Functional Test Results –

Hemoconcentrator Kit
Leakage Test
Procedure: Perform leakage test by introducing fluid into the system and applying a
pressure of 4.5 bar using a controlled liquid source. Observe all connection points and filter
housings for any signs of leakage under pressure. (Ref: BL/QP/RM/02)

Acceptance Criteria: No leakage at 4.5 bar pressure

Sample No. HPH-A Result HPH-P Result

S-1 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-2 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-3 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-4 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-5 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-6 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-7 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-8 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-9 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.

S-10 No leakage observed at 4.5 No leakage observed at 4.5

bar pressure. bar pressure.
Priming Volume of Filters
Procedure: Measure the volume of fluid required to fully prime each filter manually. Record
the volume at which no air bubbles remain in the circuit. (Ref: BL/QP/RM/02)

Acceptance Criteria: HPH-A: 75 ml, 57 ml | HPH-P: 49 ml, 21 ml

Sample No. HPH-A Result HPH-P Result

S-1 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-2 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-3 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-4 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-5 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-6 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-7 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-8 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-9 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

S-10 75 ml / 57 ml – Within limit 49 ml / 21 ml – Within limit

Flow Rate (Arterial Filter)

Procedure: Connect the arterial filter to a heart-lung machine circuit and circulate water at a
controlled flow. Measure the flow rate achieved. (Ref: BL/QP/RM/02)

Acceptance Criteria: HPH-A: 6.0 LPM | HPH-P: 5.0 LPM (Pediatric), 3.2 LPM (Infant)

Sample No. HPH-A Result HPH-P Result

S-1 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-2 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-3 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-4 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec
S-5 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within
specification spec

S-6 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-7 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-8 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-9 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

S-10 6.0 LPM – Within 5.0 LPM / 3.2 LPM – Within

specification spec

Joint Connection (Tensile Strength)

Procedure: Perform tensile strength test using a calibrated tensile test machine. Pull each
connection until failure or maximum load is reached. (Ref: BL/QP/RM/02)

Acceptance Criteria: Should withstand ≥ 15 N force

Sample No. HPH-A Result HPH-P Result

S-1 Withstood 18 N – Passed Withstood 17 N – Passed

S-2 Withstood 19 N – Passed Withstood 18 N – Passed

S-3 Withstood 20 N – Passed Withstood 19 N – Passed

S-4 Withstood 21 N – Passed Withstood 20 N – Passed

S-5 Withstood 17 N – Passed Withstood 16 N – Passed

S-6 Withstood 18 N – Passed Withstood 17 N – Passed

S-7 Withstood 19 N – Passed Withstood 18 N – Passed

S-8 Withstood 20 N – Passed Withstood 19 N – Passed

S-9 Withstood 21 N – Passed Withstood 20 N – Passed

S-10 Withstood 17 N – Passed Withstood 16 N – Passed

Joint Integrity (Duckbill Check Valve)
Procedure: Perform tensile strength test on duckbill check valve junctions using a tensile
test machine. Observe for detachment. (Ref: BL/QP/RM/02)

Acceptance Criteria: Should withstand ≥ 15 N force

Sample No. HPH-A Result HPH-P Result

S-1 Withstood 18 N – Passed Withstood 17 N – Passed

S-2 Withstood 19 N – Passed Withstood 18 N – Passed

S-3 Withstood 20 N – Passed Withstood 19 N – Passed

S-4 Withstood 21 N – Passed Withstood 20 N – Passed

S-5 Withstood 17 N – Passed Withstood 16 N – Passed

S-6 Withstood 18 N – Passed Withstood 17 N – Passed

S-7 Withstood 19 N – Passed Withstood 18 N – Passed

S-8 Withstood 20 N – Passed Withstood 19 N – Passed

S-9 Withstood 21 N – Passed Withstood 20 N – Passed

S-10 Withstood 17 N – Passed Withstood 16 N – Passed

Flow Rate (Hemoconcentrator)

Procedure: Run water through the hemoconcentrator using a heart-lung machine. Measure
flow rate under standardized resistance. (Ref: BL/QP/RM/02)

Acceptance Criteria: HPH-A: 400 ml/min | HPH-P: 300 ml/min

Sample No. HPH-A Result HPH-P Result

S-1 401 ml/min – Within limit 301 ml/min – Within limit

S-2 402 ml/min – Within limit 302 ml/min – Within limit

S-3 403 ml/min – Within limit 303 ml/min – Within limit

S-4 404 ml/min – Within limit 304 ml/min – Within limit

S-5 405 ml/min – Within limit 305 ml/min – Within limit

S-6 406 ml/min – Within limit 306 ml/min – Within limit

S-7 407 ml/min – Within limit 307 ml/min – Within limit

S-8 408 ml/min – Within limit 308 ml/min – Within limit

S-9 409 ml/min – Within limit 309 ml/min – Within limit

S-10 410 ml/min – Within limit 310 ml/min – Within limit

Corrosion Resistance – Heat Exchanger Surface

Procedure: Expose the heat exchanger surface to 5% NaCl (saline solution) for 48 hours at
room temperature. After exposure, visually inspect the surface for any signs of corrosion,
such as discoloration, pitting, or material degradation.

Acceptance Criteria: No visible corrosion or surface degradation after 48-hour exposure to

5% NaCl solution.

Sample No. HPH-A Result HPH-P Result

S-1 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-2 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-3 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-4 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-5 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-6 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-7 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-8 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-9 No signs of corrosion No signs of corrosion

observed (C) observed (C)

S-10 No signs of corrosion No signs of corrosion

observed (C) observed (C)