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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital EQUIPMENT 1 AUDIOMETER, TESTING BOOTH Acoustic Performance Frequency (Hz) Noise Reduction in dB * As per recommendation by Act Standard Room Dimension External Dimension Internal Dimension Door Perimeter 1200 W x 950 L x 2100 mmH 1000 W x 750 L x 1800 mmH 710 W x 1780 mmH Wall Panel Thickness External Acoustic Infill Internal 100 mm 2.3mm M.S painted with epoxy finishing 60 - 80kg/m3 0.7mm M.S Cold Rold painted with epoxy density Rockwool. Floor Construction Thickness Upper Surface Bottom Surface 100 mm 3.0 mm M.S c/w structurally reinforced Loaded with vibration isolator acting as Floating Floor. Door Construction Flush Mounted c/w magnetic-seal Jack Panel Standard Features 3 ring tip with sleeve stereo plug completely wired Double glazed observation window Carpeted floor Absorptive acoustic ceiling Lighting & Electrical Connection Ventilation Silencers for Inlet and Outlet Jacked panel Environment Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive EQUIPMENT 2 AUDIOMETER, CLINICAL SPECIAL TESTS/TEST BATTERY Minimum 2 channel speech, 2 channels Master Hearing Aid and Auto threshold feature. Auto threshold tests : Available time for patient to respond: Same as tone presentation Increment of hearing level: Minimum 5dB. Auto threshold test (Békésy): Mode of operation: Békésy Rate of level change: Minimum 2.5 dB/s ±20% Smallest increment of level: 0.5 dB

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Page 1: 4th Batch Equipmentv

TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 1 AUDIOMETER, TESTING BOOTHAcoustic Performance

Frequency (Hz)Noise Reduction in dB

* As per recommendation by Act

Standard Room Dimension

External DimensionInternal DimensionDoor Perimeter

1200 W x 950 L x 2100 mmH1000 W x 750 L x 1800 mmH710 W x 1780 mmH

Wall Panel

ThicknessExternalAcoustic InfillInternal

100 mm2.3mm M.S painted with epoxy finishing60 - 80kg/m30.7mm M.S Cold Rold painted with epoxy density Rockwool.

Floor Construction

ThicknessUpper SurfaceBottom Surface

100 mm3.0 mm M.S c/w structurally reinforcedLoaded with vibration isolator acting as Floating Floor.

Door Construction Flush Mounted c/w magnetic-sealJack Panel

Standard Features

3 ring tip with sleeve stereo plug completely wired

Double glazed observation windowCarpeted floor Absorptive acoustic ceiling Lighting & Electrical Connection Ventilation Silencers for Inlet and Outlet Jacked panel

Environment Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive

EQUIPMENT 2 AUDIOMETER, CLINICALSPECIAL TESTS/TEST BATTERY Minimum 2 channel speech, 2 channels Master Hearing Aid and

Auto threshold feature.

Auto threshold tests: Available time for patient to respond: Same as tone presentationIncrement of hearing level: Minimum 5dB.Auto threshold test (Békésy):Mode of operation: Békésy Rate of level change: Minimum 2.5 dB/s ±20%Smallest increment of level: 0.5 dB

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 3 DEFIBRILLATOR, BIPHASICSPECIFICATIONDefibrillation Type- Should have Manual, Synchronized, or AED function.- Should Built in AED (Automated External Defibrillation) with voice prompt.

Built in paediatric paddles under adult paddles for both adult and paediatric use. - Energy selectable from 2 to 270J.- Charging time to 270J less than 5 seconds- Charge and discharge buttons on paddles as well as front panel- 3 LEDs contact indicator when paddles applied is available.- 1-2-3 Step instruction on equipment is available.- Discharge test is available.- Output waveform Biphasic Truncated Exponential.- Protection against Sudden Capacitor Failure.ECG Monitor- Should come with 3 lead ECG monitoring.- Should have Display screen size at least 6.5 inch.- Up to 4 waveforms can be displayed in TFT colour LCD screen.- ECG picked up via paddles or separate ECG leads.- The monitor shall display of the following:-

Numerical display of heart rate from 20 to 300bpm Lead selection ECG gain Synchronization mode Battery indicator Available and delivered energy

Non-invasive Pacing- Pacing mode: fixed or demand- Waveform: modified trapezoid- Pulse rate” 30 to 180 ppm, 10 ppm step- Pacing current: 0, 8 to 200 mA in 1 mARecorder- Should have two channel thermal recorder- Should have Automatic recording at defibrillation or manual recording- Report shall be providing annotation consists of:-

Date and time Delivered energy

Power Source- Rechargeable battery power source as as well as being mains powered 240V/50Hz- NiMH type battery

Environment- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for

Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 4 DEFIBRILLATOR, AEDSPECIFICATION

1- FEATURES - Should have 3 steps to save a life

i- Turn on the AEDii- Attach the electrode padsiii- Press the shock button

- Daily and monthly self-test function is available from main unit, battery and pads.- Waveform: Truncated exponential constant power biphasic.- Output energy range: 50, 70, 100, 150, 200J (at 50ohm).- Output energy sequence:

i) 150J-200J-200J for adult mode. ii) 50J-70J-70J for child mode.

- Analyse-to-SHOCK cycle time: less than 8 seconds (when using new battery).- End of CPR to SHOCK cycle time: less than 8 seconds (when using new battery).- Automatic internal discharge: the charged energy is discharged in the following conditions; - 30 seconds passes after the SHOCK BUTTON starts blinking- When A pad is disconnected from the AED or patient, System must be turned off- Normal ECG appears during the self-test- Battery removed

2- ARRHYTHMIA ANALYSIS - Should have an accuracy of:

i) 90% or more for VF (sensitivity)ii) 75% or more for VT (sensitivity)iii) 95% or more for non-shockable waveform (specificity)

3- BATTERY REMAINING LAMP - 100%: 4 green lamps light - 75%: 3 green lamps light- 50%: 2 green lamps light- 25%: 1 green lamp lights- 0%: red lamp lights

4- Environment - Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 5 ECG MACHINE, 12 CHANNELSPECIFICATION1- DESIGN FEATURE

- Should have 12-channel recording- Should have LCD display in Colour- Should have data transfer to PC by SD memory or LAN Connection- Should come with memory capabilities. - Should have Paper-saving recording- Should have High level 12-lead ECG analysis- Meets IEC60601-2-51 international standard for digital electrocardiographs specifying accuracy and

digital filter performance.2- DISPLAY

- Must have Colour LCD as a Display screen - Should have ECG waveform: 12 lead ECG - Display include Patient information, hospital name, recording settings, operation mode, heart rate,

QRS mark, CAL mark, error message, electrode detachment, noise3- ECG ACQUISITION

- Should have 12 ECG leads- Should have Common mode rejection ration: ≥100 dB - Should have Input circuit is isolated and protected against defibrillator discharge- Should have Input impedance is ≥ 20MΩ

4- RECORDER - Should have High resolution thermal array printer- Should have Printing density 200 dpi (8 dots/mm), 320 dot dot/mm² (25 mm/s)- Should have Number of channels: 3, 4, 6, 12- Should have Paper speed: 5, 10, 12.5, 2, 50mm/s- Should have Automatic or manual recording with grid- Should have Recording data include program type, version, date and time, paper speed, sensitivity,

lead name, filter, hospital name, - Should have patient information, timing mark, event mark, electrode detachment, noise- Should have Recording mode: Manual, Auto, Rhythm, Periodic

5- TROLLEY - Should come with trolley

6- Environment - Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 6 HOLTER ANALYSER SYSTEMSPECIFICATION

A microprocessor based digital holter, which is small, lightweight, and able to pick up and record interfaced cardiac activity of ambulatory patients. The unit should able operate with window based Microsoft system.

FEATURES

- System should run at least windows 7 and above based software design - User friendly menus and control for faster scanning and editing- Automatic upload with full analysis in less than 60 seconds. The system must be capable of multiple

modes scanning options below: - Prospective or Manual- AutoScan

- Should acquire data from 2 or 3 channel recorder for up to 24 & 48 hours or up to 7 days- Should analyse and do reporting of the R-R interval and frequency variation whereby data can be

selected for analysis via optional beat filters and V and SV ectopic, or from the arrhythmias.- Graphic trending for HR, RR interval, RR Variance, 12 lead ST, SVPB, VPB & Atrial Fibrillation - Capable of identifying and classifying heart beat : Normal, ventricular, paced supraventricular, R on T- ST segment analysis should offer full disclosure or summary tables. Capable of pacemaker analysis for

both arterial and ventricular, and dual pacemaker detection: capture, over sensing, under sensing- The system should allow simultaneous loading and editing.- Multi-tasking system that allows digitalization, beat and arrhythmias analysis.- Split screen mode allows different section of report to be viewed simultaneously.- Histogram for RR interval, SVE and pace spike distribution- Traditional 2- and 3-Channel recording analysis for 24 or 48 hours and up to 7 days: Analysis of

Bipolar and Unipolar leads acquired using a traditional 5-wire patient cable provides beat to beat review and complete presentation of all arrhythmias and ischemic events. Prints 1-, 2- or 3-channel ECG strips at any point in time as per user’s requirement.

- Download and Scan Time: Less than 90 seconds.- Color Coded Beat Identification: according to beat types for easy identification. - Callipers: Allow measurements of amplitude, time and heart rate. - Report Preview Capability: Facility of editing / reviewing of final reports before printing. System

allows preparation of final reports, including automatic strips, comments, morphology report, full disclosure and ECG strips.

- Full Disclosure Archive: Facility to archive complete full disclosure to external media such as CD or DVD or any arbitrary drive to create an off-line library of patient recordings. Archived data is then available to restore from the on-line library that automatically identifies the storage media disc number or drive location.

- Advanced Algorithm Signal Processing: Algorithms provide superior accuracy in beat detection, labelling and noise rejection for rapid identification of rhythm events.

- Rhythm Analysis: Rhythm Analysis of Ventricular and Supraventricular singles, couplets, runs (longest and fastest), bradycardia, tachycardia, atrial fibrillation, Atrial and Ventricular Pacemaker rhythms, pause, longest RR, RR standard deviation, and Heart Rate Variability. Percent and total beats in

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

summary and hourly.- Diary Events: Configurable diary entry labels with automatic patient event stop during the scan. - Final patient report export utilizing PDF and XML technology.- Optional HL7 or EMR and DICOM Interface capability

COMPUTER HARDWARE REQUIREMENT

- CPU with Latest Proccessor, Speed and Catch- Minimum 2GB RAM- Minimum Hard-disk Capacity 500GB HDD- Minimum LCD monitor is 23” Touch Screen High Resolution- One Drive of CDR-W- Internal Modem 115Kbps & network card- Preinstalled MS Windows 7 Professional or latest (System Compatible)- Printer Laserjet- Holter Software Installation CD

ACCESSORIES

- 3 channel digital holter recorder x 3 unit- Recorder carrying case x 3 unit- Patient 5 lead electrodes cable x 3 unit- USB Transfer cable x 1 unit

WARRANTYMinumum Two years warranty against manufacturing defective. Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOn site training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 7 EEG MACHINE, WITH VIDEOSPECIFICATION

- EEG Amplifier must be IP addressable - EEG amplifier must be connected via CAT5 networking cable - Must be able to initiate impedance check from amplifier - EEG amplifier must have built-in electrode connections - Must have a passive headbox with cable (min. 32 inputs) - Amplifier noise in the recording must be less than 2 uV (microvolts) peak to peak, at any frequency 0.1 to 100

Hz. - Amplifier sampling rates must be software controlled and adjustable from 125 to 2000 Hz. - Programmable and adjustable montages, recording parameters and recording notations. - Programming must be fully Windows XP Professional compatible. - Filing system and database management software - Must be capable of archiving patient files to CD, DVD, or Network server. - Must be USB 2.0 compatible. - Must be network ready. - Must provide user in-service for Neurology Technologists. - Must have LED photic strobe capable of 60Hz stimulation - Must be capable of displaying EEG trends such as amplitude integrated EEG (aEEG), Envelope, Absolute Band

Power, Total Power, Burst Suppression Monitoring, Spectral Edge, Peak frequency, and Spectrogram, during acquisition and review

WARRANTYMinumum Two years warranty against manufacturing defective. Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOn site training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 8 EMG MACHINE

SPECIFICATION1- COMPUTER HARDWARE

- Minimum Latest processor- 4 GB RAM, minimum 500GB harddisk Drive- Writeable DVD-ROM drive, sound card, keyboard and mouse- Windows 7 Professional - Laser printer- 23" Full Touch HD display- Mounting bracket for LCD display- User interface Control Panel- Mobile cart on castors

2- AMPLIFIER - Minimum 4 channel input or more- Input impedance : 200 MΩ ±- Noise level < 0.6 µVrms or less at 1 Hz to 10 kHz with input shorted- CMMR: ≥106 (Balanced mode), ≥112 dB (Isolation mode)- Sensitivity: 1, 2, 5, 10, 20, 50, 100, 200, 500 µV/div, 1, 2, 5, 10 mV/div ±5%- Low-cut filter: 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, 100, 200, 500 Hz, 1, 2, - 3 kHz at 6 dB/oct (±20%)- High-cut filter: 10, 20, 50, 100, 200, 500 Hz, 1, 1.5, 2, 3, 5, 10, 20 KHz at 12 dB/oct - (±20%)- AC interference notch filter: 50/60 Hz (rejection ratio: < 1/20)- Amplitude calibration: 1, 10, 100 µV, 1, 10 mV (within ±5%)

3- AVERAGER - A/D converters: 16 bits- Conversion speed: 10 µs/channel max- Analysis time base:

With a list box:0.1, 0.2, 0.5, 1, 2, 3, 5, 10, 20, 30, 50ms/div, 0.1, 0.2, 0.5, 1 s/div- (within ±5%)- With a keyboard:

i) to 0.9 ms in 0.1 ms steps (within ±5%)ii) to 99 ms in 1.0 ms steps (within ±5%)iii) 100 to 1,000 ms in 10 ms steps (within ±5%)

- Time base mode: Individually selected for each channel

- Number of averaging: 1 to 9999

- Artifact reject inhibit range: ±1, ±2, ±3, ±4, ±5 div on screen or off (No artefact rejection)

4- STIMULATOR COMMON FUNCTIONS - Trigger modes:

Recurrent, Random, Foot Switch, Signal, External- Stimulation modes:

Single, Double, Train- Trigger signal output

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

Amplitude: 5 V (within ±5%)Duration: 1, 5, 10 ms (within ±20%)

5- ELECTRIC STIMULATOR - Stimulation intensity:

i) to 100 mA (in 0.1, 0.2 or 1 mA steps)ii) 2.1 mA to 100 mA: within ±5%

- Stimulation pulse duration: 1, 0.5, 0.3, 0.2, 0.1, 0.05, 0.03, 0.02, 0.01 msi) ms to 1 ms: within ±10%ii) 0.05 ms: within ±20%

6- AUDITORY STIMULATOR - Output type: Headphone, Earphone- Stimulation modes: Click, Tone burst- Stimulation phase (polarity): Condensation (positive), Rarefaction (negative), Alternating- Stimulation intensity: 0 to 135 dB SPL in 1 or 5 dB steps (within ±2 dB)- Contralateral white noise masking:

0, -10, -20, -30, -40dB or off (no masking) (within ±5 dB)- Click pulse duration: 0.1 to 1.0 ms in 0.1 ms steps (within ±5%)

7- VISUAL STIMULATORS - Stimulation modes:

Pattern reversal. LED goggles, External visual stimulation- Pattern reversal:

i) Field format: Full, left half, right half, upper half, lower half, upper left, lower left, upperii) Right and lower right fieldiii) Patterns: Checkerboard, horizontal bars, vertical barsiv) Number of horizontal division for pattern: 4, 8, 16, 32, 64, 128v) Display time (duration): 20 to 1000 ms in 10 ms steps

8- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

EQUIPMENT 9 STRESS TEST SYSTEM, WITH TREADMILLOPERATIONAL REQUIREMENTIn this system the patient exercises on a treadmill according to a standardized protocol and the cardiac abnormalities can be studied under stress conditions which we may miss under resting

SPECIFICATION1- Should acquire and analyse 12 simultaneous ECG Leads2- Should have facility for display of all 12 leads real time Rhythm ECG on screen3- Should have facility of on line storage of patient ECG data. Storage of at least 500 patients on HDD. 4- In addition the storage on floppy drive or CD should be possible5- Updated medians with elimination of Artifact ectopy and aberrancy in all leads6- Filters with facility to eliminate Artifact due to respiration muscle/noise, AC interference, baseline

wandering without compromising/distortion in ST segment changes7- Should have facility to do the reanalysis of stored ECG report with reanalysis of the current stress

report by changing the measurement point i.e. E, J and post J points8- The monitor should display auto comparison of resting versus current lead of maximum ST

depression separately with colour coded protocol, stage, clocks for elapsed time, total time, Target HR, Treadmill speed & grade, PVC counts/minute, warning messages & prompts, lead check torso

9- Should have facility for 12 lead resting electrocardiogram with full interpretation10- System should print comprehensive final report on a minute by minute record of ST segment changes

ST segment trend plot and acceleration of ST segment11- Display should have facility to amplify a normal gain along with a sample of resting ECG complex for

close test12- System should be able to provide the real time printing by auto or manual mode in desired formats.

Writer resolution should be thermal 1000 line/sec x 200 dpi for printing13- The treadmill should always start from 0 mph and has load capacity of 450 lbs. And speed range of 0-

13.5mph and elevation 0-25% and should have facility to run the self-calibration programme. Treadmill should have minimum 60" walking surface.

14- Treadmill should have two stop modes with digital Microprocessor control, including one patient activated stop mode. The same should be interfaced to the main analysis system.

15- Shall meet IEC-60601-1-2 :2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility.

EQUIPMENT 10 NEBULIZER

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

SPECIFICATION1- Particle Size

- Shall Designed for continuous use- Suitable for Hospital, clinic and home use- Should have Powerful compressor for heavy usage

2- Desk Type Nebulization - Minimum Output is 1 to 5 microns

3- Maximum Cup Capacity - 0.4-0.7 ml/min

4- Oscillating Frequency - 8ml Particles :1-5 micron - 2.4 MHz approx.- Including mouth piece , tubes , filters , masks for infant and paediatrics 220v/50hz

EQUIPMENT 11 HEMODIALYSIS MACHINESPECIFICATION

1- Machine should have facility for Acetate, Bicarbonate and sequential dialysis 2- Cab be linked to patient data Management System and should be upgradeable to future

development 3- Should have facility for conventional and high flux dialysis 4- Battery backup for at least 30 min to run complete machine with heater supply 5- Should have Na, Bicarbonate and UF profiling 6- Dialysate temp selectable between 35-39 degree Celsius. 7- Variable conductivity between 12-15.8- Should have dialysate flow 250-800ml/min. 9- Heparin pump with syringe sizes up to 50ml and pump rate of 1-10ml/hr. 10- Stroke pressure operated short term single needle dialysis.11- UF 0.1-2.5 litre/hr. The in and out fluid circuit must be separated so that there is no chance of

contamination in case of membrane rupture. 12- Treatment parameter should be displayed by graph and digitally both. 13- Should have integrated heat and chemical disinfection. 14- Should have accurate feedback control conductivity mixing technique. 15- Should have drain facility. 16- Should have accurate UF control by flow measurement technique. 17- Extra facilities like blood volume sensor, Bicab select technique and online clearance (optional) 18- All important data should be present so that the machines can be used anytime without feeding data

every time. 19- Should have automatic test facility. 20- Should have auto on off facility. 21- Should have touch button screen. 22- Easy to service, trouble shoot and calibrate. 23- Machine can be connected to computer to feed all data and trouble shoot and calibrate. 24- Blood pump rate from 20-500ml/min adaptable to all standard AV blood lines. 25- Audio visual alarms on limit violation of conductivity, blood leak, air leak, transmembrane pressure

alarms, dialysis temp alarms, dialysis can empty alarm, end of disinfection alarm, bypass alarm, and blood pump stop alarm.

26- Alarm for reverse Ultra filtration. 27- The unit shall be capable of being stored continuously in ambient temperature of 0-50 deg C and

relative humidity of 15-90%. 28- The unit shall be capable of operating continuously in ambient temperature of 10-40 deg C and

relative humidity of 15-90%. 29- Manufacturer/Supplier should have ISO certification.

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

30- Shall comply with IEC 60601-2-16 safety requirements of medical electronic equipment part requirement for HD machines.

WARRANTYMinumum Two years warranty against manufacturing defective. Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOn site training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveShould have FDA, CE, UL and BIS approved product.

EQUIPMENT 11 HEMODIALYSIS MACHINESPECIFICATION

- Machine should have facility for Acetate, Bicarbonate and sequential dialysis (isolated UF) - Can be linked with patient Data Management System (Optional) and should be upgradeable to future

software developments - The blood pump should run even in the absence of water or dialysis flow- Should have facility for conventional dialysis with latest microprocessor controlled technology. - Machine should have one 10 microns filter at water inlet and one bacterial filter before water going to

dialyzer (in built) - Battery back-up for at least 20-30 mins. - Should have Na and UF profiling - Dialysate temperatures selectable between 35 degrees to 39 deg. 3.6 Variable conductivity setting

between 13-15 - Should have variable dialysate flow 300-800 ml per minute or more. - Should have facility to show trends curve of all parameter for 15-20 minutes. - Heparin pump with syringe sizes up to 10-20 ml or more with pump flow rate from 1-10 ml per hour (0.1

increments) - Stroke pressure operated short term single needle dialysis (Optional) - Ultra filtration 0.1 to 2.5 litres/hr. The in and out fluid circuit must be separated so that there is no

chance of contamination in the event of membrane rupture. - Treatment parameter should be displayed both by graph and digitally - Should have integrated heat and chemical disinfections facility. - Should have accurate feedback control conductivity mixing technique. - Should have drain facility. - All important data should be present so that machine can be used anytime without feeding data every - Should have automatic self-test facility. - Should have auto ON/OFF Facility. - Machine should have TFT screen with soft touch button controls. - Easy to service, troubleshoot and calibrate - Machine can be connected to computer to feed all data and trouble shoot whenever any problem. - Blood pump rate from 20-500 ml/min adaptable to all standard A - V blood lines - Ability to monitor pulse rate and NIBP with graphic and tabulated trends. - Audio visual alarms on limit violation of conductivity, blood leak, air leak, trans membrane alarm can

empty alarm, end of disinfection alarm, bypass alarm and blood pump stop alarm. - Alarm for reverse Ultra filtration.

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

- Machine should have real time clearance surveillance for urea & Kt/V to assess adequacy of dialysis. It should display real time urea clearance, plasma sodium, current Kt/V and time required to achieve target Kt/V.

Power Supply - Power input to be 220-240 VAC 50 Hz fitted with plug. - On line UPS of suitable rating with voltage regulation and spike protection for 60 minutes backup

Standards, Safety and Training - Should be CE/ UL /BIS approved product - Manufacturer/Supplier should have ISO certification for quality standards. - Shall comply with IEC 60601-2-16 SAFETY requirements of medical electric equipment Part-2 particular

requirements for the safety of Haemodialysis - Comprehensive training for staff and support services till familiarity with the system. - Should have local service facility or service provider must attend break down call within 24 hours. - The service provider should have the necessary equipment recommended by the manufacturer to carry

out preventive maintenance test as per guidelines provided in the service documentation

EQUIPMENT 12 STETHOSCOPE (ADULT, PAEDS & INFANT)SPECIFICATION

1- Should have Chrome-plated. 2- Dual-head chest piece with chest-piece has white diaphragm Complete with 2 spare ear tips

and a spare diaphragm.3- Size: Adult, Paediatric & Infant

EQUIPMENT 13 RESUSITARE BAG (ADULT, PAEDS & INFANT)SPECIFICATIONS

1- Hand held silicon type. 2- Main unit consists of :

- Pressure regulator with mask and plastic hood. - Face mask for child (3 pieces) - Face mask for adult (3 pieces)- Oxygen reservoir bag with safety valve (1 piece)

3- Oxygen feeding tube (4 pieces) including carrying bag- Specifications : Self inflating bag volume: approx. 1600ml - Oxygen reservoir bag volume : approx. 2600 ml, - Autoclavable Materials: Self inflating bag: semi. - Transparent silicon rubber. - Valve housing: transparent polysulfone Shell of mask: transparent polysulfone. - Cushion of mask: transparent silicon rubber

EQUIPMENT 14 LARYNGOSCOPE (ADULT, PAEDS & NEONATE)SPECIFICATION

1- Stainless steel construction with satin, 2- Non-glare finish that provides rugged durability. 3- Both Macintosh and Miller laryngoscope style blades are available. 4- The Size of Blade are;

i- Adult: 2,3 & 4ii- Paeds: Curve & Straightiii- Neonate: 0 & 00

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

5- Langyngoscope Handle:i- Suitable for Adult, Paeds & Neonate

6- Satin chrome-plated brass with a knurled finish for a positive grip7- Rugged durability and lightweight design8- Battery Operated

EQUIPMENT 15 HARMONIC SCAPLE

SPECIFICATION- Ultrasonic generator

i- with fixed frequency of 55.5 KHz (as per manufacturer recommendation & specification)

ii- with capable of incising tissue and providing homeostasis iii- with minimal thermal injury iv- with having 5mm instruments/probes/shears for both Open and laparoscopic

surgeries. v- with minimal 3 discreet audible tone settings possible to indicate generator status

with have an option of reusable HAND ACTIVATION vi- with bilateral switches to change power levels with having vii- with provision for connecting 2 footswitches for two surgeons to work

simultaneously viii- with having self-diagnostic mode to detect any problem with generator, footswitch,

transducer or instruments ix- with a graphical display to enable surgeon/technicians to understand the problem x- with have a warning system for a worn out probe/shear/instrument xi- with error codes for better diagnosisxii- with have a vibration range of 50-110 microns (micro meters,μm) for optimal

cutting and coagulation(as per manufacturer recommendation and specification)xiii- with have an option of using 5mm Laparoscopic/Open Shears with integrated hand

activation for better control xiv- with having shears of variable lengths for different surgeriesxv- with having probes with integrated hand activation and ability to adjust the lengths

in order to facilitate better dissection in open surgeries.

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

Onsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 16 REFRIGERATOR, PHARMACEUTICALSPECIFICATION- Minimum Capacity required is 1,000 Litre- Internal and External Chamber should be EXPOXY Coated- Temperature Control / Range should be within +2°C to +8°C and being display in LED- Temperature Fluctuate is ±1°C to 2°C - Refrigerant is R134A / R407 CFC free- Should have at least 1 door lock and castor- Should have alarm system feature: High Low Alarm, Power Failure, Remote Alarm Contact- Should have UPS with capacity 3kVA- Standard complied with IEC601 electrical safety and ISO 13485

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 17 REFRIGERATOR, MEDICAL

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SPECIFICATION- Minimum Capacity required is 800 Litre- Internal and External Chamber should be EXPOXY Coated- Temperature Control / Range should be within +2°C to +8°C - Temperature Fluctuate is ±1°C to 2°C - Refrigerant is R134A / R407 CFC free- Should have alarm system feature: High Low Alarm, Power Failure,

Remote Alarm Contact- Standard complied with IEC601 electrical safety and ISO 13485

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 18 HEAD LIGHTSPECIFICATION- Should be use White, xenon-quality light - System Should produce at least 550 hours of Operation time- Unit interface must be Soft, flexible in headband with dual ratchets for superior comfort and fit- Should have Fiber-optic bundle with layers of protective materials to prevents fiber breakage

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 20 HEART LUNG MACHINE1. GENERAL FEATURES

i- Programmable & Modular System ii- Capabilities for future upgrading iii- Console to accommodate 5 pumps iv- Includes Uninterruptible power supply (UPS)

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

v- Bi-directional brushless horse-shoe shaped roller pump vi- Displays Temperature/Pressure vii- Audible and visual alarms

2. TECHNICAL SPECIFICATIONS i- Microprocessor controlled Single head roller pump with touch-screen panel is mainly used

for arterial blood flow, for suction and venting ii- Double head roller pump with touch screen panel which can be operated together iii- All roller pumps shall be a direct-drive DC brushless motor type. The pumps shall be quiet

and vibrations-free during operation iv- Incremental encoders (IE) is capable of both fine and coarse adjustments, audible indication

at 0 to 250 rpm v- Rotatable pump head can be adjusted in 15 degree increments from -90 deg to +90 deg vi- Battery backup time under operating conditions must be at least 90 minutes when fully

charge vii- Single Head Pump

Diameter of pump head raceway : 150mm Diameter of occlusion roller : 30.5mm Speed range : 0 to 250 RPM (clockwise, anticlockwise) Deviation in speed accuracy +/- 1% Deviation in speed accuracy in case of error +/- 15% Direction of rotation: Clockwise / Anti-clockwise Concentricity of Pump Head Raceway 45 deg C Measuring Interval : +/- 1 - 2 seconds Accuracy of SAT measurement: in 60 to 100% range : +/- 4% And in 40 to 59% range

: +/- 6% Accuracy of HCT value measurement: in the 15 to 50% range: +/- 6% Accuracy of temp. measurement: in the 25 to 40deg C: +/- 0/6 deg C (at room temp

of approx 23 deg C) viii- OXYGEN ANALYZER * Oxygen Analyzer & Monitor for the medical industry

Microprocessor based with LCD backlight for easy visual/Large easy to read display Alarms if sensor becomes disconnect Auto Calibration Battery Test Key Sensor comes with flow diverter V mount adapter supplied Two alarm set points - fully adjustable

ix- Essential Components 1 x 4-Pump Console to accommodate up to 5 pumps complete with built in

Emergency Pack (EP Pack) and UPSE battery with charger/discharger 1 x 5-slot system panel 5 x Control Display Module 3 x Single Roller Pump 1 x Double Roller Pump 3 x Tubing Clamps Variolock 1 x 2-Channel Pressure Transducer with clamps/holders & connecting cable 1 x Timer 1 x Temperature Module 1 x Level Module 1 x Sensor Module for Bubble Detector sizes 3/8 – ½” 1 x Cardioplegia Sensor Module 1 x Venous Occluder (Electronic) 1 x Air & Oxygen Blender 1 x Heating Cooling System 3-Channels 2 x Chair for perfusionist 1 x Remote Control (Patient Circuit) 1 x Remote Control (Cardioplegia Circuit) 1 x Adult Blanket/OR Table size 24”x 60”

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

1 x Blanket Adaptors 1 x LED Lamp 1 x Integrated In-Line Blood Gas Monitoring 1 x Digital Oxygen Analyzer Monitor with Alarms 1 x Various Tubing inserts necessary for machine operations 1 x Disposable Pads for Level Sensors

3- Power Supply - Power input to be 220-240 VAC 50 Hz fitted with plug. - On line UPS of suitable rating with voltage regulation and spike protection for 60 minutes backup

4- Standards, Safety and Training - Should be CE/ UL /BIS approved product - Manufacturer/Supplier should have ISO certification for quality standards. - Shall comply with IEC 60601-2-16 SAFETY requirements of medical electric equipment Part-2

particular requirements for the safety of Haemodialysis - Comprehensive training for staff and support services till familiarity with the system. - Should have local service facility or service provider must attend break down call within 24 hours.

EQUIPMENT 21 BLOOD GAS ANALYSERSPECIFICATION

- Handheld ABG Reader. - It should measure Blood Gas (full parameters) in its addition to measure Electrolytes. pH, pCO2, pO2,

Na+, K+, Ca++, Cl-, Glu, Hct, Lac, and Crea.- Calculated values: cHCO3-, cTCO2, BE(ecf), BE(b), cSO2, cHgb, eGFR, eGFR-a, AGap, and AGapK- Room temperature test card storage- Internal electronic QC and automated internal QC check- Critical result reporting- Test Card and patient ID barcoding- Transmit results securely in real time- Should display all results in print out and c/w thermal printer- Analyzer with memory of storing patient data/result

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

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EQUIPMENT 22 INFUSION PUMP, VOLUMETRICSPECIFICATION

- The equipment should have Roller type Peristaltic pump /Volumetric pump technology for delivery of IV fluids and blood/blood products ranging

- Volume delivery is 0-9,999ml- The Equipment should have high levels of safety from air embolism by integrating at least two

ultrasonic air detection sensors.- Heating process should be done by an electromagnetic induction heating system.- The equipment should have the facility to automatically purge air for removal of any outgassed air to

prevent it from entering the patient line. No manual process should be involved.- The equipment should have a line pressure control sensor for restriction of flow in case of line

occlusion immediately and stop the delivery of fluids for patient safety.- The equipment should have an internal rechargeable battery backup.- Consumables should be universal for all flow.

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

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EQUIPMENT 23 INFUSION PUMP, SYRINGESPECIFICATION

- The equipment should have plunger type- Volume delivery is 0-9,999ml- The equipment should have operator controlled Bolus infusion key for rapid response in critical

situations.- The equipment should have a line pressure control sensor for restriction of flow in case of line

occlusion immediately and stop the delivery of fluids for patient safety.- The equipment should have an internal rechargeable battery backup.- Should have compatible syringe sizes

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 24 PULSE OXIMETERSPECIFICATION

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- Display – LCD, Backlight illuminated.

- Parameters and waveform displayed – SpO2, pulse rate

- SPO2 range – 60-100%

- Accuracy of SPO2 -3%

- Pulse rate range should be 30-240 bpm

- Audio-visual Alarms- high/low SpO2 and pulse rate, sensor off, sensor failure, low battery.

- Alarm override facility.

- RS 232C Interface for data communication (as per manufacturer design)

- Battery back-up operating minimum up to time 5 hours.

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 25 CARDIOTOCOGRAPHY (CTG MACHINE)SPECIFICATION

- Cardiotocograph (CTG) machine wide TFT- color LCD screen for Fetal Heart Rate, Uterine contraction & fetal movement.

- It should have Twin Fetal Monitoring system- LCD Screen should be tiltable & rotatable. It should have display modes of Trend mode, Number mode &

Graph mode.- It should have alarm functions in all movement - It should have facility to increase / decrease / mute alarm sounds- It should have Automatic track & hold facility - It should have high sensitivity less than 1 MHz FHR upper limit should be 130 - 240 BPM & lower limit

should be 30 -150 BPM - It should have Fetal Heart Rate & Uterine pressure- It should have automatic and manual fetal movement detection- It should have in built thermal recorder with A4 size- It should have battery back up- It should have a built-in memory to save patient graph data.- Should be supplied with trolley.- Should be supplied with standard accessories

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY

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240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 26 ELECTROSURGICAL UNIT, GENERAL PURPOSEFUNCTIONAL REQUIREMENTS The unit is intended for use in cutting and coagulation of tissues in operating theatre.

GENERAL REQUIREMENTS - The unit shall be designed to perform monopolar and/or bipolar electrosurgery.- The unit shall have the following mode of operation:

a. Pure Cuttingb. Coagulationc. Blend Cuttingd. Bipolar coagulation

- The unit shall be compact, portable and water resistant.- The unit shall be designed to activate the high frequency generator by means of finger switch or

footswitches.- The unit shall be equipped with a digital display indicating estimated delivered output power.- The unit shall be capable of monitoring the contact impedance between the patient and patient

dispersive-electrode and shall prevent ESU output activation if the contact impedance rises above the manufacturer's preset value.

- The unit shall be equipped with dispersive-electrode cable continuity monitor that prevent ESU activation if the cable breaks or disconnected from either the ESU or the dispersive electrode.

- The unit shall be designed with an isolated output capable of eliminating the risk of burns to the patient that may come in contact with grounded object.

- The unit shall be able to use both adhesive return electrode and non-adhesive type i.e under-body gel pads on patient.

- The unit shall be capable of using any brand of diathermy pencil / electrodes.- The unit shall be equipped with automatic self-diagnostic program upon start-up. It shall continually

monitor, detect and indicate defects and malfunctions.- The strain relief for the line cords and footswitch cables should be durable and able to

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withstand a strong pulling force.- Front-panel controls should be visible to the user and easily identifiable and clearly marked- If an alarm is silenced, a visual display shall indicate clearly which alarm is disabled.- The unit shall be equipped with visual and audible indicator peculiar to the mode of operation

POWER REQUIREMENT

- The unit shall operate directly from a 230V ± 10%, 50 ± 2 Hertz,- All accessories shall be fully integrated, with a single 13A moulded construction power plug.

- The unit shall be protected from transient power disruptions during use. The disruption shall not affect the performance of the unit.

- The unit shall be equipped with self-tripping circuit breaker for protection against overload.

SAFETY REQUIREMENTS- The construction of the unit shall ensure a sufficient degree against safety hazards caused by overflow,

spillage, leakage, humidity, ingress of liquids, cleaning, sterilisation and disinfection.- The enclosure shall be secure and provide adequate protection against moving and electrically

energized parts- Switches and controls should be protected against penetration of fluids.

- Switches and controls shall be protected against accidental setting changes.- The controls (i.e. switches, knobs, etc.) should be visible and clearly identified, and their function

should be self-evident. Device design should prevent misinterpretation of displays and controls settings.

- The unit should resist tipping over during use and transport.- The unit shall have no sharp edges.- Connections shall be secured to resist accidental disconnection.- Mechanical electric and pneumatic terminators, connectors, sockets and solder joints shall be

designed to prevent fluid penetration, incorrect connections and mismatch of fitting and couplings

CERTIFICATION & STANDARD- The system shall fully conform to the following (or equivalent) :

a. IEC / EN 60601-1, General safety requirements for medical electrical equipment;b. IEC / EN 60601-1-2 , Standard for Electromagnetic Compatibility – Requirements and tests;c. IEC / EN 61000-4-x series, Safety requirements and tests for Electromagnetic compatibility,

Immunity;d. IEC / EN 60601-2-2, safety requirement for High Frequency Surgical Equipmente. IEC / EN 60529 (1989), Degrees of protection provided by enclosures (IP code).f. Particular requirements for safety and performance of the tendered Article(s);g. FDA clearance.

TECHNICAL REQUIREMENTS

- The output power display should be within 20% of the actual power delivered in a manufacturer-specified load resistance of 100 to 1,000 Ω unless the operator's manual contains a different value.

- Maximum output power for 100 to 500 Ω rated load:

a. Cutting : ≤ 300 watts b. Blending : ≤ 200 wattsc. Coagulation : ≤ 120 wattsd. Bipolar coagulation : ≤ 80 wattse. Output frequency : ≈ 400 kHz

- Maximum line frequency source leakage current from electrodes shall be less than 10 microamperes.- Maximum line frequency leakage current from chassis shall be less than 100 microamperes- Maximum line sink leakage current when 230V, 50 Hertz, Alternating Current is applied across either

electrode or ground shall be less than 100 microamperes.

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- Maximum high frequency leakage current from either electrode shall be less than 150 microamperes.

ACESSORIES - All standard accessories required for the normal operation, shall be listed with itemised prices and

included in the unit base price.- The standard accessories shall include the following:

a. Single used Hand switch;b. Monopolar Footswitchc. Bipolar Footswitch;d. Monopolar adapter;e. Patient return electrode pad;andf. Mobile cart.g. All other accessories, cables, connectors and consumables shall be included for the safe and

smooth operation (full functional) of the unit.

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

EQUIPMENT 27 OPEN CARE RESUSITAREOPERATIONAL REQUIREMENTS

Complete system with cart and oxygenation facility is required.

TECHNICAL SPECIFICATIONS

- Essential parts: Cart & bassinet Warming system with controls & alarms. Examination light

- Storage space- 2 sliding drawers below bassinet 2 platforms

- Cart: Should swivel on 4 wheels with foot operated., 2 front lockable wheels.

- Bassinet : 1 fixed and 3 movable transparent side walls :Portion above X-Ray cassette holder

radiolucent.

- Mattress- Bassinet tilt in steps Trendelenburg or reverse Trendelenburg

- Warmer module swivel

- Warming systems- Modes :Manual & skin. Manual mode :Adjustable in steps from zero to 100

- Skin mode - Method : Flexible, unbreakable skin temperature probe Set point range : 34 – 38 degrees

C. Skin temp variability at Temperature equilibrium :+ 0.2 degrees C

- Skin temperature display- Accuracy : + 0.2 degrees C. Type : digital LED with 0.1 degree resolution.

Correlation of displayed And actual skin temp Silence/ Reset switch : To silence the alarm & reset set

point.

- Alarms

i- Probe failure

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ii- Heat failure

iii- High and low temperature

iv- Power failure

v- System failure

- Examination light : Illuminance 100 foot candles at mattress center

- Storage space : 2 drawers, preferably covered and sliding

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 28 PHOTOTHERAPY UNITSPECIFICATION

- Phototherapy chamber of 18 UVA+18 NB UVB tubes designed for providing even irradiation of the

body in the treatment area.

- UV chockes must be provided to provide long life to the tube light and cooling fans for effective

cooling of the unit.

- Body to be of a metal which is rust free so as to ensure long rust free life of the unit.

- Automated and/or mechanical safety mechanism to prevent excess irradiation to the patients so as

to avoid/prevent burns etc.

- Electrical leakage circuit tripper/breaker in each panel to ensure maximum safety of the patient.

- Open top unit to ensure maximum ventilation and prevent claustrophobia.

- Black UV Goggles and Eye pads cover (3 pairs each for adult and 3 pair for children ) as protective

WARRANTYMinumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

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Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 30 INCUBATORSPECIFICATION

- Continuous bed tilt up to 8° on either sides

- Head end raise facility with auto lock.

- Both visual and audible alarms for

i- Patient and control and high / low temperature alarm.

ii- Air circulation / probe / system / power failure alarm.

iii- Humidity control alarm.

- Facility to display and trends of temperature information on compatible monitors with other

physiological parameter

- With caster wheel with swivel in all directions and with front lockable wheels. Two shelves cabinet

with door.

- Patient control (Servo) mode – 35 deg-37 deg C. and Air Control (Manual mode)- 20 deg C o 39 deg C.

- Air velocity less than 10 cm/sec with inner wall.

- Temperature variability less than +/-0.2 deg C. and Temperature resolution 0.1 deg C

- Average oxygen input concentration range 5-15 liters/min or 25-70%.

- Humidification adjustable electronically with digital display. Standard: 10-80% dependent on nursery

environment and incubator temperature setting.

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

- Double wall canopy with Six hand ports with elbow operated flaps with separate ports for tubing.

- Servo control for Oxygen with integrated monitoring

- Air filter :- 0.3 micron

- Mattress should be radiolucent

- 2 drawer storage facility and two platforms for keeping monitors

WARRANTY

- Minumum Two years Full warranty against manufacturing defective. - Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING- Onsite training is to be provided on the operating and simple maintenance of the equipment. Service

manual and operational manual must be provided.

POWER SUPPLY- 240VAC/50Hz.- Suitable battery backup for 30 minutes- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive- System should have FDA, CE, UL and BIS approved product.

EQUIPMENT 31 INCUBATOR, TRANSPORTSPECIFICATION

- Continuous bed tilt up to 8° on either sides

- Head end raise facility with auto lock.

- Both visual and audible alarms for

i- Patient and control and high / low temperature alarm.

ii- Air circulation / probe / system / power failure alarm.

iii- Humidity control alarm.

- Facility to display and trends of temperature information on compatible monitors with other

physiological parameter

- With caster wheel with swivel in all directions and with front lockable wheels. Two shelves cabinet

with door.

- Patient control (Servo) mode – 35 deg-37 deg C. and Air Control (Manual mode)- 20 deg C o 39 deg C.

- Air velocity less than 10 cm/sec with inner wall.

- Temperature variability less than +/-0.2 deg C. and Temperature resolution 0.1 deg C

- Average oxygen input concentration range 5-15 liters/min or 25-70%.

- Humidification adjustable electronically with digital display. Standard: 10-80% dependent on nursery

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

environment and incubator temperature setting.

- Double wall canopy with six hand ports with elbow operated flaps with separate ports for tubing.

- Servo control for Oxygen with integrated monitoring

- Air filter :- 0.3 micron

- Mattress should be radiolucent

- 2 drawer storage facility and two platforms for keeping monitors

- Come with Trolley

WARRANTY

- Minumum Two years Full warranty against manufacturing defective. - Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING- Onsite training is to be provided on the operating and simple maintenance of the equipment. Service

manual and operational manual must be provided.

POWER SUPPLY- 240VAC/50Hz.- Suitable battery backup for 30 minutes- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive- System should have FDA, CE, UL and BIS approved product.

EQUIPMENT 32 INFANT WARMERSPECIFICATION

- Temperature control:

i- Range 30-38° C

ii- Skin range 25 – 42 °

iii- Increment 0.1°

- Display Digital

- Control Unit (to be supplied with.)

- Automatic heat control type

- Set point mechanism

- Heater Indicator.

- Alarms (Audible and Visual)

- High air temperature

- Sensor disconnect

- Power Failure

- The warmer should include:

- Self- check features

- Breaks for casters

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

- Skin sensor

- Protection against breaks and bursts of radiant and light source

WARRANTY

Minumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 33 FETAL DOPPLERSPECIFICATION

- Handheld and easy to use- Accurate FHR detection and LCD display- Auto counting- Built-in speaker- Automatic switch-off- Battery operated

WARRANTY

Minumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

EQUIPMENT 34 EXAMINATION LIGHT (HIGH END)SPECIFICATION

- Colour temperature to be between 3,000 and 5,000 K; shadow less

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

- Maximum illumination level at 1m distance to be at least 30,000 lux- 50,000 lux

- Colour rendering index to be 93 or greater

- Minimum bulb life required 1,000 hours (incandescent type) or 20,000 hrs (LED type)

- Field diameter required 16cm, field depth required 50cm

- Focal length required 65 cm

- Heat to light ratio to be ≤ 6 mW/m2.lx

- Brightness control to allow full adjustment from zero to maximum illumination

- Bulb voltage and type to be clearly labelled on external body

- Replacement bulbs to be locally available

- Front panel to include power switch and battery state indicator

- Automatic switching to battery power in the event of power failure

WARRANTY

- Minumum Two years Full warranty against manufacturing defective. - Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING- Onsite training is to be provided on the operating and simple maintenance of the equipment. Service

manual and operational manual must be provided.

POWER SUPPLY- 240VAC/50Hz.- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive- System should have FDA, CE, UL and BIS approved product.

EQUIPMENT 35 EXAMINATION LIGHT (LOW END)SPECIFICATION

- Colour temperature to be between 3,000 and 5,000 K; shadow less

- Maximum illumination level at 1m distance to be at least 60,000 lux- 70,000 lux

- Colour rendering index to be 93 or greater

- Minimum bulb life required 1,000 hours (incandescent type) or 20,000 hrs (LED type)

- Field diameter required 16cm, field depth required 50cm

- Focal length required 65 cm

- Heat to light ratio to be ≤ 6 mW/m2.lx

- Brightness control to allow full adjustment from zero to maximum illumination

- Bulb voltage and type to be clearly labelled on external body

- Replacement bulbs to be locally available

- Front panel to include power switch and battery state indicator

- Automatic switching to battery power in the event of power failure

WARRANTY

- Minumum Two years Full warranty against manufacturing defective. - Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING

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- Onsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY- 240VAC/50Hz.- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic

Compatibility. Or should comply with 89/366/EEC;EMC directive- System should have FDA, CE, UL and BIS approved product.

EQUIPMENT 36 RIPPLE MATTRESSSPECIFICATION

- Alternating pressure mattress with support area of 1720MM X 860MM.

- To contain 14 air cells with variable geometric section 83MM X 14MM. The material to contain an

anti-bacterial agent.

- To have a reinforced base sheet membrane with tucks apron, removable cells and protective cover.

- The compression pump to have a built in equalizing device to prevent over inflation.

- Cycle time to be 10 minutes, to have a low-pressure indicator.

- 6.To be supplied in a plastic case with handles for easy storage complete with five spare Cells

WARRANTY

- Minumum Two years Full warranty against manufacturing defective. - Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAINING- Onsite training is to be provided on the operating and simple maintenance of the equipment. Service

manual and operational manual must be provided.

POWER SUPPLY- 240VAC/50Hz.- Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for

Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directive- System should have FDA, CE, UL and BIS approved product.

EQUIPMENT 37 VENTILATOR, PORTABLESPECIFICATION

- Should be microprocessor controlled, portable, light weight.

- Should operate with main electric supply as well as with battery.

- Should be able to work both with cylinders and pipeline, connectors and high-pressure tubing of

appropriate length to be supplied

- Should have turbine/piston- technology for supplying air- oxygen mixture.

- Should have following modes of ventilation CMV, Assist-control, PS-PEEP

- Audio-visual alarms for:

i- Low supply pressure

ii- High/low airway pressure

iii- Leakage/disconnection

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

iv- Power failure

v- Apnea

vi- Low battery

- Should have following settings

i- TV 50 – 1500ml

ii- PEEP/CPAP & PS

iii- RR up to 40bpm

iv- I: E ratio 1:3 to 2:1

v- FiO2 40 – 100%

- Rechargeable batteries.

- Should fix, on rails of transport trolley and on stand with wheels. Two sets of reusable silicon

ventilator circuits.

WARRANTY

Minumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT 38 OPERATING MICROSCOPE, ENTSPECIFICATION

FLOOR STANDi. Roll able heavy Floor Stand with locking device.

ii. Magnetic system for balancing lock and release of magnetic breaks.iii. Manipulation to any position with locking for trouble free operationiv. LCD display of function and parameters, individual programming for differentv. Surgeons.

MICROSCOPE BODYi- Motorized Zoom Magnification system with apochromatic opticsii- Magnification 2.1X to 21.5 or better activated by hand grip and foot control with manualiii- Overrideiv- Eye piece 12.5Xv- Internal Motorized fine focusing system, activated by hand grip and foot controlvi- continuously

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital

vii- Adjustable working distance from 200 mm to 500 mm or more without exchange ofviii- Objective lens, manual override, integrated continuously variable illumination field spotix- sizex- integrated beam splitter with two additional output inbuilt for connection of observationxi- device and videoxii- Stereo co observation system for assistant surgeon/ teaching purposexiii- Future up gradation to XY module

BINOCULAR TUBEi- 180 Degree or more tilt able binocular tube with focal length f= 180 mm or moreii- Graduated knob for continuous adjustment of inter- papillary distance from 55 mm to 75mm

EYE PIECEi- Pair of wide field push in eye piece 12.5 X with magnetic locksii- Diopter setting from -8 D to +5 D

ILLUMINATION SYSTEMi- Coaxial xenon illumination minimum 180 Watt with a backup lamp changer Xenon or halogen bulb

HANDGRIPSi- Easily removable handgrips with adjustable keys for zoom and focusii- Four freely programmable keys for setting illumination intensity, controlling the video camera

FOOT CONTROL PANELi- Control keys for zoom, focus, movements and light intensity

DIGITAL VIDEO CAMERA SYSTEMi- 3 CCD advanced digital camera with adapterii- LCD monitor compatible with camera- 21 inchesiii- Compatible recording device preferably a digital one with USB Port.iv- Above microscope should be compatible for LASER usev- Compatible CVT should be supplied for protection from voltage fluctuation

WARRANTY

Minumum Two years Full warranty against manufacturing defective. Minimal Preventive maintenance (PM) shall provided as per manufacturer recommendation.

TRAININGOnsite training is to be provided on the operating and simple maintenance of the equipment. Service manual and operational manual must be provided.

POWER SUPPLY240VAC/50Hz.Meet IEC-606001-1-2:2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility. Or should comply with 89/366/EEC;EMC directiveSystem Should have FDA, CE, UL and BIS approved product.

EQUIPMENT CAMERA SYSTEM, LAPAROSCOPYCAMERA SYSTEM, ARTHROSCOPY

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TECHNICAL SPECIFICATION OF MEDICAL EQUIPMENT For KPJ Pahang Specialist Hospital and KPJ Perlis Specialist Hospital