certified Engineers in India (Enclose List of Names and their Locations).

d Remote Diagnosis Facility (India / Abroad) availability

17 Equipment and the supporting items quoted should not be a second hand/refurbished/on verge of obsolescence/outdated model. Similarly, after award of contract, the item supplied should be a newly manufactured item and not old item which has manufacturing date older than 6 months of the supply.

18 Uptime Guaranty (96 %) / Penalty Clause

a The supplier and / or its Indian agent will be required to maintain the equipment and all its bought out items (including software updates and various licenses) used for the functionality of the system in good working condition during the warranty/ CMC period with 96% uptime guarantee.

b Equipment shall be fully functional to be considered as the uptime. In case of partial functionality, the proportion of functionality shall be determined and downtime shall be adjusted by such proportion (i.e. if the equipment is 70% functional, 30% downtime shall be applicable). In cases where it is not possible to definitely determine the proportion of functionality, the downtime shall be considered as 100%.

c The decision of the TMC management or its representative in determining the % of the downtime shall be final and binding.

d Essential period to shut down the equipment entirely or partially during warranty/CMC period shall also be included in the downtime while calculating the guaranteed uptime i.e. all features as per specifications in purchase order should be functional for uptime.

e The penalty applicable for downtime shall be calculated on an hourly basis and will be at the rate of 0.004% per hour (0.1% per day) of the total cost of the equipment (excluding works), during and up to the period of warranty/ CMC. There shall be a permissible down time of 360 hours per year, beyond which the down time penalty will be applicable.

f However, in case of the downtime exceeding seven days (i.e. 168 hrs) at a stretch, the downtime beyond these 168 hours will be considered for calculation of downtime penalty.

g The levy of this penalty shall be at the discretion of director TMC irrespective of the overall up time of the equipment throughout the period of the warranty or CMC.

h This clause is to ensure maximum uninterrupted service to patients and hence Director, TMC’s decision in enforcing / invoking this clause will be final and binding for all.

i For CMC, W.O. issued by TMC shall be final as per D.A.E. Norms. TMC & its units shall not sign separate legal contract as per vendor’s format.

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