NOTICE FOR AMENDMENT

Ref.No : 94(R2)E(P)/CGMSC/EQP/2019, Dt 18/07/2019

S.N. Particulars (As per Amended

existing tender)
Last Date : 13-09-2019

1 Haemodialysis machine Specification Attached.

CODE - CARDIAC35
EMD – 30000

HAEMODIALYSIS MACHINE
(SPECIFICATION)

Technical Specifications- HD Machine with OCM, BPM

 Should be microprocessor controlled & capable of providing therapies such as

Conventional HD, Online HDF, HF & features such as Online priming, Acetate &Bicarb
dialysis, Volumetric UF, Sodium/UF profiling, Online help options (in case of alarm),
BPM, OCM
 High resolution TFT touch screen with functional keys & provide cumulative graphical
display of treatment data & physiological trends including sodium & UF profiles.
 Should display different menus indicating blood system, preparation, dialysate, UF,
Treatment, Reinfusion, Cleaning, System parameters & screen saver option.
 Safety Features: Should be a close system design with Volumetric dilution of
concentrates with RO water & Volumetric UF. Self Test after switching ON, Start up T1
test before each treatment, to ensure functioning of all hardware components.

Performance Requirements:

1. Blood Circuit:

a. Vascular Access: Single Needle click clack should be available. Blood pump with
features such as flow range of 20-600m1/min, with 10m1 increments adaptable to
standard A-V blood lines. An emergency hand crank should be provided to enable
reinfusion in case of power failure.
b. Heparin Pump: Should be automatic or manual start/stop, with infusion rate of 0.5-
10m1/hr in 0.1m1/hr increments. Heparinization stop time should be user-adjustable ' in
1min increment, & positive/negative extracorporeal blood circuit pressure should not
affect infusion rate. Auto Bolus administration should be programmable from 1-20m1/hr.

c. Pressure Monitoring & Alarms: Venous pressure monitoring & adjustment in case of
alarm condition.(Range: -100 to +500mmHg), Arterial pressure monitoring & adjustment
in case of alarm condition. (Range: -300 to +300mmHg)

d. Air Detection: Ultrasonic design & should be activated for air & micro bubbles over
entire blood flow range.

Sensitivity of detection mechanism should be specified in terms of air bubble size & on detection
of excessive air, venous clamp should activate & blood pump stop.

2. Dialysis Circuit:

a. Treatment/Therapies: Should facilitate Acetate & Bicarbonate dialysis. Variable sodium

& bicarbonate options. Volumetric UF & Sodium/UF profile options.

b. b) Dialysate Flow Rates: A Range of 100-1000m1/min should be available, with

resolution of 100m1/min, with Accuracy- ± 10%

c. Temperature Control & Alarm: Control Range: 34.0 to 39.0 deg Celsius with 0.5
increment. Alarm Limits: 33.5 to 40.0 deg Celsius

d. Conductivity Control & Alarm: Range: 12 to 16mS/cm. Accuracy: ± 0.1 mS/cm

e. Blood Leak Detection: Photo detector used, & alarm should be activated for blood loss

f. Volumetric UF: Control Range: 0-4L/hr, given by set values of UF volume & treatment
time, with accuracy ±1%. TMP monitoring: -100 to +400 mmHg. Isolated ultrafiltration
process should be provided.

Equipment should be capable of on-line preparation of bicarbonate dialysis fluid &It

should be handle by one hands only

g. Ultra-pure Dialysate Filter: Should have hygienic connection for ultra-pure dialysate
filter. Should have endotoxin retention capacity not less than 106 IU. Machine should
have an automatic program to change filter, including emptying & filling cycles. Filter
should have life span not less than 12weeks or 100 treatments. Filter should be arranged
in cross flow setting & equipment should perform flushing during treatment
automatically every 1hr. Filter change reminder should be available.
3. Online Fluid Circuit: For HDF: Both option of Pre-dilution & post-dilution of blood
should be available. Automatic control substitution program with pre/post dilution
identity integrate function, dialyser integrate function, Effective blood flow rate integrate.

4. Dialysis Parameter Display: Equipment should display following parameters: Arterial

Pressure, Venous Pressure, Blood flow rate, Dialysate Conductivity, TMP, UF volume,
UF rate, Remaining treatment time, Heparin infusion rate, Alarm information, etc.

5. Online Clearance Monitor: Equipment should have Inbuilt measurement & monitoring of
effective Urea clearance, Dialysis dose Kt/v, & Plasma sodium during dialysis

This measurement should be done without any additional cost & disposable during each
treatment.

6. Blood Pressure Monitoring: Equipment should have built in non-invasive device for
measuring the patient blood pressure automatically. Cuff pressure range: 10-325 mmHg
or wider choice; Systolic range: 30-280 mmHg or wider choice

MAP range: 20-255 mmHg or wider choice; Diastolic range: 10-240 mmHg or wider
choice; Pulse rate range: 20-245 1/min or wider choice.

Alarm values should be: Systolic range: 90 & 165 mmHg; MAP range: 70 & 120 mmHg;
Diastolic range: 50 & 100 mmHg; Pulse range: 40 & 150 1/min.

7. Battery Backup: The equipment should be able to operate and monitor the extracorporeal
circuit without interruption for 20-30 min. in case of AC power failure by backup battery.

8. Disinfection and Cleaning: Both chemical and heat disinfections should be performed.
Sodium hypochlorite should be used as cleansing disinfectant. Various Programmable
Cleansing Cycles should be provided with different phases and timings in accordance
with different disinfectants. Should be One-touch fully automatic operation including
pre-rinse, chemical-intake for combined disinfection & decalcification, post-chemical
mandatory rinse, and automatic power-off; without the need of any end-user handling
during this whole disinfection process.

The machine should be US FDA/European CE approved

OR
Haemodialysis machine (Specification)
A
Technical Specifications of HEMODIALYSIS (HDF Machine)
Special Features Colour monitor, TFT Display, 15", Rotatable, Touch screen for
easy handling Optical Status light clearly indicates the treatment

Dimensions: 510x637x1678 mm (W x D x H), 85 Kg.

Water Supply:
Water inlet pressure: 0.5 to 6.0 bar
Water inlet temperature: 10°C - 30°C
Max. drain height 1m
Electrical Data
Power supply 230 V, 50 Hz
Current consumption Max. 11 A
Rating 2500 VA
Power consumption, 1.5 KWh
Average
Extracorporeal circuit
Arterial pressure
monitoring
Display range -400 to +400 mm Hg'
Accuracy ± 10mm Hg
Venous pressure
monitoring
Working range 20 to + 390 mm Hg
Accuracy ± 10mm Hg
PBE - Blood entry If PBE pressure sensor is used, the blood-side entry pressure at
pressure at the Dialyser the dialyser is controlled by its upper limit. The PBE monitoring
function warns or signals a possible blockage of the dialyser due
to a kinked tube or increased clotting within the dialyser.

Operating Range 0 to +700 mm Hg'

Tolerance ± 10mm Hg
Transmembrane pressure
Display range 0 to +700 mm Hg'
Arterial blood pump
Blood flow range 50 to 600 ml/min
Accuracy ± 10%
Safety Air Detector Ultrasound measurement in the tube
Arterial Bolus Function For Heparine free Dialysis
Heparin pump
Profile Available
Delivery range 0.1 to 10 ml/hr
Bolus rate
Syringe size
Dialysis fluid circuit
Dialysis fluid flow range
Dialysate flow profile
Dialysate flow range
SLED / EDD dialysate flow
rate
Dialysate flow range
Tolerance
Dialysis fluid temperature
Temperature profile
Selectable
Bicarbonate Conductivity
Profile available
Range
Accuracy
Dialysis fluid conductivity
Profile available
Range
Accuracy
Ultrafiltration
UF profile
UF rate
Accuracy
Allowed dialyser UF factor
Parameters displayed
Substitution volume
Substitution flow
No. of. Dialysate Ultra
pure filter
Bicarbonate mixing
technic
Online Kt/V monitoring
Single needle dialysis
Batter backup
Absolute theraphy end
time
600 ml/h
10,20 & 30 ml
Available
increment
Should be achievable at 300 ml / min
increment, Preset to 600 ml/min for post dilution, preset to 700
ml/min for pre dilution
± 5%
Available
+33°C to +40°C
Available
4.0 to 7.0 mS/cm
± 0.2 mS/cm
12.5 to 16.0 mS/cm
± 0.2 mS/cm
30 profile available
0 to 4 Litres / Hr
0.2 ml per chamber cycle, UP pump tolerance <1%
Unlimited
UF goal, UF time, UF rate, UF volume
192 Litres max.
20 - 400 ml/min
2
Inbuilt, in the cartridge
Available
With Single pump possible
monitoring, Blood pump & SAD
Can set theraphy end time by entering absolute time
Blood leak detector
Type Optical, colour specific
Sensitivity > 0.50 ml/min (HCT 45%) > 0.35 ml/min (HCT 25%)

Disinfection and cleaning

Rinse
Temperature/flow 40°C/ 1400 mL/min
Thermal disinfection
Temperature/flow Automatic running of program at approx. 85°C/ 1400

Chemical disinfection Citric acid 50%

Temperature/flow Automatic running of program at approx. 85°C/ 1400

CERTIFICATION It Must be US FDA and CE certified

Additional options :

Automatic Blood Pressure

Monitoring (ABPM)
Display range, Sytole 45 - 280 mm Hg
Diastole 15 - 220 mm Hg
MAP 25 - 240 mm Hg
Accuracy ± 2%
Automatic Blood pressure Thru UF control
stabilisation

Accurate Dialysis Accurate dialysis measurement, To measure adequacy of

Measurement thru URR Dialysis
count via UV
spectroscopy

Sd/-
Managing Director
CGMSC, Raipur