5. Technical Safety Inspection and Preventive Maintenance
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BA-TE-DE08C M.KAY
SW9xx_SM_Chapter 5-1_1-2010.doc/pdf <110301> yymmdd
B. Braun Avitum AG
Dialog
+
SW 9.xx
S M
Check List (S = Technical Safety Inspection Points; M = Preventive Maintenance Points)
Note:
Text in { } brackets is information for the execution of the check list!
NO YES OK
S
3.9
Staff Call:
Option present
3.9.1
- Function or contact continuity passed
S
3.10
Automatic Blood Pressure Measurement ABPM:
Option present
3.10.1
- ABPM inspection protocol performed {see separate ABPM inspection protocol, paragraph 5.2}
4.
Electrical Safety Check According to EN 62353/EN 60601-1
S
4.1
Protective Earth Resistance:
<
0.3 [
Ω
]
{note highest value}:
.......................
[
Ω
]
{(Machine incl. power supply cord. Move the power supply cord during the check. Thus possible loose connections can be detected. Data lines
and potential equalisation cable must not be connected during the check of the protective earth resistance (see figure 1)}
{Measurement points:}
{Exterior:
Potential equalisation bolt, rinsing bridge (dialyser inlet and outlet)}
{Interior:
Heater body (top), rear door (top left corner), frame (rear), housing cover (top left), front door (top left)}
{Monitor:
Monitor (one of the screws in the front panel/housing}
S
4.2
Equipment Leakage Current:
{
All water connections and data lines must be connected during the check (see figure 2) of the equipment leakage current.}
≤
0.5 [mA]:
- During heat-up phase {change mains polarity and note highest value}:
....................
[mA]
S
4.3
Patient Leakage Current:
{
All water connections and data lines must be connected during the check (see figure 3) of the patient leakage current.}
≤
10 [µA] DC:
- Under normal conditions {at dialyser coupling}, conductivity at 13 - 15 mS/cm:
......................
[µA]
≤
10 [µA] AC:
- Under normal conditions {at dialyser coupling}, conductivity at 13 - 15 mS/cm:
......................
[µA]
5.
Setting into Service According to Instructions for Use
S
5.1
Applied Accessories/Disposables:
Applied line system:
Name:
........................................................................................................................................
S
5.2
Switch on machine:
- Self-test passed
S
5.3
Power Fail Function:
{Activate buzzer in power supply, i.e. switch on machine for approx. 5 minutes and then disconnect mains plug.}
- Check function, duration of a constant audible alarm > 1 minute
S
5.4
Temperature:
- Comparison measurement {at dialyser coupling}, at 37
o
C (-1.5; +0.5):
............................
[
o
C]
S
5.5
Conductivity:
- Comparison measurement {at dialyser coupling, e.g. 14.3 mS/cm (
±
0.2)}: ..................
[mS/cm]
S
5.6
Safety Air Detector (SAD):
- Test alarm function (visual/audible) passed
S
5.7
Monitor
5.7.1
Function of the keys, display illumination, OSDs (for ) and touch screen OK
5.7.2
Image display OK
S
5.8
Ultrafiltration:
{see chapter 3 Measures after Repair, paragraph 3.8.2.5 Test Run UF Comparison Measurement}
- Comparison measurement at 15 min with UF rate 500 ml/h (125 ml UF volume
±
15 ml) :
Display on machine:
.................................
Meas. instrument: ...........................................
[ml]
S
5.9
Battery Option:
Option present
5.9.1
- Activate audible alarm
{The machine must be in therapy mode. Disconnect mains plug: The buzzer from the SMPS-MC gives three signalling tones as
an indication that the machine is running in battery mode.}
M
5.10
Disinfection:
- Perform by responsible organisation {user}
{inform responsible organisation}
- Performed by service technician
