B. Braun Dialog+ - 5.2 Inspection Protocol for Automatic Blood Pressure Measurement ABPM together with the Dialog+

5. Technical Safety Inspection and Preventive Maintenance 1/2010 5 - 8
BA-TE-DE08C M.KAY Dialog+ SW9xx_SM_Chapter 5-1_1-2010.doc/pdf <110301> yymmdd B. Braun Avitum AG
Dialog
+
SW 9.xx
5.2 Inspection Protocol for Automatic Blood Pressure
Measurement ABPM
Measurement Inspection The measurement inspection is recommended every 12 months and should be
documented. The measuring methods are described in the execution procedures.
Dialysis Machine Dialog REF {Type/Typ}:
........................................... SN {Serien-No./Nr.} .............................................
Automatic Blood Pressure
Measurement ABPM
ABPM Module M2009/2010
Manufacturer
B. Braun Avitum AG, 34209 Melsungen, Germany
Responsible Organisation (User)
Address:
..............................................................................................................................................................
................................................................................................................................................................................
................................................................................................................................................................................
1. Visual Inspection - Tight seat of all connectors : ----------------------------------------------- OK 
- No damages which could affect the function or the safety
(incl. tubing and cuff): ------------------------------------------------------OK 
2. Limits of Error of the Pressure
Indication
Admit a static pressure to the machine.
Pressure [mmHg] Measurement Values
Dialog Reference
Deviation
[mmHg]
290
200
100
50
0
The permissible tolerance for each measurement is:
ABPM Module: ------------------------------------------------- ± 3 mmHg: OK 
3. Air Leakage
Initial Pressure
[mmHg]
Final Pressure
[mmHg]
Air Leakage
[mmHg]
Pressure drop ABPM Module: ------------------------- ≤ 18 mmHg in 3 min: OK 
4. Rapid Exhaust - Time for pressure reduction from >260 mmHg to <15 mmHg max. 10 s: ....... s OK 
- Trigger of rapid exhaust between 300 mmHg and 330 mmHg: --------------- OK 
5. Function Inspection The results of a measurement on a test person are plausible ------------------- OK 
6. Result of Inspection
The blood pressure measurement module has passed the
measurement inspection: -------------------------------------------- No  Yes 
Comments:
........................................................................................................................................................
................................................................................................................................................................................
The measurement inspection was
performed correctly.
Name Service Technician:
................................................................................................................................................................................
................................................................................................................................................................................
Date / Signature