WI - 12 - Final Unit Test - Infusion Pump

Doc. No.
: AME/WI/12
AKAS MEDICAL EQUIPMENT
Rev. No.: 00
WORK INSTRUCTION Issue No.: A
FINAL UNIT TEST – INFUSION PUMP Date: 29.12.2022
The following document shall be used by testing engineer at production to conduct the final
unit testing. This document contains the detailed procedure of each test to be conducted.
DAY 1
1.0 Service settings:
 Menu key long press when set key is disabled which will enter into service settings.
 Compare the setting values available to default values.
S.NO PARAMETERS DEFAULT VALUES

1 Adult Ratio 19.3
2 Pedia ratio 55.0
3 Decimal F/R ON
4 Backlight Option ON
5 Wireless CMS ON
6 Application Mode PRM
WT, ZP, 20 PSI
7 Calibration (ADULT&MICRO)
8 Pressure unit Psi/mmHg- ON
9 LCD Brand 1
10 Hospital name edit Hospital name
11 Pressure drop 40
12 Model INFUMAX 5005
13 Vref level 0
1.1 Occlusion Calibration:

 Set the enable key and press menu key to enter into menu settings and use inc key to
scroll the settings then go to Tube type and change when calibrating respective mode.
 Long press menu key in set disabled condition and use inc key for calibration and press
set key to enter.
 Do the without tube calibration in door open condition.
 Then insert the tube in tube path and close the door and press set key. After the 20
seconds the tube will be calibrated.
 Then connect the pressure meter at the end of the tube and press run/stop key. When
pressure meter reaches 10PSI, press set key to store the value.
Prepared by K. Sai Kumar Approved by U. Suganth
Designation Engineer Trainee Designation Management Representative
Signature Signature
Doc. No.: AME/WI/12
Rev. No.: 00
1.2 Menu setting:
Enable the set key then press the menu key and enter into Menu setting.
Compare the setting values available to default values.

1 IV set brands
2 Bolus mode Auto, Purge
3 Quick ml/hr Adult, Pedia
4 Last data ON
5 KVO F/R 2
6 Air alarm ON
7 Occlusion Medium
8 Alarm Type Moderate
9 Alarm LED Bright 5
10 Door alarm ON
11 Clock Settings Current date and time
12 Event Log Settings reset
13 Drug Display ON
14 Standby mode ON
15 Pressure Drop ON
1.3 Bolus Setting- Purge bolus:

 Enable the set key then press the menu key and enter into Menu setting and change the
mode purge bolus.
 Enable the set key then press the Bolus key and set the bolus F/R to 300 ml/hr.
 Then Long press bolus key to Run the machine in purge bolus.
1.4 Bolus Setting- Auto bolus:
 Enable the set key then press the menu key and enter into Menu setting and change the
mode Auto bolus.
 Enable the set key then press the Bolus key and set the bolus F/R to 300 ml/hr. Disable
the set key and long press Bolus key to set the bolus volume
 Then Long press bolus key to Run the machine in Auto bolus.
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Doc. No.: AME/WI/12
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1.5 Factory Settings:
Set disabled condition, long press Clear key + dec. key to enter into factory settings.

1 Mfg. date/yr. 0
2 Serial number 0
3 S/W version
4 Communication mode WI-FI/RS 232
5 Max. F/R 1500, 1800, 2000 ml/hr
1.6 Vibration Test & lever test:

1. Procedure: In the vibration test the machine is hung on the respective pole and it is
connected to power supply. The machine is set to run at a flowrate of 25ml/Hr. the vibration
machine is turned on and the level is set to 2. Once the setting is made the vibration initiates and
these results in machine running in the vibration state. The machine left to run for duration of 20
minutes. The operator needs to make sure that no form of alarm is created during this operation.
The possible outcomes have mentioned below and Later, Take out the machine and check for
any irregularities internally like
a. Screws and other component becoming loose
b. Any other wired components are loosened
c. Check if Bolus and other features are activated when performed Etc.
1.7 Tube Calibration:

Long press Menu key+ Quick ml/hr to enter into the tube calibration.
ADULT MODE:
1. Take the 10ml syringe and collect the 10ml then press run/stop key.
2. Take the 20ml syringe and collect the 20ml then press run/stop key.
PEDIA MODE:
1. Take the 10ml syringe and collect the 10ml then press RUN/STOP key.
Manual calibration:
1. Fix the IV set properly
2. Take 10ml syringe and set the piston at 10ml mark and place output of IV to syringe.
3. Run 100mL/Hr. Once 10mL reached stop the machine. Check total drop counts. Drops/ml
Ratio= Total drop counts divided by 10
**Go to service settings and Edit Drop/ml ratio for Adult & Pedia IV
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Doc. No.: AME/WI/12
Rev. No.: 00
1.8 Event log checking in the menu settings:
For checking the event logs, enable the set key and press menu key and enter into the menu
settings to view the events by generating the above-mentioned events.
1.9 Dynamic Pressure Test:

1.Select the mmHg mode.
2.Off the occlusion level.
3.Set the flow rate as 60ml/hr.
4.Connect the IV tube in the pressure meter.
5.Press run key to start the pump.
1.10 Functions and alarm test:
S.NO FUNCTION TEST

1 Power Button ON/OFF
2 Run in AC Check the indication- Orange LED
3 Run in BATT Check the indication- Green LED
4 Old data Check the Old data ON/OFF condition
5 Buzzer Check the Buzzer working
6 Version Used Check the S/W Version no.
7 LoFl Alarm Check less flow alarm
8 HiFl Alarm Check high flow alarm
9 Door open Check door open alarm
10 Occlusion Check the Pre occlusion and occlusion alarm
11 Pressure drop Check the pressure drop alarm
12 tr-1 alarm Target volume reached alarm
13 tr-2 alarm target time reached alarm
14 AL3 alarm Internal malfunction
15 KVO KVO: ON/OFF and flowrate
16 Air alarm Air alarm ON/OFF (Verification)
17 Battery OFF Battery critical level alarm
18 View used hours Long press DEC+TAR key
19 Reset Used Hours Long press CLEAR key in used hours
Procedure to stimulate above alarm list.

1. Old Data - Turn LAST DATA ON in MENU settings and ON/OFF the machine. Previous data in
the screen should not be reset.
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2. Lo-FL Alarm - Run the machine in High Flow rate and Lock the IV regulator. Machine should
give
Lo-FL Alarm.
3. Hi-FL Alarm - Run the machine in Low Flow rate and cut the Drop Sensor sensing area as fast as
you can repeatedly. Machine should give Hi-FL Alarm.
4. tr-1 Alarm - Set some Target volume 1.0 ml and run the machine in high flow rate. After
reaching target volume machine should give tr-1 Alarm.
5. tr-2 Alarm - Set some Target time1 minute and run the machine in low flow rate. After
reaching target time machine should give tr-2 Alarm.
6. AL3 Alarm - AL3 ALARM should not come through out the testing days.
7. Pressure drop alarm-Block the IV tube then remove the blocking scissors machine should give
pressure drop alarm.
8. KVO - SET any KVO flow rate in MENU settings. Now set the target volume or time and run
the machine. After target reached machine should run in KVO Flow rate.
9. KVO OFF - SET KVO OFF in MENU settings. Now set the target volume or time and run the
machine. After target reached machine should give only TARGET alarm and KVO should not
run.
10. AIR alarm - Turn air alarm ON in MENU Settings. Generate air bubble at chamber side and
run the machine. After few movements air alarm should come.
11. Battery OFF - Verify this OFF alarm when Battery backup is testing. After Battery dry then
this alarm should come.
12.Door open alarm-Verify the door open alarm or close the door on the time of run
condition.
13.Occlusion Alarm-Verify the blockage in the IV tube or check the mode of levels in the
menu setting.
Note: Mute key should be used to mute the Alarm.
1.11 Accuracy test (AC mode)- Adult tube/night test:

1.Enable the set key and press menu key to enter menu settings. Go to Tube type to set
adult mode and F/R mode to set dr/min.
2.Set the flowrate to 1 dr/min and enable set key and press target key to set target time for
16hrs
3.Collect the volume either in syringe or Collecting beaker for 16 hrs.
4. Note the accuracy using the reference table mentioned the value in Accuracy Table.
5.Calculation of Actual ml: Actual Accuracy % = {Collected O/p mL}/ {Actual mL
should deliver} x 100.
6.Calculation of Actual ml: Machine Accuracy % = {Elapsed mL shown in Machine}/
{Collected mL} x 100
DAY 2
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Doc. No.: AME/WI/12
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2.0: Accuracy test (AC mode)- Adult tube:
1. Enable the set key and press menu key to enter menu settings. Go to Tube type to set
2. Set the flowrate and enable set key and press target key to set target time.
 Set F/R- 100 dr/min. Target Time- 5 mins.
3. Collect the volume either in syringe or Collecting beaker.
5. Calculation of Actual ml: Actual Accuracy % = {Collected O/p mL}/ {Actual mL
6. Calculation of Actual ml: Machine Accuracy % = {Elapsed mL shown in Machine}/
{Collected mL} x 100.
2.1: Accuracy test (AC mode)- Adult tube:
adult mode and F/R mode to set ml/hr.
 Set F/R- 500 ml/hr. Target Volume- 450 ml.
2.2: Accuracy test (AC mode)- Adult tube-Night loop test:
2. Set the flowrate for 300 ml/hr.
3. Put the tube into the loop and run the machine for ≤ 7hrs
4. If the machine run for ≤ 7hrs. Then it is pass
DAY 3
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3.0: Accuracy test (Battery mode)- Romsons tube:
2. Remove the Power cord for Battery mode and set the flowrate to 25 ml/hr.
3. Collect the volume either in syringe or Collecting beaker until the machine OFF.
4. Backup hrs: ≥ 4hrs.
5. Note down the time when machine is offed due to battery drained.
6. Calculate the start time and end time. If the time is reached more than 3 hours enter
the testis passed else enter the test is failed.
3.1: Accuracy test (AC mode)- Romsons tube:

 Set F/R- 900ml/hr. Target Time- 1 hr.
 Set F/R- 1200 ml/hr. Target Volume- 1hr.
3.2: Accuracy test (AC mode)- Romsons/Night test:
2. Set the flowrate to 1 dr/min and enable set key and press target key to set target time
for 16hrs
3. Collect the volume either in syringe or Collecting beaker for 16 hrs.
3.3: Accuracy test (AC mode)- Romsons tube:

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 Set F/R- 10 dr/min. Target Time- 15 mins.
3.Collect the volume either in syringe or Collecting beaker.
4.Note the accuracy using the reference table mentioned the value in Accuracy Table.
5.Calculation of Actual ml: Actual Accuracy % = {Collected O/p mL}/ {Actual mL
6.Calculation of Actual ml: Machine Accuracy % = {Elapsed mL shown in Machine}/
DAY 4
4.0: Accuracy test (AC mode)- Micro tube (Romson):
micro mode and F/R mode to set ml/hr.
 Set F/R- 100 ml/hr. Target time- 30 min.
4.1: Accuracy test (AC mode)- Micro tube (Romson)/Night test:

2. Set the flowrate to 10ml/hr and enable set key and press target key to set target
volume for 20ml.
4.2: Accuracy test - Micro tube (Romson)-Night loop test:

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2. Set the flowrate for 200 ml/hr.
3. Put the tube into the loop and run the machine for ≤ 7hrs
4. If the machine run for ≤ 6hrs. Then it is pass
DAY 5
5.0: Bolus test- Purge bolus (Manual Bolus)- AC mode:
1. Enable the set key and press menu key to enter menu settings. Go to bolus mode and
set purge bolus.
2. Press set key and press bolus key to set bolus Flowrate for 300 ml/hr.
3. Collect the volume for 5ml with the syringe.
4. Observe the value in syringe and enter the value in table. If the syringe is collected in
5 ml enter the test is passed, else enter the test is fail.
5.1: Bolus test- Auto bolus (Programmed bolus)-AC mode:

 Enable the set key then press the menu key and enter into Menu setting and
change the mode Auto bolus.
 Enable the set key then press the Bolus key and set the bolus F/R to 600 ml/hr.
Disable the set key and long press Bolus key to set the bolus volume
 Then Long press bolus key and set the target volume for 10ml and run the
machine in Auto bolus.
 Collect 10ml in the syringe.
 Observe the value in syringe and enter the value in table. If the syringe is collected
in 10 ml enter the test is passed, else enter the test is fail.
 Calculation of Actual ml: Actual Accuracy % = {Collected O/p mL}/ {Actual mL
 Calculation of Actual ml: Machine Accuracy % = {Elapsed mL shown in
Machine}/ {Collected mL} x 100.
5.2: Accuracy test (Battery mode)- Adult tube (Romsons)
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1. Enable the set key then press the menu key and enter into Menu setting and change
the mode Auto bolus.
2. Remove the power cord for battery mode. Press set key and press bolus key to set
bolus Flowrate for 60 ml/hr.
3. Set the target for 1 hr.
4. Check the drop count on machine that matches with actual drop of 1200 drops.
5. Backup hrs: >3hrs
6. Note down the time when machine is offed due to battery drained.
7. Calculate the start time and end time. If the time is reached more than 3 hours enter
the testis passed else enter the test is failed.
5.3: Accuracy test- Adult (Romsons)- AC mode:

2. Set the flowrate to 1 ml/hr and enable set key and press target key to set target time
for 16hrs
3. Collect the volume either in syringe or Collecting beaker for 16 ml.
DAY 6
6.0 Occlusion Blocking test- Adult & micro:
Procedure for setting the PSI& mmHg
 Enable the set key and press menu key to enter menu settings. Go to Tube type to set
adult mode
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 First go to the service setting number 10 and change the pressure units by pressing
target key (PSI or mmHg) then turn ON the pressure unit display by using the
increment key.
 Go to the menu setting number 6 and set the occlusion levels (low, medium and high)
one by one by using increment decrement key
 Run the flow rate according to test chart, block the edge of the IV tube with the help
of blocking scissor.
 Finally check the occlusion alarm testing for different levels of 300 mmHg,
600mmHg, 900mmHg/ 6PSI, 12PSI, 18PSI.
 The tolerance level should be ±3PSI or ±150 mmHg.
 Perform occlusion for the flowrates 50ml/hr and 50 dr/min.
6.1 Accuracy night test- Romsons Adult:
2. Set the flowrate to 10 ml/hr and enable set key and press target key to set target time
for 16hrs
3. Collect the volume in beaker for 160 ml.
DAY 7
7.1 Packing Day test:
A. Used Hours Resetting:
1. In machine stop state, long press the unit down key and Target key to see
machine Used Hours (in hours).
2. To reset the Used Hours, long press Clear key in the used hours settings then the
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Used Hours will be reset.

B. Factory Setting:
1. Long Press the key combination of unit down key and clear key long press to
enter the factory setting.
2. Set the manufacturing date, SI.NO, Note Down the software version,
communication mode and enable three maximum flowrates if needed.
C. Check all the items before packing the machine.
S.NO ITEM NAME S.NO ITEM NAME

1 Small Knob 1 no. 16 warning sticker
2 Sticker AC voltage 17 QR code sticker
3 Bottle hanger 18 Door sticker
4 Operator Manual 19 OP sticker
5 Power chord 20 Press sticker left
6 Clean Unit 21 Pedia IV set
7 Corrugated box- SL No Sticker 22 Front flow sticker
8 Drug label folder 23 Wiring Diagram Sticker
10 Wi-Fi sticker 24 Flow arrow small sticker
11 instruction sticker 25 SI No. sticker
12 Sticker AKAS passed 26 sticker warranty DPR
13 Handle from corrugated Box 27 Press sticker right
14 Reset used hours 28 Adult IV set
15 IV chamber sticker
D. Verification by QC:
To verify the below functions by QC
1. Keep KVO Flow rate as 0.1ml/hr.
2. Machine Run in AC and DC condition.
3. Plug in the power Chord Orange colour indication mains’ icon should glow in LCD
display.
4. Plug out the power Chord battery icon should glow in DC indicator symbol.
5. tAr.1 ALARM-Target Volume reached Alarm.
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6. tAr.2 ALARM-Target Time Reached Alarm.

7. OFF ALARM (OFF)-Turn off the machine, to verify the OFF alarm both AC and
DC condition.
8. Old Data ON-when we turn OFF and, ON the machine, the infused volume and
Elapsed time Flowrate display.
9. Machine stop state –Red LED glow in Alarm LED
10. Machine run state –Green LED glow in Alarm LED
11. In Keypad enable the set key LED glow.
12. AL3 Alarm -Internal Malfunction, during the test AL3 Alarm should not occur.
13. Low Battery Warning and Indication.
14. Check the Bolus functionality.
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WI - 12 - Final Unit Test - Infusion Pump

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S.NO PARAMETERS DEFAULT VALUES

1.1 Occlusion Calibration:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

S.NO PARAMETERS DEFAULT VALUES

1.3 Bolus Setting- Purge bolus:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

S.NO PARAMETERS DEFAULT VALUES

1.6 Vibration Test & lever test:

1.7 Tube Calibration:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

1.8 Event log checking in the menu settings:

1.9 Dynamic Pressure Test:

1.10 Functions and alarm test:

S.NO FUNCTION TEST

Procedure to stimulate above alarm list.

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

1.11 Accuracy test (AC mode)- Adult tube/night test:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

3.1: Accuracy test (AC mode)- Romsons tube:

3.3: Accuracy test (AC mode)- Romsons tube:

Designation Engineer Trainee Designation Management Representative

4.1: Accuracy test (AC mode)- Micro tube (Romson)/Night test:

4.2: Accuracy test - Micro tube (Romson)-Night loop test:

Designation Engineer Trainee Designation Management Representative

5.1: Bolus test- Auto bolus (Programmed bolus)-AC mode:

5.2: Accuracy test (Battery mode)- Adult tube (Romsons)

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

5.3: Accuracy test- Adult (Romsons)- AC mode:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

Designation Engineer Trainee Designation Management Representative

Used Hours will be reset.

C. Check all the items before packing the machine.

S.NO ITEM NAME S.NO ITEM NAME

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

6. tAr.2 ALARM-Target Time Reached Alarm.

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

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