1 . C o m m i s s i o n i n g
1 / 2 0 1 0
1 - 5
BA-TE-DE08C M.KAY
SW9xx_SM_Chapter 1-1_1-2010.doc/pdf <110301> yymmdd
B. Braun Avitum AG
Dialog
+
SW 9.xx
Check List
Note:
Text in { } brackets is information for the execution of the check list!
SN {Serien-No./Nr.}
............................................
OK
5.
Setting into Service According to Instructions for Use with Electrical Safety Check According to
EN 62353/EN 60601-1
5.1 Applied
Accessories/Disposables:
- Applied line system:
Name: ......................................................................................................................................................................................
5.2
Switch on machine:
- Self-test passed {and 15 minutes therapy with UF safety check}
- Ultrafiltration comparison measurement 15 minutes with UF rate 500 ml/h:
......................... [ml]
(125 ml UF volume
±
15 ml)
5.3 Temperature:
- Comparison measurement {at dialyser coupling}, at 37
o
C (-1.5; +0.5):
.........................
[oC]
5.4 Conductivity:
- Comparison measurement {at dialyser coupling}, e.g. 14.3 mS/cm (
±
0.2):
................. [mS/cm]
5.5
Equipment Leakage Current:
{All water connections and data lines must be connected during the check of the equipment leakage current (see figure 2)}
≤
0.5 [mA]
- During heat-up phase {change mains polarity and note highest value}:
....................... [mA]
5.6
Patient Leakage Current:
{All water connections and data lines must be connected during the check of the patient leakage current (see figure 3)}
< 10 [µA] AC
- Under normal conditions {at dialyser coupling}, conductivity at 13 – 15 mS/cm:
........................ [µA]
5.7
Safety Air Detector (SAD):
- Test alarm function (visual/audible) passed
5.8 Disinfection:
-
Start
Applied Measurement Equipment:
Electrical Safety: ........................................................................................
* ID/Serial No.: .................................
Conductivity: ...............................................................................................
* ID/Serial No.: .................................
Temperature: ...............................................................................................
* ID/Serial No.: .................................
Pressure: .......................................................................................................
* ID/Serial No.: .................................
Balance: ........................................................................................................
* ID/Serial No.: .................................
Pressure Manometer: ...............................................................................
* ID/Serial No.: .................................
Other Measurement Device: ...................................................................
* ID/Serial No.: .................................
......................................................................................................................... *
ID/Serial No.: .................................
* If applicable, please enter the type and identification number of the equipment used.
Comments:
..........................................................................................................................................................................................................................................................
..........................................................................................................................................................................................................................................................
..........................................................................................................................................................................................................................................................
Next Inspection Date:
............................................................................................................................................................
The commissioning was performed and the
machine was hand over to the responsible
organisation (user).
Name Service Technician:
Name of Company:
...................................................................................
................................................................................... .................................................................
Date/Signature
