B. Braun Dialog+ Service Manual page 12

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