Description - Technical Measurement Checks And Maintenance - Fresenius Medical Care 4008 E Technical Manual

2.2.2 Description – Technical measurement checks and maintenance
BPM 4008
The following inspections must be carried out every 24 months at the latest by persons who are
qualified to properly perform the specified technical measurement checks owing to their educa-
tional background and training, their knowledge and experience gained in practice and who are
not subject to any directions with regard to this inspection activity.
TMC MA No.
1
MA 1.1
MA 1.2
MA 1.2.1
MA 1.2.2
MA 1.2.3
2
MA 2.1
MA 2.2
TMC 2.3
TMC 2.4
TMC 2.5
TMC 2.6
Scope and intervals of technical safety checks
INTERVAL: every 24 months
Description
Visual checks
Labels and indications
Mechanical condition
Check whether the line connector is correctly attached to the device.
Check whether the internal blood pressure module, the printed circuit boards and
all cable connections are correctly fixed.
Replace damaged lines or cuffs.
Functional checks
Indicating elements
Touch panel
Leakage test
Calibration
Safety valve
Measuring of blood pressure
Expected value / function
Must be present and clearly legible.
Check of the actual condition.
Must permit further safe use.
Visual and audible functional checks after turn-on.
(See Operating Instructions BPM 4008, Chapter
2.2)
Check whether the touch panel is functioning cor-
rectly.
Perform the leakage test with cuff and pressure
line connected.
The pressure leakage rate must be less than
6 mmHg/min.
(See Technical Manual BPM 4008, Chapter 3.1)
Calibration:
Pressure values: Tolerance:
250 mmHg
200 mmHg
150 mmHg
100 mmHg
050 mmHg
(See Technical Manual BPM 4008, Chapter 3.2)
Check the safety valve.
The system must be discharged at
320 mmHg ± 10 mmHg.
(See Technical Manual BPM 4008, Chapter 3.3)
Measure the blood pressure in the manual mode.
Check the results for plausibility.
Fresenius Medical Care 4008 4/09.03 (TM)
±5 mmHg
±4 mmHg
±3 mmHg
±3 mmHg
±3 mmHg
2-25