gujarat medical services corporation limited (a … · 16 compliance with – nsf49 /ansi49 / en...

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GUJARAT MEDICAL SERVICES CORPORATION LIMITED (A Government of Gujarat Undertaking)

Regd. Office: Block No. 14/1, Dr. Jivraj Mehta Bhavan, Sector-10, Gandhinagar

079-23250767, 23250766, 23257696

Pre-Bid Meeting No. 11/2017-18

A Pre-Bid meeting for specification of following items is organized in the Committee room of this Organization. Manufacturers, Authorized representatives / Dealers of this item are invited to attend this meeting. Only one authorized person from each company would be allowed to attend subject to the production of authorization letter, Valid photo ID Card and product literature of the company conforming that company manufactures the product for which pre-bid is being held.

No. Name of item Date & Time

1 Biosafety Cabinet Type 2A : 22/08/2017 – 12:00 hrs.

2 High Speed Centrifuge (36 Tubes) : 24/08/2017 – 12:00 hrs.

3 HbA1C Analyser : 24/08/2017 – 15:00 hrs.

4 Surgical Blade with ISI Mark : 28/08/2017 – 12:00 hrs.

5 Surgical Rubber Gloves with ISI Mark

: 28/08/2017 – 13:00 hrs.

6 Vital Sign Monitor (Multipara) : 29/08/2017 – 12:00 hrs.

Specification of above items can be downloaded free from web site: http://gmscl.gujarat.gov.in.

INF- MANAGING DIRECTOR

http://gmscl.gujarat.gov.in/

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-679.01 & 02 /RC/2016-17 DATE: 28/08/2017 TIME: 13.00 Hrs.

Name of Item : Surgical Rubber Gloves with ISI Mark 4148 -1989 (Non – Sterile) Disposable Surgical Rubber Gloves with ISI Mark 13422- 1992 (Sterile)

[A] Required Specifications

SPECIFICATION

Surgical Rubber Gloves (Latex) with ISI Mark 4148-1989 (Non-Sterile) with Latest amendment in following sizes:

1. Size : 6"

2 Size : 6 ½ "

3 Size : 7"

4 Size : 7 ½ "

5 Size : 8"

PACKING : (1) Box of 25 pairs. (2) Rate should be quoted for one Box of 25 Pairs only. (3) Each pair should be packed individually.

SPECIAL NOTE:-

MINIMUM 5 PAIR OF SAMPLE SHOULD BE SUBMITTED WITH THE TENDER FOR EACH SIZE.

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-679.01 & 02 /RC/2016-17 DATE: 28/08/2017 TIME: 13.00 Hrs.

Name of Item : Surgical Rubber Gloves with ISI Mark 4148 -1989 (Non – Sterile) Disposable Surgical Rubber Gloves with ISI Mark 13422- 1992 (Sterile)


SPECIFICATION

Disposable Surgical Rubber Gloves (Latex) with ISI Mark 13422 - 1992 (Sterile) with Latest amendment in following sizes:

1. Size : 6"

2 Size : 6 ½ "

3 Size : 7"

4 Size : 7 ½ "

5 Size : 8"

PACKING : (1) Box of 25 pairs. (2) Rate should be quoted for one Box of 25 Pairs only. (3) Each pair should be packed individually.

SPECIAL NOTE:-

MINIMUM 5 PAIR OF SAMPLE SHOULD BE SUBMITTED WITH THE TENDER FOR EACH SIZE.

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/F-871/RC/2016-17 DATE: 22/08/2017 TIME: 12.00 Hrs.

Name of Item : Biosafety Cabinet Type 2A


Specifications

1 Should be type 2A Biosafety cabinet, should provide protection for operator, environment and product from aerosols and micro-organisms. (Critical)

2 Size – HxWxD – Approximately 4 ft. x 2 ft. x 2 ft.(Critical)

3 Design and Construction

a 18 gauge SS 304 interior and epoxy coated steel exterior, (Critical)

b fully closing front door, front door openable to a height of 10 inches and made up of ¼” clear tempered glass, (Critical)

c should provide drain pan(Critical)

4 Work area – 16 gauge SS, seamless, dished work surface, removable with external knobs(Critical)

5 Airflow velocity – Inflow – 100fpm, down flow – 60+/-10fpm, 70% recirculation and 30% exhaust(Critical)

6 Plenum – negative pressure plena surrounding the work area and should be made up of stainless steel (Critical)

7 HEPA filters – Two HEPA filters ( Exhaust and Supply), Should be of 99.9% efficiency at 0.3μ (Critical)

8 Sound emission - <65db (Critical)

9 UV light – should be provided with UV light and UV interlock system to cut the UV light automatically if the door opens accidentally (Critical)

10 Fluoroscence light – Should be provided with fluorescence light(Critical)

11 Ports – should be provided with minimum 1 gas connection ports (Critical)

12 Electrical socket outlets – socket for 5 and 15 amp (Critical)

13 Audiovisual alarms for –

a Excessive opening of sash (Critical)

b Airflow failure or slow airflow (Critical)

14 Operating environment – should be capable of operating in 20-35C and relative humidity of 80% (Critical)

15 Power supply – 210-240V, 50Hz (Critical)

16 Compliance with – NSF49 /ANSI49 / EN 12469 certifications (Critical)

17 Certification – FDA / Conformite European certified /ISO: 13485(Critical)

18 Safety requirements –shall meet latest IEC or equivalent BIS requirements of safety for electromagnetic compatibility (Critical)

19 Accessories-should provide the following:

a Online UPS with maintenance free batteries with 1 hour battery backup must be provided. (Critical)

b Stand with leveling screws and castors (Critical)

20 Services required:

a Onsite installation and 3rd party validation by NABL accredited body. (Critical)

b Calibration certificates(Critical)

Operation manual with user demonstration video CD.

NOTE:- CMC rate shall be filled in commercial bid only. Please see general terms & condition no.5.2.9 for details.

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/ G-217/RI F-762/RC/2017-18 DATE: 28/08/2017 TIME: 12.00 Hrs.

Name of Item : Surgical Blade with ISI Mark


(1) Surgical Blades with ISI certification marked 3319-1995 with latest amendment. (Critical)

(2) Detachable, Bard Parker type. (Critical)

(3) Commercial designations for blade size: No. 10, 11, 12, 15, 20, 21, 22, 23, 24 and 25. (Critical)

(4) Packing: Each box of individually packed 100 blades (Critical).

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/G-242/RI-F-22/2017-18 DATE: 29/08/2017 TIME: 12.00 Hrs.

Name of Item : Vital Sign Monitor (Multipara)


MULTIPARAMETER PATIENT MONITOR (Critical)

1 Should be suitable for pediatric neonatal & adolescent patients monitoring. (Critical)

2 Should have minimum 4 channels of waveforms with minimum 12’’ TFT- LCD color integrated touch screen display (resolution min 1024 x 768). Should display 11 waveforms will all ECG waveforms. (Critical)

3 Should monitor ECG. Respiration NIBP, SpO2, Dual Temperature and recorder as standard. (Critical)

4 Should have ST analysis, Arrhythmia detection as standard in every monitor. (Critical)

5 Should have Drug Dose Calculation and OxyCRG as standard in every monitor. (Critical)

6 Should have pacer spike detection as standard. (Non Critical)

7 Defib and ESU protection should be present. (Critical)

8 Should have monitoring, surgery and diagnostic mode of monitoring. (Critical)

9 Arrhythmia monitoring for Asystole, Vfib/Vtac, VT>2. Couplet , Bigeminy, Trigeminy, R on T, PVC, Tachy, Brady, Missed Beats. (Critical)

10 Monitor access should be with Touch screen with or without rotary knob. (Critical)

11 Fast access key should be provided for quick function. (Critical)

12 Minimum 72 hrs of trend (tabular and graphical) with waveform as standard in all monitors. (Critical)

13 Color or position of waveforms or parameters should be able to be adjusted based on users preferences. Big font on screen formal should be present. (Critical)

14 Nurse call and VGA output port should be standard in every monitor. (Non Critical)

15 Should have inbuilt minimum two channel recorder as standard in every monitor. (Critical)

16 Should have 120 min (typically) of battery backup typically as standard in every monitor. (Critical)

17 Should be CE approved and comply to European Directive 93/42/EEC for both Monitor and software to control physiologic monitoring systems and ISO 13485. (Critical)

18 Should have following parameters:

(A) ECG:

a) Monitor should have capability for display minimum 3 Lead (Critical)

b) ST Analysis (Critical)

c) Waveform Freeze option with review of 120 sec. (Critical)

(B) RESPIRATION :

a) Through impedance pneumography method ( Critical)

(C) SpO2

a) Should display digital value and Plethysmograph (Critical)

(D) NIBP

a) By oscillometric principle of measurement (Critical)

b) Should display Systolic, diastolic, mean pressure in large easy to read display(Critical)

(E) Temperature – Core (Non Critical) and skin (Critical)

19 Scope of supply must include :

a) Basic unit with ECG, Resp, SpO2, Temp, NIBP, Inbuilt battery, Inbuilt minimum two channel recorder. (Critical)

b) 3 lead ECG Cable – 1 no. each per monitor (Critical)

c) SpO2 finger sensor and extension cable – 1 no. per monitor (Reusable one pediatric and one neonatal) (Critical)

d) Skin temperature probe – 2 no. per monitor. (Critical)

e) NIBP Hose with reusable cuff of infant and child one each per monitor. (Critical)

f) Reusable SpO2 probes for Neonates – 5 nos. for monitor. (Critical)

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/G-242/RI-F-22/2017-18 DATE: 29/08/2017 TIME: 12.00 Hrs.

Name of Item : Vital Sign Monitor (Multipara)


g) Disposable neonatal NIBP cuffs of three different sizes - 5 nos. each for monitor. (Critical) (the bidder would have to submit one sample of each size at the time of demonstration which would be kept by GMSCL for reference)

h) Paper rolls – 4 10 no. per monitor.



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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/G-387/RI-E-628/RC/2017-18 DATE: 24/08/2017 TIME: 15.00 Hrs.

Name of Item : HbA1C Analyser


1 Intended use: HbA1c testing and screening of diabetic patients at various government hospitals. (Critical)

2

Measured parameters: HbA1C. If equipment can report other hemoglobins simultaneously during HbA1C run, requiring no change in software and reagents, the equipment may be used for reporting such hemoglobins. Such tests done by the user shall be counted equivalent to HbA1C testing for payment, even though reporting of non-HbA1C hemoglobin is done. However, user shall be responsible for calibrator cost for such reporting and quality measurement criteria shall not be applicable for such uses.(Critical)

3 The equipment must be based on HPLC or capillary electrophoresis. Equipments not measuring HbA1C e.g boronate columns, are not accepted.(Critical)

Equipment Specifications

1 Equipment must be able to complete entire measurement process without user intervention except reagent reconstitution, loading reagents and consumables, loading capped primary sample tubes containing whole blood and programming testing process.(Critical)

2 The exact model of equipment with all required reagents must have NGSP or IFCC approval for use as HbA1C measurement system existing before last date of submission of tender and approval must be valid during technical scrutiny.(Critical)

3

The startup time should not be more than 30 minutes. The system must be able to complete minimum 20 analysis in one hour after end of first startup period. The company would be required to demonstrate the same during technical scrutiny. If equipment require any additional startup before completing 20 samples, this time shall be counted in total time taken for completion of 20 samples (Critical).

4 The equipment must not require preparation of any reagent by the user using materials not provided by the manufacturer. (Critical)

5 The system must have facility to measure low volume samples; in which case, requirement of external hemolysis is accepted.(Critical)

6 The system should give feedback to users for insufficient buffers.(Critical)

7 The system should have inbuilt software for real time viewing of the analysis of the sample. (Critical)

8

Training of for users must be arranged by manufacturer for operating the equipment at the installation site. Training certificate of the staff trained must be provided. New users of the laboratory, during warranty and mandatory CMC period shall be trained and certified by the same way. However, manufacturer may train trainers of the user laboratory; in which case, also, certificate of training is must from the manufacturer. (Non-Critical)

Quality Assessment

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The system should be able to quantitate HbA1c accurately and precisely during demonstration, installation and every six months during use, using following criteria. HbA1C controls with known values of at least two levels will be run for at least 20 times in a single batch. [3xSD + Bias] must be less than CLIA criteria for acceptable performance (6%). Cost of testing will be borne by the supplier during demonstration and during routine six monthly check. Non-fulfillment of this requirement during use shall be considered down-time of equipment (Critical)

2

The suppler must provide all calibrators free of charge as required by equipment user manual for use at frequency mentioned in user manual and as well as required during IQC 2(2S) and 1(3S) rejection troubleshooting and equipment repair. The supplier must provide two level IQC material free of charge sufficient to run two level IQC at least twice a day. In case of IQC 2(2S) and 1(3S) rejection, supplier will be contacted by phone / SMS and further tests running on the equipment by the user will be suspended till troubleshooting and equipment repair is completed.

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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/G-387/RI-E-628/RC/2017-18 DATE: 24/08/2017 TIME: 15.00 Hrs.

Name of Item : HbA1C Analyser


The required extra IQC material will be provided free of charge. User should be satisfied by successful run of two level QC in triplicate by the supplier.(Critical)

3 Copy of satisfaction report and contact details of at least 2 users in India must be provided for the quoted model and parameter. The same will be verified by technical scrutiny members. (Critical)

4 Quoted System must be US FDA / Conformite European certified and the certificate must be submitted along with the bid. (Critical)

Evaluation Criteria

1 Number of tests done will be based on requirements of respective hospitals and no minimum test-per-day is guaranteed (Critical)

2 Once equipment is functional, demonstration of its acceptable function will be made by running HbA1C controls with known values of at least two levels in triplicate. Cost for the same will be borne by the supplier. Time when the quality check is complete is Time B (Non-Critical)

Find time period between time B and time A in hours (T). Find average number of HbA1C analysis per hour done (N) during past one month (or next one month, if past data not available). TXNxCPT will be fined to the supplier and deducted from payment due. (non-Critical)

1. Unit Price Mentioned against tests will be multiplied with their respective weightage before summing total of all fields. It should be noted that the below mentioned figures are indicative

and being used only for price evaluation purpose. The department does not guarantee less or

more number of tests during the active life of the equipment as compared to the figure

stated. However the prices so quoted (or arrived at after negotiation) would be fixed for the

entire period of warranty and CMC. Special Note:- Formula for Price Comparison

PCS

Sr.No. Details Prices

A Basic Cost of equipment = A

B Cost of CMC for 5 years 1st year x 0.78 = B1

2nd year x 0.72 = B2

3rd year x 0.66 = B3

4th year x 0.61 = B4

5th year x 0.56 = B5

C Cost of Consumable per

test

Multiplication factor (approx.

number of various tests to be conducted

during 8 years)

x

HBA1C (64000) = C



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PRE- BID

T.E. NO.: GMSCL/EQUIPMENT PURCHASE/G-389/RI-F-429/RC/2017-18 DATE: 24/08/2017 TIME: 12.00 Hrs.

Name of Item : High speed Centrifuge (36 tubes)


(1) 36 positions Fixed Angle Rotor (Critical)

(2) Bench top centrifuge (Critical)

(3) Brushless induction motor (Critical)

(4) Suitable for the Test-Tubes / Vacutte size (75 x 13 mm to 100 x 16 mm for Serum or Plasma) (Critical)

(5) Spin speed: up to 60000 rpm for tubes with digital speed indicator (Critical)

(6) Step less speed regulation (Critical)

(7) Timed operation (0 to 99 minutes), with automatic switch-off (Critical)

(8) Auto 'IMBALANCE' stop and warning diagnostics (Critical)

(9) Over current or over heating safety auto cutoff (Critical)

(10) Low noise level (Non Critical)

(11) Sturdy metal housing and lid. Facility for lid lock to ensure that centrifuge is covered when rotor is running and prevent cover opening during centrifugation. (Critical)

(12) Easy set-up of speed and time via 2-line LED display and simple push buttons display of actual and set speed and time (Critical)

(13) It should have soft’ start-up and run-down function to avoid jolting of samples. (Critical)

(14) Company should have US FDA / CE certificate and ISO standard. They must provide valid individual Calibration Certificate from NABL approved Test Laboratory. (Critical)

Operation manual with user demonstration video CD. (Critical)


gujarat medical services corporation limited (a … · 16 compliance with – nsf49 /ansi49 / en...

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