Fresenius Medical Care GranuFlo 450368-03 User Manual

P/N 450368-03 Rev. E 5
SECTION 4: WARNINGS AND CAUTIONS
WARNING!
N
EVER PUT YOUR HEAD INTO THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
T
ANK
.
T
HIS MAY RESULT IN OPERATOR
FALLING INTO TANK.
WARNING!
I
N 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!
I
F THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
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 B FOR
FURTHER INSTRUCTIONS ON WHEN AND WHERE TO SEND SAMPLE OF THE FIRST BATCH OF CONCENTRATE.
WARNING!
T
HE USE OF EYE PROTECTION AND GLOVES IS RECOMMENDED WHEN HANDLING DRY ACID PRODUCT
.
I
F
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
P
ROTECTIVE
E
QUIPMENT
(
PPE
)
OR
E
MERGENCY REQUIREMENTS
/
INSTRUCTIONS
.
WARNING!
S
HOULD THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
F
AIL TO COMPLETE ANY OPERATION WITHIN ANY
C
YCLE DO
NOT PROCEED THROUGH CYCLE USING
STEP MODE. CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-
2572).
WARNING! FAILURES TO INSTALL, OPERATE, AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER’S
INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY
.
WARNING!
T
HIS
G
RANU
F
LO
D
ISSOLUTION
U
NIT
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!
T
HE 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!
F
AILURE TO FLUSH THE TRANSFER HOSE WITH
3.5
GALLONS PRIOR TO MEASURING SPECIFIC GRAVITY MAY
RESULT IN AN INCORRECT SPECIFIC GRAVITY READING
, AND/OR SUPPLY OF AN INCORRECT CONCENTRATE FORMULATION TO
THE
H
EMODIALYSIS
M
ACHINE
,
WHICH MAY RESULT IN PATIENT INJURY OR DEATH
.
S
EE SECTION
7.1,
#5,
PAGE
16.
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!
F
OLLOW THE MANUFACTURER
’
S INSTRUCTIONS WHEN MEASURING THE SPECIFIC GRAVITY OF A SAMPLE OF
THE MIXED
FRESENIUS MEDICAL CARE DRY ACID PRODUCT (SEE FORM 1 FOR GRANUFLO® PRODUCT, PAGE 32, OR FORM
2 FOR CITRASATE DRY PRODUCT, PAGE 34) WITH A HYDROMETER CALIBRATED AT 60°F FOLLOWING ASTM STANDARD
E126 PRIOR TO TRANSFERRING TO A DIALYSIS MACHINE OR HOLDING TANK.
WARNING!
C
ONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II.
T
HE
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.

Fresenius Medical Care GranuFlo 450368-03 Specifications

General

Brand	Fresenius Medical Care
Model	GranuFlo 450368-03
Category	Medical Equipment
Language	English