WI-10 Final Unit Test - Syringe Pump

Doc. No.
: AME/WI/10
AKAS MEDICAL EQUIPMENT
Rev. No.: 00
WORK INSTRUCTION Issue No.: A
FINAL UNIT TEST – SYRINGE 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.
Pre-unit Test:
A. Vibration Test:
1. Procedure: In 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.
NOTE: If the specimen fails this test, the machine must be reworked and the test
must be readministered
B. Free Fall Test:

Use Free Fall Testing Kit. It generally consists of an IV pole and a 50ml Syringe
(Dispovan). Do Free Fall Test for every 100th numbered Machines.
Drop the Machine 5 Times in the following mentioned ways from the height of 4 feet:
i. Free fall from Hand- from shoulder height of the respective operator
ii. Free fall from IV pole- The pole must be pushed towards Plunger
iii. Free fall from IV pole- The pole must be pushed against Plunger
iv. Free fall from IV pole- The pole must be pushed in the front side of the Pump
v. Free fall from IV pole- The pole must be pushed in the rear Side of the Pump
Note the result at which iteration the damage occurred. If No damage is observed from
the above scenarios, more than 3 times then Mark the result as “PASS”, otherwise
mention it as “FAIL”.
Notify the results to QC engineer for further investigation if there is a severe risk
identified and necessary PIR (Production Issue Raised)
Prepared by K. Sai Kumar Approved by U. Suganth
Designation Engineer Trainee Designation Management Representative
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Doc. No.: AME/WI/10
Rev. No.: 00
NOTE: The drop tested machine in case of severe damage will be disassembled and
analyse. On completion of the analysis the damage parts would be replaced and the
machine would be reworked and retested, else if the damage observed is less the
machine would be disassembled and analysed once completed the machine testing
would be resumed.
C. Syringe Calibration and Testing:

Procedure for Syringe Calibration:
1. In Stop mode, Set Disabled Condition - Long Press SYR Key and select the syringe
brand name
2. Then Long Press the MODE Key to check the base value (0 to 300) then press prime
key once.
3. Place 5mL syringe & press UNIT Increment key
6. Place 30mL syringe or jig for 30 mL & press UNIT Increment key
7. Place 50mL syringe or jig & press UNIT Increment key
8. Pull out the syringe holder & press UNIT Increment key
9. Pull in the syringe holder and now ensure 5mL LED blinks & then Press set key to
complete the syringe calibration
SD Testing Procedure:
Dispovan
Syringe 2 ml 5 ml 10 ml 20 ml 30 ml 50 ml Pull Out
Size
9 and 12 and 15.5 16 and 20 and 25 and 28 and
Range Jig Pull out 36
11.5 19.5 24 27 35
in mm (+/- 0.5)
(+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5)
BD Syringe
2 ml 5 ml 10 ml 20 ml 30 ml 50 ml Pull Out
Size
9 and 11 11.5 and 15 and 19 and 25 and 28 and
14.5 18.5 24 27 35
in mm (+/- 0.5)
(+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5)
B Braun
Syringe 2 ml 5 ml 10 ml 20 ml 30 ml 50 ml Pull Out
Size
9 and 11 11.5 and 15 and 19 and 25 and 28 and
14.5 18.5 24 27 35
in mm (+/- 0.5)
(+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5) (+/- 0.5)
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Doc. No.: AME/WI/10
Rev. No.: 00
Follow the above Table and Test the Syringe detection using the procedure given below.
A. Dispovan syringe
1. Load 5ml syringe and observe the size displayed on the machine. Fill the respective
columns in the test chart with respect to Pass/Fail based on it’s placed vs.
displayed values.
2. Follow the same procedure for 10ml, 20ml, 30ml, 50ml syringes.
B. BD precise syringe
displayed values.
C. B Braun precise syringe

displayed values.
NOTE: In case of failure the SD assembly would be analysed for any error during
assembly.
D. Occlusion Calibration Settings:
1. Take a 5ml, 10ml, 20ml and 50 ml Syringe filled with saline/water connected with
an HPM line.
2. In Set disabled stop state condition, Long Press Mute key and Unit down key to
enter the Service setting.
3. In the service settings go to the 0PSI Calibration option using decimal Up/Down
key.
4. 0PSI Calibration: LCD displays the pressure value - live strain gauge value, if
mode key is pressed it stored the zero PSI value, only if machine is in no syringe
condition Show “done” message after value stored.
5. In the service setting go to the 20PSI Calibration option then press mute key to
enter into 20psi calibration section.
a. 20PSI Calibration: 20psi calibration mode, if syringe selection is in auto syringe
detection mode, user kept syringe size will be displayed in the LED display.
User can change syringe in 20 psi setting itself and again calibrate.
b. Connect the IV line into pressure gauge.
c. Press RUN/STOP key then RUN the pump.
d. Once the value in pressure gauge reached to 20 PSI value, the MODE key must
be pressed to store the 20 PSI value, the stored 20 PSI value will be displayed
when the respective syringe is placed.
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Doc. No.: AME/WI/10
Rev. No.: 00
E. EOS Calibration:
1. Fix the 50 ml syringe in machine.

2. Move the piston to 5 ml mark near the end position.
3. Run the pump in 60 ml/Hr until near empty alarm comes, then stop the pump
immediately when near empty warning starts
4. Remove the syringe
5. Measure the collar length (mm) by using a Vernier caliper at the outer edges of
the collar and piston.
6. After measuring the collar length, multiply the value with 10 and subtract from 240.
(Example: - Measured collar Length is 25mm. Then the value will be 25X10=250.
Now subtract 240 from this value. 250-240=10. Now the calculated EOS value is
10).
7. Feed the calculated EOS value to the EOS calibration setting - Go to the EOS
option in service settings. Enter the calculated value. (The default value is 80)
8. Press SET key to store and exit the setting.
9. Again, run the pump till end of syringe as per the END Testing in Final Unit test
chart. Also perform the EOS Test in Day 2 to ensure EOS calibration is
successful. (Follow the same procedure for all syringe sizes)
IMPORTANT NOTE:
***The above measured collar value should come ≥ 240. If value is below 240 then EOS
position in pump assembly needs to be corrected.
F. High Pressure Mode Test:
1. In Set enabled stop state condition, press the menu key to enter the Menu setting.
2. In the Menu setting, the 9th setting will be High Pressure Mode - ON
3. Then place the 50 ml filled Syringe with HPM line to the machine and connect the
other end of the HPM line to the Pressure gauge.
4. Then set a flow rate of 60 ml/hr and run the machine.
5. If the machine pressure value reaches the 1000mmhg –PASS. Otherwise “FAIL”.
G. Menu Settings Verification:
1. Press the Unit Up and syr Key when set mode is Disabled.
2. Compare the setting values available to the default values.
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Doc. No.: AME/WI/10
Rev. No.: 00
Default
Parameter
Value
Occlusion Level - mmHg 700
Last Data: ON / OFF OFF
KVO Flowrate 0.1
Buzzer Volume 10
High Pressure mode OFF
Note: Update the default values before packing.
H. Service Settings Verification:
1. Long Press the Menu Key when set mode is disabled.

2. Compare the setting values available to the default values.
Default
Parameter
Value
Engage Value – E 3
Syringe End- ES ON
AL9 Alarm - AL 9 OFF
OFF
AL 12 Alarm - A12
AL 13 Alarm - A13 OFF

AL 14 Alarm - A14 OFF
Sensor based alarm – Aln OFF
Flow rate S/H limit 15
ALARM LED Brightness(ALb) 5
Bolus Limit – bolu -
Potentiometer Calibration-Pot -
Manual Syringe Selection – Syr -
Syringe Length- Leng -
Collar Length- End.L -
Note: Update the default values before packing.
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Doc. No.: AME/WI/10
Rev. No.: 00
I. Accuracy - Night test / AC:
1. Load a 50 ml Syringe with saline/water connected with a HPM line & a needle with
fluid primed all the way till the tip of the neelde. Take a measuring jar of 50 ml to
measure the output of the machine.
2. Set a Target Time 16hrs and run it at flow rate of 1ml/hr. (Ensure to clear the
previous infused volume & time by long press Run Stop Key while start of the
infusion).
3. Once the target is reached, fill the parameter stop time, total time in actual &
machines, total volume displayed in machine & true volume collected in the
measuring jar.
4. Note the accuracy using the reference table mentioned below Accuracy
Table:001
Day 1 TESTS:
1A.AL12 Alarm Test:

1. This alarm indicates syringe plunger not engaged.
2. This alarm must occur during the initiation of infusion
3. This alarm can be made ON/OFF. Two Options should be provided. DECIMAL
increment decrement key should be used to change the values in Service settings.
4. Try to run the machine without engage the plunger with syringe –AL12
Alarm comes-PASS, otherwise “FAIL”.
1B. AL13 Alarm Test:

1. If plunger is disturbed or removed during RUN condition this alarm should come.
3. Disengage the Plunger in Run state AL13 Alarm comes-PASS otherwise “FAIL”.
1C. AL14 Alarm Test:

1. This is plunger is not engaged in stop state, give al14 alarm.
3. Plunger is not engaged in stop state AL14 Alarms Comes-PASS otherwise “FAIL”.
1D. Occlusion Test in AC mode (Dispovan):
1. Take a Dispovan 50ml syringe and fill it with 30ml of distilled water.
2. Do manual priming with the HPM Line.
3. Then load to syringe pump and conduct machine priming (Press Bolus until 3ml of
drug is delivered in order to engage the plunger)
4. Connect the other end of HPM Line to a Pressure gauge
5. Run the device at flow rate mentioned in the test chart.
6. Verify the following conditions:
7. Occurrence of Pre-occlusion (P. Occl) Warning on display
8. Activation of Anti-Bolus/Anti Occlusion
9. Occlusion Alarm is displayed.
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Doc. No.: AME/WI/10
Rev. No.: 00
10. Note Down the values of Occlusion maximum pressure level and reduced
pressure level displayed in the pressure gauge.
11. Mark the result as PASS if the results of Occlusion maximum pressure level and
reduced pressure level are within the given respective ranges mentioned in test
chart.
12. Follow the same procedure for dispovan Brand 5ml, 10ml, 20ml, 30ml, and
syringes.
1E. 15 hr Accuracy - Night test / AC:
1. Load a 50 ml Syringe with saline/water connected with a HPM line & a needle.
Take a measuring jar of 50 ml to measure the output of the machine.
2. Set a Target Volume of 16ml and run it at flow rate of 1ml/hr. (Ensure to clear the
infusion).
measuring jar.
4. Note the accuracy using the reference table mentioned below Accuracy
Table:001
DAY 2 TESTS
2A. Mains and Battery Indication Test:
1. AC Mains Voltage as 100V put it as Auto Transformer, AC Mains LED On –PASS

otherwise Fail.
2. AC Mains Voltage as 18V put it as Auto Transformer, DC LED On –PASS otherwise
Fail
2B.EOS Test:
1. Take a 50ml syringe and set the plunger & syringe piston to 10ml mark.
2. Set the flow rate as per the test chart.
3. Verify the following conditions.
4. Near empty run (Yellow light blinks & beep occur)
5. Syringe End (Red Light Blinks & Alarm occurs)
6. Note down the Balance Drug After reaching the End position.
7. If the balance drug available in syringe is more than 0.2 ml, then mark it as FAIL.
8. Follow the same procedure for 5ml, 10ml, 20ml, 30ml, 50ml syringes.
2C. Occlusion Test in DC mode (Dispovan):

1. Take a Dispovan 50ml syringe and fill it with 30ml of distilled water.
2. Do manual priming with the HPM Line.
3. Then load to syringe pump and conduct machine priming (Press Bolus until 3ml of
drug is delivered in order to engage the plunger)
4. Connect the other end of HPM Line to a Pressure gauge
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Doc. No.: AME/WI/10
Rev. No.: 00
5. Run the device at flow rate mentioned in the test chart.
6. Verify the following conditions:
7. Occurrence of Pre-occlusion (P. Occl) Warning on display

8. Activation of Anti-Bolus/Anti Occlusion
9. Occlusion Alarm is displayed.
10. Note Down the values of Occlusion maximum pressure level and reduced
pressure level displayed in the pressure gauge.
11. Mark the result as PASS if the results of Occlusion maximum pressure level and
reduced pressure level are within the given respective ranges mentioned in test
chart.
12. Follow the same procedure for dispovan Brand 5ml, 10ml, 20ml, 30ml, and
syringes.
2D. Manual Syringe Test:

1. Load the 50ml syringe and go to the manual syringe selection option in service
setting.
2. Navigate to Manual syringe setting and turn it ON using Decimal Up/Down key.
3. Long press the SYR key and select the syringe size in Unit Up/Down key.
4. Run the machine at 0.1ml/hr
5. Disturb the syringe holder if AL1 is not generated-PASS, otherwise FAIL
6. Manual syringe OFF using Decimal Up/Down key.
7. Run the machine at 0.1ml/hr
8. Disturb the syringe holder if AL1 is generated-PASS, otherwise FAIL
2E. Accuracy - Night test / AC:

1. Load a 20 ml Syringe with saline/water connected with a HPM line & a needle. Take
a measuring jar of 20 ml to measure the output of the machine.
2. Set a Target Time 16hrs and run it at flow rate of 1ml/hr. (Ensure to clear the
infusion).
measuring jar.
4. Note the accuracy using the reference table mentioned below Accuracy Table:001
DAY 3 TESTS
3A. Occlusion Blocking and Anti Bolus Volume Test:
AC Mode, Occlusion Level: 700mmhg

Load a 50 ml Syringe with saline/water connected with a HPM line & a needle.
1. Run the machine at 3min.
2. Block the HPML line at the end. After Occl alarm came Remove the blocking
and check the drops leakage in needle end. The drop count should be less
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Doc. No.: AME/WI/10
Rev. No.: 00
than 6 drops.
3B. Purge Bolus Volume Limit Test
1. Load the syringe and set bolus flowrate (Press the purge key set enabled condition)
2. Press and hold purge key machine should run in purge Bolus mode
3. The purge bolus run mode must continue till the Purge Key is kept pressed but the
infusion must not cross the BOLUS volume limit set inside service settings.
4. If release or remove pressing the purge key, then the purge bolus mode should
come to end
5. In case the user release the key before the bolus limit reaches & again if press the
purge key within 2 seconds then the bolus purge mode should be continued and the
infused ml volume should continue from the previous infused bolus volume.
3C.AC Mode Day Accuracy Testing:
a. Load a 50 ml Syringe with saline/water connected with a HPM line & a needle. Take
b. Set a Target Time of 50ml and run it at flow rate of 30ml/hr. (Ensure to clear the
infusion).
c. Once the target Time is reached, fill the parameter stop time, total time in actual &
measuring jar.
d. Follow the same procedure for 5ml, 10ml, 20ml, 30ml syringes with the input as per
the table given below.
Syringe. F/R Target

Expected ml
Size (ml) Time
50 30 1hour 30
20 15 1hour 15
10 5 1hour 5
5 3 1hour 3
3D. Accuracy - Night test / AC:
1. Load a 10 ml Syringe with saline/water connected with a HPM line & a needle. Take
2. Set a Target Time 16hrs and run it at flow rate of 0.5ml/hr. (Ensure to clear the
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Rev. No.: 00
infusion).
measuring jar.
DAY 4 TESTS:
4A. Battery Backup Test
Load the 50ml syringe and run the machine at 5ml/hr in dc condition battery backup
greater then 4hrs-PASS otherwise fail.
NOTE DOWN:
1. Start Time
2. Battery Low time (red indication)
3. Battery Off time
4. Total Hrs
4B. Accuracy - Night test / AC:

1. Load a 5ml Syringe with saline/water connected with a HPM line & a needle. Take a
measuring jar of 5 ml to measure the output of the machine.
2. Set a Target Time 16hrs and run it at flow rate of 0.2ml/hr. (Ensure to clear the
infusion).
measuring jar.
DAY 5 TESTS
5A. Battery Backup Test

Load the 50ml syringe and run the machine at 5ml/hr in dc condition battery backup
greater then 4hrs-PASS otherwise fail.
NOTE DOWN:
5. Start Time
6. Battery Low time(red indication)
7. Battery Off time
8. Total Hrs
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Doc. No.: AME/WI/10
Rev. No.: 00
DAY 6 TESTS
6A. Vibration Test:

Procedure: In 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
d. Screws and other component becoming loose

e. Any other wired components are loosened
f. Check if Bolus and other features are activated
when performed Etc.
NOTE: If the specimen fails this test, the machine must be
reworked and the test must be readministered
6B. KVO Functions Test:

1. If KVO flow rate is greater than the set flow rate, KVO flow rate gets
automatically reduced.
2. If Set flow rate is <= 5ml/hr, then KVO = 0.1ml/hr.
3. If set flow rate is > 5ml/hr and <= 10ml/hr, then KVO= 0.2 ml/hr.
4. If set flow rate is greater than 10 ml/hr,then KVO = 0.3 ml/hr.
5. If above set conditions results then the test PASS else FAIL
6C. High and Low voltage test:
Take the Auto Transformer of Range 0-300V. Set the voltage at the levels indicated
below and supply it to the machine for a period of 10 min. Mark the result as FAIL if the AC
LED Indication stops glowing/battery LED is indicated during the test.
1. 290V (High voltage)

2. 100V (Low Voltage)
6D. Soft Limit checking:
1. Go to the Flow rate soft limit option in service setting.

2. This option is used in settings enabled state while flow rate is incrementing by
long pressing units key, value should get incremented up to soft limit set inside
the soft limit option,
3. If the user wants to increment more than soft limit the increment key must be
released and pressed again.
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Rev. No.: 00
4. If reached the limit values then give warning beep, with Beep repeated till
pressed key released-PASS otherwise Noted as “FAIL”.
5. The soft limit Values can be incremented up to 100.
6E. Alarm LED Checking (Brightness Level):
1. This option used to change the Alarm LED brightness from level.
2. There should be 5 levels are from (1 -5) and after 5 user tries to increment then
display full option and value increment/decrement If the option FULL chosen
then the alarm LED will always ON. In run state, alarm led should be
continuously ON.
3. If user selection between (1 – 5) level, in run state, alarm led flash in green
color, in stop state alarm led should glow in red without flashing. If any alarm
comes, led in flash in red. Show alarm LED brightness as “5.Alb”.
4. If alarm brightness greater or less than 5, then reset alarm brightness value to
default value as 5.
5. Decimal increment decrement key should be to change the values the set key
should be used to confirm the values changed.
6F. Buzzer volume checking:
1. Buzzer volume can be controlled in this option from 0 to 10 different level.

2. Option 0 can be given as “0.vol” in selection. Buzzer volume should
increment/decrement using decimal UP/DOWN key. Default buzzer volume is
10.
6G. Accuracy - Night test / AC:

1. Load a 50ml Syringe with saline/water connected with a HPM line & a needle. Take
2. Set a Target volume 16 and run it at flow rate of 0.2ml/hr. (Ensure to clear the
infusion).
3. Once the target is reached, fill the parameter start time and stop time, total time in
actual & machines, total volume displayed in machine & true volume collected in
the measuring jar.
DAY 7 TESTS
7A. Bolus Test-Auto Bolus (Manual Bolus) AC mode:

1. Load the 50ml syringe and set bolus flowrate as 600ml/hr(Press the purge key set
enabled condition)
2. Long Press the Auto Bolus key in machine and set the Auto Bolus Volume as 50ml
and machine should run in Auto Bolus mode
the measuring jar.
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Rev. No.: 00
7B. Bolus Test-purge Bolus (programmed Bolus) AC mode:

enabled condition)
3. The purge bolus run mode must continue and keep pressing the Purge Key for 1min
but the infusion must not cross the BOLUS volume limit set inside service settings
and set the bolus volume limit as 6 in service settings.
the measuring jar.
7C. Bolus Test-Auto Bolus (Manual Bolus) DC mode:
enabled condition)
2. Long Press the Auto Bolus key in machine and set the Auto Bolus Volume as 50ml
and machine should run in Auto Bolus mode
the measuring jar.
7D. Bolus Test-purge Bolus (programmed Bolus) DC mode:

enabled condition)
3. The purge bolus run mode must continue and keep pressing the Purge Key for 1min
but the infusion must not cross the BOLUS volume limit set inside service settings
and set the bolus volume limit as 6 in service settings.
the measuring jar.
DAY 8 TESTS
8A. Factory settings:
DECIMAL UP key and SET key long press same time. SET Key long press to
edit the manufacturing date & Sl.No. Use Mode Keys to change next
parameter.
8B. USED HOURS RESETTING:
a. VIEW USED HOURS: Decimal up key and Set key long press to enter into
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factory settings and mode key to use change option, see used hours in total
used hours screen.
b. USED HOURS RESET: long press the SYR key in used hours screen.
8C. Verification by QC:
1. Check the Menu settings, service settings and Bolus Flow rate as per the Test
chart
2. Keep KVO Flow rate as 0.1ml/hr.
3. Near Empty Indication and Beep sound.
4. Brand selection-Check the default Brand name (DISPOVAN)
5. Check the Syringe and collar Length for Custom Syringe.
6. Machine Run in AC and DC condition.
7. Plug in the power Chord Orange color indication should glow in AC mains
indicator.
8. Plug out the power Chord green color indication should glow in DC indicator.
9. TAr.1 ALARM-Target Volume reached Alarm.
10. TAr.2 ALARM-Target Time Reached Alarm.
11. OFF ALARM (OFF)-Turn off the machine, to verify the OFF alarm both AC and
DC condition.
12. Old Data ON-when we turn OFF and, ON the machine, the infused volume and
Elapsed time Flowrate display.
13. Near empty run (Yellow light blinks & beep occur).
14. Syringe End (Red Light Blinks & Alarm occurs).
15. Occurrence of Pre-occlusion (P. Occl) Warning on display.
16. Activation of Anti-Bolus/Anti Occlusion.
17. Occlusion Alarm and indication display.
18. Machine stop state –Red LED glow in Alarm LED
19. Machine run state –Green LED glow in Alarm LED
20. Machine warning state-Yellow LED glow in Alarm LED
21. Syringe Holder disturbed in run condition –AL1 Alarm Occurs and Red-Light
Blinks.
22. All Keypad LED glow.
23. AL3 Alarm -Internal Malfunction, during the test AL3 Alarm should not occur.
24. AL10 Alarm –Occlusion sensor failed, during the test AL10 Alarm should not
occur.
25. Error2-Motor Reverse, during the test Error2 Alarm should not occur.
26. Low Battery Warning and Indication.
27. AL3.1-MFB cuts high, during the test AL10 Alarm should not occur.
28. Error 1- MFB cuts Low, during the test AL10 Alarm should not occur.
29. Check the Bolus functionality.
30. AL9 Alarm Functionality.
31. Keep LCD Brand as 2.
32. Check FSR functionality.
8D. Packing Day Verification:
1. All Stickers are Pasted Properly.

2. Cabinet water proof Sealant fixed properly.
3. Plunger bush fixed properly.
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4. Screw cap fixed in rear cabinet
5. Silicon Sealant for keypad (666)
6. User Manual for 4004A
7. power chord
8. QC Pass Certificate
9. QR code for 4004A
10. Proper Packaging (visual inspection
ACCURACY TEST - REFERENCE TABLE
The following table shall be used as a reference to note the accuracy % of the volume
collected at the end of the accuracy night test conducted for 16hrs – 6PM to 10AM as per
final unit test chart of AKAS SYRU 4004, AKAS TERUMAX RX & AKAS SYRU 6006.
(Target Time(Hr) = Target volume(mL)/Flow Rate(mL/Hr))

(Target volume(mL)=Flow Rate(mL/Hr)*Target Time(Hr))
10ML 10ML syringe-

50ML syringe-1ml/hr 20ML syringe-1ml/hr
syringe-0.5ml/hr 0.2ml/hr
Collected Collected Collected Collected
Accurac Accurac
Volume(M Accuracy Volume(M Accuracy Volume(ML Volume(M
y y
L) L) ) L)
16 100 16 100 8 100 3.2 100
16.2 101.25 16.2 101.25 7.8 97.5 3 93.75
16.4 102.5 16.4 102.5 7.6 95 2.8 87.5
16.6 103.75 16.6 103.75 7.4 92.5 2.6 81.25
16.8 105 16.8 105 7.2 90 2.4 75
17 106.25 17 106.25 7 87.5 2.2 68.75
17.2 107.5 17.2 107.5 6.8 85 2 62.5
17.4 108.75 17.4 108.75 6.6 82.5 1.8 56.25
17.6 110 17.6 110 6.4 80 1.6 50
17.8 111.25 17.8 111.25 6.2 77.5 1.4 43.75
18 112.5 18 112.5 6 75 1.2 37.5
18.2 113.75 18.2 113.75 8.2 102.5 1 31.25
18.4 115 18.4 115 8.4 105 3.4 106.25
15.8 98.75 15.8 98.75 8.6 107.5 3.6 112.5
15.6 97.5 15.6 97.5 8.8 110 3.8 118.75
15.4 96.25 15.4 96.25 9 112.5 4 125
15.2 95 15.2 95 9.2 115 4.2 131.25
15 93.75 15 93.75 9.4 117.5 4.4 137.5
14.8 92.5 14.8 92.5 9.6 120 4.6 143.75
14.6 91.25 14.6 91.25 9.8 122.5 4.8 150
14.4 90 14.4 90 10 125 5 156.25
14.2 88.75 14.2 88.75 10.2 127.5 5.2 162.5
14 87.5 14 87.5 10.4 130 5.4 168.75
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Doc. No.: AME/WI/10
Rev. No.: 00
Accuracy Table:001
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B. Free Fall Test:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

C. Syringe Calibration and Testing:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

C. B Braun precise syringe

D. Occlusion Calibration Settings:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

1. Fix the 50 ml syringe in machine.

F. High Pressure Mode Test:

G. Menu Settings Verification:

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

Note: Update the default values before packing.

H. Service Settings Verification:

1. Long Press the Menu Key when set mode is disabled.

AL 13 Alarm - A13 OFF

Note: Update the default values before packing.

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

I. Accuracy - Night test / AC:

1A.AL12 Alarm Test:

1B. AL13 Alarm Test:

1C. AL14 Alarm Test:

Designation Engineer Trainee Designation Management Representative

1E. 15 hr Accuracy - Night test / AC:

2A. Mains and Battery Indication Test:

1. AC Mains Voltage as 100V put it as Auto Transformer, AC Mains LED On –PASS

2C. Occlusion Test in DC mode (Dispovan):

Designation Engineer Trainee Designation Management Representative

7. Occurrence of Pre-occlusion (P. Occl) Warning on display

2D. Manual Syringe Test:

2E. Accuracy - Night test / AC:

3A. Occlusion Blocking and Anti Bolus Volume Test:

AC Mode, Occlusion Level: 700mmhg

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

3B. Purge Bolus Volume Limit Test

3C.AC Mode Day Accuracy Testing:

Syringe. F/R Target

3D. Accuracy - Night test / AC:

Designation Engineer Trainee Designation Management Representative

4B. Accuracy - Night test / AC:

5A. Battery Backup Test

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Designation Engineer Trainee Designation Management Representative

6A. Vibration Test:

d. Screws and other component becoming loose

6B. KVO Functions Test:

6C. High and Low voltage test:

1. 290V (High voltage)

6D. Soft Limit checking:

1. Go to the Flow rate soft limit option in service setting.

Prepared by K. Sai Kumar Approved by U. Suganth

Designation Engineer Trainee Designation Management Representative

6E. Alarm LED Checking (Brightness Level):

6F. Buzzer volume checking:

1. Buzzer volume can be controlled in this option from 0 to 10 different level.

6G. Accuracy - Night test / AC:

7A. Bolus Test-Auto Bolus (Manual Bolus) AC mode: