Fresenius Medical Care GranuFlo Dissolution Unit II - Appendix C: First Batch Verification; Sample Collection and Analysis Procedure

P/N 450368 Rev I—APPENDIX C 40
APPENDIX C: FIRST BATCH VERIFICATION INSTRUCTIONS
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 Operators Manual section 6.0, secure the tank lid and initiate the RINSE CYCLE.
3. As per the Operators 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®.
4. As per the Operators Manual, section 7.1, perform the Specific Gravity Test and record the results
on the GranuFlo Batch Production 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 the GranuFlo Batch Production Record Form (Operator’s Manual, pg 31)
 Batch Analysis Form (Operator’s Manual pg 41)
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® must be tested by a qualified testing
laboratory to ensure that the resulting product meets the GranuFlo® specifications. If final solution
did not meet final batch criteria for use, the batch of concentrate must be discarded (SEE SECTION 13:
DISPOSAL OF CONCENTRATE SOLUTION, PAGE 36).
NOTE: MAKE SURE TO FILL THE GRANUFLO BATCH PRODUCTION RECORD FORM, PAGE
31, ATTACHED TO THIS MANUAL WITH THE PRODUCT INFORMATION.
WARNING: DO NOT USE ANY BOX OF GRANUFLO® THAT HAS BEEN OPENED OR TAMPERED
WITH. IT IS IMPORTANT THAT THE ENTIRE CONTENTS OF EACH BOX IS 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.