VOLUME 4 - SUPPLY AND INSTALLTION OF CATHETERIZATION

PROPOSED CONVERSION OF THE OLD KITCHEN BUILDING INTO A

CARDIAC CENTER FOR THE NAIROBI HOSPITAL.

PROJECT TEAM.

PSRM CONSULTANTS LTD MUTISO MENEZES INTERNATIONAL LTD

PROJECT MANAGERS PROJECT ARCHITECTS

P.O. BOX 60824-00200, P.O. BOX 44934 - 00100,

NAIROBI, KENYA NAIROBI, KENYA

LINEAR PROJECTS LTD. NATCONSULT CONSULTING ENGINEERS LTD

PROJECT QUANTITY SURVEYORS PROJECT CIVIL / STRUCTURAL ENGINEERS

P.O. BOX 106188 - 00101, P.O. BOX 3975 - 00506,

NAIROBI, KENYA NAIROBI, KENYA

GEOMAX CONSULTING ENGINEERS LTD

PROJECT SERVICES ENGINEERS

P.O. BOX 53748 - 00200,

NAIROBI, KENYA

AUGUST, 2021.

VOLUME 4 - SUPPLY AND INSTALLTION OF

CATHETERIZATION LABORATORY EQUIPMENT AND

OTHER AUXILIARY EQUIPMENT

2

Table of Contents

1. CARDIAC MONITOR FOR NEONATAL AND PAEDIATRICS

2. CARDIAC MONITOR, ECG MACHINE AND DEFIBRILLATOR

3. FEEDING PUMP SPECIFICATIONS

4. HOSPITAL BED SPECIFICATIONS

5. TECHNICAL SPECIFICATIONS FOR PEADIATRIC VENTILATOR

6. INFUSION PUMP SPECIFICATIONS

7. STRESS TEST WITH TREADMILL SPECIFICATION

8. SYRINGE PUMPS SPECIFICATIONS

9. CATHETERIZATION LABORATORY (CATHLAB) TECHNICAL SPECIFICATION

10. TECHNICAL SPECIFICATIONS FOR VENTILATOR

BILLS OF QUANTITIES

3

1. CARDIAC MONITOR FOR NEONATAL AND PAEDIATRICS ITEM FUNCTION MET

SPECIFICATION YES/NO

COMMENT

Monitor is required to monitor vital parameters of the patients

OPERATIONAL REQUIREMENTS 1. Monitor should be portable

and light weight and should monitor vital parameters of patients

2. Must have capability of storage of patient report

TECHNICAL SPECIFICATIONS 3. Portable and light weight

preferably <10kg

4. At least 12inch multi-color TFT display

5. Monitored parameters: -ECG, Respiration, NIBP, SaO2, capnometry and temperature

6. Digital and at least 4 waves / traces display

7. Should have a visual and audible alarm capability. Alarms should have three distinct visual and audible alarm to distinguish alarm levels.

8. Monitor should permit viewing of operational and alarm parameter, waveform/numeric from any bedside as and when connected to the network

9. Trends should be automatically stored for at least 72 hours in at least one minute interval

4

ITEM FUNCTION MET SPECIFICATION YES/NO

COMMENT

10. Numeric monitored data trend shall be viewable and recordable in a patient chart type format in at least 1,5,15 and 60 minutes intervals

11. Convenient handle for carrying the same

12. Able to be fixed on the bed/trolley

SYSTEM CONFIGURATION ACCESSORIES, SPARES, AND CONSUMABLES

13. Portable/Transport monitor 14. Patient cables (5 lead). 5

No.

15. Neonatal cuff 5 No.

16. Pediatric cuff. 5 No.

17. Neonatal probe SPO2 5 No.

18. Pediatric probe SPO2 5 No.

19. Skin temp probe. 5 No.

20. Dual channel recorder 21. Paper recorder-100 cases 10

Rolls

ENVIRONMENTAL FACTORS 22. The unit shall be capable of

operating continuously in ambient temp of 10-400C and relative humidity of 15-90%

23. Shall meet IEC-60601-1-2:2001 (Or equivalent) General requirements of safety for electromagnetic compatibility

POWER SUPPLY 24. Power input to be 220 -

240VAC, 50HZ fitted with UK plug 13A three pin top plug

5


COMMENT

25. Should be fitted with an inbuilt rechargeable battery with a capacity of at least 1 hour off power in the event of power failure

STANDARDS, SAFETY 26. Should be FDA and CE

approved

27. Shall meet safety requirements as per IEC 60601-2-27:1994-medical electrical equipment-Part 2: Particular requirements for the safety of electrocardiographic monitoring

DOCUMENTATION 28. User manual in English 29. Service manual in English 30. List of important spare parts

and accessories with their part number and costing for the active life of the equipment

31. Certificate of calibration and inspection from the factory

32. Logbook with instruction for periodical maintenance checklist

33. List of equipment available for providing calibration and routine maintenance support as per manufacturer documentation in service technical manual

TRAINING AND INSTALATION 34. The installation and

commissioning of the equipment will be considered complete after:

6


COMMENT

1. Training of users on operation of the machine.

2. Training of Biomedical engineering team on the care and maintenance of the unit

Advance maintenance tasks required shall be documented

WARRANTY AND MAINTENANCE 35. Should offer warranty of at

least 2 (two) years

36. Free service during the warranty period

37. Maintenance manual detailing Complete maintenance schedule and protocol

38. Service contract clauses, including prices: The spare, accessories & consumables list required for maintenance and repairs in future after guarantee/ warranty

7

2. CARDIAC MONITOR, ECG MACHINE AND DEFIBRILLATOR I. CARDIAC MONITOR

ITEM MINIMUM SPECIFICATIONS BIDDERS RESPONSE

YES/NO

REMARKS

28. A physiological monitor for use in intensive care settings

29. Make: 30. Model:

31. At least 22 inch monitor with high resolution 32. The monitor must be compatible with various

brands of Central Station monitoring. Bidder to list brands compatible brands

33. Modular, state of the art technology, suitable for neonates to adult

34. Microprocessor controlled with automatic self-test and calibration

35. The following parameters must be measured and displayed :

36. ECG waveform 37. Oxygen saturation, waveform + digital 38. Heart rate, digital 39. Respiration, waveform + digital 40. 3X Invasive pressure, waveform + digital

(systolic, diastolic, mean)

41. NIBP, digital (systolic, diastolic, mean) 42. Temperature, digital 43. PICCO/CO with cable and temperature probe 44. Side-stream Capnography highly desirable.

Provide full information

45. The monitor must operate on both 220 V, 50 Hz single phase AC power supply and an internal rechargeable battery.

46. If mains power fails, the monitor must operate on battery power for at least 2 hours.

47. Visible indication to show whether the monitor is operating from the mains or battery power with both visual and audio alarm while on battery.

48. All control keys must be splash proof and resistant to the entry of fluids into the unit.

49. The front panel must be easy to clean and disinfect.

8


YES/NO

REMARKS

50. At least 6 waveforms must be displayed 51. Digits: large: 100mm, small: 5 mm 52. Sweep speeds : 25 and 50 mm/s 53. It must be possible to freeze the display. This

must not affect the QRS signal.

54. Trending for 72 hours must be possible on the monitor,

55. Unit to provide at least 72 hours of full disclosure wave data for review

56. Defibrillator-proof up to 360 Joules 57. Protected against HF interference 58. Patient isolated from all potentially harmful

circuits

59. Must comply with IEC 60601-1 ECG 60. Must comply with IEC 60601-2-27 61. ECG 12 lead with arrhythmia detection 62. Adult ECG lead must be supplied 63. The amplitude of the ECG trace must be

adjustable from 1 mV = 5 mm to 1 mV = 20 mm.

64. Digital display of heart rate : 30 - 300 bpm 65. Accuracy : 3 bpm 66. Resolution : 1 bpm 67. Differential input with CMRR > 80 dB 68. Input impedance > 10 MOhm 69. Respiration monitoring through ECG

electrodes

70. Pacemaker detection/rejection : 2 to 500 mV; 0,1 to 2 ms

71. Synch pulse for defibrillator OXYGEN SATURATION 72. It must be the latest technology with clinical

research support based on accuracy and real-time monitoring. Please submit the published peer reviewed/researched paper as supporting documents.

73. The unit should indicate whether the signal from the pulse oximeter sensor is adequate for reliable measurements. If the signal strength

9


YES/NO

REMARKS

or quality is inadequate, this must be clearly displayed.

74. An audible bleep must sound for each heartbeat. The pitch must vary with the oxygen saturation.

75. Measurement range : 0 - 100% 76. Accuracy: 77. 80 - 100% : 1,5% 78. 60 - 80% : 3,5% 79. Continuous waveform display 80. Digital display of SpO2%

81. The sensor lead must be at least 3 mettres long.

82. Automatic calibration for skin color 83. Pulse rate: 25 - 250 bpm NON-INVASIVE BLOOD PRESSURE 84. Must comply with IEC 60601-2-30 85. Oscillometric measurement method 86. Automatic, manual, and stat modes 87. Measure and display:

• Systolic pressure • Diastolic Pressure • Mean Pressure

88. The interval between measurements must be selectable from 1 to 60 minutes.

89. Ranges (approximate) : • Systolic : 30 - 270 mmHg. Resolution : 1

mmHg • Diastolic : 10 - 150 mmHg. Resolution :

1 mmHg • Mean : 20 - 250 mmHg. Resolution : 1

mmHg • Cuff pressure : 0 - 280 mmHg • Cuff inflation time < 10 s

90. Automatic deflation if measurement exceeds 3 min or if mains power fails

INVASIVE BLOOD PRESSURE 91. Must comply with IEC 60601-2-34 92. Measure and display:

• Systolic Pressure

10


YES/NO

REMARKS

• Diastolic Pressure • Mean Pressure

93. Systolic : 0 - 300 mmHg. Resolution : 1 mmHg 94. Diastolic : 0 - 250 mmHg. Resolution : 1 mmHg 95. Mean : 0 - 250 mmHg. Resolution : 1 mmHg TEMPERATURE

96. Range : 10 - 45 ˚C 97. Digital display 98. Surface and oral probe to be supplied 99. Accuracy: 0.3 ˚C 100. Resolution : 0.1 ˚C ALARMS

101. Visual and audio alarms 102. The monitor must automatically set default

alarms when switched on.

103. The alarms must be programmable 104. Alarm limits must be displayed with the

parameter digit

105. Heart rate alarm : 30 - 300 bpm 106. Asystole alarm 107. Arrhythmia alarms 108. Apnea alarm 109. Alarms for faulty/not-connected

electrode/probe

110. User Selectable Alarm Limits For Systolic, Diastolic and Mean Pressures

111. Alarm for incorrect NIBP cuff connection 112. Adjustable SpO2 high and low alarms: 113. High : 70 - 100% 114. Low : 50 - 95% 115. Adjustable high and low temperature alarms 116. Violation of limits must result in both audible

and visible alarms and indicate which parameter is affected.

117. The sound level of the audible alarm must be adjustable.

118. It must be possible to temporarily silence the audible alarm but not remove the visible alarm.

119. Duration of the silenced period: 2 minutes.

11


YES/NO

REMARKS

120. Mains Power Failure and Low battery alarm GENERAL

121. All cables and sockets must be color coded, labelled or otherwise prevented from being incorrectly coupled

122. The unit must be handed over in full operating order

123. A starter-pack of consumables must be supplied with the unit.

124. Transport monitor with at least 6.1-inch touchscreen display with modular concept to be provided.

125. Transport to have uninterrupted patient monitoring at the bedside and during transport

126. Monitor to have at least 4 invasive pressures 127. Transport monitor should have a battery

backup of at least 3hrs. off power

128. Monitor to have ffeature for integration with HIS and secondary display

129. Modular monitor that can hold up to 8 modules on a rack

130. Capability for wireless and LAN connectivity to the central station

131. Capability for 3rd party equipment connectivity to the monitor

STANDARD ACCESSORIES AND CONSUMABLES 132. Pediatric 3/5 lead ECG cables 5No.

133. Adult 3/5 lead ECG cables 5No. 134. ECG interface cable. 3No. 135. Reusable latex-free pediatric cuff 5No. 136. Reusable latex-free adult cuff 5No. 137. Reusable latex-free neonate cuff 5No. 138. Reusable latex-free obese cuff 5No. 139. NIBP hose 5No. 140. Finger sensor for paeds 5No.

141. Finger sensor for adults 5No.

142. Finger wrap-around probe for neonates 5No.

12


YES/NO

REMARKS

143. Spo2 interface cable 5No.

144. Five reusable temperature probes GENERAL 145. The unit on offer must be the latest

technology.

146. Monitor Front bezel 147. Battery 148. NIBP pump module 149. Wall bracket, height adjustable on which the

monitor can be mounted.

UPGRADE CAPABILITIES 150. EEG (UPGRADE)

151. Intra-cranial pressure (UPGRADE) 152. Cardiac output (UPGRADE) 153. CO2/EtCO2 (UPGRADE)

154. Built-in Printer (UPGRADE) 155. Apnea monitor for neonatal use (UPGRADE)

13

II. ECG MACHINE


YES/NO

REMARKS

1. Product Offered: 2. Make: 3. Model:

TECHNICAL SPECIFICATIONS 4. Twelve channel portable electrocardiograph 5. The unit must contain a recorder/printer. 6. The unit must have a display of at least approx.

15 inch color touch screen

7. High resolution display: at least 1024 x 768 XGA 8. The unit must do a self-test at power-on 9. Unit must have STEMI clinical decision support

10. The following must be displayed: 11. Heart rate 12. Patient ID 13. 12 lead waveforms 14. Lead identification 15. ECG gain 16. Paper speed 17. Filters 18. Electrode connection indicator 19. Messages and prompts 20. Clock with date and time 21. Battery power status 22. R-R analysis for 30 to 300 sec 23. Pacemaker detection 24. The display screen must be capable of

displaying two lines of text and a minimum of three ECG waveforms.

25. The unit must be supplied with a 10 lead ECG cable and be able to record 3, 6 and 12 lead configurations.

12 LEAD CONFIGURATION: 26. Lead I, Lead II, Lead III 27. AVR, AVL, AVF 28. V1, V2, V3, V4, V5, V6 29. Manual and automatic modes 30. The unit must be capable of ECG interpretation

for pediatric to adult.

14


YES/NO

REMARKS

31. Full alphanumeric keyboard or touchscreen 32. The unit must have facility for entering patient

data and text

33. The unit must offer a minimum of six pre-set ECG programs.

34. Event markers 35. Automatic indication of disconnected

leads/electrodes

36. Automatic check for incorrect lead placement 37. Full screen print preview of ECG waveforms

prior to printing

38. Heart rate recognition: peak-to peak detection. 30 - 300 bpm, accuracy 1 bpm

39. Electrode connection quality check. 40. Supported by standard HL7 and DICOM

interfaces for departmental and hospital systems.

41. Event markers to appear on ECG reports 42. Ability to show Interpretive statements on ECG

reports

43. Simultaneous acquisition of 12 leads 44. Frequency response: 0.05 - 150 Hz 45. Sensitivity: Automatic or selectable: 2.5 - 20

mm/mV

46. Automatic amplitude adjustment in the range of 2.5 to 40 mm/mV.

47. Sensitivity threshold: 20 µV 48. Input impedance: > 50 MΩ 49. Patient leakage current: < 10 µA 50. Calibration pulse: 1 mV 51. Filters: 52. 50 Hz 53. Low pass: 25, 35, 75, 100, 150 Hz 54. CMRR: > 100 dB 55. Sampling frequency: 1 kHz 56. Artifact rejection 57. Baseline stabilizer 58. Automatic and manual printout mode. 59. In addition to the required ECG waveforms the

printer must be able to print:

60. Device Settings

15


YES/NO

REMARKS

61. Heart Rate 62. Date and Time 63. Lead Identification 64. Calibration Pulse 65. Patient Data 66. The ECG printout must be available on A4 size,

Z fold paper.

67. Printer quality: 8 dots/mm (vertical), 20 dots/mm (horiz, 25 mm/s)

68. Paper speed must be selectable as follows: 25 and 50 mm/s.

69. Internal memory capable of storing at least 200 patient files.

70. External storage by means of SD card, USB, (or other) for at least 2 000 patient files

71. Internal protection against damage from 360 J defibrillator discharge.

72. The unit must have an internal battery with integrated charger

73. Battery capacity: at least 2 hours of continuous recording

74. The unit must be fully operable from mains power regardless of the internal battery condition.

75. A sturdy trolley to house the ECG machine and accessories must be supplied.

76. Trolley must have at least one drawer 77. Trolley must have at least four castors, two with

brakes

78. Mains cable at least four metres long with 13A, 3 pin UK plug .



81. ECG cable with adaptor clips 82. ECG electrodes (25/Pack) 5 Boxes 83. NIBP cuffs adult/pediatric 5No. each 84. SPO2 sensors adult/pediatric 5No. each 85. Dedicated trolley

STANDARDS

16


YES/NO

REMARKS

86. The unit must comply with an acceptable international electrical safety standard such as IEC 601-1 for medical equipment, attached certification

87. OEM must comply and certified on ISO 9001 quality standards, attach proof of compliance

88. Please provide unique ref number of the ISO 9001 certificate:



91. Model quoted for must be FDA and CE certified. Attach a copy of certification

92. Please provide unique ref number of the FDA and EC certificate:

93. ECG cable with adaptor clips 94. Dedicated trolley 95. Battery

17

III. DEFIBRILLATOR WITH SPO2, NIBP


YES/NO

REMARKS

1. Defibrillator to reverse fibrillation to a normal rhythm with ECG, peripheral oxygen saturation and NIBP monitoring

2. Product Offered: 3. Make: 4. Model:

TECHNICAL SPECIFICATION 5. The defibrillator offered must provide

ECG monitoring, a printer SpO2, and NIBP

6. The defibrillator, monitor, printer, SpO2 unit, NIBP, battery and battery-charger must be integrated into a single unit.

7. The defibrillator must deliver a bi-phasic impulse

8. The Defib paddles must be detachable from the cable or machine to exchange with AED pads

9. The defibrillator must have manual and automatic (AED) modes

10. Automatic mode must measure patient impedance and deliver an appropriate impulse automatically generated, between 0 and 250 J

11. The unit must offer audible/voice and on-screen messages for use during AED mode

12. Manual mode energy selection: 5 - 200 J 13. Selection of manual energy must be simple

with a clear unambiguous indication of the energy selected

14. The defibrillator must have the following selection of defibrillation:

15. a. Non-synchronous defibrillation 16. b. Synchronous defibrillation 17. The defibrillator must have external

paddles and PCI

18. The defibrillator must indicate if the synchronous mode has been selected.

18


YES/NO

REMARKS

19. The defibrillator must default to non-synchronous mode at initial switch on.

20. Synchronous defibrillation detection must be possible via ECG patient cable and via paddles

21. The synch marker must be clearly indicated on the ECG trace.

22. The defibrillator must operate from a 220 V, 50 Hz. supply

23. The defibrillator must contain a rechargeable battery which charges automatically when the defibrillator is plugged into the 220 V, 50 Hz supply.

24. The battery must charge whether the defibrillator is switched on or not

25. The defibrillator must have a visual indicator to indicate that the mains supply is switched on.

26. The internal rechargeable battery must be able to deliver at least 50 defibrillations at the maximum setting and provide a minimum of 2 hours ECG monitoring in the event of a mains power failure

27. Battery status indicator with audible and visual alarm for low battery

28. Audible tone while charging capacitor 29. Audible tone, different from above, to

indicate full charged capacitor

30. Visual indication of fully charged state 31. Defibrillating charge time to maximum

setting must not exceed 10 seconds.

32. In the event of a completely depleted battery, the defibrillator must be fully operable on the 220 V, 50 Hz supply.

33. The defibrillator must do an automatic self-test when switched on.

34. Override of test must be possible 35. Operation of the defibrillator must be user-

friendly with clear indications for:

36. Switch on; 37. Select energy; 38. Charge;

19


YES/NO

REMARKS

39. Discharge. 40. The defibrillator must be portable and

weigh less than 7 kg with all accessories attached

41. The unit must have a carry handle 42. The defibrillator must incorporate an

internal 50 ohms test load to allow a check for satisfactory functioning.

43. The defibrillator must incorporate an emergency dump circuit that will automatically provide a safe current path for unused energy when the paddles are charged but not discharged within sixty seconds.

44. The defibrillator must be able to do both internal and external defibrillation.

45. Energy selection must accommodate patients from paeds to adults for both internal and external defibrillation.

46. The defibrillator must automatically sense when internal paddles are in use and restrict the maximum selectable energy to 50 Joules.

47. Apex paddle to incorporate a push button to charge the defibrillator.

48. Energy discharge via defibrillator paddles to patient or test load must be activated by pressing buttons on both apex and sternum paddles simultaneously.

49. Energy discharge via AED pads or internal electrodes by means of a button on the panel

50. ECG monitoring must be possible through either the ECG leads or the paddles and unit must display the ECG lead selected (I, II or III)/(aVl, aVR or aVF) or indicate whether the paddles are the source of the ECG

51. Size of ECG: 0,5; 1; 2 and 4 cm/mV 52. Sweep rate: 25 mm/s 53. 50 Hz filter 54. Heart rate: 30 - 300 bpm

20


YES/NO

REMARKS

55. Analysis time: maximum 15 s 56. Artefact detection 57. Pacemaker detection

THE FOLLOWING ALARMS MUST BE DISPLAYED: 58. Low Battery, 59. No Paper (Printer) 60. ECG Lead Off/Fault. 61. Device must alarm audibly and visually

on violation of adjustable setting of LOW and HIGH heart rate

62. Alarm limit range: adjustable from 30 to 300 bpm (approximately) and 4 seconds of asystole.

63. The audible alarm should have a mute function to temporarily silence the audible alarm.

Audible alarm-silencing period: 120 s (max)

64. The screen must be visible under all lighting conditions.

65. Display size: Approximately 115 x 85 mm. 66. Display resolution: Approximately 320 x

240 pixels

DISPLAY TO INDICATE THE FOLLOWING: 67. Alarm Messages 68. Heart Rate 69. Systole Blinker 70. Alarm Limits

71. ECG, With Freeze Capability 72. A high-resolution, approximately 200 dpi,

printer must be incorporated in the unit

73. Two channel printer for ECG and SpO2 waveform

74. Printer sensitivity range 1 mV = 5 mm to 1 mV = 25 mm

75. Muscle artifact filter PRINT-OUT OF THE FOLLOWING:

76. ECG Trace 77. Spo2 Waveform

78. Date 79. Time

21


YES/NO

REMARKS

80. Energy Selected 81. Energy Delivered 82. Printer paper: 50 - 100 mm 83. Paper speed: 25 to 50 mm/s . 84. Manual and automatic printer modes. 85. Automatic mode must print ECG trace

before and after alarm/defibrillation conditions

86. Memory/storage: At least 1 hour of ECG recording with all significant events

SPO2

87. Alarm for max and min SpO2

88. Saturation range: 80 - 100%, accuracy within 2% to 3% for readings between 70 - 90%

89. Pulse rate range: 30 - 300 ppm, +- 5 ppm NIBP

90. Oscillometric measurement method 91. Ranges (approximate) : 92. Systolic : 30 - 270 mmHg. Resolution : 1

mmHg

93. Diastolic : 10 - 150 mmHg. Resolution : 1 mmHg

94. Mean : 20 - 250 mmHg. Resolution : 1 mmHg

95. Cuff pressure : 0 - 280 mmHg 96. Cuff inflation time < 10 s 97. All available adult reusable cuffs must be

supplied with the monitor.



STANDARD ACCESSORIES AND CONSUMABLES 100. 3-Lead ECG patient cable (x1)

101. ECG electrodes (25/Pack) 102. AED pads (x2 pairs - Paeds & Adults)

103. Cable for AED pads (x1) 104. Electrode gel (x1: 250ml)

105. Printer paper (x 10 rolls)

22


YES/NO

REMARKS

106. SpO2 sensor 5No.

107. SpO2 cable 3No.

108. BP hose 3 No. 109. BP cuff (Adult) 5No.

STANDARDS 110. The unit must comply with an acceptable

international electrical safety standard such as IEC 601-1 for medical equipment, attached certification





115. Model quoted for must FDA and EC certified. Attach a copy of certification

116. Please provide unique ref number of the FDA and EC certificate:

117. A 3-year warranty inclusive maintenance and service

118. The unit on offer must be the latest technology.

119. 3-Lead ECG patient cable (x1) 120. ECG electrodes (25/Pack)

121. AED pads (x2 pairs - Paeds & Adults) 122. Cable for AED pads (x1) 123. Electrode gel (x1: 250ml)

124. Printer paper (x 10 rolls) 125. SpO2 sensor

126. SpO2 cable

127. BP hose 128. Dedicated trolley 129. Internal paddles

130. Reusable external adult/pediatric defibrillator paddles

23


YES/NO

REMARKS

TRAINING AND INSTALATION 131. The installation and commissioning of the

equipment shall be considered complete after:




WARRANTY AND MAINTAINANCE 132. Free service during the warranty period



DOCUMENTATION 135. Operating manuals, service manual should

be supplied both in soft and hard copy. (User, technical, maintenance and service manuals to be supplied along with machine diagrams.) List of equipment and procedures required for routine calibration and maintenance.

24

3. FEEDING PUMP SPECIFICATIONS ITEM FUNCTION MET


COMMENT

1. Solutions obtainable

2. Weight, kg (lb) (DISPLAY) 0.5

(1.1)

3. The system should be Self-test enabled

4. Flow rate should be , ml/hr

5. Precision,

6. Should be mains power operated as well as equipped with Battery back up

7. Battery operation should be More than 20hrs off power

8. Power rated 220V/240V

ALERTS (CONFIGURATION)

AUDIO (ALERTS)

9. Different alarms warnings;

10. Intermittent, low battery;

11. Deviation of selected rate;

12. Permanent, incorrect rate

selection;

13. Occlusion;

14. Air-in-line;

15. End of batter;

25


COMMENT

16. Open door;

17. End of infusion;

VISUAL (ALERTS);

18. Intermittent, low battery;

19. Deviation of selected rate;

20. Permanent, incorrect rate

selection;

21. Occlusion;

22. Air-in-line;

23. End of battery;

24. Door open;

25. End of infusion.

STANDARDS

26. Should have safety certificate

from a competent authority

CE/FDA(US)

WARRANTY AND MAINTENANCE

27. Should offer warranty of at least

2 (two) years

28. Free service during the

warranty period

29. Maintenance manual detailing Complete maintenance

schedule and protocol

26


COMMENT


TRAINING AND INSTALATION

31. The installation and commissioning of the equipment will be considered complete after:




DOCUMENTATION

32. User and service manuals both in hard and soft copy in English shall be provided.

33. List of important spare parts and accessories with their part number and costing for the active life of the equipment




27

28

4. HOSPITAL BED SPECIFICATIONS S/No. Item Specifications Met

Yes/No comment

1. The hospital bed should be supplied complete with overbed feeding table and bedside lockers

Electrical 2. Shock protection Class1, Type B 3. Power in 3A max at 230Vac

50/60Hz

4. Power back up Inbuilt battery back up 5. Power adaptation British standard three

pin top plug

6. Electrical safety standards IEC60601-2-52

Dimensions 7. Standard length 2350mm 8. width 1030mm 9. Mattress length 2020mm

10. Mattress width 880mm 11. Overall extended length 2470mm

Angle 12. Head down tilt 12˚ 13. Foot down tilt 12˚ 14. Backrest angle 62˚ 15. Backrest pause 30˚ 16. Thigh angle 20˚ 17. Calf angle 20˚

Other specifications 18. Electrically operated

backrest, knee-break and height adjustment

19. Electrically operated Trendelenburg / Reverse Trendelenburg tilt

20. Auto-CPR and Auto-contour button Bio-Contour profiling system

21. One button chair position

29

S/No. Item Specifications Met Yes/No

comment

22. Dual sided CPR levers 23. Angle indicators for

backrest

24. Built-in bed extension with mattress platform extension

25. Removable head and foot panels with choice of color infills

26. Drainage bag rails 27. Removable plastic deck

sheets

28. Linked braking / steering system with four braking castors

29. 125mm single wheel castors

30. Additional brake pedals at head end Full width brake bar (foot end only)

31. Under-bed light 32. Folding safety sides rails

with a lock

33. Safety working load 250kg. maximum patient weight 185kg

34. shock protection 35. Standard Drip stand

holder

36. Should be fitted with anti-entrapment system and bed exit alarm

37. Should be supplied with a therapeutic alternating pressure mattress

38. Should have integrated weighing scale

BEDSIDE LOCKER 39. Overall length 500mm 40. Overall width 495mm

41. Overall height 890mm

30


comment

42. Top size 470mmx450mmx18mm 43. castors 65mm 44. Top material MDF core 45. Body material MDF with aluminum

extrusion corners

OVERBED TABLE 46. Split with tilt 47. Thermo foam PVC 48. Overall size 700mmx425mm

Or better

49. height 745mm to 1050mm Or better and adjustable

50. casters lockable RIPPLE MATTRESS

51. Electronic pressure settings

52. Should have variable cycle flow

53. Should have auto firm 54. Should have two modes

of operations: • Active/Alternative

mode • Reactive/Static

mode

55. Should have audio visual alarms

56. Should have modular construction concept/cell on cell technology

57. Should have Transport facility

58. Should have provision for CPR deflation

59. Mattress Dimensions: 850 x 1950 x 200mm

60. Should have light weight pump, with 10min & 20 min cycles

61. Pump should have audio and visual alarms

31


comment

DOCUMENTATION 62. User manual in English 63. Service manual in English 64. List of important spare

parts and accessories with their part number and costing for the active life of the equipment




TRAINING AND INSTALATION 68. The installation and

commissioning of the equipment will be considered complete after:




WARRANTY AND MAINTENANCE 69. Should offer warranty of

at least 2(two) years

32


comment




5. TECHNICAL SPECIFICATIONS FOR PEADIATRIC VENTILATOR.

S/NO. MINIMUM SPECIFICATIONS MEET SPECS? YES/NO.

REMARKS

PEADIATRIC VENTILATOR Compliance on each parameter with detailed substantiation how the other product meets the requirement. (simply writing as YES/Complied/As per FDA/CE/ISO terms is not allowed)

1. Microprocessor Control suitable for Pediatric ventilation;

2. Should have modes of ventilation equipped with newer modes of ventilation: 2.1) Assist/ Control 2.2) Volume Control 2.3) Pressure Control 2.4) Pressure Support 2.5) SIMV with pressure support (pressure and volume control) 2.6) PEEP 2.7) Inverse ratio ventilation 2.8) Noninvasive ventilation –BIPAP, CPAP

33


REMARKS

2.9) Apnea ventilation, user selectable ,volume & pressure control

3. Should have facility for Invasive and Non-invasive ventilation

4. Should have built in color screen TFT/LCD display of minimum 12 inches for display of waveforms and monitored values.

5. Should have inbuilt facility to upgrade with ETCO2.

6. Should have facility to measure and display the following parameters: 6.1) Airway Pressure (Peak & Mean) 6.2) Tidal Volume (Inspired & Expired) 6.3) Minute Volume (Inspired & Expired) 6.4) Respiratory Mechanics. 6.5) Spontaneous Minute Volume 6.6) Total Frequency 6.7) FIO2 Dynamic 6.8) Plateau Pressure 6.9) Intrinsic PEEP 6.10) Resistance and Compliance 6.11) User Selector Alarms for All Measured & Monitored Parameters 6.12) Occlusion Pressure 6.13) Pressure Flow & Volume Curves

7. Should have the following settings; 7.1) Tidal Volume (Minimum 2ml, Maximum up to 2000ml) pre-set range for both Neo-Natal & Pediatric modes to be provided 7.2) Inspiratory Pressure (up to 60cm of H2O) 7.3) Respiratory Rate 1 to 80 bpm 7.4) Apnea Back up rate

34


REMARKS

7.5) CPAP/PEEP 7.6) Pressure Support 7.7) FIO2 setting range between 21 and 100% 7.8) Pause time 7.9) Pressure/Flow Trigger 7.10) Inspiratory Flow up to 120Lpm

8. Automatic Compliance and Leakage Compensation For Circuit and ET Tube

9. Should have facility of event log, for events and alarms with date & time and capacity up to 72 hours.

10. Oxygen cylinder/central pipeline connector (British Standard)/(to be supplied along with the machine) should be compatible with ventilator

11. Disposable heat moisture exchanger, Qty 100 to be supplied with unit

12. User interface: Manual and automatic.

13. Software and /or standard of communication (wherever required):

a) Inbuilt software b) Convenient and quick

USB interface

PHYSICAL CHARACTERISTICS 14. WEIGHT(Ibs, kg): <50kg

including trolley.

15. Configuration: a) Compatible hanged arm for

holding the circuit b) Should have casters with

braking system

16. Noise (in (Dba) heat dissipation: a) Noise of device operation

max – 50dbA

35


REMARKS

b) Should have audio visual alarm for battery operation, battery low, Main power failure, source gas flow and high/low pressure in the breathing circuit or source gas inlet

c) Should maintain nominal temperature of the control unit and the heat should be disbursed through a cooling mechanism

d) Alarm volume –min 65dB 17. Mobility, portability: Standard

feature

ENERGY SOURCE (electricity, UPS, SOLAR, GAS WATER) 18. Power requirements: input

voltage 220VAC, 50Hz

19. Battery operated: a) Battery powered, silence

able alarm for power failure.

b) Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit

c) Internal, replaceable, rechargeable battery allows operation for at least four hours in the event of power failure.

20. Tolerance (to variations, shutdowns): Voltage corrector/stabilizer to allow operation at ±10% 0f 220V AC.

21. Power consumption: to be declared by the supplier.

ACCESSORIES, SPARE PARTS 22. Accessories & Spares:

a) Full face mask-5Nos each of 0.1 and 3

36


REMARKS

b) Nasal cannula for neonates-5 no’s

c) Reusable breathing circuit of silicone material(5Nos)

d) Disposable breathing circuit (50No.s)

e) Air & oxygen hose-1 each ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS

23. Atmosphere / ambiance (air conditioning, humidity, dust.):

a) Operating condition: capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90% in ideal circumstances.

b) Storage condition: capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.

24. User’s care, Cleaning, Disinfection & sterility issues: complete unit to be easily washable and serializable using alcohol and other chemical agents.

STANDARDS AND SAFETY 25. CERTIFICATIONS:

a) FDA(US) & CE (from notified body) from authorized third party and ISO 3485

b) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency

26. Local and/or international : manufacturer/supplier should have ISO certificate for quality standard.

TRAINING AND INSTALLATION

37


REMARKS

27. Training of staff (medial, paramedical, technical staff

a. Training of users in operation and basic maintenance shall be provided.

b. Advance maintenance tasks required shall be documented

28. WARRANTY AND MAINTENANCE 29. WARRANTY: 2 YEARS 30. Maintenance tasks:

a) Maintenance manual detailing

b) Complete maintenance schedule

31. Service contract clauses, including prices:

a) The spare, accessories & consumables list required for maintenance and repairs in future after guarantee/ warranty period should be attached

b) Free servicing during warranty period

DOCUMENTATION. 32. Operating manuals, service

manuals, other manuals : should be provided 2 sets (hardcopy) and soft copy of :

a) User, technical, maintenance and service manuals to be supplied along with machine diagrams.

b) List of equipment and procedures required for routine calibration and maintenance.

38

39

6. INFUSION PUMP SPECIFICATIONS


REMARKS

1. Should be operated on drip rate Peristaltic finger pump method.

2. Should be compatible with most of the IV set (macro/micro drip sets).

3. Should have the following flow rates.

4. IV Set ml/hr drops/min

a. 15 drops/ml 3~450ml/hr

1~100drops/min

b. 20drops/ml 3~450ml/hr

1~100drops/min

c. 60drops/ml 1~100ml/hr

1~100drops/min

5. Should have a flow rate accuracy of ±10% and drip rate accuracy of ±2%.

6. Should have a volume infused display from 0 to 999.9ml.

7. Should have a purge and KVO facility.

8. Should have an audible and visual alarm for occlusion pressure, air alarm, door open, Empty, Mains power failure, Battery Operation and low battery.

9. Should have an LCD display with backlight and graphical display of infusion should have a minimum 2hr battery back up at highest delivery rate.

10. Should work with input 200 to 240Vac 50 Hz supply.

40


REMARKS

11. Should have safety certificate from a competent authority.

12. Should be CE and FDA approved


13. Should offer warranty of at least 2(two)

years









DOCUMENTATION





41


REMARKS


42

7. STRESS TEST WITH TREADMILL SPECIFICATION ITEM FUNCTION MET


COMMENT

1. Analysis in an anatomically intelligent format. • View ST Maps, patented visual anatomical representation of ST

deviations in frontal and horizontal plan • Monitor ST changes with auto-comparison of current and reference beat

• Watch for ST level and slope changes using the 12-lead average

complexes. • Clearly see arrhythmias with Dominant Rhythm Change notifications.

• Access comprehensive and customizable reports with prognostic

indicators (Risk Scores Quickly identify anomalies with the dynamic Zoomed ST display. Pre-programmed standard exercise protocols Create, store and edit up to 100 protocols Three default user profiles (with different functions); administrator, clinician, technician Create up to 100 user profiles with specific usernames and passwords Default event labels with ability to add new event labels Username and password (including Windows and/or domain username and password)

TECHNICAL REQUIREMENTS WORKSTATION OPERATING SYSTEM 2. Windows 10 (standard, recommended)

64-bit

3. RAM: 16GB

4. Hard drive: at least 1 TB

5. DVD drive

6. LAN for in-hospital networking

7. 2 x RS232 ports (RS232-to-USB adapters available)

8. 4 x USB ports Keyboard and mouse Display: 19 in to 24 in display with 1920 x 1080 resolution Printers and laser or network printer

9. All-in-one computer with 24 in. HD (1920 x 1080) touchscreen or customer-provided display and Windows

Must have trolley with

43

ITEM FUNCTION MET SPECIFICATION

YES/NO

COMMENT

10. Mounting for all-in-one PC or customer-supplied wall-mountable display using VESA adapter

11. Integrated isolation transformer 12. Wire storage tray 13. Cable hook 14. Paper tray 15. Large writing surface 16. Storage drawer 17. Cabling with covered cable

management

18. 4 x locking casters POWER SUPPLY

19. Isolation transformer input voltage per local requirements, included with trolley

20. 240 V Supply 50Hz with a 3pin 13A UK standard top plug

TANGO BP SPECIFICATION. 21. Auscultatory, using R-wave gating and

k-sound analysis, during all static and active phases of stress testing Diastolic pressures correlate to K-5 Korotkoff sound

RANGE 22. Pressure: 23. Dia. 20-150 mmHg 24. Sys: 50-280 mmHg 25. Heart Rate: 26. 40-200 M (beats per minute)

Accuracy 27. Blood pressure measurements

determined with this device are equivalent to those obtained by a trained American National Standard, Manual, electronic or automated sphygmomanometers

ENVIRONMENTAL OPERATING CONDITIONS Operating:

28. 10°C (50°F) to 40°C (104°F) Less than 95% RH non-condensing.

Storage: 29. -20°C (-4°F) to 50°C (122°F)

Less than 95% RH non-condensing.

44


YES/NO

COMMENT

TO NOTE: The system might not meet its performance specifications if used or stored outside the specified temperate

POWER REQUIREMENTS 30. External power supply, Input: 220-240

VAC @ 1.6A max, 50-60 Hz. Output +9VDC @ 5A IEC 320 type input

CALIBRATION 31. The accuracy of cuff-pressure

transducers/indicators should be verified annually;

SAFETY SYSTEMS 32. Independent hardware over-pressure

circuit and redundant software overpressure algorithm to limit cuff redundant software timer algorithm to limit the duration of a blood pressure cycle to less than 180 second

DIMENSIONS 33. Size: 22.8 cm x 15.9 cm x 9.7 cm (9.0” x

6.3’’ x 4.1’’) Weight: 1.2 Kg

PULSE OXIMETER ACCURACY 34. 70 - 100% ± 2 digits (± 1 Standard

Deviation*).

PC AND DESKTOP SPECIFICATION 35. At least Core

i7/16GB/1TB/DVDRW/DOS/ With at least 19-inch Monitor + Win10 Prof + USB-to-serial port adapter.

TREADMILLS SPECIFICATIONS 36. User weight capacity up to 500 lb/227

kg

37. Safe, low-profile deck 7" (18 cm) from floor

38. 22" x 63" (56 x 160 cm) running surface Self-aligning running belt

39. Cushioned and reversible running deck 40. All steel chassis Powder Coat finish 41. Emergency stop and patient tether 42. Space Requirements 33" x 78.5" (84 x

199cm)

DRIVE SYSTEM 43. 220-240V, 50/60 Hz, dedicated 15A

service

SPEED RANGE 44. Zero start, .1—12 mph (. 16—19 kph)

45


YES/NO

COMMENT

45. Zero start, .1—15 mph (.16—24 kph) Self-calibrating.

ELEVATION RANGE 46. 0-25%

Self-calibrating

DISPLAYS TO INCLUDE: 47. Protocol/workout name 48. Stage number 49. Stage time countdown 50. Speed (mph/kph) 51. Pace (minutes/mile or km) 52. Distance (miles or km) 53. METS, total calories 54. Elevation 55. Body weight, age, gender input 56. Elapsed time

WARRANTY AND MAINTENANCE 57. Should offer warranty of at least

2(two) years


59. Maintenance manual detailing Complete maintenance schedule and protocols


TRAINING AND INSTALATION 61. The installation and commissioning of

the equipment will be considered complete after:




DOCUMENTATION

46


YES/NO

COMMENT

62. User and service manuals both in hard and soft copy in English shall be provided





47

8. SYRINGE PUMPS SPECIFICATIONS ITEM FUNCTION MET


COMMENT

1. Should be easy to use and nurse friendly

2. Should accommodate automatic syringe size and model detection

3. Should have large format LCD/TFT display.

4. Should have a minimum flow rate range from;

0.1 – 1200 ml/hr. for 50ml syringe, 100 ml/hr. for 20ml syringe and 0.1 – 60 ml/hr. for 10ml syringe.

5. Syringe range from 20-50/60 ml.

6. Should have a flow rate accuracy of ±2%

7. Should have a bolus rate up to 1000ml/hr. for 50 ml syringe.

8. Should have automatic and manual bolus.

9. Should have at least 3 levels of programmable occlusion pressure.

10. Should have automatic bolus reduction system to avoid accidental bolus delivery after occlusion incident.

11. Should have a rechargeable battery with back up time of minimum 3 hours.

48


COMMENT

Alarms

12. Pump must trigger following alarms with visual indication:-

13. Occlusion Pressure Alarm

14. KVO or 3 min pre-alarm

15. Syringe empty and volume infused alarm

16. Internal malfunction and Battery Charge Low Alarm

17. Syringe disengaged and incorrectly placed alarm

18. Alarm loudness control.

19. No mains alarm

20. Line disconnected (rapid pressure drop).

21. Should work with input 200 to 240Vac 50 Hz supply.

22. Should have safety certificate from a competent authority CE / FDA (US).


23. Should offer warranty of at least 2(two) years




49


COMMENT

The spare, accessories & consumables list required for maintenance and repairs in future after guarantee/ warranty



a) Training of users on operation of the machine.

b) Training of Biomedical engineering team on the care and maintenance of the unit


DOCUMENTATION






50

51

9. CATHETERIZATION LABORATORY (CATHLAB) TECHNICAL SPECIFICATION

S/No. MINIMUM SPECIFICATIONS MEET

SPECS? YES/NO.

REMARKS

GENERAL DESCRIPTION 1. Proposed system should be a

dedicated biplane system for peripheral vascular, neuro angiography, cardiac interventional procedures, 3D rotational angio & CT imaging is required for peripheral and neuro diagnostic & interventional procedures

2. The system should be state of the art, high resolution flat detector technology

3. The Cath lab should be EP (electrophysiology study capable- (workstation, mapping Eg.carTo system, stimulator and Ablator

4. The cathlab should have the following auxiliary equipment;- • IFR /IVUS/OCT. (single machine

profinding all 3 will be preferred) • Rotor blater upgrade

(ROTORPRo ) • IBP –intra-Aortic balloon pump

upgrade • lithotripsy to be provided

5. The system should be capable of real time digital angiography acquisition.

6. Model/ Version should be recently launched within a period of 2 yrs.

7. All support services for the supplied model should be available for at

52

S/No. MINIMUM SPECIFICATIONS MEET SPECS? YES/NO.

REMARKS

least 10 yrs. from the time of installation

GANTRY 8. The system should have two C-

arm gantries: one floor mounted and one ceiling suspended providing full body coverage. Both gantry movements should be rapid, motorized and collision proof.

9. Manual override by the operator should be possible. Gantry angulations & rotations in both planes, frontal and lateral should be freely user selectable to satisfy clinical imaging needs.

10. All movements of the gantries should be controlled from the joystick on the table-side as well as from the control desk.

11. The system should have at least user defined 25 programmed positions and angulations of C- arm.

12. Both gantries should have fast speed for angulations and positioning. The frontal system should have a speed of at least 15 deg/sec for all positions and lateral plane should have a speed of at least 8 deg/Sec.

13. Gantry angulations & rotations in both planes, frontal and lateral should be freely user selectable to satisfy clinical imaging needs.

14. System should have an automatic positioning capability as projected from relevant reference image including 3D images.

53


REMARKS

15. Head to toe coverage with any one plane gantry should be possible.

16. Full configuration, positioning range, speed, weight of the c-arms with and without the tube / detector assembly should be clearly mentioned in the offer.

PATIENT TABLE 17. The table should be

ergonomically designed, made of radiolucent carbon fibre, contoured for all neuro radiological examinations & interventional procedures. Suitable soft mattress, easy to clean & to last long should be provided. It should adequately support patients who are tall & heavy weight at least 200 kg

18. It should be possible to swivel the table in case of emergencies.

19. All patient positioning accessories to be supplied (Head holders-2, Chin support-2, Abdominal compression device-2, Arm support for brachial approach-2, body straps-2, shoulder harness-2, ankle restrainer-2, as well as sand bags for thickness compensation for the head - adult & Paediatric)

20. Fully ergonomic foot switch should be provided

21. Gantry Collimator & table operations must be possible from control room as well as exam room.

22. Table side controls for 3D reconstruction and C-Arm

54


REMARKS

positioning with respect to 3D image & selection of 3D image with respect to C-arm positioning should be provided.

23. The table should have motorized, longitudinal, vertical travel and floating tabletop for longitudinal and transverse movements with electromagnetic locking facility.

24. Accessories for the table & table mattress:

• Should include Sand bags for thickness compensation for the head.

• adult & paediatric (n-1 each), • Arm supports-

catheterization arm support (n-2),

• Foot support (n-4), • Accessory clamps (n-2)

25. It should have the facility for automatic bolus chase for peripheral angiography.

X -RAY GENERATOR AND TUBES 26. The generator should be high

frequency (at least 100KW at 100 KV or more) microprocessor controlled for constant output for radiography and fluoroscopy.

27. Radiography KVP range should be between 40-125 KV.

28. Generator should have automatic exposure control device for radiography, fluoroscopy, and angiography mode.

29. Generator should have tube overload protection.

30. It should have digital display for KVP & mAs.

31. Pulsed fluoroscopy at variable rates for reducing the X- ray dose to the patient during

55


REMARKS

interventional procedures should be possible without image drag during pulsing intervals.

32. Anode heat storage capacity for the X- Ray tubes should be at least 2.4 MHU or more having liquid bearing technology or metal lubricant for optimal heat dissipation and noiseless operation. Maximum continuous heat dissipation rate should not less than 3 kW.

33. The system should have adequate cooling facility for the X-ray tubes for uninterrupted performance and should have long shelf life. Please mention.

34. Cooling rate or Anode Heat Dissipation of X- ray tube should be at least 3000 W or more.

35. The system should have adequate cooling facility for the X-ray tubes for uninterrupted performance & should have long self life.

36. Adequate filtration for clinical setting should be provided & clearly mentioned in the offer.

37. Leakage radiation should conform to international standards. Filtration & leakage radiation dose should be indicated in the offer.

38. The lateral plane tube should be mounted on the far side (left of the patient) of the ceiling suspended C- arm to reduce scatter radiation to operator.

39. One collimator for each plane with motorized transverse, transverse & hexagonal leaves to be provided. The collimator leaf

56


REMARKS

should have IRIS type arrangement.

40. The collimator should have facility for automatic copper pre-filtration for reducing X-ray dose as per patient thickness. Additional filters with multiple leafs should be provided & it should be possible to position these filters & collimators leafs without live fluoroscopy & independent of each other.

41. The collimator should have integrated dose measurement chamber to display skin dose on the live monitors in the lab

42. Automatic rotation of the displayed live image at all positions of the C-arms relative to the table should be possible, keeping the head- end of the image uppermost in the monitor. It should also be possible to rotate the image from control consoles as per user preference.

FLAT PANEL DETECTORS 43. Detector in the Frontal Plane

should have a minimum of at least 30 x 40cm or bigger.

44. Detector in the Lateral Plane should have a minimum of at least 30 x 30cm or bigger

45. Please mention detector zoom fields

46. Detector quantum efficiency should be 70% minimum

47. Detector pixel size should be at least 200 microns, the lower will be preferred for better resolution.

MONITORS 48. Six TFT/LCD monitors at least

19” in size, for each plane for

57


REMARKS

display of live, reference and subtracted image with high resolution flicker free display should be provided or a single high resolution monitor of at least 56” and 8 megapixel resolution to display live and reference image from each plane, patient hemodynamic monitoring, 3D image and input from external ultrasound. One medical grade 19” monitors should be provided as back up.

49. Monitors should be of flat TFT technology permitting high resolution image display & undistorted viewing from any angle in ambient lighting.

50. Similarly Two high resolution medical grade TFT/LCD monitor for live image of both planes and one color monitor for 3D workstation in control room.

51. Additional 19” high resolution color TFT monitor should be provided in the examination room.

52. The TV stand should be ceiling suspended & easily manoeuvrable to suit the operators viewing.

53. Display of parameters of the tube, radiation dose, C-arm positions & orientation should be provided on the monitors in the examination room.

PRESSURE INJECTOR PUMP 54. Pressure injector pump of stand–alone

type desirable. High pressure injector for contrast delivery.

55. Feasibility of reusable and disposable syringes.

56. 100 disposable / reusable syringes to be provided.

58


REMARKS

57. Syringes of at least 150ml capacity with min 200 disposable syringes.

58. All accessories including rubber pushes -10 extra numbers

59. Make and model of the injector to be mentioned in the offer along with the brochure

OPERATOR LAMP 60. Ceiling- mounted examination lamp,

flexibly adjustable towards the user, for diagnostics and minor surgery.

61. Luminance: 50,000 Lux (4,650) for 100 cm distance

62. Working distance: 70 to 140 cm 63. Color rendering index Ra (gen): 96 64. Color temperature: 4,3000 Kelvin 65. Focusable spot size: 14 to 25 cm 66. Light body diameter: 22 cm 67. LED Technology light system, Power

supply, 230/240 V

DIGITAL IMAGING SYSTEM & SOFTWARE 68. Biplane digital pulse fluoroscopy at

variable pulse frequencies from 10 to 30p/s should be available at 1024 x 1024 matrix preferably with real time and motion detection.

69. Availability of vascular analysis software both in examination room and console room.

70. System should be capable of virtual collimation of the shutters and wedges in the last image to reduce the X- ray dose.

71. Grab function to allow storage and archiving of both a fluoro image.

72. Lower & Upper Body Protection Shield to be provided.

73. Pivot or Swivel of the Table should be provided.

74. Facility to use the reference image as a roadmap by superimposition of fluoro

59


REMARKS

image on the reference image should also be provided for both planes.

75. The Biplane Dual Fluoroscopy mode allows side-by-side display of digitally processed non- subtracted fluoroscopy and trace-subtract fluoroscopy for visualization and catheter guidance during complex procedures.

76. It should have an optimum image storage capacity of images in 1024 x 1024 matrix.

77. System should be DICOM compatible and PACS connectivity should exist.

78. Archiving of all the patient images on a CD/DVD should be provided.

79. The digital system should high resolution subtracted fluoroscopy in both planes (simultaneous & random). It should be possible to display subtracted and native images for both planes simultaneously alongside the reference image in the examination room.

80. Automatic pixel shift during road- mapping should be available.

81. Access to all series / images should be fast & possible from the control room as well as the examination room.

82. Digital rotational angiography at a speed of up to at least 30deg/sec or more should be available.

83. System should have advanced image processing techniques for; real time edge enhancement, real time harmonization, real time noise reduction and dose correction algorithms.

84. The system should be capable of giving 3D image and CT image from the same acquisition.

85. Digital subtraction angiography software for automatic pixel shift,

60


REMARKS

enhancement for iodine and CO2, contrast should be possible.

86. Remote service should be provided for hardware and software remote diagnosis.

87. Subtracted Bolus Chase: For visualization of lower peripheral vessel structures wherein the contrast bolus is followed interactively by a motorized table scan movement.

88. 2D/DSA Roadmap

• Roadmap should have presets application wise (Abdomen, Peripheral & Neuro).

• Should also be able to select the procedures like Navigation, Coil, Stent, Glue, and Particle in the Roadmap to visualize different materials.

89. Intervention Tools

• System should have integrated 3D Rotational Angiography application wherein the rotational scan data can be automatically sent to integrated interventional tool for creating 3D view for lesion assessment.

90. System should have an integrated 3D workstation for reconstruction of images in 3D and display of 3D images and control in examination with following advanced features.

• 3D reconstruction using SSD, VRT, MIP in true 512 matrix with colour display in the control & Examination room.

• Reconstructive zooming, spine view, calci view automates vessels analysis, computer assisted Aneurysm analysis, virtual

61


REMARKS

stenting & automatic voxel shift should be possible.

• Stereoscopic display of 3D reconstructed image on the workstation. If available should be quoted separately as an optional item.

• Retrieve & review any image / any series from the system disc independent to the ongoing work on the main system

• Retrieve & review any image / any series from the PACS independent of the ongoing work on the main system.

• All Post-processing functions for images including fusion of CT, MR and angio images with 3D display & 3D volume measurement. Immediate background transfer of all images as soon as they are acquired, to the PACS.

• Compose & hardcopy images independent of the ongoing work on the main system. Split screen function to be provided to facilitate comparison of different sets of images.

• It should be possible to view dual density objects in one view to differentiate blood vessels form coils, devices in neuro exams.

91. Post processing software facilities with real time edge enhancement, re-masking, peak opacification, image inversion, anatomical background display, windowing, electronic shuttering, roaming, zooming and magnifying with text and annotation

62


REMARKS

functions should be provided. All essential post processing functions should be possible from table side consoles and from the control room.

92. Access to all series/ images should be fast & possible from the control room as well as the examination room.

93. The digital system should have facility to acquire & store physiological signals (ECG trace etc) along with the images. All images should register & display the date time, acquisition rate & image number in the series as well as the frame photo file.

94. Selection of venous phase DSA image as roadmap should be possible. It should be possible to have independent windowing of live fluor image and roadmap image.

95. Soft Tissue Imaging: CT option to visualize soft tissue by rotational scan of the cathlab gantry. The CT 3D volume can be viewed in control room and examination room also.

• Contrast resolution for soft tissue imaging should be up to 5 HU.

• Image reconstruction should be fast & automatic

• It should be possible to post process CT images (set slice thickness, distance & angle measurement etc.) Both in the control room & the examination room.

• It should be possible to fuse the 3D CT data with 3D angio to combine high resolution vessel information with soft tissue information.

• It should be possible for different

63


REMARKS

density structures such as bone, contrast filled vessels, stents, clips & coils to be identified separately in image in real time.

96. Beyond the clot visibility: Protocol for viewing the vasculature beyond the clot thru Bolus injection using the retrograde filling. Should have the feature to display Vessel Structures Before and After Occlusions in Ischemic Stroke Intra – venous injection protocol using High Resolution soft tissue CT imaging inside Cath lab.

HEMODYNAMIC RECORDER. 97. 1. 12 channel EKG waveform

display. 2. 2 or preferably three invasive

pressure display and necessary reusable transducers (10) cables connectors. Display should be adjustable scales with at least 8 different scales (0-20, 0-30 ,0-50, 0-100,0-200.0-300,0-400)

3. dp/Dt Waveform display 4. SPO2 monitoring and display

of waveform and value; necessary equipment should address (reusable paediatric/adult clip spo2 sensor, spo2 adapter cable.

5. Should provide 4 transducers. -connector cables

6. Laser printer to be supplied. 7. Should have all calculations

packages and pressure wave form analysis, valve area format

98. Subtracted Bolus Chase: For visualization of lower peripheral

64


REMARKS

vessel structures wherein the contrast bolus is followed interactively by a motorized table scan movement.

99. 3D Dynamic Road mapping to reduce contrast and time, should allow overlay of real- time 2D fluoro images, CT images (Acquired in Cath) on the 3D vessel image to see the advancement of the guide wire, catheter and coils on the 3D volume in real time. Roadmap should have presets application wise (Abdomen, Peripheral & Neuro). Should also be able to select the Procedures like Navigation, Coil, stent, Glue, Particle in the Roadmap to visualize different materials.

100. The 3D images should be able to superimpose on the acquired CT datasets.

101. 2D PERFUSION: 2D Perfusion high-definition visualizations should be based on special DSA (Digital subtraction angiography) acquisition protocols dedicated per anatomical region or any other equivalent protocols, which should show small blood vessels and parenchymal enhancement

• Should support subtracted X- ray exposure runs acquired with a 2D perfusion protocol.

• It should be possible to select the individual frames where the presence of contrast is detected to reduce motion artifacts.

• 2D perfusion should provide different options for exploring the time-to density curve, which quantifies the presence of contrast at a certain point in time:

65


REMARKS

• By drawing a region of interest (ROI) the curve in the analysis graph should be updated automatically.

• In procedures that compare left and right hemispheres, it’s possible to draw a mirror line, and compare the perfusion behaviours in the ROI on the hemisphere suspected to have a perfusion alteration, with the normal perfused hemisphere.

• Parameters: Mean transit time, Arrival time, Time to peak, wash in rate, width and area under curve.

102. CD Recording and Archival

• DICOM 3.0 based CD recording for recording on CD/ DVD. CD review DICOM CD’s

• System should have ability to record DSA runs on the CD and the embedded viewer should support review of these DSA runs at referring physician’s PC.

• The workstation provided should have the ability to view CT and MR images also.

• The complete digital system along with workstation should be networked and connected to a DICOM compatible laser camera and it should be possible to hardcopy from the main system as well as the 3D workstation. All image & photofile transfers from the main system & the workstation should be instantaneous permitting rapid

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review & hardcopy

• The digital system should have software for vascular analysis and quantification including stenosis quantification, auto–calibration (to the catheter ID) automatic contour recognition, slicing, measurement tools for distance, angle, surface area, circumference & volume assessment. All quantification functions should be possible from table side as well as from the control room.

• One pressure injectors compatible with the system from branded company or better make, pedestal mounted, single barrel, along with 50 disposable syringes.

• Online UPS for the complete system including the X- ray system for both planes with at least 15 min. back up.

103. Radiation Protection:

• Any available special software required for reduction of X-ray dosage given to patient should be offered as part of the standard offer and not as an added option. This includes and encompasses all and any kind of software, image processing tools etc. for reducing dose. It is re-integrated that the basic standard offer should include all the software, hardware etc. for this and related functions. Any offer which includes additional components as options will be summarily rejected.

• The system should have integrated computer controlled X- ray beam filtering with copper

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REMARKS

filters of varying dimensions.

• The system should have positioning of collimator blades without radiation exposure.

• The system should have monitoring and display of X- ray dose during the patient examination.

• Lead Glass 100 x 80 cms or bigger with lead equivalent as prescribed by IAEA or KeNRA recommendations (for control room window) to be fixed between console room and gantry room for radiation protection.

• Ceiling suspended radiation protection system and tableside protection system for the operator

• Lead glass upper shield mounted on a movable stand one on each side of the angiography table to protect the angiographer from the radiation source to be provided preferably form the branded well known radiation protection device supplying company.

• Lead protection Accessories (lead aprons and thyroid shields) 15 nos. each.

• Note: Lead aprons should be of standard state of the art make, lightweight, should be double sided. 7 of which should be two-piece and remaining 8 should be single piece. Design should be wrap around. (Confirm the design before supply) It should have lead equivalent of 0.5 mm.

• Thyroid shield should have lead

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equivalent of 0.5mm

• Radiation protection Visors/ Light weight lead goggles (for operator use) x 6 numbers

• Metal stands to hold the 15 lead aprons.

• 2No. Patient monitoring systems to monitor ECG, heat rate, invasive & non-invasive pressures in the exam room with slave monitor to display all the parameters in the control room. The slave monitor should be 19” colour TFT/ LCD monitor.

STANDARDS AND SAFETY 104. System should be FDA and CE

approved

105. System should conform to standards for electrical safety IEC -60601/ ISO -13450

106. Should comply with IAEA and KeNRA Guidelines.

INSTALLATION AND COMMISSIONING 107. • The chosen supplier would be

expected to to undertake a Turnkey project wherein necessary work at the present site will include all the Civil works as detailed in ANNEX 1.

WARRANTY AND COMPREHENSIVE AMC 108. Warranty: Warranty should be for a

minimum period of Three years from the date of successful Installation, Commissioning, Training and acceptance of the system. System will be considered as successfully installed, commissioned and accepted only after satisfactory training of the users and technical team, as well as demonstration to the concerned

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Doctor (HOD, cardiology) and concerned Biomedical Engineer.

109. A certificate has to be collected from HOD, Cardiology & Hospital Biomedical Engineer, /medical director to prove that all the items supplied as per purchase Order are installed & commissioned satisfactorily.

110. Comprehensive AMC: a) company should enter into comprehensive AMC as per the terms & conditions of TNMSC for a period up to end of life support of each equipment. The supplier should specify the date of end of life support.

GENERAL REQUIREMENTS 111.

Basic support biomedical engineer should be available on site during the whole life period of equipment.

112. After each service, the service engineer should submit the detailed service report of each work carried out and get the same signed by Hospital Biomedical Engineer record the same in the log book along with the satisfactory service report from the user in the work permit issued.

113. The equipment should address EPP-electrophysiology

MR/CT Roadmap: Should extend the capabilities of the integrated 3D product by providing a sustainable 3D roadmap based on previous acquired CT or MR scans to support interventional procedures. The MR/ CT Roadmap option should be able to match the real-time 2D fluoroscopy images with the 3D volume of CT or MR.

114. Real- time needle guidance in the angio suite: Virtual needle paths to be created on a soft Tissue CT dataset or on the previous acquired CT or MR dataset. This option should match the real-time 2D fluoroscopy images with the 3D volume of soft Tissue CT, CT

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or MR; to visualize the actual needle path versus the virtual path previously planned.

115. The real time needle guide should have laser tool for positioning aid.

116. Guide Ablation options should enable to visualize the isotherm of the ablation needles during the planning phase of the real time guide. This tool should facilitate the planning of tumour ablation procedures. It should allow the positioning of multiple needles and visualizing the combined action of the ablation zones.

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10. TECHNICAL SPECIFICATIONS FOR VENTILATOR.


REMARKS

VENTILATOR Compliance on each parameter with detailed substantiation how the other product meets the requirement. (simply writing as YES/Complied/As per FDA/CE/ISO terms is not allowed)

1. Microprocessor Controlled Ventilator with integrated facility for ventilation management for Adults/ Paediatric/ Infant/ Neonates. (All age groups)

2. Should have modes of ventilation equipped with latest modes of ventilation including: 2.1) Assist/ Control 2.2) Volume Control 2.3) Pressure Control 2.4) Pressure Support 2.5) SIMV with pressure support (pressure and volume control) 2.6) PEEP 2.7) Inverse ratio ventilation 2.8) Noninvasive ventilation –BIPAP, CPAP 2.9) Apnea ventilation, user selectable ,volume & pressure control

3. Should have facility for Invasive and Non-invasive ventilation

4. Should have built in color screen TFT/LCD display of minimum 12 inches for display of waveforms and monitored values.

5. Should have the following display: • At least 3 waves- Pressure and

time, Volume and time and Flow and time.

• At least 2 loops’ P-V, F-V with facility of saving of 1 loop for reference.

• Graphic display to have automatic scaling for waves

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• The 2 loops and 2 waveforms should be displayed simultaneously.

• End tidal CO2 with capnography integrated I the ventilator with display of value and ETCO2 on the same screen of ventilation should be optionally available.

• Trending facility for at least 72 hours.

• Automatic compliance and leakage compensation.

6. Should have facility to monitor and display the following parameters: 6.1) Airway Pressure (Peak & Mean) 6.2) Tidal Volume (Inspired & Expired) 6.3) Minute Volume (Inspired & Expired) 6.4) Respiratory Mechanics. 6.5) Spontaneous Minute Volume 6.6) Total Frequency 6.7) FIO2 Dynamic 6.8) Plateau Pressure 6.9) Intrinsic PEEP 6.10) Resistance (Inspired & expired) and Compliance(Static and dynamic) 6.11) User Selector Alarms for All Measured & Monitored Parameters 6.12) Occlusion Pressure 6.13) Pressure Flow & Volume Curves

7. Should have the following settings for all age groups; 7.1) Tidal Volume 2ml to 2000ml 7.2) Pressure 0-60cmH2O 7.3) Respiratory Rate 5 to 100 bpm or more 7.4) CPAP/PEEP: 0-45cnH2O 7.6) Pressure Support: 2 to 70cmH2O 7.7) FIO2: 21 to 100% 7.8) I:E ratio: 1:4 to 4:1

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7.9) Pressure and Flow Trigger 7.10) Inspiratory Flow up to 120Lpm

8. Automatic Compliance and Leakage Compensation For Circuit and ET Tube

9. Should have facility of event log, for events and alarms with date & time and capacity up to 72 hours.

10. Integrated ultrasonic vibrating mesh technology nebulizer/Inbuilt jet nebulizer/Inbuilt pneumatic nebulizer should be standard with supply of required nebulization chamber.

11. The ventilator shall be supplied with servo-controlled humidifier from the same manufacturer of Fisher Paykel with suitable reusable chamber for neonatal, paediatric and adulty patients.

12. Oxygen cylinder/central pipeline connector (British Standard)/(to be supplied along with the machine) should be compatible with ventilator

13. Disposable heat moisture exchanger, Qty 100 to be supplied with unit

14. User interface: Manual and automatic.

15. Software and /or standard of communication (wherever required):

23. Inbuilt software 24. Convenient and quick USB

interface

PHYSICAL CHARACTERISTICS 16. WEIGHT(Ibs, kg): <50kg including

trolley.

17. Configuration: c) Compatible hanged arm for

holding the circuit d) Should have casters with

braking system

18. Noise (in (Dba) heat dissipation:

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e) Noise of device operation max – 50dbA

f) Should have audio visual alarm for battery operation, battery low, Main power failure, source gas flow and high/low pressure in the breathing circuit or source gas inlet

g) Should maintain nominal temperature of the control unit and the heat should be disbursed through a cooling mechanism

h) Alarm volume –min 65dB 19. Mobility, portability : Standard

feature

ENERGY SOURCE (electricity, UPS,SOLAR, GAS WATER) 20. Power requirements: input voltage

220VAC, 50Hz

21. Battery operated: d) Battery powered, silence able

alarm for power failure. e) Battery charger to be integral

to mains power supply, and to charge battery during mains power operation of unit

f) Internal ,replaceable, rechargeable battery allows operation for at least four hours in the event of power failure.

22. The Ventilator should have a standard hinged arm holder for holding the circuit. The arm shall be from the same Ventilator OEM.

23. Tolerance (to variations, shutdowns): Voltage corrector/stabilizer to allow operation at ±10% 0f 220V AC.

24. Power consumption: to be declared by the supplier.

ACCESSORIES, SPARE PARTS

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25. Accessories & Spares: f) Full face mask-5Nos each of

0.1 and 3 g) Nasal cannula for neonates-5

no’s h) Reusable breathing circuit of

silicone material(5Nos) i) Disposable breathing circuit

(50No.s) j) Air & oxygen hose-1 each k) Number of disposable and/or

external flow sensors required over a period of a year/Replacement hour period must be mentioned considering continuous use of the ventilator. Min. 10No. startup kit supplied.

l) Oxygen Sensor, if considered as consumable, the cost and life of the cell from the OEM should be indicated and the supplier should provide the O2 cells for at least 5 years as and when required without any extra cost.

ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS 26. Atmosphere / ambiance (air

conditioning, humidity, dust.): c) Operating condition: capable

of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90% in ideal circumstances.

d) Storage condition: capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.

27. User’s care, Cleaning, Disinfection & sterility issues: complete unit to be easily washable and serializable

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using alcohol and other chemical agents.

STANDARDS AND SAFETY 28. CERTIFICATIONS:

c) FDA(US) & CE (from notified body) from authorized third party and ISO 3485

d) Relevant IEC-60601-Part 1 & 2, certificates by a notified agency

29. Local and/or international : manufacturer/supplier should have ISO certificate for quality standard.

TRAINING AND INSTALLATION 30. Training of staff (medial,

paramedical, technical staff c. Training of users in operation

and basic maintenance shall be provided.

d. Advance maintenance tasks required shall be documented

WARRANTY AND MAINTENANCE 31. WARRANTY: 2 YEARS 32. Maintenance tasks:

c) Maintenance manual detailing d) Complete maintenance

schedule


c) The spare, accessories & consumables list required for maintenance and repairs in future after guarantee/ warranty period should be attached

d) Free servicing during warranty period

DOCUMENTATION. 34. Operating manuals, service manuals,

other manuals : should be provided 2 sets (hardcopy) and soft copy of :

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c) User, technical, maintenance and service manuals to be supplied along with machine diagrams.

d) List of equipment and procedures required for routine calibration and maintenance.

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BILLS OF QUANTITIES S/NO. EXPECTED EQUIPMENT QTY UNIT PRICE

(US$) TOTAL (US$)

1 CARDIAC MONITOR FOR NEONATAL AND PAEDIATRICS

2

2 CARDIAC MONITOR, ECG MACHINE AND DEFIBRILLATOR

I CARDIAC MONITOR 4

II ECG MACHINE 1

III DEFIBRILLATOR 1

3 FEEDING PUMP 24

4 HOSPITAL BED 6

5 PEADIATRIC VENTILATOR 2

6 INFUSION PUMP 24

7 STRESS TEST WITH TREADMILL

1

8 SYRINGE PUMPS 24

9 CATHETERIZATION LABORATORY (CATHLAB)

1

10 VENTILATOR 6

TOTAL CARRIED TO SUMMARY TABLE

Documents

VOLUME 4 - SUPPLY AND INSTALLTION OF CATHETERIZATION