P/N 450368 Rev I 5
SECTION 4: WARNINGS AND CAUTIONS
WARNING! NEVER PUT YOUR HEAD INTO THE GRANUFLO DISSOLUTION UNIT II TANK. THIS MAY RESULT IN OPERATOR
FALLING INTO TANK.
WARNING! IN THE EVENT OF A FOREIGN OBJECT FALLING INTO THE TANK DURING ANY ACTIVE OPERATION, THE
OPERATION SHOULD BE PAUSED. IF NEEDED, USE STEP MODE TO PLACE UNIT INTO A DRAIN OPERATION TO EMPTY THE
TANK. IF CONCENTRATE SOLUTION NEEDS TO BE DISPOSED, MAKE SURE TO COMPLY WITH LOCAL, STATE AND FEDERAL
REQUIREMENTS. AFTER DRAIN OPERATION, UNPLUG GRANUFLO DISSOLUTION UNIT II FROM ITS POWER SOURCE. A
REACH TOOL IS RECOMMENDED FOR REMOVING FOREIGN OBJECT OUT OF TANK. HOWEVER, SHOULD THE FOREIGN OBJECT
BE UNATTAINABLE, CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-2572).
WARNING! IF THE GRANUFLO DISSOLUTION UNIT II IS RELOCATED A SAMPLE MUST BE DRAWN FROM THE FIRST BATCH
OF CONCENTRATE MADE, WHICH MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE CONCENTRATE CAN BE USED.
PRIOR TO RELOCATION, REQUEST TWO (2) EMPTY SAMPLE BOTTLES (P/N G83-535-02) THEN SEE APPENDIX C FOR
FURTHER INSTRUCTIONS ON WHEN AND WHERE TO SEND SAMPLE OF THE FIRST BATCH OF CONCENTRATE.
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.
WARNING! SHOULD THE GRANUFLO DISSOLUTION UNIT II FAIL TO COMPLETE ANY OPERATION WITHIN ANY CYCLE DO
NOT PROCEED THROUGH CYCLE USING STEP MODE. CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-
2572).
WARNING! FAILURE TO INSTALL, OPERATE, AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER’S
INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY.
WARNING! THIS GRANUFLO DISSOLUTION UNIT II MAY BE SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE (EMI).
DEVICES EMITTING ELECTROMAGNETIC RADIATION SUCH AS ANALOG PORTABLE PHONES, RADIO EQUIPMENT (WALKIE-
TALKIES, ETC.), RADIO TRANSMITTERS, AND LIKE EQUIPMENT, SHOULD NOT BE USED IN THE VICINITY OF THIS EQUIPMENT.
THE OPERATOR SHOULD MONITOR THE FUNCTION OF THE MACHINE AND REMOVE UNNECESSARY EQUIPMENT FROM THE
TREATMENT AREA SHOULD THESE EVENTS OCCUR.
WARNING! THE ELECTRICAL SOURCE MUST BE SINGLE PHASE, THREE-CONDUCTOR TYPE PROVIDED WITH A GROUND FAULT
INTERRUPTER AT 120 VAC, 60 HZ. THE PROPER POLARITY AND GROUND INTEGRITY MUST BE INITIALLY CHECKED AND
MAINTAINED. FAILURE TO DO SO MAY RESULT IN ELECTRICAL SHOCK OR BURN TO THE OPERATOR.
WARNING! SHOCK HAZARD. DO NOT REMOVE PANELS. REFER SERVICING TO QUALIFIED PERSONNEL. REPLACE FUSES
ONLY WITH THE SAME TYPE AND RATING.
WARNING! FOLLOWING DISINFECTION, TWO (2) COMPLETE RINSE CYCLES MUST BE PERFORMED AND THE UNIT TESTED
TO ENSURE THE ABSENCE OF RESIDUAL BLEACH. SEE SECTION 8.3, PAGE 23.
WARNING! USE THE SUPPLIED HYDROMETER TO MEASURE THE SPECIFIC GRAVITY OF A SAMPLE OF THE MIXED FRESENIUS
MEDICAL CARE DRY ACID PRODUCT (SEE APPENDIX A FOR GRANUFLO® DRY ACID).
WARNING! CONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE GRANUFLO DISSOLUTION UNIT II. THE
WATER USED MUST MEET ANSI/AAMI OR ISO STANDARDS FOR WATER USED IN HEMODIALYSIS (CURRENTLY ANSI/AMMI
RD62, OR ISO 13959). THE CORRECT IONIC CONCENTRATION AND BACTERIAL QUALITY CAN GENERALLY BE ACHIEVED IN
THE DIALYSATE ONLY WITH TREATED WATER. BE SURE THAT ALL SPECIFICATIONS ARE SATISFIED. THE WATER SOURCE MUST
BE MONITORED PERIODICALLY TO DETECT FLUCTUATIONS IN WATER COMPOSITION AND QUALITY THAT COULD HAVE AN
ADVERSE EFFECT ON THE PATIENT, HEMODIALYSIS MACHINE OR GRANUFLO DISSOLUTION UNIT II. PARTICULAR ATTENTION
MUST BE TAKEN FOR CHEMICALS SUCH AS ALUMINUM, CHLORINE, AND CHLORAMINES, AS THESE CHEMICALS CAN CAUSE
COMPLICATIONS IN DIALYSIS PATIENTS. THE CHEMICAL QUALITY OF THE TREATED WATER USED FOR DIALYSIS SHOULD BE
ANALYZED A LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF ANSI/AMMI RD62, OR ISO 13959.
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