B. Braun Dialog+ - Page 12

1. Commissioning 1/2010 1 - 5
BA-TE-DE08C M.KAY Dialog+ 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)
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5.3 Temperature: - Comparison measurement {at dialyser coupling}, at 37
o
C (-1.5; +0.5): ......................... [
o
C]
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5.4 Conductivity: - Comparison measurement {at dialyser coupling}, e.g. 14.3 mS/cm (±0.2): ................. [mS/cm]
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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]
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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]
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5.7 Safety Air Detector (SAD): - Test alarm function (visual/audible) passed
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5.8 Disinfection: - Start
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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