8 - 6
8 -
Procedural Instructions for Inspection
8
1. Visual Inspection
2. Electrical Safety Inspection as per IEC/EN60 601-1
Operating unit, lock mechanism, pump cover, seal membrane, flow inhibitor. Door lock: easy opening and closing, correct top and bottom locking.
Pump cover must automatically open when the unit door is opened.
Protective Conductor Resistance
Protective conductor resistance < 0.2
Ω. incl. mains lead.
Measurement points:
Potential equalization bolt
Bolt for door lock
Unit housing: a) If the unit is not sealed countersunk screw at the rear of the unit.
b) If the unit is sealed, remove lacquer from one of the holes in the foot stands.
Note
Do not use the foot stand assembly screws as alternative measurement points.
Document the largest value.
Insulation Resistance
Insulation resistance >> 2 M
Ω
Measurement with 500 V between shorted mains connectors and potential equalization bolt.
Earth Leakage Current
Earth leakage current
≤ 30 µA incl. mains cable.
Measurement under standard conditions at the protective conductor of the mains cable. Two measurements (one with changed poles).
Document the largest value.
Infusomat P 2.0gb 8 - 1
8 - 2
8
Procedural Instructions for Inspection
3. Functional Inspection
Fig.: 8 - 1
Switch-on Test
Switch-on test keypad and display: check correct procedure.
Alarm tone, display: rate 000.0, VOL, TIME etc., display of all pixel, contrast, display light, alarm and operating LED.
Battery Test
Switch mains/battery/mains: Interrupt mains supply twice in intervals of 1 second. Pay attention to the switch-over in the display. The unit must not switch to malfunction.
Note
Running time minimum 30 minutes after charging of 16 hours.
Air Sensor
Set rate to 400 ml/h.
Then inject 0.4 ml air bubble (inject piece). An alarm must be activated.
Drop Sensor
Set rate to 400 ml/h.
Simulate occlusion: Clamp infusion line in front of the pump to prevent any drops. Alarm in less than 5 sec.
Simulate free flow: Press the bottom part of the drop chamber together, to generate a jet. Immediate alarm.
Staff Call
Connect MFC test plug
Generate an alarm (e.g. open pump cover during operation), red LED is on in the test plug
If ”dynamic” is set, 1 sec.
If ”static” is set, until the alarm is acknowledged
Alarm Suppression
Press the alarm key. The current alarm is suppressed for 2 minutes.
Infusomat P 2.0gb
4. Pump Unit Inspection
Fig.: 8 - 2
Infusomat P 2.0gb
Procedural Instructions for Inspection
8
General
Room temperature 20 - 28° C
Use infusion line Intrafix AIR P (PVC) only once.
Connect manometer to the outlet side of the pump and position the manometer approx. to medium height of the Infusomat P.
Vent manometer (filled with water)
φ100 mm or 160 mm.
Measurement range: 4 bar
The results differ according to different measurement procedures.
With electronic measurement devices the values may be approx.
0.1 bar higher than indicated.
Electronic Occlusion Pressure (Occlusion Sensor)
Switch off drop control.
Set 600 ml/h and deliver in an open system for one minute.
Close the system and build-up pressure against a manometer with
100 ml/h.
Occlusion sensor threshold low. . . . . . . . . . . . . 400 to 1000 mbar
Occlusion sensor threshold high . . . . . . . . . . . 1000 to 1600 mbar
Note
The pressure threshold can be changed in the service program (not recommended).
Default setting:
- low pressure: 0.6 bar
- high pressure: 1.2 bar
Tolerance range:
- set value: ± 0.3 bar.
Mechanical Occlusion Pressure
Set occlusion sensor threshold to mechanical (test plug).
Switch off drop control.
Build up pressure with 600 ml/h. Then measurement with 100 ml/h.
Read 90 seconds after start of delivery:
Measurement upper pressure value
Measurement lower pressure value
Measured values
(see „Technical Safety Inspection TSI“
➨
pg. 7 - 1)
.
After the measurement inspection the mechanical setting must be switched off! The electronic occlusion pressure is not automatically activated again when the service plug has been disconnected.
8 - 3
8 - 4
8
Procedural Instructions for Inspection
Mechanical Pressure Setting
Check pump pressure. If the deviation is max. ± 0.3 bar from set range, the pump can be calibrated.
Perform pressure measurement. Calibrate the pressure range at the set screw with an Allen key 2.5 mm. to the upper pressure value of 2.4 bar.
After the measurement inspection the mechanical setting must be switched off! The electronic occlusion pressure is not automatically activated again when the service plug has been disconnected.
Flow Inhibitor
Switch to stop at high pressures. Then open unit door. The pressure must stay above 0.8 bar.
Delivery Accuracy
Temperature 22° C
Rate > 1 ml/h
Typically ± 5% at a measurement of more than 8 hours.
Infusomat P 2.0gb
80 ± 0.4 ml
Fig.: 8 - 3
Procedural Instructions for Inspection
8
Reference Height
80 ± 2 cm
Determination of Delivery Rate
Alternative procedure (12 minutes short measurement)
Temperature 20 - 28° C
Measurement Equipment:
500 ml glass bottle, vented
Intrafix AIR P (PVC), drop chamber filled 2/3
Graduated cylinder 25 ml, accuracy ± 0.4 ml
Infusion solution NaCl or distilled water .
Procedure:
Use a new infusion line for every measurement.
Check the system for narrow sections or kinks.
Delivery rate 125 ml/h.
The system run-in time is 1 - 2 minutes, but not longer than
2 minutes.
Insert the outlet cannula in the graduated cylinder.
Measurement rate: 125 ml
Measured volume: 25 ml
Simultaneously start stop watch and Infusomat P.
Stop when the 25 ml mark is reached and read time.
As shown in the graph the delivery behaviour slightly changes over the infusion time. Consequently the tolerances must be in the upper range when the delivery accuracy (± 5% over 8 hours) is checked with a short measurement over 12 minutes.
Expected rate deviation due to the short time method:
Software IFPC:+4.5% tolerance range -0.5% bis +9.5% of the set rate.
Software IFPe / IFPE:+2.5% tolerance range -2.5% bis +7.5% of the set rate.
Fig.: 8 - 4 Graph
Infusomat P 2.0gb 8 - 5
8 - 6
8
Procedural Instructions for Inspection
Measurement Time
11 min
11 min
11 min
11 min
11 min
11 min
11 min
11 min
12 min
12 min
12 min
12 min
12 min
12 min
11 min
10 min
10 min
10 min
10 min
45.9 sec
39.0 sec
32.3 sec
25.7 sec
19.7 sec
12.9 sec
6.7 sec
0.6 sec
37.9 sec
30.0 sec
22.3 sec
14.7 sec
7.3 sec
0.0 sec
52.9 sec
54.5 sec
48.5 sec
42.9 sec
26,1
+6
+7
+8
+9
+2
+3
+4
+5
+10
+11
+12
+15
-2
-1
0
+1
-5
-4
-3
Deviation
%
135,00
136,25
137,50
138,75
140,00
143,75
125,00
126,25
127,50
128,25
130,00
131,25
132,50
133,75
118,75
Rate ml/h
120,00
121,25
122,50
123,75
Table 8 - 1 Measurement Examples
The inspection and calibration - if required - must be performed with the infusion line Intrafix AIR P (PVC)!
Alternative Measurement Procedure
Inspection of the delivery rate with a weight measurement. Avoid errors due to evaporation!
Measurement Equipment:
Scales
Accuracy 0.1 g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 min
Delivery Rate Determination:
Set the delivery rate to 125 ml/h.
The run-in time is 1 - 2 minutes.
Insert the outlet cannula in container and simultaneously start stop watch and Infusomat P.
After the time has expired stop Infusomat P and stop watch.
Immediately determine the delivery rate.
Infusomat P 2.0gb
