Fresenius Medical Care 460018, Operator'S Manual

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7 . 1 S P E C I F I C G R A V I T Y T E S T
P/N 460018 Rev. D 19
8. Measure Temperature:
•
Place Hydrometer Cylinder on a level table and using a
Thermometer measure the temperature of the solution in the
Hydrometer Cylinder immediately.
•
For Thermometer requirements refer to Form 1 or 2. The
measurement of the temperature collected during this step will
be known as the measured temperature of the solution and will
be required on the next step.
W
ARNING
: I
N ORDER TO ACCURATELY DETERMINE IF THE ACID
CONCENTRATE HAS BEEN PREPARED CORRECTLY
,
THE TEMPERATURE OF
THE SOLUTION MUST BE MEASURED AND THE
S
PECIFIC
G
RAVITIES
T
ABLE IN FORM
1 (G
RANU
F
LO
)
OR
F
ORM
2 (C
ITRASATE
D
RY
)
MUST BE
CONSULTED
. S
UPPLYING AN INCORRECTLY PREPARED ACID
CONCENTRATE TO THE
H
EMODIALYSIS
M
ACHINE MAY RESULT IN
PATIENT INJURY OR DEATH
.
9. Depending on what Dry Acid Product is being used go to Form 1:
GranuFlo Dry Acid Specific Gravities Table, page 32, or Form 2: Citrasate DRY Specific Gravities
Table, page 34.
In the table:
•
Locate the Catalog number of the dry acid product being used
•
Using the measured temperature from step 8, locate the value of the measured temperature of
the solution in the table.
•
Moving across and then down, identify the ‘low’ and ‘high’ specific gravity numbers.
•
These ‘low’ and ‘high’ numbers can be recorded in the appropriate box in the Batch Production
Record Form (GranuFlo® Form 1, page 31, or Citrasate Form 2, page 32).
•
Record the measured temperature in the appropriate box in the Batch Production Record Form
as well.
10. Obtain the clean hydrometer and measure the specific gravity of the solution in the Hydrometer
Cylinder.
11. If the hydrometer or the surface of the solution is not clean, discard the contents of the
hydrometer cylinder into the Residual Solution Bucket. Clean the hydrometer and the hydrometer
cylinder and restart from Section 7.1, #6, page 17.
12. Do not take a reading if the hydrometer is touching the side of the hydrometer cylinder.
13. Document the Specific Gravity in the Batch Production Record Form in the “Measured Specific
Gravity Value” box.
14. If the actual Specific Gravity value that you measured falls within the ‘low’ and ‘high’ range on the
Batch Record Production Form, then the value is acceptable, the solution can be used and its
ready for TRANSFER Operation. Prior to Transfer Batch Record Form must checked for
completeness and signed off by qualified verifier. Place the solution in the Hydrometer Cylinder
into the Residual Solution Bucket. Rinse the hydrometer cylinder and the hydrometer before
storing equipment. To dispose the solution in the Residual Solution Bucket, See section 13.1:
Residual Solution Bucket Disposal , page 43.
15. If the actual Specific Gravity value does not fall with in the ‘low’ and ‘high’ range, then the entire
batch must be disposed, See Section 13.2: Tank Disposal, page 43.
16. Complete the doucmentation on the Batch Production Record and obtain reviewer’s signature for
the batch prepared before transfer.
Figure 14