SILEX
DEIONIZER FOR DIALYSIS
OPERATION & MAINTENANCE MANUAL
Manufactured With Pride
In The USA
www.ameriwater.com • 800-535-5585
AmeriWater • 3345 Stop 8 Rd • Dayton, OH 45414
06FEB17 P/N: 98-0099
Rev. E
WARNING: When used as a medical device, Federal Law restricts this device to
sale by or on the order of a physician.
WARNING: The entire Operation and Maintenance Manual should be read before
placing the Silex Deionizer in service. Failure to do so may result in
serious personal injury and / or injury and illness to the patient.
WARNING: It is required that deionizers be preceeded by an activated carbon
absorption bed and followed by a bacteria and endotoxin filter.
Contents
1. YOUR SILEX SYSTEM ...................................................................................................................................... 1
1.1. HOW DOES THE SILEX DEIONIZER WORK? ............................................................................................................. 1
1.2. HOW DOES THE REGENERATION WORK? ............................................................................................................... 1
1.3. ABOUT THE RESIN PACK. ................................................................................................................................... 1
2. SILEX FEATURES ............................................................................................................................................ 2
3. INSTALLATION IN 10 EASY STEPS .................................................................................................................. 3
4. MONITORING ............................................................................................................................................... 8
5. RESIN PACK & FILTER EXCHANGE .................................................................................................................. 9
5.1. RESIN PACK EXCHANGE .................................................................................................................................... 9
5.2. FILTER CARTRIDGE & NEPHROS FILTER CAPSULE REPLACEMENT ............................................................................. 12
6. RESIN PACK REGENERATION ....................................................................................................................... 13
7. SERVICING YOUR SILEX SYSTEM .................................................................................................................. 14
7.1. DISINFECTION ............................................................................................................................................... 14
8. SPARE PARTS LIST ....................................................................................................................................... 16
9. TROUBLESHOOTING FOR THE ECOCIRC PUMP ............................................................................................ 17
9.1. PUMP COMPONENTS ...................................................................................................................................... 17
9.2. PUMP DOES NOT RUN ..................................................................................................................................... 17
9.3. LOUD FLOW NOISE ......................................................................................................................................... 17
9.4. CLEANING THE PUMP – CHANGING THE ROTOR .................................................................................................... 18
10. WARRANTY POLICY ..................................................................................................................................... 19
1. YOUR SILEX SYSTEM
1.1. How does the Silex Deionizer work?
This Silex system is designed to provide purified water that meets or exceeds AAMI
product water quality requirements for water used to prepare dialysate or concentrates
in a dialysis facility. The facility’s tap water first passes through a regulator to maintain
the feed pressure at 50 psi (pounds per square inch) or less. The tap water then passes
through (2) 10” ChlorPlus carbon block filters that removes chlorine, chloramines, and
particulates. The filtered water enters the first deionizer column (worker) where the
deionizer resin removes chemical contaminants from the water through an ion
exchange process. A resistivity light, set at 50K Ohms, monitors the water exiting the
worker column as it travels into the second column (polisher). As it leaves the polisher,
the purified water passes through a 1 Meg-Ohm resistivity monitor with alarm, followed
by a normally closed solenoid valve which stays closed with a signal of alarm. The
solenoid valve is followed by a Nephros Dual Stage Ultra-Filter Capsule that removes a
spectrum of bacteria, viral agents and biological toxins (including endotoxin) down to
required levels. The water then travels to the point of use. This unit utilizes an Ecocirc
Pump that is used for recirculating the water back through the Silex system.
1.2. How does the regeneration work?
The ion exchange capacity of the resin packs used in the Silex system will eventually
exhaust. AmeriWater’s regeneration center maintains the resin used in the Silex
Deionizer. When resin packs are exhausted, simply replace the packs in the Silex
system with new resin packs and return the exhausted packs to AmeriWater for
regeneration. The resin will be regenerated in our GMP/QS regeneration facility and
returned within one week.
1.3. About the resin pack.
The resin packs contain mixed bed resin contained in a polypropylene bag that never
has to be opened. Resin packs are shipped in plastic sleeves to prevent the
exchangers from drying out and to protect them from contamination. They have a shelf
life of approximately six months.
CAUTION: Return resin packs stored for more than six months to AmeriWater
for regeneration. DO NOT use resin packs that have been stored for
more than six months.
1
2. SILEX FEATURES
2
3. INSTALLATION IN 10 EASY STEPS
CAUTION: The Silex Deionizer is designed to operate at pressures up to 50 PSI
(Pounds per Square Inch). Operating the system at pressures
greater than 50 PSI may result in damage to the system and personal
injury!
1. Locate the Silex system on a firm, level
foundation.
2. It is recommended, but not required, to locate the
system near a standard floor drain or sump and a
115 volt receptacle. If a drain is not feasible, the
system can be drained into a container. The
receptacle is where the power supply cord will be
plugged in. The ON/OFF switch on the control box
should be set at OFF. The switch will activate the
pump, the worker quality light, the polisher quality
light and the solenoid valve. There must be water
through the Silex system before turning the switch
to the ON position. A green light located on the
switch also indicates that the unit is on. Attention:
running the pump dry may cause premature
failure.
3. It is recommended to install shut-off valves on the inlet side of the unit to facilitate
changing of resin packs.
4. Connect the inlet supply hose to the hose barb fitting on the left side of the
system (while facing the label). Use the hose clamps provided with the system to
secure the hose to the hose barb fitting.
3
NOTE: 16 feet of hose has been provided with the Silex system. Cut the hose to the
desired lengths for the inlet hose and outlet hose and install the provided fittings as
needed. (See drawing)
5. Connect the outlet hose to the male garden hose thread adaptor on the right side
of the system (while facing the control box and label). Use the swivel adaptor nut,
garden hose adaptor, garden hose adapter washer and the ferrule hose clamp
provided with the system to secure the hose.
6. Disinfect the system prior to installing the components. See section 7.1 for
complete instructions.
a. The ON/OFF switch on the control box should be set at OFF. Turn off the
water supply to the Silex system.
b. Pour 5 oz (150 mL) of PAA (such as Peracidin or Minncare) into each pre-
filter sump as well as each Silex column.
c. Close all drain valves, sample ports, and filter drains and open the air
vents located in the center of the top plates.
4
d. Turn on the water supply to the Silex system and allow the system to fill
with water until the presence of PAA can be detected at the outlet of the
system. Verify the concentration of PAA at the outlet using a high level
concentration PAA test strip (P/N 97HP20401).
e. Turn off the water supply to the Silex system and allow the system to soak
for 1 hour.
f. After the soak time, drain the water out of the system by placing a
container under the drain valves and opening the valves. Open the filter
sump valves.
g. Turn on the water supply to the system. Allow the system to flush until
PAA is no longer detected. (Use low-level PAA test strips, P/N
97PX20501, to test for residual PAA).
h. Place the container under the filter drains and open the valves to drain the
water out of the filter sumps.
i. Close all valves when water is no longer flowing out of them.
7. Install the ChlorPlus carbon block filter in both of the filter housings.
8. Install the resin pack(s):
a. Lock the front wheels.
Remove the cover plates by
unscrewing the four black
knobs on each plate. To
break the seal between the
cover plates and the upper
plates, use a slotted screw
driver in the pry notch located
in the top of each upper plate.
Open the drain valve at the
bottom of each column.
b. Remove the resin pack from
the shipping box and open the
tied end of the plastic sleeve.
DO NOT remove the resin
pack from the plastic sleeve at
this time.
5
c. Stretch the resin pack
over your arm to
elongate the pack, and
feed it into the Silex
column allowing the pack
to slide out of the plastic
sleeve. Save the plastic
bag for future exchange.
d. Verify that the O-ring is clean and
in place and replace the cover
plates. Tighten the black knobs
evenly by turning the knobs at
opposite corners at the same time.
Repeat for the other two corners.
CAUTION: Failure to tighten the knobs completely may cause the cover plate to
separate from the system when pressurized.
e. Close the drain valve at the bottom of the column.
f. Repeat steps a. through e. for each of the columns.
AIR VENT
9. Open the air vents located on the top of the
cover plates and turn on the water supply.
Tighten the air vents closed when water begins
to escape through the vents.
10. Allow water to flow through the Silex system
chloramine port for 5 minutes. Turn the ON/OFF
switch on the control box to ON. Continue
running water through the system until the water
quality lights change from red to green. The
green lights indicate that the Silex is producing
deionized water.
6
Dialysis machine should be placed in rinse during start up of the Silex system
until both resistivity monitors indicate a green light. If either light does not
indicate green after a period of 10 minutes, change the resin packs and repeat the
rinsing process.
WARNING: Always allow the system to rinse up to quality prior to placing in
service. Failure to do so may result in patient injury or illness.
CAUTION: DO NOT attempt to open the cover plates while the system is
pressurized or severe injury may occur! Always turn off the water
supply, open the air vents, and drain the water out of the system prior to
opening the cover plates.
7
4. MONITORING
Item to
What to
Normal
Action when out of
AmeriWater recommends the following monitoring guidelines to ensure ongoing quality
of the water produced by the Silex Deionizer System.
Monitor
Product
water at
chloramines
sample port
Pressure
regulator
gauge
Worker
quality light
(50K light)
Polisher
quality light
(1 Meg light)
Endotoxin
filter
(Nephros
filter
capsule)
Product
Water
Product
Water
Monitor
Product water
free of total
chlorine
Regulated
feed water
pressure
Worker
product water
resistivity
Final product
water
resistivity
Flow rate Daily
Bacterial
cultures &
endotoxin in
LAL
Chemical
analysis
Interval
Prior to each
treatment
Daily < 50 psi
Continuous
Continuous
Monthly
Annual
Specification
< 0.1 mg/L of
total chlorine
Light green
> 50K Ohms
Light green
> 1 Meg-Ohm
Drop in flow
rate
Bacterial
count < 50
CFU/mL;
endotoxin
< 1 EU/mL
AAMI
RD52 4.1.1
(Table 1)
specification
Replace the carbon
block filter
Adjust the pressure
regulator to 50 psi or
less
Exchange the resin
packs if light is red.
Terminate treatment
immediately if
polisher light is red.
Terminate treatment
immediately if light is
red and exchange
resin packs.
Replace the
endotoxin filter
(Nephros filter
capsule)
Terminate treatment
immediately, disinfect
the system;
exchange resin
packs and filter
cartridges.
Terminate treatment
immediately and
exchange resin
packs
WARNING: Terminate treatment immediately if product water total chlorine is
greater than 0.1 mg/L or if product water quality drops below the 1
Meg-Ohm set point. Serious injury or illness to the patient may
result!
8
5. RESIN PACK & FILTER EXCHANGE
5.1. Resin Pack Exchange
1. Lock the front wheels. Turn the ON/OFF
switch on the control box to OFF. Turn off the
water supply to the system and place a
container under the drain valves located on
the bottom plates of the system. Open the
valves and allow the water to drain into the
container.
AIR VENT
2. Do not open the cover plates while the
system is pressurized. Always turn off the
water supply, open the air vents, and drain
the water out of the system prior to opening
the cover plates.
3. Remove the cover plates by unscrewing the
black knobs located at each corner of the
cover plates.
9
4. Pull the exhausted resin pack part of the way out of
the column and lay it over the top of the system.
NOTE: If the drain valve located on the bottom plate is
not open, a vacuum will be created making it
difficult to remove the resin pack.
5. Slowly pull the exhausted resin pack over the side of
the column while sliding it out of the column and into
the plastic bag that it was shipped in. Return the
exhausted resin pack to AmeriWater for regeneration.
6. Remove the new resin pack from the
shipping box and open the plastic bag being
careful not to touch the resin pack. Stretch
the resin pack over your arm to elongate the
pack. Feed the pack into the column
allowing it to slide out of the plastic bag.
Save the plastic bag for the next resin pack
exchange.
7. Replace the cover plate and tighten the knobs. To
ensure proper tightening and a good seal, tighten the
knobs in opposite corners simultaneously and then
tighten the knobs in the remaining corners.
CAUTION: Failure to tighten the knobs completely may cause the cover plate to
separate from the system when pressurized.
10
8. Close the drain valves and turn on the water
AIR VENT
supply. Release trapped air from the Silex
system by loosening the air vent screws
(located in the center of the cover plates).
a. Tighten the Air Vent Screws when water
begins to flow from the air vents. This
ensures that all of the air has been removed
from the system and maximizes the life and
efficiency of the resin packs.
NOTE: Vent the system after every resin pack exchange to maximize the life
and efficiency of the resin packs.
9. Turn the switch on the control box to ON. Run the system until the 2 indicator lights
turn green before placing in service. This will ensure that good quality water will be
entering the dialysis machine.
WARNING: Always allow the system to rinse up to quality prior to placing in
service. Failure to do so may result in patient injury, illness, or
death! NEVER place the Silex system in service if the quality
light/alarm indicates poor quality water!
11
5.2. Filter Cartridge & Nephros Filter Capsule Replacement
Carbon block filter cartridges should be replaced when the chloramines sample
indicates total chlorine greater than 0.1 PPM. This sample is to be taken after the
system has been allowed to run for a few minutes while flushing the water through the
chloramine sample port.
The Silex system is equipped with pressure gauges on the filter housing, both filter
cartridges should be exchanged when the differential pressure is greater than 10 psi
(Pounds per Square Inch).
1. Turn the ON/OFF switch on the control box to OFF. Turn off the water supply to
the system.
2. Place a container under the filter housing sumps and open the filter drain ports
on the bottom of the sumps to drain the water out of the filter housing. Close the
filter drains when water ceases to flow out of them.
3. Use the filter wrench supplied in the installation kit to turn the filter housing
counterclockwise.
4. Remove and discard the old filter cartridge(s).
5. Partially unwrap the plastic from the new filter cartridge. Holding the end covered
in plastic, place the new filter cartridge in the housing. Discard the plastic
wrapper after installation.
6. Thread the filter housing back on making sure the O-ring is in the groove and is
not pinched.
The Endotoxin filter (Nephros filter capsule) is expected to last up to approximately 12
months. To change this filter, first follow steps 1 & 2 for the filter cartridges. Disengage
the Nephros filter capsule from the system by pushing the button on each quickconnect, on either end of the filter (SEE BELOW FIGURE) and lifting the filter from the
(2) mounting brackets. The arrow tape on the tubing indicates the flow of the water. The
arrows on the filter, which indicate direction of flow, should match the tubing flow arrows
direction. To connect the new filter to the system, place the filter in the mounting
brackets, make sure that the direction of flow is correct and connect the outlet of the
filter followed by the inlet. Turn the water supply on followed by the power switch on the
Silex and flush the system to drain for ~10 min to ensure no air is trapped in the
Nephros DSU filter.
12
6. RESIN PACK REGENERATION
Certificates Make Exchanging Packs a Breeze!
Regeneration certificates are used to simplify the exchange of your exhausted Silex
system packs. The certificate has been purchased and will be used as payment for the
resin pack regeneration service. Simply follow these steps:
Fill out a regeneration certificate by printing your name, phone number, company and
address.
1. Work with your dialysis provider for this process.
2. Fill out a regeneration certificate by printing your name, phone number, company
and address.
3. When you send each pack to AmeriWater, enclose the regeneration certificate in
the box. AmeriWater will ship you a freshly regenerated resin pack.
4. To order more certificates, contact the company that originally sold you the
deionizer.
5. It is recommended to send the exhausted resin to AmeriWater immediately after
exchange. This will allow time for shipment and will maintain your uninterrupted
supply of deionized water.
Fill out and enclose in box for return shipment
• NO Paperwork
• NO Phone Calls
• NO Purchase Orders
13
7. SERVICING YOUR SILEX SYSTEM
7.1. Disinfection
It is recommended that the Silex system be disinfected monthly to assure continuous
high-quality product water. To efficiently and quickly disinfect the system, follow these
easy steps: NEVER ALLOW THE RECIRCULATION PUMP TO RUN DRY.
a. Turn the ON/OFF switch on the control box to OFF. Turn off the water
supply to the Silex system.
b. Remove the carbon filter as well as the resin packs from the system.
Ensure that the endotoxin filter (Nephros filter capsule) is left in.
c. Pour 5 oz (150 mL) of PAA (such as Peracidin or Minncare) or chlorine
(5% sodium hypochlorite, household bleach) into each filter sump as well
as each Silex column.
d. Reinstall the filter sumps and both cover plates. Close all drain valves,
sample ports, and filter drains and open the air vents located in the center
of the top plates.
e. Turn on the water supply to the Silex system and allow the system to fill
with water. Close the air vent once water begins to seep out of the top of
the column.
f. Once the system is full of water, turn the power switch to “ON” and
remove the power cord from the Polisher Quality Light so water can
pass the solenoid valve. Leave the water supply on until the presence of
chlorine can be detected at the outlet of the system. Verify the
concentration of disinfectant at the outlet of the system. Verify the
concentration of disinfectant at the outlet using a high level concentration
test strip (P/N 97HP20401 for PAA or P/N 97RC22101 for chlorine).
g. Turn the power switch to “OFF” to shut the pump off preventing excessive
wear. Turn off the water supply to the Silex system and allow the system
to soak for 1 hour.
h. After the soak time, drain the water out of the system by placing a
container under the drain valves and opening the valves. Open the air
vents on the top of the columns.
i. Open the drain valves on the carbon block filter bowls and allow them to
drain completely. After the water has completely drained, remove the
bowls and dump out any remaining water to ensure all disinfectant is
removed from the system before flushing.
14
j. Close all drain valves, sample ports, and filter drains and ensure the air
vents located in the center of the top plates remain open before turning
the water supply on.
k. Turn on the water supply to the system. Allow the system to fill with water.
Close the air vents when water begins to seep out. Turn the power switch
to “ON” and be sure the power cord for the Polisher Quality Light is still
disconnected.
l. Allow the system to flush until the disinfectant is no longer detected at the
outlet. (Use low-level test strips P/N 97HP20401 to test for residual PAA
or P/N 97CM20201to test for residual chlorine).
m. Once disinfectant is no longer detected anywhere in the system, turn the
power switch to “OFF” and drain the water from the system by opening all
of the drains. Close drains once the water stops draining from the system.
n. Follow the Resin Pack + Filter Exchange instructions to replace the resin
packs and carbon block filters. Reinstall the power cord to the Polisher
Quality Light to complete the disinfection.
WARNING: DO NOT place the system in service until a negative result for
chlorine is achieved at the outlet hose! Serious injury, illness, or
death to the patient may result!
Apart from regular resin pack and filter exchange, and periodic disinfection, the Silex
system requires no maintenance. In the event that the system is damaged, all parts can
be ordered from AmeriWater by calling 1-800-535-5585.
15
8. SPARE PARTS LIST
Part Name Part Number Part Name Part Number
Pressure Regulator
Valve
System Vent Screw 19530901 Filter Gauge 43530702
Replacement Filter
Cartridge 10”
Caster with Brake 94560410 Caster without Brake 94560411
Worker Quality Light
Check
50K
Column O-Ring 19300001-00 Hose Clamp 15650038
Hose 12677138 Resin Pack 45101C
PAA High Level
Concentration Test
Strips
Water Check RC
Chlorine 0.5-1.0-500
(1%) Test Strips
44-0002 Pressure Gauge 43530701
Replacement
20-5011
75679121
97HP20401
97RC22101
Nephros Filter
Capsule
Polisher Quality Light
1 Meg W/Alarm
RenalCheck,
Residual Peroxide
Test Strips
Water Check 2 Low
Level Chlorine /
Chloramine
20-0009
75679117
97PX20501
97CM20201
Replacement Kit,
Wheel Mounting Plate
Solenoid Valve
2-Way
Normally Closed
0-60 PSI
12VDC
0119-0016
59-0024
Recirculation
Pump
16
80-0137
9. TROUBLESHOOTING FOR THE ECOCIRC PUMP
9.1. Pump components
9.2. Pump does not run
Check if the voltage is correct. If voltage is correct, and the pump is hot, the thermal
overload protection might have switched-off the pump. Wait until the pump is cooled
again. It will turn on automatically.
The pump is blocked – clean the pump of impurities (The pump must be without power.
Turn the ON/OFF switch on the control box to OFF. Close the shut-off valves. Open the
screw ring carefully and clean the pump. Attention: water will run out of the pump, avoid
electric parts getting wet).
The pumped fluid is too hot. (Make sure the pumped fluid temperature is within the
allowed range of the temperature) Max. Ambient Temperature: 50 Degrees C
9.3. Loud flow noise
The system has not been purged correctly. Re-purge the system. Flush the system to
remove dirt. Make sure the system is filled and the air has been forced out. The pump
must be without power to rid the system of air. Turn the ON/OFF switch on the control
box to OFF. Remove the screw ring from the pump a little, so that the air can leak out of
17
the pump. Attention: Avoid electric parts getting wet! Then open the lead-in carefully,
until some water runs out of the pump. Now fasten the screw ring. The pump can be
switched on. If you hear air noises at first, these should lessen after a short while.
Turning the pump off and back on accelerates the air removal. If the air noise does not
disappear or at least decrease substantially, repurge the system. Avoid dry run in any
case! This will damage the pump. Be sure there is water throughout the system.
There might be dirt inside the pump housing. Clean the pump inside (The pump must be
without power. Turn the ON/OFF switch on the control box to OFF. Close the shut-off
valves. Open the screw ring carefully and clean the pump. Attention: water will run out
of the pump, avoid electric parts getting wet).
9.4. Cleaning the pump – changing the rotor
The pump must be without power. Turn the ON/OFF switch on the control box to OFF.
Close the shut-off valves. Open the screw ring carefully. Attention: water will run out of
the pump. Avoid electric parts from getting wet or water running over the motor. Take
away the stator. Take out the rotor carefully by grabbing it at the blade wheel. Check the
pump housing, the rotor and the stator for impurities and remove them. Clean the pump.
Put the rotor back in the stator and check whether it can be turned easily. If not, the
bearing might be worn (swirl marks on the bottom side of the rotor). Put in the new rotor.
Change the pump against a new one. If the rotor can be turned easily, close the pump
again. Remove the gasket. Clean the gasket and the nut and the area on the stator
where the gasket lays. Put the gasket back inside the pump housing. Assemble the
slator with the screw ring. The screw ring must not be installed using tools. Normally it is
enough to assemble the screw ring manually. If the pump does not work, replace the
motor.
18
10. WARRANTY POLICY
The buyer has a lifetime warranty on the PVC housing and a one year warranty on all
other equipment and parts, excluding non-durable components (e.g., resin packs, filter
cartridges, and water quality monitors); provided that the system is not subject to abuse,
misuse, alteration, neglect, freezing, accident or negligence; and provided further that
the system is not damaged as the result of any unusual force of nature such as, but not
limited to, flood, hurricane, tornado or earthquake.
The warranty covers the replacement of equipment and/or parts only. The warranty
does not cover labor charges or travel expenses resulting from the service of
equipment. The manufacturer is excused if failure to perform its warranty obligations is
the result of strikes, government regulation, materials shortages, or other circumstances
beyond its control.
To obtain warranty service, notice must be given to AmeriWater within 30 days of the
discovery of the defect.
There are no warranties on the SILEX system beyond those specifically described
above. All implied warranties, including any implied warranty of merchantability or of
fitness for a particular purpose are disclaimed to the extent they might extend beyond
the above periods. The sole obligation of the manufacturer under these warranties is to
replace or repair the component or part which proves to be defective within the specified
time period, and the manufacturer is not liable for consequential or incidental damages.
No dealer, agent, representative, or other person is authorized to extend or expand the
warranties expressly described above.
Some states do not allow limitations on how long an implied warranty lasts or exclusions
or limitations of incidental or consequential damage, so the limitations and exclusions in
the warranty may not apply to you. This warranty gives you specific legal rights, and
you may also have other rights, which vary from state to state.
19
Loading...