67
98-0157 Rev K
9.3
MEDICAL DEVICE TRACEABLE COMPONENTS
Description
AmeriWater
Part Number
User
replacement
code
Batch
controlled
spare
Control Panel
Contact AmeriWater
AT
Yes
Tank Line Cell
69-0030
AT
Yes
Pressure Switch
68-0008
AT
No
Pressure Switch
68-0006
AT
No
Product Line Cell
69-0029
AT
Yes
Tank / Tank Return Temp
Sensor
39-0004
AT
No
Permeate Temp Probe
39-0005
AT
No
Loop Return Temp Probe
39-0007
AT
No
Tank Float Switch
67-0012
AT
No
Conductivity Board
69-0098
AT
Yes
Pressure Transducer
68-0009
AT
Yes
Permeate Flow Meter
41-0027
AT
Yes
Concentrate Flow Meter
41-0026
AT
Yes
Recirculation Flow Meter
041-9007
AT
Yes
AT: AmeriWater technician level (AmeriWater trained Technician: special tools required plus
additional instructions outside of the scope of this manual. Only AmeriWater trained technicians
must replace parts with this assigned code for health and safety reasons. These parts are
critical part of the system.)
The MediQA is classified as a medical device. Any person replacing a batch controlled spare, as
identified above must, as a matter of due diligence, request from AmeriWater, that it is supplied
with a clearly identifiable batch number. Also the authorized person who will install the
component must quote the serial number of the machine in which it will be installed at order
placement.
The replacement of the batch controlled spare must be recorded using the log sheet (below).
This must be done in order to maintain the integrity of the machine throughout its operational
life in accordance with medical device regulations.
If batch controlled parts are not installed, or are not installed by approved AmeriWater
Technicians, then the responsibility for any subsequent incidents linked to the replaced part or
affected parts rest with the buyer / hospital / maintenance staff or service provider.
Failure to install AmeriWater supplied replacement parts will invalidate the warranty.
Summary of Contents for MediQA MDP Series
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