5
98-0157 Rev K
2.
INTRODUCTION AND SAFETY INFORMATION
2.1
INDICATIONS FOR USE
The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment
system designed to pre-treat and purify potable water using reverse osmosis for making
dialysate for hemodialysis applications. The device is intended to be a component in a complete
water purification system, and is not a complete water treatment system. It must be preceded
by pre-treatment devices, and may need to be followed by post-treatment devices as well to
meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in
water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat
sanitization process.
The MediQA is available in both single pass and double pass models that supply from 5.5 to
12.0 gallons per minute (gpm) of product water. Model MSP2 is a single pass, dual-membrane
RO that produces up to 9 gpm of product water. Model MSP3 is a single pass, 3-membrane RO
that produces up to 12 gpm of product water. Model MDP2 is a double pass, 3-membrane RO
that produces up to 5.5 gpm of product water. Model MDP4 is a double pass, 5-membrane RO
that produces up to 10.0 gpm of product water.
The MediQA is a Medical Device; as such modifications to the device are not
permitted. Modifications to the machine by anyone other than AmeriWater
personnel will invalidate the marketing clearance for the device.
This Reverse Osmosis System (RO) contains a preservative solution to
prevent microbiological growth and freezing. Discard all product water for
at least two hours of operation before placing the RO in service.
When used as a medical device, Federal law restricts this device to sale by
or on the order of a physician per 21 CFR 801.109(b)(1)!
2.2
CONTROLS
The processes of the MediQA units are controlled automatically. The MediQA is operated via a
touch screen display panel which also displays system performance data. Process water is
constantly monitored for:
Water quality (μS/cm)
Temperature (°F)
Flowrate (gpm)
Pressure (psi)
These parameters can be viewed via the touch screen display. A data logger is provided and the
data logger information can be downloaded via a memory stick to a PC.
2.3
ALARMS AND MAINTENANCE
The MediQA incorporates monitoring devices and will report alarms and warnings via the touch
screen display. These indicate malfunctions or that preventative action is required. This ensures
the unit is maintained and operated correctly. Reference to these alarms and appropriate
actions can be found in Section 7.
Summary of Contents for MediQA MDP Series
Page 70: ...69 98 0157 Rev K 10 FLOW DIAGRAMS SPH UNITS ...
Page 71: ...70 98 0157 Rev K DPH UNITS ...
Page 72: ...71 98 0157 Rev K 11 WIRING SCHEMATIC SPH UNITS ...
Page 73: ...72 98 0157 Rev K ...
Page 74: ...73 98 0157 Rev K ...
Page 75: ...74 98 0157 Rev K ...
Page 76: ...75 98 0157 Rev K ...
Page 77: ...76 98 0157 Rev K ...
Page 78: ...77 98 0157 Rev K ...
Page 79: ...78 98 0157 Rev K ...
Page 80: ...79 98 0157 Rev K DPH Units ...
Page 81: ...80 98 0157 Rev K ...
Page 82: ...81 98 0157 Rev K ...
Page 83: ...82 98 0157 Rev K ...
Page 84: ...83 98 0157 Rev K ...
Page 85: ...84 98 0157 Rev K ...
Page 86: ...85 98 0157 Rev K ...
Page 87: ...86 98 0157 Rev K ...
