5. Technical Safety Inspection and Preventive Maintenance
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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