Fresenius Kabi Volumat Agilia, Technical Manual

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vafiche_001g_Eng.fm 53
Main
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4.5.5 Quality Control Certificate
Use this table to summarise the results obtained from the various tests.

These tests can be carried out using a software dedicated to the Agilia devices.
Device type: Code: Device serial n°:
N° Procedure Value Obtained
Conformity
Yes No
1  Check the general appearance of the case, label containing serial number and
product code.
2  OCS check:
 Switch the device on.
 Install an administration set filled with water.
 Check OCS.
3  Check the upstream pressure (without drip detector): *********** ..........................
 Start a 100ml/h infusion without a drop detector.
 Clamp the administration set between the drop chamber and the pump.
 Check that the Upstream occlusion alarm is triggered before 30 seconds.
 Unclamp the tube.
 Press "silence alarme".
 "Start" displays.
Refer to section 7 "Calibration / Calibration procedure /
EtAL1
pressure
calibration", if one of the values is out of range.
4  Check the downstream pressure.
 Install the water manometer at the administration set outlet.
 Set the pressure threshold at 750mmHg.
 Start infusion at 100ml/h.
 Check that the Downstream occlusion alarm is triggered at 7125

(1bar + 0.15).
Refer to section 7 "Calibration / Calibration procedure /
EtAL1
pressure
calibration", if one of the values is out of range.
5  Check the drop detector "if present".
6  Check the air detector.
 Start the test with at a flow rate of 500ml/h,
 Create an air bubble in the administration set with a minimum length of 5 cm.
 Check the presence of the air bubble alarm (sound and visual) when the air
bubble passes through the air bubble detector.
Refer to section 7, "Calibration / Calibration procedure /
EtAL3
calibration of the
air detector", if the values are out of range.
7

Display the running time and the last maintenance date, test 2 (in hours, days or
months). ************************************************************* ..........................
8  Check the LCD screen, all light indicators and buzzer, test 9. ** ..........................
9  Check the keyboard, test 10. ************************************** ..........................
Maintenance préventive