Fresenius Medical Care 4008 4/09.03 (TM) 2-25
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. Description Expected value / function
1 Visual checks
MA 1.1 Labels and indications Must be present and clearly legible.
Check of the actual condition.
Scope and intervals of technical safety checks
INTERVAL: every 24 months
MA 1.2 Mechanical condition Must permit further safe use.
MA
MA
MA
1.2.1
1.2.2
1.2.3
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.
2 Functional checks
MA 2.1 Indicating elements Visual and audible functional checks after turn-on.
(See Operating Instructions BPM 4008, Chapter
2.2)
MA 2.2 Touch panel Check whether the touch panel is functioning cor-
rectly.
TMC 2.3 Leakage test 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)
TMC 2.4 Calibration Calibration:
Pressure values: Tolerance:
250 mmHg ±5 mmHg
200 mmHg ±4 mmHg
150 mmHg ±3 mmHg
100 mmHg ±3 mmHg
050 mmHg ±3 mmHg
(See Technical Manual BPM 4008, Chapter 3.2)
TMC 2.5 Safety valve Check the safety valve.
The system must be discharged at
320 mmHg ± 10 mmHg.
(See Technical Manual BPM 4008, Chapter 3.3)
TMC 2.6 Measuring of blood pressure Measure the blood pressure in the manual mode.
Check the results for plausibility.
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