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Harvey
®
Chemiclave EC5500/EC6000
Sterilizers
Owner/Operator Manual
EC5500 Series 1121
EC6000 Series 1122
LT1121X1 • 1/9/03
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Table of Contents
Safety Information ..................................................................................................................................................................3
Alert Signals..........................................................................................................................................................................3
Warnings ..............................................................................................................................................................................3
General Description ................................................................................................................................................................4
Controls and Features..........................................................................................................................................................5
Power Switch......................................................................................................................................................................5
Control Panel......................................................................................................................................................................5
Chemi-Filter........................................................................................................................................................................6
Door Latch..........................................................................................................................................................................6
Waste Tank Drain ..............................................................................................................................................................6
Pressure Relief Valve ........................................................................................................................................................6
Chemipurge........................................................................................................................................................................6
Operation ................................................................................................................................................................................7
Preparing Items for Sterilization ..........................................................................................................................................8
Items Not Recommened for Chemical Vapor Sterilization ..................................................................................................8
Recommended Sterilization Monitoring Program ................................................................................................................9
Filling The Vapo-Steril Reservoir ........................................................................................................................................10
Emergency Treatment......................................................................................................................................................10
Draining the Waste Tank ..................................................................................................................................................11
Filling the Reservoir ........................................................................................................................................................12
Running a Cycle ................................................................................................................................................................14
Preparation ......................................................................................................................................................................14
Power ..............................................................................................................................................................................14
Loading the Chamber ......................................................................................................................................................14
If the Door Will Not Open ................................................................................................................................................16
Starting the Cycle ............................................................................................................................................................17
Completing the Cycle ......................................................................................................................................................18
Removing the Goods ......................................................................................................................................................18
Stopping a Cycle ..............................................................................................................................................................20
Power Interruption ............................................................................................................................................................20
Troubleshooting ....................................................................................................................................................................22
Maintenance ........................................................................................................................................................................22
Daily....................................................................................................................................................................................22
Cleaning the Door Gasket................................................................................................................................................22
Draining the Waste Tank ..................................................................................................................................................24
Weekly................................................................................................................................................................................25
Cleaning the Chamber and Trays ....................................................................................................................................25
Monthly ..............................................................................................................................................................................25
Checking the Pressure Relief Valve ................................................................................................................................25
When Required ..................................................................................................................................................................26
Replacing the Chemi-Filter ..............................................................................................................................................26
Finding the Replacement Date ........................................................................................................................................26
Replacing the Door Gasket ..............................................................................................................................................27
Door Adjustment ..............................................................................................................................................................28
Installation ............................................................................................................................................................................29
Positioning the Sterilizer ....................................................................................................................................................29
Electrical Requirements......................................................................................................................................................31
Chemi-Filter Installation......................................................................................................................................................31
Operational Check-Out ......................................................................................................................................................31
Technical Specifications........................................................................................................................................................32
Declaration of Conformity ..................................................................................................................................................33
Environmental Conditions ..................................................................................................................................................33
Replacement Parts ..............................................................................................................................................................34
Ordering Information ............................................................................................................................................................35
Glossary................................................................................................................................................................................36
Two Year Limited Warranty ..................................................................................................................................................40
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Safety Information
Your Harvey®Chemiclave EC5500/EC6000 sterilizer has
been designed with function, reliability and safety in
mind. It is your responsibility to install it in conformance
with local electrical codes. This manual contains important safety information. You must carefully read and understand the contents of this manual prior to the use of
this equipment. For safe operation, please pay attention
to the alert signals throughout the manual.
Warnings
This sterilizer employs a chemical vapor process using
Harvey Vapo-Steril solution, which contains 0.23% formaldehyde by weight.
Employers should be familiar with any occupational
Safety and Health Administration (OSHA) regulations
which apply to their workplace. OSHA standards (29
CFR 1910.1048) for Formaldehyde applies to the workplace. For a copy of this standard, contact your nearest
OSHA office.
Refer servicing to qualified service personnel.
Warning
Warnings alert you to a possibility of
personal injury.
Caution
Cautions alert you to a possibility of
damage to the equipment.
Note
Notes alert you to pertinent facts and
conditions.
Hot Surface
Hot surfaces alert you to a possibility
of personal injury if you come in contact with a surface during use or for a
period of time after use.
Alert Signals
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The Harvey®Chemiclave sterilizer is a safe, fast and effective
sterilizer for use in medical and dental offices, hospitals, clinics and other health care facilities.
To sterilize goods, Chemiclave sterilizers use an unsaturated
chemical vapor process. This method is proven for sterilizing
instruments without dulling, rusting, corroding or otherwise
impairing their properties. Cycles require no drying time—
goods come out dry.
The Chemiclave sterilizer is not intended for use with liquids,
agars, textiles or heat-sensitive items. Sterilization processes
of unique loads not specified in this manual must be validated
by the end users.
General Description
Figure 1: Chemiclave EC5500 (Front View)
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Controls and Features
Power Switch
The power switch on the front of the sterilizer turns
power to the sterilizer ON (I) or OFF (O). See Figure 1.
Control Panel
Pressure Gauge
Displays the chamber pressure. See Figure 2.
Timer
Times the 20 minute exposure phase and the purge
phase. During the countdown, the decimal point flashes.
Control Knob
When the control knob is turned to PRESSURIZE at the
start of a cycle, Vapo-Steril enters the chamber, enabling
a cycle to begin. Turning the control knob to DEPRESSURIZE after the exposure phase permits vapors to
exhaust from the chamber.
Indicators
POWER: Lights when power to the unit is ON.
TEMP: Turns on and off as the chamber heaters cycle
on and off.
PURGE: Flashes when the exposure phase or purge
phase is complete. Lights during the purge phase.
COMPLETE: Lights when the exposure phase is complete. Also lights when the purge phase is complete.
VAPO: Lights when the reservoir must be filled with
Vapo-Steril solution. The indicator will remain lit until
solution is added.
GENERAL DESCRIPTION
Figure 2: Control Panels
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Chemi-Filter
®
The Chemi-Filter is a cylindrical filter that is placed in the top
of the sterilizer, directly behind the fill funnel. It removes formaldehyde and potentially objectionable odors from the
Chemiclave exhaust.
Door Latch
The door latch secures the door. It is opened by the door
handle. The handle mechanism prevents the door from being
opened while there is pressure in the chamber.
Waste Tank Drain
A quick-disconnect drain port below the sterilizer door is provided to drain used Vapo-Steril solution from the waste tank.
A drain hose connects to the port when required.
Pressure Relief Valve
A safety valve on the rear of the sterilizer relieves excess
chamber pressure (see Figure 3).
Chemi-Purge
The Chemipurge pumps filtered air into the chamber after a
cycle. This forces residual vapors out of the chamber into the
condenser and through to the Chemi-Filter.
GENERAL DESCRIPTION
Figure 3: Pressure Relief Valve
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Warning
Do not attempt to open the door until
the pressure gauge has returned to 0
psig.
Warning
Do not use this equipment to sterilize
volatile substances or for any purpose
other than its intended design.
Warning
Do not operate the Chemiclave without
a Chemi-Filter in place. Operation without a Chemi-Filter could result in emissions above the permissible exposure
levels (PELs) established by OSHA.
Warning
Do not use the equipment to sterilize
liquids or solutions. Attempts to
process liquids or solutions could result
in (1) the liquids boiling over, and/or (2)
the containers exploding.
Caution
Replace the door gasket when damage, deterioration or wear prevents a
proper seal. A proper seal is essential
to safety and performance (see instructions in the “Maintenance” section of
this manual.
The Chemiclave sterilizer uses Harvey® Vapo-Steril
solution to sterilize instruments without dulling, rusting or
corroding. To ensure safe and effective use, follow these
precautions:
• Follow the instructions in the Owner/Operator
Manual. Do not try to open the door until the chamber is
fully depressurized and the pressure gauge reads “o.”
Replace the door gasket when damage, deterioration or
wear is evident.
• Operate the Chemiclave sterilizer in a wellventilated area. Ventilation requirements will vary with
room size, frequency of use, the number of sterilizers
operated within a given area, etc. Ventilation must be
adequate to ensure compliance with applicable Occupational Safety and Health Administration (OSHA) standards for levels of exposure to formaldehyde and ethyl
alcohol.
Operation
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Preparing Items for Sterilization
1. Thoroughly clean, rinse and dry the items before
placing them in the sterilizer, An ultrasonic cleaner
is suggested for removal of debris.
2. Clean and lubricate instruments according to the
manufacturer’s instructions.
3. If processed instruments will be stored, Harvey
Chemi-Test indicator bags and pouches are recommended. These permit chemical vapor penetration
during processing and maintain integrity after
removal from the sterilizer.
4. Open any hinged instruments.
5. Uncover empty containers.
6. Chemical process indicators should be placed in
the center of each load. Weekly use of biological
indicators is recommended (see “Recommended
Sterilization Monitoring Program.”
Items not Recommended for
Chemical Vapor Sterilization
• Linen, textiles or fabrics— incompatible with the
chemical vapor process.
• Liquids and agars— incompatible with high temperature processing (132°C [270°F]).
• Items contained in tightly woven packs or wraps or
sealed containers—cause poor vapor penetration.
Chemi-Test indicator bags and pouched are recommended.
• Plastics which cannot tolerate temperatures in
excess of 132°C (270°F).
• Polycarbonate—chemically incompatible.
• Nylon tubing and bags—inhibit penetration of
chemical vapors.
OPERATION
Note
Items placed in the sterilizer must be
dry. Moisture on items processed in
the sterilizer may cause an incomplete
cycle or corrosion of the instruments.
Note
Unwrapped instruments processed in
the sterilizer should not be considered
sterile when exposed to unsterile environments
Caution
Consult the manufacturer of the item
that will be placed in the Chemiclave to
determine its compatibility with high
temperatures. A single unwrapped
instrument may be exposed to a possible peak temperature of up to 150°C
during the normal cycle.
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OPERATION
Recommended Sterilization Monitoring Program
All functions of the sterilizer should be monitored to provide maximum sterilization assurance.
The Joint Commission on Accreditation of Hospitals and the American Dental Association recommends that
biological indicators be used at least weekly to check the ef fectiveness of sterilizers. The biological indicator
recommended for monitoring chemical vapor sterilization contains Bacillus stearothermophilus. W e recommend using Harvey Spor-Test biological indicator.
We also recommend using chemical process indicators such as Harvey Chemi-Test within each package in
each cycle. For additional assurance that minimum sterilizing conditions have been achieved, use a biological
indicator such as Harvey B/T Sure Biological Monitoring Service at least once a week.
The items below may be ordered from your authorized Harvey dealer , or contact the Customer Service
Department at Barnstead International at (800) 553-0039.
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Filling the Vapo-Steril Reservoir
When the VAPO indicator lights, drain the waste tank (a
drain fitting and tubing are provided) and fill the Vapo-Steril
reservoir. See “Draining the Waste Tank” and “Filling the
Reservoir.”
Emergency Treatment
In case of contact with Vapo-Steril solution, immediately
flush eyes or skin with water for at least 15 minutes. For
eyes, call a physician. Get medical attention if irritation persists.
OPERATION
Warning
Avoid breathing Vapo-Steril fumes.
Warning
Vapo-Steril solution causes eye damage and may cause skin irritation. Do
not get in eyes or on skin or clothing.
Wear goggles or face shield when handling. Harmful or fatal if swallowed.
Avoid contamination of food.
Warning
Never fill the reservoir while a cycle is
in progress. Vapo-Steril solution could
be forcibly expelled, splashing solution
on the operator.
Warning
Vapo-Steril is flammable. Keep away
from heat or flame.
Caution
Always drain the waste tank before filling the reservoir. Otherwise waste
could overflow, damage the ChemiFilter and require cleanup.
Note
Adding Vapo-Steril solution is required
only when the VAPO indicator lights
on the control panel.
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Draining the Waste Tank
1. Insert the open end of the tubing into a container.
2. Lock the drain fitting into the drain port. Waste
will begin to exit the drain (see Figure 4).
3. To release the drain fitting, press the release tab.
4. Store the tubing with the drain fitting attached.
5. Dispose of Vapo-Steril solution in accordance
with all prevailing federal, state and local
regulations.
OPERATION
Warning
Do not drain the waste tank while a
cycle is in progress. This could depressurize the chamber and interfere with
sterilization.
Warning
Do not reuse Vapo-Steril solution
removed from the waste tank. This liquid may be contaminated or chemically
altered. It may damage the sterilizer.
Warning
Dispose of Vapo-Steril solution in
accordance with all prevailing local
jurisdictional requirements.
Warning
Flammable liquid. Treat Vapo-Steril
solution as a hazardous waste.
Dispose of it properly.
Figure 4: Draining the Waste Tank
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Filling the Reservoir
1. Locate the fill funnel (see Figure 5). Remove
cap from the fill funnel.
2. Remove the cap from a bottle of Vapo-Steril
solution, and attach the fill spout.
3. Invert the bottle. Insert the fill spout completely
into the fill funnel.
4. Empty the bottle into the reservoir. If the reservoir fills before the bottle is empty, the flow will
stop automatically. When this occurs, air bubbles will stop entering the bottle.
5. Remove and store the fill spout. Dispose of the
bottle properly.
Warning
Do not fill the Chemiclave sterilizer
without a Chemi-Filter in place.
Operation without a Chemi-Filter could
result in emission above permissible
exposure levels (PELs) established by
OSHA.
Note
Use only Harvey Vapo-Steril
Solution in the sterilizer. Do not
dilute, alter or otherwise change
Vapo-Steril solution in any way. Do
not use water in the Chemiclave
sterilizer. The Harvey Chemiclave
sterilizer was designed to use the
Vapo-Steril solution. If a solution
other than Vapo-Steril is used and
damages the Chemiclave sterilizer,
the warranty is void.
Caution
Always drain the waste tank before filling the reservoir. If this is not done,
excess waste could overflow, damage
the Chemi-Filter and require substantial
cleanup.
Figure 5: Filling the Vapo-Steril Reservoir
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OPERATION
Figure 6: Controls and Features
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Warning
Do not use this equipment to sterilize
volatile substances or for any other
purpose than its intended design.
Warning
Do not use this equipment to sterilize
liquids or solutions. Attempts to
process liquids or solutions in the sterilizer could result in (1) the liquids boiling over and/or (2) the containers
exploding.
Running a Cycle
Preparation
1. Set control knob to DEPRESSURIZE. Do this
before turning the sterilizer ON (see Figure 5).
2. Check that the Chemi-Filter is in place. If it is
not, install it. (See “Chemi-Filter Installation.’)
Power
1. Switch the POWER switch to the ON (I) position. All the indicators (LED’s) should light for
approximately two seconds, then extinguish
except for the POWER and TEMP indicators
which should remain ON.
• The POWER indicator will stay lit as long as the
POWER switch is on.
• The TEMP indicator lights whenever the heating
elements are on.
• The timer displays “00” during warm-up.
Loading the Chamber
When the TEMP indicator cycles off and on, the chamber
is ready to be loaded.
1. Open the door:
2. Check that chamber pressure is less than 2 psi.
The door latch cannot be released if pressure in
the chamber exceeds approximately 2 psi.
3. Pull the door handle to the right. This releases
the door latch (see Figure 8).
4. Swing the door open.
5. Place the items to be processed in the appropriate trays.
If the door will not open, refer to “If the Door Will
Not Open” at the end of this section.
OPERATION
Caution
Do not operate the Chemiclave sterilizer without a Chemi-Filter in place.
Operation without a Chemi-Filter could
result in emission above permissible
exposure levels (PELs) established by
OSHA.
Figure 7: Power Switch
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Unwrapped Goods
• Use Harvey Chemi-Test tray liners.
• Be sure instruments are clean and dry.
• Do not overload. Maximum loads: EC5500—3.1
lb. (1400 g); EC6000— 6.2 lb. (2800g).
Wrapped Goods
• Package loads loosely—single wrapped, paper
bags or pouches. This permits chemical vapor
penetration.
• Arrange pouches on edge, not flat, to permit
chemical vapor penetration.
• Do not stack bags or pouches. Do not allow
bags or pouches to touch the wall of the chamber.
• Do not overload. Maximum load: EC5500—2.6
lb. (1200 g); EC6000—5.3 lb. (2400 g).
6. Set the trays in the sterilizer chamber (see
Figure 9).
7. Close and latch the door.
8. Turn the control knob to PRESSURIZE.
OPERATION
Note
Harvey recommends lining each tray
with a Harvey Chemi-Test tray liner.
Do not use paper towels as tray liners—the chamber will turn black.
Note
Do not use heavy or multiple wraps.
These will prevent proper penetration
of the VAPO-Steril vapor.
Figure 8: Door Release
Figure 9: Loading the Chamber
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If the Door Will Not Open
1. Swing the door handle 180°.
2. Hook the fingers of your left hand around the
door handle and brace your left thumb against
the right side of the sterilizer.
3. Squeeze so the handle pulls directly to the right
(see Figure 10). This will release the door latch.
The door will now open.
4. If the door handle will not engage when chamber pressure is less than 2 psig, adjust the door
(See “Door Adjustment” under the
“Maintenance” section.
Note
If there is pressure in the chamber, the
handle will pivot without releasing the
door latch. This safety feature helps
prevent opening the door accidentally.
Figure 10: Alternative Door Release
OPERATION
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Starting the Cycle
1. Turn the control knob to PRESSURIZE.
• This starts the EXPOSURE phase of the cycle
(see Figure 11).
• The timer will display “20.”
• Chamber pressure will increase.
Timed Exposure Begins
• When chamber pressure reaches 20 psi, the
timer starts automatically (see Figure 12).
• The timer counts down to zero. During the countdown, the decimal point flashes to show it is in
the EXPOSURE phase.
• The decimal point flashes while chamber pressure exceeds 20 psi. If the decimal point stops
flashing, chamber pressure has dropped below
20 psi.
Timed Exposure Ends
The tone sounds.
• The timer displays “00.”
• The PURGE indicator flashes.
• The COMPLETE indicator lights.
Figure 11: Starting the Cycle
Figure 12: Automatic Timed Exposure Display
OPERATION
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Completing the Cycle
1. After the tone sounds, turn the control knob to
DEPRESSURIZE (see Figure 13).
After 1 minute, the automatic purge phase begins (see
Figure 14).
• The PURGE indicator lights.
• The complete indicator goes out.
• The timer displays “07” (EC5500) or “09”
(EC6000).
• The decimal point on the timer flashes as the
timer counts down to “00.”
When the purge phase ends:
• The tone sounds.
• The PURGE indicator flashes.
• The COMPLETE indicator lights.
When the tone stops, the PURGE indicator goes out. The
COMPLETE indicator remains lit for about a minute and
then goes out. The timer continues to display “00.”
2. Wait 60 seconds.
This allows chamber pressure to drop and permits the
door to open easily.
Removing the Goods
1. Release the door latch. Open the door slightly.
Wait 15 seconds for any residual vapors to
escape.
If the door will not open:
• Swing the door handle 180°.
• Hook the fingers of your left hand around the
door handle and brace your left thumb against
the right side of the sterilizer.
OPERATION
Figure 13: Exposure Complete
Figure 14: Automatic Purge
Warning
Chemical Hazard: Vapo-Steril solution
may be in the chamber. Wear protective goggles and gloves when opening
the door.
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• Squeeze so the handle pulls directly to the
right (see Figure 15 ). This will release the
door latch. The door will now open.
2. Open door fully.
3. Use the tray handle to remove the tray from
the sterilizer (see Figure 16).
When the unit is not in use, leave the door closed but
unlatched. This will prolong the life of the door gasket.
Between cycles, leave the unit ON with the door unlatched and closed. This will give the fastest load turnaround.
Turn the unit OFF only at the end of the working day or
when it is not to be used for a long time.
OPERATION
Figure 15: To Release the Door Figure 16: Removing the Tray
Note
If there is pressure in the chamber, the
handle will pivot without releasing the
door latch. This safety feature helps
prevent opening the door accidentally.
Warning
Hot goods! The tray and instruments
will be hot after processing. Use the
tray handle to remove the tray. DO
NOT carry the tray by the handle. Tray
must be supported by a gloved hand.
Wear heat-protective gloves when handling the tray or goods. Otherwise
burns could result.
Note
The tray handle is also the tool to
adjust the door (see “Door
Adjustment”).
Note
During normal working hours when the
sterilizer is not being used, leaving the
door closed but unlatched will keep
the sterilizer in READY condition.
Caution
Failure to follow the routine cleaning
procedures in the “Maintenance” section may cause equipment malfunction
and/or void the warranty.
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Stopping a Cycle
If you must stop a cycle before it is complete, follow the
procedure below:
1. Turn the control knob to DEPRESSURIZE.
2. Observe the sterilizer.
a. The timer displays “00.”
b. The tone sounds.
c. The PURGE indicator flashes during the tone.
d. The purge phase will run (refer to “Completing
the Cycle”).
• The timer displays “00.”
• The PURGE indicator lights as the timer counts
down.
e. The tone sounds.
• The COMPLETE indicator does NOT light.
3. Wait 60 seconds.
4. Remove the load as usual (see “Removing the
Goods”).
5. Clean the items in case of contamination.
Process the load again.
Power Interruption
If the power is interrupted, follow the procedure below:
Power Off
While the power is off:
1. The POWER and TEMP indicators will be off.
2. Do not open the door.
OPERATION
Figure 17: Stopping a Cycle
Warning
Reprocess the load completely.
Otherwise the load may not have been
subjected to sterilizing conditions.
Caution
Danger of load contamination. Cooling
of the chamber may create a partial
vacuum in the chamber. If the control
knob is set to DEPRESSURIZE, this
vacuum could draw back waste VapoSteril solution back into the chamber.
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3. Leave the control knob at PRESSURIZE. This
keeps the chamber sealed.
4. Do not remove the load yet. Wait for the
power to be restored.
Power Restored
When the power is restored, the sterilizer responds differently depending on (1) the model and (2) where in the
cycle it was interrupted. (See table.)
After Prolonged Power Interruption
1. Turn the knob to DEPRESSURIZE.
2. Wait 60 seconds.
3. Remove the load.
4. Clean the items in case of contamination.
Process the load again.
OPERATION
Warning
Chemical Hazard: Vapo-Steril solution
may be in the chamber. Wear protective goggles and gloves when opening
the door.
Warning
Reprocess the load completely.
Otherwise the load may not have been
subjected to sterilizing conditions.
Figure 18: When Power is Restored
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Page 23
23
Daily
Cleaning the Door Gasket
Wipe the door gasket and mating surface each day with a
clean, damp cloth (see Figure 19 ) Do not use abrasive
cleaners.
Examine the door gasket for cracks or damage, which
could result in a poor pressure seal. If replacement is
required, refer to “Door Gasket Replacement.”
Maintenance
Warning
Avoid burns. Be sure the sterilizer is
cool maintaining areas around the
chamber and door.
Figure 19: Cleaning the Door Gasket
Warning
Failure to follow the routine cleaning
instructions in the “Maintenance” section of the Owner/Operator Manual
may cause equipment malfunction
and/or void warranty.
Page 24
24
Draining the Waste Tank
Drain the waste tank when the VAPO indicator lights on the
control panel (see Figure 20).
If preferred, drain the waste tank daily – but also when the
VAPO indicator lights.
Store the tubing with the drain fitting attached.
Warning
Vapo-Steril solution causes eye damage and may cause skin irritation. Do
not get in eyes or on skin or clothing.
Wear goggles or face shield when handling. Harmful or fatal if swallowed.
Avoid contamination of food.
MAINTENANCE
Warning
Do not drain the waste tank while a
cycle is in progress. This could depressurize the chamber and interfere with
sterilization.
Warning
Do not reuse Vapo-Steril solution
removed from the waste tank. This liquid may be contaminated or chemically
altered. It may damage the sterilizer.
Warning
Flammable liquid. Treat Vapo-Steril
solution as a hazardous waste.
Dispose of it properly.
Warning
Dispose of used Vapo-Steril solution in
accordance with all prevailing local
jurisdiction requirements.
Caution
Always drain the waste tank before filling the reservoir. If this is done, excess
waste could overflow, damage the
Chemi-Filter, and require substantial
cleanup.
Figure 20: Draining the Waste Tank
Page 25
25
Weekly
Cleaning the Chamber and Trays
1. Close the door.
2. Turn ON the POWER switch. Wait 2 minutes.
3. Turn OFF the POWER switch.
4. Open the door. The chamber should be warm,
not hot.
5. Clean the chamber and trays with Harvey
Chamber cleaner. Follow the instructions on the
container.
Monthly
Checking the Pressure Relief Valve
Manually operate the valve plunger of the pressure relief
valve on the back of the sterilizer (see Figure). This is to be
sure the plunger will move should the chamber become
over-pressurized.
To check the plunger:
1. Pull on the ring several times to ensure free
movement.
2. If the plunger does not move freely, contact service personnel to replace the pressure relief
valve.
MAINTENANCE
Note
Harvey chamber cleaner works best in
a warm, dry chamber.
Hot Surface
Wear protective gloves and safety
glasses. Chamber and trays may
cause burns if touched.
Figure 21: Cleaning the sterilizer chamber
Figure 22: Checking the Pressure Relief Valve
Warning
Exposure Hazard. Do not operate the
valve plunger while the sterilizer is in
cycle or under pressure. Exposure to
chemical vapor could result.
Page 26
26
When Required
Replacing the Chemi-Filter
1. Be sure the power switch is OFF. (See Figure.)
2. Grasp the pull strap at the top of the used
Chemi-Filter. Remove the filter from the filter
opening. Dispose of it properly.
3. Remove the new Chemi-Filter from its package.
4. Mark the replacement date in the “Replace By’
box on the Chemi-Filter label. To calculate this
date, read the Chemi-Filter label or refer to
“Finding the Replacement Date.”
5. Grasp the pull strap at the top of the ChemiFilter. Insert the filter into the filter opening. Push
the filter down as far as possible.
Finding the Replacement Date
Calculate the replacement date by adding the number of
months until replacement to the current date. Mark the replacement date in the “Replace By” box on the filter label.
Use the chart on the Chemi-Filter label to find the number
of months until replacement.
The chart on the Chemi-Filter label is based on a 5-day
work week and an average number of cycles/workday of 2,
4, 6, 8, 10 or 12.
If your usage differs from these values, calculate the
months until replacement as shown:
MAINTENANCE
Warning
If the Chemi-Filter cartridge is broken,
avoid contact with skin and eyes and
avoid breathing dust. For additional
information, see the Material Safety
Data Sheet.
Warning
Do not attempt to remove the cartridge
while the sterilizer is processing.
Warning
Replace only with a Harvey ChemiFilter.
Warning
To dispose of the used cartridge, consult the Material Safety Data Sheet.
Figure 23: Replacing the Chemi-Filter
Page 27
27
Months Until Replacement Calculation
Values Needed:
1. Assign proper values to c, D and T.
c = no. of cycles/workday (operator defined)
D = no. of workdays/week (operator defined)
T= Total no. of cycles before filter needs replacement (see chart )
Calculation:
2. Insert the values for c, D and T into the formula:
no. of months until replacement = 0.231 x (T/[c x
D])
Example:
A. An operator has an EC5500 sterilizer. She
intends to run it 7 cycles each day, 4 days/week.
How soon must she replace the Chemi-Filter?
Solution:
c = 7, D = 4 and T = 500. Substituting into the
formula, we get:
0.230 x (500/[7 x 4]) = 4.125
Replace the Chemi-Filter after 4 months.
Replacing the Door Gasket
Replace the door gasket at least once a year.
1. Open the door.
2. Remove the gasket from the gasket grove in the
rim of the chamber (see Figure).
3. Clean the groove and surrounding area so that it
is free of dirt or deposits.
4. Wipe the replacement gasket with a clean, damp
cloth. Then insert the gasket into the gasket
groove. Follow the instructions packaged with
the gasket.
MAINTENANCE
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Figure 24: Door Gasket Replacement
Page 28
28
Door Adjustment
If chamber pressure is not retained during a cycle, door
adjustment may be necessary.
1. Clean or replace the door gasket if necessary.
2. Turn the sterilizer ON. Run a “no load” cycle to
heat it to operating temperature. When the cycle
is complete and chamber pressure is below 2
psi, open the door.
• If chamber pressure is retained during the cycle,
do not adjust the door.
• If chamber pressure is not retained, go to step
3.
3. Hold the tray handle at the fork end so the fork
points towards you. Insert the hex end of the
tray handle through the slot in the bottom of the
door cover (see Figure 25 ).
4. To Tighten: Move the fork end of the tray handle toward the right of the slot. Fit the hex end
onto the adjusting nut. Move the tray handle to
the left side of the slot, turning the adjusting nut
clockwise.
5. Moving the tray handle from one side of the slot
to the other should be enough to achieve a seal.
If the door is difficult to close, loosen the door
slightly.
6. To Loosen: Position the fork end of the tray
handle to the left of the slot. Then fit the hex
end onto the adjusting nut. Move the tray handle
toward the right side of the slot, turning the
adjusting nut counterclockwise.
MAINTENANCE
Figure 25: Door Adjustment
Page 29
29
Installation
To install the sterilizer, complete these steps:
• Position the sterilizer.
• Make the electrical connection.
• Install the Chemi-Filter.
• Perform an operational checkout.
Positioning the Sterilizer
Area of Operation
Operate the system only in a well ventilated area.
Support Surface
Place the sterilizer on a level, heat-resistant surface.
Temperatures at the bottom of the sterilizer could reach
55°C (131°F).
Clearance
Allow a minimum of 3 inches clearance around the sterilizer for air circulation (see Figure 26).
Warning
Locate the sterilizer away from areas
where explosive anesthetics are used
or stored.
Warning
Ventilation must be adequate to ensure
compliance with applicable
Occupational Safety and Health
Administration (OSHA) standards for
exposure levels for formaldehyde and
ethyl alcohol.
Warning
Ventilation requirements will vary with
room size, frequency of use of the system, the number of systems operated
within a given area, etc.
Note
The door must open far enough to
permit removal of trays and racks.
Page 30
30
Figure 26: Positioning the Unit
MAINTENANCE
Figure 27: Electrical Connection
Page 31
31
Electrical Requirements
a separate electrical circuit is recommended for the electrical power source for the Chemiclave (see Figure 27).
Chemi-Filter Installation
1. Remove the new Chemi-Filter from its package.
2. Mark the replacement date in the “Replace By”
box on the Chemi-Filter label or refer to “Finding
the Replacement Date” under the “Maintenance”
section.
3. Grasp the pull strap at the top of the new ChemiFilter. Insert the filter into the filter opening. Push
the filter down as far as possible ( see Figure
28).
Operational Check-Out
1. Run a cycle with no load in the chamber (see
“Running a Cycle” p.).
2. If operating pressure is not retained throughout
the cycle, set the control knob to DEPRESSURIZE. Wait 60 seconds. Then run a second noload cycle.
3. If pressure drops again, adjust the door. Refer to
Door Adjustment.”
4. If operating pressure is retained throughout the
cycle, the sterilizer is ready for operation.
MAINTENANCE
Figure 28: Installing the Chemi-Filter
Page 32
32
Technical Specifications
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Page 33
33
TECHNICAL SPECIFICATIONS
Declaration of Conformity
Barnstead International hereby declares under its sole
responsibility that this product conforms with the
technical requirements of the following standards (230
volt models only):
EMC: EN 61326-1
Safety: EN 61010-1
EN 61010-2-010
and meet(s) the requirements of the Medical Device
Directive 93/42/EEC, and its relevant transition into the
national laws of the member states into which we place
the device(s).
The authorized representative located within the
European Community is:
Electrothermal Engineering Ltd.
419 Sutton Road
Southend On Sea
Essex SS2 5PH
United Kingdom
Copies of the Declaration of Conformity are available
upon request.
Environmental Conditions
Operating:
10° to 40°C; 30% to 70% relative humidity,
non-condensing. Installation Category II (overvoltage) in accordance with IEC 664. Pollution
Degree 2 in accordance with IEC 664.
Altitude limit: 3,650 meters.
Storage:
-25° to 65°C; 10% to 85% relative humidity.
Page 34
34
Replacement Parts
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Page 35
35
Ordering Procedures
Please refer to the Specification Plate for the complete model number, serial number and series number when
requesting service, replacement parts or in any correspondence concerning this unit.
All parts listed herein may be ordered from the Barnstead International dealer from whom you purchased this
unit or can be obtained promptly from the factory. When service or replacement parts are needed we ask that
you check first with your dealer. If the dealer cannot handle your request, contact our Customer Service
Department at 563-556-2241 or 800-553-0039.
Page 36
36
Agar: Semisolid growth medium used in growing microorganisms.
Biological Indicator: A calibrated population of bacterial spores (of high resistance to the mode of steriliza-
tion being monitored) in or on a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether the contents have
been subjected to sterilizing conditions.
Celsius: (Centigrade) Metric scale of temperature.
Chamber: The portion of the sterilizer in which items are processed.
Chemical Indicator: A sterilization process monitoring device designed to respond with a characteristic chem-
ical or physical change to one or more of the physical conditions within the sterilizing chamber. Chemical indicators are intended to detect potential sterilization failures that may result from incorrect packaging, incorrect
loading of the sterilizer, or malfunctions of the sterilizer. The “pass” response of a chemical indicator does not
prove that the item accompanied by the indicator is sterile.
Chemi-Filter: Cartridge used to remove formaldehyde from the exhaust air of the Chemiclave sterilizer.
Chemi-Test Indicator: A chemical indicator strip available from Harvey.
Chemi-Test Indicator Bag: A bag, with an integral chemical indicator, in which an instrument can be pro-
cessed and stored. Available form Harvey.
Control Panel: The panel on the front of the sterilizer containing the selectors and indicators.
Cycle: The processes and events that take place from when the control knob is turned to PRESSURIZE until
the door is opened to remove processed goods.
Dedicated Circuit: Electrical circuit with no other major appliances or equipment connected.
Exposure: Phase of cycle when items in the sterilizer chamber are subjected to sterilizing conditions.
Gasket: Soft ring which seals against the door.
kPa: (kiloPascal) Metric unit of pressure.
No-Load Cycle: A cycle with no items in the chamber.
OSHA: Occupational Safety and Health Administration; a U.S. agency that regulates safety in the workplace.
Phase: a timed portion of a cycle.
Pre-Set: Adjusted in advance or at the factory.
Pressure Relief Valve: A valve that automatically opens at a preset pressure to prevent an overpressure con-
dition in the chamber.
Glossary
Page 37
37
GLOSSARY
PSI: (pounds per square inch) English unit of pressure.
Purge: Phase of the cycle when vapors are removed from the chamber.
B/T Sure Biological Indicator: A biological indicator strip for monitoring steam and chemical vapor steriliza-
tion, available from Harvey.
Sterilant: Chemical solution (Vapo-Steril solution, for example) used as an agent in the sterilization process.
Ultrasonic: A sound vibration above the audible range of the human ear. Ultrasonic vibrations are used in cer-
tain instrument cleaners.
Vapo-Steril Solution: The sterilant produced by Harvey for use in the Chemiclave sterilizers.
Volatile Substances: Substances that vaporize or evaporate quickly.
Alfa Medical
265 Post Ave Westbury, NY 11590
1-800-801-9934 Fax 516-977-7434
email@sterilizers.com
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