Ppendix B: First Atch Verification; Instructions - Fresenius Medical Care 460018 Operator's Manual

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 left
side of the Dry Acid Dissolution Unit). Verify the power light activates.
2. As per the Operator's Manual P/N 460018 section 6.0, secure the tank lid and initiate the RINSE
CYCLE.
3. As per the Operator's Manual P/N 460018 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 eight (8) boxes of GranuFlo® or Citrasate DRY
product.
NOTE: M
C
OR ITRASATE
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! T
PRODUCT
FLUSH WITH PLENTY OF SOAP AND WATER
A P
CID
REQUIREMENTS
4. As per the Operator's Manual P/N 460018 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 (P/N G83-535-02). 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 Batch Production Record Form (Operator's Manual – Form 1 or Form 2)
• Batch Analysis Form (Operator's Manual page 63)
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 (
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
43).
P/N 460018 Rev. D
A B: F
PPENDIX IRST
AKE SURE TO FILL THE PRODUCTION BATCH RECORD FORM
DRY F 2,
ORM PAGE
.
HE USE OF EYE PROTECTION AND GLOVES IS RECOMMENDED WHEN HANDLING DRY ACID
. I ,
F CONTACT WITH EYES
RODUCT BEING USED FOR FURTHER
/ .

INSTRUCTIONS

S
EE ECTION
B V
ATCH ERIFICATION
34)
ATTACHED TO THIS MANUAL WITH THE PRODUCT
15
RINSE IMMEDIATELY FOR
. S M S
EE ATERIAL AFETY
P P
ERSONAL ROTECTIVE
972)-929-7291 for results.
13: C S
ONCENTRATE OLUTION
I
NSTRUCTIONS
(G F ® F 1,
RANU LO ORM
. I
MINUTES F CONTACT WITH SKIN
D S (MSDS)
ATA HEETS FOR THE
E ( ) E
QUIPMENT PPE OR MERGENCY
D D
ISPOSAL OR ISPOSITION
32,
PAGE
,
D
RY
,
PAGE
61