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58
P/N 450368-03 Rev. E
A
PPENDIX
B:
F
IRST
B
ATCH
V
ERIFICATION
I
NSTRUCTIONS
1.
Once the Final Fill Sensor is replaced or unit relocated and the empty sample bottles are available.
Plug in the power cord. Turn treated water on. Turn the power switch ON (Red switch on the right
side of the GranuFlo Dissolution Unit II). Verify the power light activates.
2.
As per the Operator’s Manual section 6.0, secure the tank lid and initiate the RINSE CYCLE.
3.
As per the Operator’s Manual section 7.0, run a DISSOLUTION CYCLE by pressing the DISSOLUTION
Start Button. When the Add Granules Light flashes check to make sure water has reached the Mid-
Level Sensor, and then add the six (6) boxes of GranuFlo® or Citrasate DRY product.
4.
As per the Operator’s Manual section 7.1, perform the
Specific Gravity
Test and record the results
on the production batch record form.
5.
Collect a sample of the final product(s) using the (2) sample bottles. The product sample(s) will be
analyzed in accordance to manufacturer’s product specifications. If only one product code is being
used, collect two (2) samples of that product to be analyzed.
6.
Place the sample bottles and the following completed forms into a shipping box:
•
Copy of the Production Record Form (Operator’s Manual – Form 1 or Form 2)
•
Batch Analysis Form (Operator’s Manual pg 44)
7.
Cutout and affix the pre-printed mailing label from the Batch Analysis Form to the box. It is the
responsibility of the RES to ship the samples to the “Ship To” address on the Batch Analysis Form.
Contact Fresenius Medical Care Laboratory at (972) 929-7291 for results.
8.
NOTICE: The composition of the first batch of GranuFlo® / Citrasate DRY product must be tested by a
qualified testing laboratory to ensure that the resulting product meets the GranuFlo® / Citrasate
DRY product specifications. If final solution did not meet final batch criteria for use, the batch of
concentrate must be discarded
(S
EE
S
ECTION
13:
C
ONCENTRATE SOLUTION
D
ISPOSAL OR
D
ISPOSITION
,
PAGE
NOTE:
M
AKE SURE TO FILL THE PRODUCTION BATCH RECORD FORM ATTACHED TO THIS MANUAL WITH
THE PRODUCT INFORMATION
.
WARNING:
DO
NOT
USE
ANY
BOX
OF
GRANUFLO®
OR
CITRASATE
DRY
CONCENTRATE
THAT
HAS
BEEN
OPENED
OR
TAMPERED
WITH.
IT
IS
IMPORTANT
THAT
THE
ENTIRE
CONTENTS
OF
EACH
BOX
ARE
EMPTIED
INTO
THE
DISSOLUTION
TANK.
WARNING!
THE
USE
OF
EYE
PROTECTION
AND
GLOVES
IS
RECOMMENDED
WHEN
HANDLING
DRY
ACID
PRODUCT.
IF
CONTACT
WITH
EYES,
RINSE
IMMEDIATELY
FOR
15
MINUTES.
IF
CONTACT
WITH
SKIN,
FLUSH
WITH
PLENTY
OF
SOAP
AND
WATER.
SEE
MATERIAL
SAFETY
DATA
SHEETS
(MSDS)
FOR
THE
DRY
ACID
PRODUCT
BEING
USED
FOR
FURTHER
PERSONAL
PROTECTIVE
EQUIPMENT
(PPE)
OR
EMERGENCY
REQUIREMENTS/INSTRUCTIONS.
Содержание GranuFlo 450368-03
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