Fresenius Medical Care GranuFlo 450368-03, Руководство оператора

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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 Continued
P/N 450368-03 Rev. E 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 (
Figure 11
).
•
For Thermometer requirements refer to Appendix A or B. 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
.
Figure 11
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 32,or Citrasate DRY Form 2, page 34).
•
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 18.
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 Transfering the finished batch, the 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 14.1: Residual
Solution Disposal, page 41.
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 41.
16.
Complete the documentation on the Batch Production Record and obtain reviewer’s signature for
the batch prepared before transfer.