Thermo Sterilemax 1277 User manual

Sterilemax

Table Top Steam Sterilizer

Operation Manual

Series 1277

LT1277X1 • 5/23/07

Model Numbers Voltage

ST75925 120V

ST75920-33 220V

Serial Number

Sterilemax Table Top Sterilizer

2

Table of Contents

Introduction..........................................................................................................................................................5

Safety Information ..............................................................................................................................................6

Warnings ..........................................................................................................................................................6

Specifications ......................................................................................................................................................9

Trays ................................................................................................................................................................9

Dimensions ......................................................................................................................................................9

Shipping Weight ..............................................................................................................................................9

Electrical ..........................................................................................................................................................9

Standards ........................................................................................................................................................9

Reservoir Water ..............................................................................................................................................9

Mounting ..........................................................................................................................................................9

Controls............................................................................................................................................................9

Environmental Conditions ..............................................................................................................................10

Declaration of Conformity ..............................................................................................................................10

Description ........................................................................................................................................................11

Operational Programs ....................................................................................................................................11

Program Summary Chart ..............................................................................................................................12

Controls..........................................................................................................................................................13

Sterilizer Features..........................................................................................................................................14

Installation ........................................................................................................................................................16

Location..........................................................................................................................................................16

Unpacking ......................................................................................................................................................16

Electrical Connections ..................................................................................................................................17

Optional Printer ..............................................................................................................................................17

Installation Instructions ..................................................................................................................................18

Altitude Adjustment............................................................................................................................................20

Display Parameter Setup ..................................................................................................................................21

Setting Month/Date/Year/Hour/Minute ..........................................................................................................21

Changing Temperature Units ........................................................................................................................22

Changing Pressure Units ..............................................................................................................................22

Changing Printer Mode ..................................................................................................................................23

Sterilization Procedures ....................................................................................................................................24

Materials Appropriate For Steam Sterilization ..............................................................................................24

Instrument Cleaning Prior To Sterilization......................................................................................................25

Preparation of Carbon Steel Instruments ......................................................................................................26

Preparing Items for Sterilization ....................................................................................................................26

Loading the Sterilizer Chamber ....................................................................................................................31

Handling Sterilized Materials ........................................................................................................................32

Recommended Monitoring ................................................................................................................................33

Process Monitoring ........................................................................................................................................33

Biological Indicators ......................................................................................................................................34

Operation ..........................................................................................................................................................36

Initial Startup ..................................................................................................................................................36

Outline of Operation ......................................................................................................................................37

Details of Operation ......................................................................................................................................37

Drying Sterilized Loads ..................................................................................................................................38

Optional Printer ................................................................................................................................................39

Connecting and Starting the Printer ..............................................................................................................39

3

TABLE OF CONTENTS

Control Panel ................................................................................................................................................39

Installing the Paper Roll ................................................................................................................................40

Printer Operation............................................................................................................................................40

Printer Tape Description ................................................................................................................................41

Printer Record Storage ..................................................................................................................................42

Special Operating Instructions ..........................................................................................................................44

Emergency Off (Cycle Abort) ........................................................................................................................44

Resetting Automatic OTP ..............................................................................................................................44

Erratic Controls Display or Operation ............................................................................................................45

Power Failure During Sterilizing Cycle ..........................................................................................................45

Problem Solving Chart ..................................................................................................................................46

Maintenance Schedule Chart ........................................................................................................................48

Maintenance ..................................................................................................................................................49

Daily Maintenance ........................................................................................................................................49

Weekly Maintenance ......................................................................................................................................49

Monthly Maintenance ....................................................................................................................................50

Emptying Collection Bottle ............................................................................................................................51

Cleaning Non-Recirculating Water Cooling Tank ..........................................................................................52

Changing Door Gasket ..................................................................................................................................53

Figures ..........................................................................................................................................................54

Parts List ........................................................................................................................................................57

Ordering Procedures......................................................................................................................................59

Decontamination Statement..............................................................................................................................59

One Year Limited Warranty ..............................................................................................................................60

4

Warning

Do not use this equipment for
any purpose other than its
intended use, described in this
manual.

Do not use the sterilizer to
process volatile substances or
materials which could release
toxic or explosive substances.

Introduction

This Thermo Scientific Sterilemax Table Top steam sterilizer
has been designed for use in medical and dental offices, uni­versity laboratories, clinics, hospitals and other locations
where a variety of materials require sterilizing.

Your sterilizer can be used for wrapped or unwrapped
instruments, packs, liquids, test tubes, petri dishes and
media.

The optional Impact printer provides a permanent
record of actual exposure times and temperatures.

General Usage

Do not use this equipment for any purpose other than its
intended use, described in this manual.

5

Safety Information

Alert Signals

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.

Warnings

1. Do not use this equipment for any purpose other than
its intended use, described in this manual.

2. Use only self-venting, automatic sealing stoppers
when processing liquids or media. Use of other stop­pers or seals, or lack of stoppers, will create the pos­sibility of burns or injury from boiling liquids and
exploding flasks.

3. Refer servicing to qualified personnel.

4. Use caution when opening the sterilizer door. Stand
to the side behind the door and open door slowly and
partially to protect yourself from escaping steam or
boiling liquids and exploding flasks.

5. Sterilizer and trays will be hot after cycle is run.
Always wear protective gloves and apron when
removing a processed load. Protective gloves and
apron should also be worn when reloading sterilizer
following previous operation.

6. Do not attempt to open sterilizer door until the display
reads "Cycle Complete". Pressure within the cham­ber could cause the door to open with extreme force,
possibly causing personal injury.

7. Ensure that the sterilizer is cool before cleaning to
avoid burns.

8. Pressurized steam will be discharged when the relief
valve is opened. To prevent burns, place a steam
barrier (such as a rolled towel) around the opening in

Consult Instructions for Use

This symbol appears on the product
to refer you to the instruction manual
for further information.

6

the back of the unit. To prevent burns, wear gloves or
use an extension device if it becomes necessary to
operate the pull ring.

SAFETY INFORMATION

9. Do not use the sterilizer to process volatile sub­stances or materials which could release toxic or
explosive substances.

10. Connect only to an electrical circuit of the appropri­ate voltage and load rating.

11. Do not overfill reservoir. To avoid slippery condi­tions and possible load recontamination, immedi­ately wipe up all spillage resulting from overfilling
chamber or reservoir.

12. Do not add water to reservoir while a sterilization
cycle is in process. When the cycle ends and
steam vents back into the reservoir, a sudden
overflow of hot water could occur, possibly result­ing in burns to personnel.

13. To prevent collection of mineral deposits and corro­sion of chamber components, use distilled or low
quality deionized water only. Clean chamber after
each use if sterilizing saline solutions.

14. Processing goods at less than recommended
time/temperature could result in unsterile goods.

15. Reprocess your load when the sterilizing cycle has
been terminated prematurely. The load may not be
sterile when the sterilizing cycle has been terminat­ed prematurely.

16. Open door slowly at the end of a liquid sterilization
cycle. Do not allow hot bottles to be jolted. This
can cause bottle explosions. Do not move bottles if
any boiling or bubbling is present.

17. Allow bottles to cool before attempting to move
them from sterilizer shelf or tray(s) to the storage
area.

18. If media is processed, bottles and tubes should
contain no more than 3/4 the total volume of the
container. When processing water bottles and test

7

SAFETY INFORMATION

tubes, the bottles and tubes should contain no
more than 3/4 the total volume of the container.
Chamber should be cleaned daily when process­ing media.

19. Keep patients at least six (6) feet away from the
sterilizer when it is in use.

20. Do not operate this sterilizer in the presence of
flammable or explosive substances (such as anes­thetics). A fire or explosion could occur.

21. Never use a wire brush, steel wool, abrasive mate­rial, or chloride-containing products to clean door
and chamber assembly.

22. Use a process monitor in every cycle to ensure
exposure to minimum sterilizing conditions. Use a
biological indicator once a week to verify your ster­ilization process.

23. Dental handpieces should be run only on optional
cycle at 132°C for 10 minutes. Check manufactur­er's recommendations for sterilization parameters.

8

Specifications

Trays

Tray Dimensions

Large - 15 1/2" x 9 3/16"

(39.4 x 23.3 cm)

Small - 15 1/2" x 6"

(39.4 x 15.2 cm)

Number of Trays

The sterilizer is supplied with two
trays, 1 large and 1 small, and one
rack.

Dimensions

Capacity

34 Liters (Vessel) (1.2 cubic feet)

7.0 Liters (Reservoir)

Overall Dimensions

W x D x H Inches(cm)
22 7/16" x 24 1/2" x 17"
(57.0 x 62.2 x 43.2)
Chamber (Dia. x Depth)
12" X 18"
(30.5 x 45.7)

Electrical

Heater Power

1500 W

Power requirements

120V, 50/60 Hz, 12.5 Amps
220V, 50/60 Hz, 6.5 Amps

Standards

ASME
UL/cUL to UL3101-1

Reservoir Water

Distilled or low quality
deionized
Max. 1.5 Megohm/cm
Min. .5 Megohm/cm

Mounting

Benchtop only

Controls

Fixed Cycles

- Liquid

- Packs

- Wrapped

- Unwrapped

Optional Cycle

Note

You can examine
the pressure vessel
rating plate for the
sterilizer chamber by
opening the panel
on the back cover of
the sterilizer, then
removing the small
plug of insulation on
the back of the ster­ilizer chamber.

Shipping Weight

85 lbs. (38.5 kg)

9

SPECIFICATIONS

Environmental Conditions

Operating: 4°C - 40°C; 20% - 80% relative humidity, noncondensing. Installation Category II
(overvoltage) in accordance with IEC 664. Pollution Degree 2 in accordance with IEC 664.
Altitude limit: 3,650 meters.

Storage: -25°C - 65°C; 20% - 80% relative humidity.

Declaration of Conformity

(for 230 volt, CE models only)

We hereby declare under our sole responsibility that this product conforms with the technical requirements of
the following standards:

EMC: EN 61000-3-2 Limits for harmonic current emissions

EN 61000-3-3 Limits for voltage fluctuations and flicker
EN 61326-1 Electrical equipment for measurement,

Safety: EN 61010-1 Safety requirements for electrical equipment

EN/EIC 61610-2-010 Part II: Particular requirements for

EN61010-2-041 Part II: Particular requirements for autoclaves using steam

and meets 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:

Thermo Fisher Scientific
419 Sutton Road
Southend On Sea
Essex SS2 5PH
United Kingdom

0086

control, and laboratory use; Part I: General
Requirements.

for measurement, control, and laboratory
use; Part I: General Requirements.

laboratory equipment for the heating of materials.

for the treatment of medical materials, and for laboratory
processes.

Copies of the Declaration of Conformity are available upon request

10

Description

Operational Programs

The sterilizer has four preset cycles which have been opti­mized to provide excellent results for most applications. In
addition, there is one optional cycle that allows you to set
your own sterilization parameters. You access the pre-pro­grammed cycles by pushing one of the four green fixed-cycle
buttons. The four preset sterilization programs are:

Unwrapped Goods

For unwrapped instruments and items made of metal,

glass or plastic. Parameters: 3 minutes at 135°C.

Wrapped Goods

For wrapped packs of clothes, bandages, pads, fabrics,
rubber tubing and metal instruments. Parameters: 10 minutes
at 135°C.

Note

The liquid cycle is not designed for
sterilization of liquids in a clinical
application. Do not prepare sterile
liquids for in vivo applications with
the Sterilemax system.

Dental handpieces should be run
in the optional cycle at 132°C for
10 minutes. Refer to manufactur­er's recommendations for contra
indication of sterilization parame­ters.

When sterilizing handpieces, refer
to the manufacturer's specifica­tions on handpieces for contra
indication of sterilization parame­ters.

Liquids

For distilled water, media solutions and other liquid pre­pared in closed bottles or flasks. Parameters: 15 minutes at
121°C.

Packs

For packs of instruments and towels and other packed
goods. Parameters: 30 minutes at 121°C.

11

DESCRIPTION

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Note

When sterilizing handpieces, refer to the manufacturer's
specifications on handpieces for contra indication of
sterilization parameters.

Program Summary Chart

12

DESCRIPTION

Controls

All cycles and programming are selected and set in using the
front touchpad selector buttons.

Power Switch

The Power Switch turns power to the unit on and off. When
you turn the power on, the display will be set to select a steril­ization cycle. It is located under the right front corner of the
sterilizer.

Cycle Buttons (Green)

These buttons allow you to run the preprogrammed cycles at
the touch of a button. See Operational Programs.

Optional Cycle (Yellow)

This parameter allows you to select different time and tem­perature levels for your cycles than those provided with our
preset programs. An optional cycle can be run as either a liq­uid or hard goods cycle. All material run in this cycle must be
validated by the user.

Note

The "Select" button is used by ser­vice personnel to adjust the oper­ating parameters of the sterilizer.

Up/Down Arrows (Yellow)

These allow you to set the time and temperature in an option­al cycle. They are also used for scrolling through other func­tions.

Start Cycle (Dark Green)

Pressing the "Start Cycle" Switch activates the currently
selected processing cycle. It is also used for scrolling through
other functions.

Stop (Red)

This control is used to terminate any cycle. It is also used for
scrolling through other functions.

13

DESCRIPTION

Sterilizer Features

Optional Printer

The optional printer available is an impact printer that records
each cycle's performance. See page 39 for more information.

Pressure Monitor

The pressure monitor indicates the pressure inside the chamber.
This monitor's readings can be found on the display as each
cycle is running.

Door Security

While the chamber is under pressure, the door is held securely
closed with three separate locking systems. First, there is a lock­ing handle that you must tighten to hold the door fully closed. The
locking handle turns clockwise to close and counterclockwise to
open. Second, there is a pressure actuated locking pin which
automatically secures the door, preventing it from being inadver­tently opened while there is pressure in the chamber. Finally,
there is a backup catch which will prevent the door from opening
fully even if there is a small amount of pressure in the chamber.
You release this catch with a lever which is located in the lower
left side of the door. To fully open the door, pull the door release
lever toward you.

14

Optional Non-Recirculating Tank

The optional non-recirculating tank is used to collect the remain­ing cycle water after a cycle has completed. This prevents any
debris from the cycle to go back into the fresh water reservoir.

Door Switch

Actuated by the door, the door switch prevents operation of the
sterilizer if the door is not fully closed.

Pressure Relief Valve

This valve protects the coded vessel from pressures exceeding
the pressure rating of the vessel. The valve opens and releases
steam in the event that pressure in the vessel exceeds 45 PSIG
(310 kPa). The pressure line is located in the back of the unit. An

Warning

Pressurized steam will be
discharged when the relief
valve is opened. To prevent
burns, wear gloves or use
an extension device if it
becomes necessary to oper­ate the pull ring.

DESCRIPTION

access hole is located in the back panel to allow you to peri­odically check relief valve operation.

Reservoir Drain

A drain assembly is provided to empty the reservoir. The
reservoir drain assembly and plug are located at the lower
right of the chamber opening on the front of the sterilizer (as
you face the unit). The drain assembly attaches to the drain
connector so a hose can be attached for draining the steriliz­er reservoir into a container.

Trays and Tray Rack

A rack for the inside of the sterilizer is provided to hold the
instrument trays. The rack slides out of the chamber to allow
periodic cleaning of the chamber and rack.

Three large trays and one small tray can be placed into the
rack or the rack can be used with only one or two trays or no
trays. Tall items can be sterilized by removing both trays and
placing the objects on the bottom surface of the rack. One
large and one small tray are provided with the unit. See
"Loading the Sterilizer Chamber" on page 31 of this manual.

15

Installation

Caution

The surface beneath the sterilizer
could reach 100°F (38°C).

Location

For optimum performance of your sterilizer, the sterilizer
should be installed in conformance to the following parame­ters:

Surface

For proper operation, the sterilizer must be placed on a level,
heat and water resistant surface. If the surface is not level,
the water in the sterilizer will be unevenly distributed, possibly
resulting in a sterilizer malfunction. Do not adjust position of
the feet on the sterilizer.

Clearances

Allow at least 3" (75mm) between the sterilizer and walls on
the sides and back for air circulation. Also allow at least 8"
(204mm) between the top of the sterilizer and any overhang­ing cabinet above it. Overhangs should not project more than
8" (204mm) over the rear of the sterilizer.

Surroundings

If the sterilizer will be operated continuously, locate it in an
area where its steam emissions will not damage equipment or
materials.

Unpacking

Remove the sterilizer carefully and inspect it for any shipping
damage. Do not throw away packing materials until you
inspect the unit.

1. Turn the door handle counterclockwise until it is
completely loose and move the locking mechanism
to the left. Pull on the latch release lever built into
the left side of the sterilizer door and carefully
open the sterilizer door.

2. Remove all packing materials and accessories
from the chamber.

3. Remove the trays and rack assembly from the
chamber.

16

Warning

Connect only to an electrical cir­cuit of the appropriate voltage and
load rating.

INSTALLATION

4. Check for any foreign material in the chamber.
Wipe clean with a damp, lint-free cloth if neces­sary.

Electrical Connections

We recommend that you use a separate (dedicated) circuit
for this sterilizer. Ensure that the circuit is rated for the load.
(See Electrical Specifications.)

1. Connect power cord to power entry module on
back of unit.

2. Plug power cord into a grounded outlet of the
appropriate voltage and load rating.

Optional Printer

See section "Optional Printer" for installation, startup and
operation.

17

Optional Non-Recirculating Tank

NOTE: If you did not purchase an optional non-recirculation
tank, please proceed to Altitude Adjustment

Installation Instructions

Cap

1. To connect the non-recirculating water accessory
to the back of the sterilizer.

a. Unplug the sterilizer power cord. Allow the unit to

cool to room temperature.

b. Move the sterilizer to gain access to the rear of

the unit.

c. Unscrew the cap from the nonrecirculating dis-

charge port of the sterilizer (located on the rear of
the sterilizer).

d. Attach the discharge hose from the non-recircu-

lating discharge port.

Removing Cap

Tighten nut fin­ger tight plus 1/4
turn with
wrench.

1/4 turn

After discharge
hose assembly
from cooling tank to
non-recirculating
discharge port.

e. Tighten the nut finger tight plus a quarter turn with

a wrench.

f. Attach the other end of the discharge hose to the

fitting on the lower left (rear) of the non-recirculat­ing cooling tank. Follow the same procedure as
steps d and e above.

Caution

Be sure connection
nut is started straight.
Cross threading will
cause leaks and dam­age the nut and fitting.

Discharge Hose Connection

18

Improper Discharge Hose Connection

Cap Replacement

OPTIONAL NON-RECIRCULATING TANK

2. Install the cap removed in step c. To the fitting
located in the reservoir. See Cap Replacement

3. Fill the cooling tank with distilled or deionized
water until the water begins to overflow from the
cooling tank into the collection bottle (or into the
drain if the overflow tube is installed).

4. Plug in the power cord.

Warning

Non-recirculating option must be installed
before proceeding.

Remove Cap

Optional
Overflow Drain

Filling Cooling Tank

Full mark

Fill with distilled or
deionized water until
it overflows into the
collection bottle
(approx. 3 gal.)

Collection Bottle

Caution

The non-recirculating tank (cooling tank)
must be connected to the sterilizer before
filling with distilled or deionized water.

Caution

Do not operate sterilizer unless the non-recirculating
tank is filled with distilled or deionized water and
attached to the sterilizer.

19

Altitude Adjustment

For proper operation, the sterilizer program accounts for the
altitude in controlling certain functions. The sterilizer is
shipped with a factory-set altitude value suitable for all alti­tudes up to an altitude of 1000 feet above sea level. If your
altitude is above 1000 feet above sea level, you will need to
enter a new value for the altitude adjustment. To change the
altitude adjustment value:

1. At the "Select Cycle" screen, press the "Select"
key and then the up arrow key. The sterilizer will
display a "Configuration Info" screen, then it will
automatically change to displaying the "Change
Time" screen.

2. At the "Change Time" screen, press the "Select"
key and then the "Liquids" key.

3. At the "Altitude Adjustment" screen, press the up
arrow to select "Yes".

4. At the "Current Altitude" screen, press the up and
down arrows to set the value for your location's
altitude to the nearest one hundred feet.

5. After you have set your altitude value, press the
"Start" key to return to the "Select Cycle" screen.

20

Display Parameter Setup

Note

Sterilemax sterilizers are shipped
with the display units set as fol­lows:

120 volt units - °C, PSI

Setting Month/Date/Year/Hour/
Minute

To set the current date and time:

1. From the "Select Cycle" screen, press the "Select"
key and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"
Screen. Press the up arrow key to select "Yes."

220 volt units - °C, BAR

If your unit is not set to these fac­tory settings or if you require other
settings, refer to "Changing
Temperature Units" and "Changing
Pressure Units" to set the units to
your requirements.

3. At the "Set Current Month" screen, press the up or
down arrow key to set the current month. Press
the "Start" key when the current month is set.

4. At the "Set Current Date" screen, press the up or
down arrow key to set the current date. Press the
"Start" key when the current date is set.

5. At the "Set Current Year" screen, press the up or
down arrow key to set the current year's final two
digits. Press the "Start" key when the current year
is set.

6. At the "Change Hour" screen, press the up or
down arrow key to set the current twenty-four hour
clock hour. Press the "Start" key when the current
hour is set.

7. At the "Change Minute" screen, press the up or
down arrow key to set the current minute. Press
the "Start" key when the current minute is set.

8. At the "Change Temperature Units" screen, press
the down arrow key to select "No."

Note

If you desire to change the tem­perature units, press the up arrow
to select "Yes", then refer to
"Changing Temperature Units."

9. At the "Change Pressure Units" screen, press the
down arrow key to select "No".

10. At the "Change Printer Mode" screen, press
DOWN ARROW key to select "NO" and return to
the "Select Cycle" screen.

21

DISPLAY PARAMETER SETUP

Note

If you desire to change the pres­sure units, press the up arrow to
select "Yes", then refer to
"Changing Pressure Units."

Note

If you desire to change the pressure
units press the UP ARROW to select
"YES", then refer to "Change Printer
Mode."

Changing Temperature Units

To change the units in which the chamber temperature is dis­played on the digital display and printer tape (°C or °F):

1. From the "Select Cycle" screen, press the "Select" key
and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"
Screen. Press the down arrow key to select "No."

3. The sterilizer will then display the "Change
Temperature" screen. Press the up arrow key to select
"Yes."

4. At the "Temperature Units" screen, press the up arrow
key to toggle between °C and °F.

Note

If you desire to change the pres­sure units, press the up arrow to
select "Yes", then refer to
"Changing Pressure Units."

5. After you have selected your desired temperature
units, press the "Start" key.

6. At the "Change Pressure Units" screen, press the
DOWN ARROW KEY to select "NO".

7. At the "Change Printer Mode" screen, press the
DOWN ARROW KEY to select "NO" and return to the
"Select Cycle" screen.

Changing Pressure Units

To change the units in which the chamber pressure is displayed
on the digital display and the printer tape (PSI, BAR or KPA):

1. From the "Select Cycle" screen, press the "Select" key
and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"
Screen. Press the down arrow key to select "No."

3. The sterilizer will then display the "Change
Temperature" screen. Press the down arrow key to
select "No."

22

DISPLAY PARAMETER SETUP

4. At the "Change Pressure Units" screen, press the
up arrow key to select "Yes."

5. At the "Pressure Units" screen, press the up arrow
to cycle between the three available units.

6. When you have selected your desired pressure
units, press the "Start" key to enter units.

7. At the "Change Printer Mode" screen, press the
DOWN ARROW key to select "NO" and return to
the "Select Cycle" screen.

Changing Printer Modes

This display is used to change the mode serial port of use for
optional printers from USED/UNUSED:

1. From the "Select Cycle" screen, press the "Select"
key and then the UP ARROW key.

2. Wait for the "Change Time" screen. Press the
DOWN ARROW key to select "NO."

3. The sterilizer will then display the "Change
Temperature" screen. Press the DOWN ARROW
key to select "NO."

4. At the "Change Pressure Units" screen, press the
DOWN ARROW key to select "NO."

5. At the "Change Printer Mode" screen, press the
UP ARROW to select "YES."

6. At the "Printer Mode" screen, press the UP
ARROW to toggle between the available modes.

7. When you have selected your desired mode of
operation, press the "Start" key to return to the
"Select Cycle" screen.

23

Sterilization Procedures

Warning

Do not attempt to sterilize volatile
or toxic substances. Serious injury
or death could result.

Caution

Do not attempt to sterilize any
object composed of materials
which cannot withstand high tem­peratures (135°C or greater).

Materials Appropriate For Steam
Sterilization

• Straight stainless steel instruments

• Surgical stainless steel hinged
instruments

• Pouches of instruments

• Carbon steel instruments (see special
preparation instructions)

• Air powered instruments made to be
autoclaved

• Needles

• Syringes

• Treatment trays

• Heat resistant plastic items

• Rubber gloves

• Heat resistant rubber tubing

24

• Heat resistant rubber sheeting

• Glass slabs and beakers

• Gauze

• Sutures

• Linen packs

• Liquids, non-clinical

• Other heat-resistant, immersible items

Always check with the manufacturer of your supplies for
specific instructions for sterilization

.

Warning

Thoroughly clean instruments
before placing them in the steriliz­er. Sterilizing items contaminated
with blood or debris will impede
sterilization and may result in
unsterile instruments, which may
cause personal injury or death.

Warning

Always wear protective gloves
when handling soiled instruments
to protect yourself from the possi­bility of serious infection. Clean
gloved hands with a germicidal
cleaner when finished handling
soiled instruments.

STERILIZATION PROCEDURES

Instrument Cleaning Prior To
Sterilization

Transport soiled instruments to your cleanup area on a tray.
Sort out any instruments unsuitable for sterilization (see list
on page 24).

Follow manufacturer's recommendations for cleaning
and preparing any particular item.

In the absence of manufacturer's specific instructions, clean
instruments as follows:

1. Rinse instruments thoroughly with a hard stream of
water to remove debris.

2. Sort instruments by their metallic composition. Do
not mix instruments of different metals, as instru­ment damage will result.

3. Using either a fresh solution of detergent and dis­tilled water or a germicide solution, wash instru­ments in an ultrasonic cleaner for five to ten min­utes. Clean all instruments in an open position.

Caution

Sterilizing items contaminated with
blood or debris may cause staining
or damage to the instruments or
the sterilizer.

Caution

Use of soaking solutions contain­ing phenols or quaternary ammo­nium compounds may cause cor­rosion of the instruments, trays
and the stainless steel chamber.

Use a detergent or germicide with a neutral pH (7)
specifically designed for use in an ultrasonic clean­er.

Use new ultrasonic cleaning solution each day.

4. After cleaning, rinse instruments thoroughly in dis­tilled or deionized water. Inspect to ensure that all
debris has been removed. Repeat cleaning as
necessary.

If distilled or deionized water is unavailable and
instruments are rinsed in tap water instead, all
instruments should be dried before sterilizing to
prevent staining.

5. Refer to manufacturer's recommendations for lubri­cating instruments after ultrasonic cleaning. Use a
silicon lubricant which will not interfere with steril­ization.

25

STERILIZATION PROCEDURES

Note

Do not place carbon steel instru­ments directly onto stainless steel
trays. Place an unbleached towel
or paper wrap on the tray and
place the instruments on the towel
or paper.

When wrapping instruments for
sterilization, use a material which
promotes drying.

Preparation of Carbon Steel
Instruments

Carbon steel instruments must be carefully prepared prior to
sterilization to prevent rusting. After cleaning according to the
manufacturer's recommendations or the methods presented
in Instrument Cleaning Prior To Sterilization, prepare car-
bon steel instruments as follows:

1. Prepare a 2% solution of sodium nitrate in water
(approximately one table spoon in a quart of
water). Completely immerse the instruments in the
solution and allow them to soak for three minutes.

2. Remove the instruments and package them for
sterilization or place on trays if sterilizing
unwrapped. Do not rinse or wipe instruments

prior to sterilization.

Warning

Do not overload the trays.
Overloading trays may result in
inadequate sterilization and
unsterile instruments.

Warning

Monitor the sterilization process with
process monitors and biological indi­cators as described in
Recommended Monitoring (p. 33).

Preparing Items for Sterilization

General Preparation Guidelines

1. Clean items thoroughly before placing them in the
sterilizer. Follow good laboratory or medical proce­dures for cleaning and decontamination of items.

2. Place absorbent paper or linen towel in the bottom
of trays before use.

3. Unwrapped goods should only be processed on
trays. Do not place items on the rack or the bottom
of the sterilizer.

4. Liquids must not exceed 75% of capacity of flask.
Use self-venting caps.

5. Open all hinged instruments.

26

Caution

Do not mix different metals in the
same pack or wrapping or loose
on the same tray. Instrument dam­age will result.

STERILIZATION PROCEDURES

6. Remove the covers from empty containers. Stand
the containers and covers on their sides.

7. Turn curved vessels upside down so no water will
collect in the vessel.

8. Place all sharps (knives, scissors, etc.) so that
they do not touch during sterilization. Cotton or
gauze may be used to isolate and protect the
sharp edges and the smaller instruments.

9. Disassemble syringes if possible.

10. Do not plug syringes or needles.

Warning

Unwrapped items cannot be con­sidered sterile once removed from
the sterilizer chamber.

Do not overload the trays.
Overloading trays may result in
inadequate sterilization and
unsterile instruments.

Note

Unwrapped trays are used
for sterilizing nonsurgical
instruments, canisters and
other items to prevent trans­mitting infectious disease.

Items to be Sterilized Loose and
Unwrapped

Items to be sterilized loose and unwrapped should be distrib­uted in a single layer on the bottom of a lined, perforated tray.
Do not overload tray; allow space around instruments for
steam circulation.

Metal and glass canisters and containers should be placed
upside down on a perforated tray. Make sure containers are
placed so that they will drain, or they will not dry sufficiently to
ensure sterilization.

Appropriate Wrapping Materials for Steam
Sterilization (Partial List)

Muslin (2 layers), Nylon bagging material,
Commercial autoclave paper (must be as permeable
as muslin), Permeable paper and plastic bags, Cloth
or paper-covered trays

Materials Inappropriate for Wrapping for Steam
Sterilization (Partial List)

Canvas, Impermeable plastics, Aluminum foil,
Sealed jars, canisters or tubes.

27

STERILIZATION PROCEDURES

Warning

Do not wrap packs tightly and do
not over fill autoclave bags. Steam
must penetrate through entire
pack. Inadequate sterilization may
result from improper packaging.

Do not seal with staples, pins or
other methods which will puncture
the wrapping material. If wrapping
material is punctured, sterility can­not be assured once items are
removed from the sterilizer cham­ber.

Items to be Sterilized Wrapped

Cleaned items may be wrapped individually in autoclave
paper or placed in commercially prepared autoclave bags. Do
not wrap tightly. Seal with autoclave tape or heat sealer.

Cleaned items may also be sterilized as a group of instru­ments wrapped together. You may desire to wrap a group of
similar instruments together, or you may desire to wrap
together the instruments needed for a particular procedure.
Wrap the instruments loosely in 2 to 4 layers of autoclave
paper or muslin or place them in autoclave bags. Seal with
autoclave tape or heat sealer.

Place wrapped items on a perforated tray. Do not overload
tray; allow space around wrapped items for steam circulation.

When using commercial sterilization bags, follow the
manufacturer's instructions for proper use.

Do not overload the trays.
Overloading trays may result in
inadequate sterilization and
unsterile instruments.

Note

If you desire to include a large
number of instruments in a single
package, see Items to be

Sterilized in Packs.

Appropriate Wrapping Materials for Steam
Sterilization (Partial List)

Muslin (2 layers), Nylon bagging material,
Commercial autoclave paper (must be as permeable
as muslin), Permeable paper and plastic bags, Cloth
or paper-covered trays

Materials Inappropriate for Wrapping for Steam
Sterilization (Partial List)

28

Canvas, Impermeable plastics, Aluminum foil,
Sealed jars, canisters or tubes.

STERILIZATION PROCEDURES

Warning

Do not seal with staples, pins or
other methods which will puncture
the wrapping material. If wrapping
material is punctured, sterility can­not be assured once items are
removed from the sterilizer cham­ber.

Do not wrap items tightly and do
not over fill autoclave bags. Steam
must penetrate through entire
wrapped group. Inadequate steril­ization may result from improper
wrapping.

Do not overload the trays.
Overloading trays may result in
inadequate sterilization and
unsterile instruments.

Items to be Sterilized on Wrapped Trays

Place cleaned items loose in the bottom of a lined, perforated
tray. Additional layers of instruments may be added, separat­ed by fabric. Do not overload the tray; steam must be able to
penetrate through the entire tray. Wrap the tray in 2 to 4 lay­ers of muslin or other appropriate wrapping material. Seal
with autoclave tape.

Items to be Sterilized in Packs

Use packs to sterilize a number of instruments together, to
sterilize textile products and to sterilize surgical gloves. When

using commercial sterilization packs, follow manufactur­er's instructions for proper use.

Instruments

Loosely package cleaned instruments into packs of not
more than 10 instruments each. Instruments which might nest
together should be separated by a layer of absorbent material
and placed in the pack in a manner that will allow water to
flow out of them. Seal with autoclave tape or heat sealer.

Textile Products

Launder textile products before sterilization.

Loosely roll or fold textile products. Place in commercially
prepared packages or wrap in 2 to 4 layers of muslin or other
appropriate wrapping material. Seal with autoclave tape or
heat sealer.

Surgical Gloves

Disposable gloves should not be sterilized.

Clean and dry gloves. Place a piece of muslin or other

Appropriate Wrapping Materials for Steam
Sterilization (Partial List)

Muslin (2 layers), Nylon bagging material,
Commercial autoclave paper (must be as permeable
as muslin), Permeable paper and plastic bags, Cloth
or paper-covered trays

Materials Inappropriate for Wrapping for Steam
Sterilization (Partial List)

Canvas, Impermeable plastics, Aluminum foil,
Sealed jars, canisters or tubes.

29

STERILIZATION PROCEDURES

Caution

Do not use detergents with a high
chlorine or phosphate content or
chlorine bleach when laundering
items prior to sterilization. Damage
to instruments and to the sterilizer
chamber could result.

Warning

Do not overload tray; allow space
around packs for steam circula­tion. Pack density should not
exceed 50% of the capacity of the
tray. Metal or glass should not be
used to separate packs, as these
will inhibit drying. Overloading the
tray or failure to allow the packs to
dry properly can result in non-ster­ile goods.

absorbent material into the central area of the glove. Place a
strip of muslin or other absorbent material around the cuff and
fold the cuff back over it. Wrap the gloves in muslin or other
appropriate wrapping material. Seal with autoclave tape.

Place packs on a perforated tray. Place packs of gloves so
that the glove stand on end in the sterilizer. Load packs side­by-side; do not stack packs.

Preparing Liquids for Sterilization

Place liquids in heat-proof containers. Place containers on
perforated tray. Do not fill flask more than 75% full.

Items to be Sterilized in Optional Cycle

Place material to be sterilized in appropriate containers or on
trays prior to placement in sterilizer. Follow instructions on
display for setting cycle time, temperature and drying para­meters. If running a liquid-optional cycle, ensure that contain­ers are not more than 75% full. User must follow proper safe­ty procedures and sterilization monitoring procedures for the
optional cycle. Every optional cycle should be validated by
the user.

Dental handpieces should be run at 132°C for 10 minutes.

30

Warning

Do not exceed the sterilizer's rated
capacity for liquid sterilization.
Non-sterile liquids could result. Fill
flasks no more than 75% full. User
should validate material in optional
cycle.

Note

User should not attempt to sterilize
more than 10 handpieces per ster­ilization cycle.

STERILIZATION PROCEDURES

Warning

Use only self-venting, automatic
sealing stoppers when processing
liquids or media. Use of other
stoppers or seals, or lack of stop­pers, will create the possibility of
burns or injury from boiling liquids
and exploding flasks.

If media is processed, bottles and
tubes should contain no more
than 3/4 the total volume of the
container. When processing water
bottles and test tubes, the bottles
and tubes should contain no more
than 3/4 the total volume of the
container. Chamber should be
cleaned daily when processing
media.

Sterilized liquids are for
non-clinical applications.

Caution

Packs must be centered in the
chamber. Do not allow packs to
touch the sterilizer chamber's
walls. Allowing packs to touch the
sterilizer chamber's walls may cre­ate an overheat condition.

Loading the Sterilizer Chamber

Loading Guidelines

1. When processing wrapped goods, fabrics and
dressings, always place items in one of the three
upper positions in the chamber. Processing items
in the bottom position could possibly result in wet
packs and unsterile goods.

2. Do not exceed the specified loads for a cycle:
Unwrapped Goods - no more than 14 lbs
Wrapped Goods - no more than 14 lbs in no more
than 12 small cassettes or 4 large cassettes
Packs - no more than 2.8 lbs and no more than 14
towels
Liquids - flasks filled no more than 75% full.

3. Do not overload the sterilizer. Steam penetrates
best with loosely packed loads.

4. Do not allow packs or wrappings to touch chamber
walls or one another.

5. Leave adequate space between trays to allow
steam circulation.

6. Do not stack trays on top of one another.

7. Use a process monitor in each load. We also rec­ommend that you use a biological indicator at
weekly intervals. An indicator containing Bacillus
stearothermophilus is the proper indicator for
steam sterilizers.

31

STERILIZATION PROCEDURES

Warning

Sterilizer and trays will be hot
after cycle is run. Always wear
protective gloves and apron when
removing a processed load.
Protective gloves and apron
should also be worn when reload­ing sterilizer following previous
operation.

Open door slowly at the end of a
liquid sterilization cycle. Do not
allow hot bottles to be jolted. This
can cause bottle explosions. Do
not move bottles if any boiling or
bubbling is present.

Allow bottles to cool before
attempting to move them from
sterilizer shelf or tray(s) to the
storage area.

Handling Sterilized Materials

Loads may be removed from the sterilizer at the end of the
drying cycle. (Liquids may be removed at the end of the steril­ization cycle.) Unwrapped items should be used immediately.
Any unwrapped items not used immediately cannot be con­sidered sterile after removal from the sterilizer chamber.

Date all wrapped packages and packs prior to storage.
Check the integrity of all wrapping materials prior to opening
and using wrapped or packed items; if the wrapping materials
are opened or torn, the instruments must be considered
potentially unsterile and should be re-sterilized prior to use.
Re-sterilize all wrapped packages and packs after one month
in storage.

32

Recommended Monitoring

All functions of a sterilizer should be monitored to provide
maximum assurance of proper performance.

Note

Refer to the manufacturer's recom­mendations for proper use of biologi­cal indicators.

Process Monitoring

For assurance that minimum sterilizing conditions have been
achieved, we recommend the use of a process monitor with
each cycle and within each package. This small process
monitoring device will provide immediate indication of expo­sure to temperature and of time in the presence of humidity
(steam).

Trays

Place a process monitor in the center of each wrapped or
unwrapped tray of loose items.

Wrapped Instruments

Place a process monitor inside each package with an instru­ment.

Wrapped Packages of Instruments

Place a process monitor in each package.

Packs

Place a process monitor inside each pack. When sterilizing
textile products, place the process monitor in the center of
the stack of textile products. When sterilizing gloves, place a
process monitor inside a glove inside each pack.

33

RECOMMENDED MONITORING

Note

Refer to the manufacturer's recommenda­tions for proper use of biological indica­tors.

Note

When using a biological indicator for a
135°C cycle, the user must be sure that
it has been validated for use at 135°C.
We recommend using the Thermo
Scientific Biological Indicator (part #
AY759X1) for this type of cycle. If any
other Biological Indicator is used, the
user must ensure that it has been vali­dated for a 135°C cycle.

Biological Indicators

Process monitors do not by themselves prove steriliza­tion has occurred. Biological indicators composed of
spores of standard organisms are considered the most
reliable means of verifying sterilization. A biological indi­cator functions by testing the sterilizer's ability to kill test
organisms of a known high resistance. Indicators con­taining Bacillus stearothermophilus should be used for
steam sterilizers. The Joint Commission on
Accreditation of Hospitals recommends that biological
indicators be used at least weekly to check the effective­ness of your steam sterilizer's sterilization cycle.

When testing the effectiveness of a sterilization cycle,
use the appropriate "worst case" test load described for
the cycle in this section:

Unwrapped Instruments

Place 100 instruments on a perforated tray lined with a
100% cotton surgical towel. Place a biological indicator
in the center of the test tray. Place the test tray in the
center rack of the sterilizer chamber. Prepare additional
trays in the same manner without biological indicators to
bring the total sterilization load to 14 lbs (6.4 kg).

Wrapped Instruments

Load a small cassette with 6 instruments. Place two bio­logical indicators inside the cassette. Wrap the cassette
with two layers of appropriate wrapping. Seal with auto­clave tape. Prepare eight other small cassettes in the
same manner without the biological indicators. Place the
cassette with the biological monitor upright in the center
of a tray. Fill the tray with the rest of the cassettes.
Place the tray in the center rack of the sterilizer cham­ber.

34

RECOMMENDED MONITORING

Packs

Textiles

Prepare a pack of 14 towels (per AAMI ST-8). Place three
biological indicators in the center of the pack, between the
sixth and seventh towels. Wrap the pack with two strips of
autoclave tape, placing the tape around the width of the
pack so that the two strips divide the length of the pack
into thirds.

Pouches

Place a biological indicator together with a surgical instru­ment into a self-sealing pouch. Place the pouch with the
indicator in the middle of the tray. Place four other surgical
instruments into pouches and place them on the tray.
Place the tray in the center rack of the sterilizer chamber.

Optional Cycle: For Dental Handpieces Only

Place a biological indicator together with one dental hand­piece in a self-sealing pouch. Place the closed pouch in
the front of the sterilizer tray. Place the tray in the lowest
level of the chamber rack.

35

Operation

Warning

Keep patients at least six (6) feet
away from the sterilizer when it is
in use.

Do not operate this sterilizer in the
presence of flammable or explo­sive substances (such as anes­thetics). A fire or explosion could
occur.

Caution

To prevent collection of mineral
deposits and corrosion of chamber
components, use distilled or deion­ized water only. See Specifications.
Clean chamber after each use if
sterilizing saline solutions.

Connect the power cord to the unit and to a grounded outlet
of appropriate voltage and rating.

Initial Startup

Power On

Push the Power Switch under the right front corner of the
sterilizer to the On position. The sterilizer will not operate
unless this switch is in the On position.

Filling Reservoir

Remove the cover to the water reservoir and fill the reservoir
with distilled or low quality deionized water (minimum 0.5
Megohm/cm, maximum 1.5 Megohm/cm) until the water level
reaches the bottom of the fill line in the reservoir. The reser­voir will hold approximately 7.0 liters (6.3 quarts) of water.
The water level should never be higher than the fill line. Do
not overfill.

Do not overfill reservoir. To avoid
slippery conditions and possible
load recontamination, immediately
wipe up all spillage resulting from
overfilling chamber or reservoir.

Warning

Do not add water to reservoir
while a sterilization cycle is in
process. When the cycle ends and
steam vents back into the reser­voir, a sudden overflow of hot
water could occur, possibly result­ing in burns to personnel.

Refilling Reservoir

When the reservoir runs low on water, the low level sensor
will alert you of the low water condition. When the display
indicates "Reservoir is empty. Fill and restart sterilization
cycle," you will need to add water to the reservoir before you
run another cycle. You should never need to add more than 5
liters (5.3 quarts) at a time to the reservoir. The water level
should never be higher than the fill line. Do not overfill.

You may determine a refill schedule dependent upon the
pattern of operation at you facility. The number of cycles you
can run before the reservoir needs to be filled will vary
according to your frequency of operation, duration between
cycles, type of cycles, etc.

36

OPERATION

Outline of Operation

Two basic steps are required to initiate a sterilizing cycle after
the load has been placed in the chamber and the door closed
and latched:

1. Select the cycle you desire.

2. Follow the displayed directions for the cycle.

Cycle selections cannot be changed once "Start
Cycle" has been pressed. To change a setting, the
cycle must be terminated by pressing "Stop." When
you select a new cycle, the cycle information will be
changed automatically.

Details of Operation

Prepare Load

Follow preparation instructions on pages 27-31.

Load the Sterilizer Chamber

You may load wrapped or unwrapped instruments, linen packs,
glassware and liquids. Follow loading instructions on page 33.

Close the Sterilizer Door

The door must be fully closed to run a sterilizing cycle. If the
door is not fully closed, the sterilizer will stop and indicate, "The
door is open. Close door to continue cycle."

Select Processing Cycle

1. Select your required cycle.

2. Set the drying cycle time for pack, wrapped and
unwrapped cycles. (See "Drying Sterilized Loads.")

37

OPERATION

Warning

Processing goods at less than rec­ommended time/temperature
could result in unsterile goods.

Setting Drying Time

(For Pack, Wrapped and Unwrapped cycles only.)

If drying is desired, set the drying time when you select
the sterilization cycle. After you select a Pack, Wrapped or
Unwrapped cycle, the cycle parameters will be displayed.
After the parameters have been displayed, you will be
prompted to enter a figure for drying time. You will find that
the default time — displayed at the prompt — is the opti­mal setting for most loads.

If your application or load composition requires a differ­ent drying time to achieve appropriate drying, you can
change the drying time setting when the display prompts
you. Use the up or down arrow to adjust the displayed dry­ing time until your desired drying time is displayed.

Press "Start Cycle"

Processing will run automatically after you press "Start
Cycle."

Warning

Use caution when opening the
sterilizer door. Stand to the side
behind the door and open door
slowly and partially to protect
yourself from escaping steam or
boiling liquids and exploding
flasks.

Do not attempt to open sterilizer
door until the display reads "Cycle
Complete." Pressure within the
chamber could cause the door to
open with extreme force, possibly
causing personal injury.

Drying Sterilized Loads

At the completion of the sterilization cycle, turn the lock­ing handle counter clockwise until the door is held in place
by the backup catch. The door must be opened approxi­mately 1 inch to operate the drying cycle. To prevent con-

tamination of wet packs and wrapped items, do not
open the door more than 1 inch during the drying
cycle. Press "Start Cycle" to start the drying cycle.

When you press "Start Cycle," the Drying Indicator will
be displayed, the chamber will heat to a low temperature
and the selected drying time will begin to count down. At
the end of the drying cycle, a five second alarm will sound.

Optional Drying Cycles

If you desire to run a drying cycle without running a
sterilizing cycle with it, you may. Press the "Optional
Cycle" button and scroll the setpoint temperature below
100°C. You will enter a menu for an optional drying cycle.
Set the drying time as instructed above, then press "Start

Cycle" to begin the drying cycle.

38

Optional Printer

The optional printer provides a paper tape record for future
reference and verifies sterilizer performance, load control
identification and quality assurance checks for each cycle.

During a sterilization cycle, the printer prints a record of the
chamber temperature, pressure and status of the cycle at 1­minute intervals.

Connecting and Starting the
Printer

1. Make sure the printer and sterilizer are
turned OFF.

Figure A: Printer

Paper Feed Button

Paper Out Light

ON/OFF Button

Error Light

Power Light

2. Connect the enclosed data cable to the
RS232 connector on the back of the steriliz­er and the power cord to the power supply.

3. Turn the printer ON.

4. Turn the sterilizer ON. The printer should
print "Barnstead/Thermolyne Sterilemax,"
"Software Version X.XX.XX"

5. If the printer does not print heading, verify
the "Printer Mode" is set to used. See
"Changing Printer Mode."

6. Turn the sterilizer off and then back on to
verify the printer prints out
"Barnstead/Thermolyne Sterilemax,"
"Software Version X.XX.XX"

7. The printer is now ready to print.

Control Panel (See Figure B)

Figure B: Control Panel

Power Switch

Located on the front of the printer, this switch turns power to
the printer ON and OFF. (See Figure A.) The green POWER
light will illuminate when the printer is ON.

39

PRINTER

Figure C: Inserting the Paper Roll

Paper Feed Button

Press this button once to advance the tape one line, or hold
the button down to advance paper continuously. When the
paper roll nears the end, the red PAPER OUT light will illumi­nate.

If the red ERROR light illuminates, the printer is off line. This
could be a result of the print head being too hot, in which
case the printer will resume printing once it cools down; or—
the paper may be jammed in the printer. Turn the printer OFF
before checking for jammed paper. Remove the paper jam
and turn the printer back ON. If the printer still will not print,
unplug it and refer servicing to qualified personnel.

Figure D: Inserting the Paper Into the
Paper Slot

Note

A colored stripe along the edge of
the paper indicates that you are
approaching the end of the tape.
When the stripe appears, approx.
23 inches of paper remain, enough
for 2-3 cycles. Replace the tape
before it is completely exhausted
to ensure a complete record of
your sterilization procedures

Installing the Paper Roll

When the red PAPER OUT light illuminates, it is time to
replace the paper roll. Replace the paper (AY669X4) roll as
follows:

1. Turn the printer ON and open the cover.

2. Make sure the edge of the paper roll is straight.

3. Insert the paper roll into the printer. (See Figure
C.)

4. Insert the paper straight into the paper slot (see
Figure D). The paper will feed automatically.

5. Tear off a strip of paper and close the cover. (The
red PAPER OUT light will be OFF if paper roll
installation is successful.)

Printer Operation

The printer automatically records sterilization cycles. During
sterilization cycles, the printer prints the chamber tempera­ture, pressure and status of cycle at one minute intervals.

40

Default Optional Cycle Printout

PRINTER

Printer Tape Description

The printer tape is designed to be easily read as a cycle is
running, allowing you to exam at a glance the progress of the
current cycle. As a result, a complete tape must be read from
the bottom up. (Sample on page 41)

When you turn on the sterilizer, the printer will print
"Barnstead|Thermolyne Sterilemax" and the software version
number. This will print only immediately after the sterilizer has
been turned on.

When you press one of the preset cycle buttons, the print­er will print the name of the cycle selected, the parameters
set for that cycle and the selected pressure units. If you
choose a default optional cycle, the printer will print the cur­rent default parameters. If you bypass the default optional
cycle for a standard, the printer will print only the name of the
cycle and the selected pressure units, since the parameters
have not been set.

When you press "Start Cycle", the printer will print the
number of cycles that have been run since the unit was
turned on, the current date and time, the notation "Cycle
Started" and column headers.

During the cycle, the printer will print the elapsed time, the
current chamber temperature and the current chamber pres­sure at one minute intervals, along with a status notation.
When you press "Start Cycle", the printer will print the num­ber of cycles that have been run since the unit was turned on,
the current date and time, the notation "Cycle Started" and
column headers.

During the cycle, the printer will print the elapsed time, the
current chamber temperature and the current chamber pres­sure at one minute intervals, along with a status notation.

When the sterilizer chamber achieves the temperature set
by the cycle parameters, the printer will immediately print a
record line, regardless of the time since the last record was
printed. The status notation will change from "Heatup" to
"Exp", indicating that the load is being exposed to the temper­ature set forth in the cycle parameters. The printer will contin­ue to print record lines at one minute increments, starting one
minute after the record line printed at the start of the expo­sure phase but still showing the total elapsed time for the
cycle.

41

PRINTER

When the sterilizer has achieved the time condition set in
the cycle parameters, the printer will print "Vent" in the cycle
status column, indicating that the sterilizer is venting.

At the end of the vent phase, the printer will print "Venting
Cycle Completed" and instructions for starting the drying
cycle. There is no printout during the drying cycle.

Printer Record Storage

To ensure the long-term legibility of your
records, it is important that you keep your
printed tapes in a dry, cool, dark place.

42

Instructions for drying

End of cycle

Elapsed time increments by minutes
from start of sterilization phase

Exact point at which sterilization
phase begins.

Vent
Phase

Exposure
Phase

RINTER

P

Current status of the cycle

Chamber Pressure

Chamber Temperature

Elapsed time since cycle started

Column Headers

Date and time of cycle initiation

Cycle record number for day

Currently chosen pressure units

Parameters for this programmed cycle
(default for this preset program)

Heatup
Phase

Name of preset program chosen for
this cycle

Software version number prints
when you turn on the sterilizer.

Printer Mode is (USED)
Version X.XX.XX

Sterilemax
Barnstead|Thermolyne

43

Special Operating Conditions

Warning

Do not attempt to open sterilizer
door until the display reads "Cycle
Complete". Pressure within the
chamber could cause the door to
open with extreme force, possibly
causing personal injury.

Reprocess your load in the event
the sterilizing cycle has been ter­minated prematurely. The load
may not be sterile when the steril­izing cycle has been terminated
prematurely.

Failure to drain excess water from
the sterilizer chamber after a cycle
abort may result in subsequent
unsterile loads as a result of con­tact with water in the chamber.
Always drain excess water from
the chamber after aborting a cycle.

Allow chamber to cool before
draining excess water.

Emergency Off (Cycle Abort)

Pressing the "Stop" button will immediately terminate steriliza­tion. Allow the sterilizer to cool and press the "Stop" button
again to reset the sterilizer. Drain excess water from the ster­ilizer chamber. Proceed with a new sterilization cycle normal­ly.

When terminating a load, pressing the "Stop" button will
vent steam from the chamber back into the reservoir.

Resetting the Automatic OTP

Display shows: "Cycle Aborted Due to AUTO OTP Device.
Press Stop Shutoff Unit Power to Reset."

1. Press the "Stop" button.

2. Wait for the display to read "Select Cycle".

3. Turn Power Switch off and then on to reset the
Low Water Cutoff.

4. Open the chamber door and allow the chamber to
cool.

44

Note

If display shows: "The Mechanical
OTP has Tripped. Shutoff Unit
Power and Reset - Caution - Unit
Hot!!" Reset as described under
"Resetting the Mechanical OTP
Sensor" in Service Manual.

5. Select your desired cycle and run the cycle with a
loaded chamber to verify operation.

6. In the event of a repetition of fault call Customer
Service.

SPECIAL OPERATING SITUATIONS

Warning

Reprocess your load in the
event the sterilizing cycle has
been terminated prematurely.
The load may not be sterile
when the sterilizing cycle has
been terminated prematurely.

Warning

Reprocess your load in the
event the sterilizing cycle has
been terminated prematurely.
The load may not be sterile
when the sterilizing cycle has
been terminated prematurely.

Erratic Controls Display or
Operation

Abnormal sterilizer operation or controls display could be

caused by an internal or external electrical voltage surge.
Such a voltage surge could be cause be any of a number of
events: a momentary surge in the power supply, a nearby
lightening storm, or even a static electrical charge carried by
operating personnel.

Abnormal operation or displays are not common occur-

rences and may never happen. No damage to the equipment
will occur if such an event should happen.

If an abnormal condition should occur, terminate any pro-

cessing cycle in process. (Press "Stop.") Reset the sterilizer
by turning the power switch (on the front right corner of the
unit) to OFF. Wait 30 seconds and turn the power switch back
on. Select your desired cycle and proceed with normal opera­tion.

Power Failure During Sterilizing
Cycle

All Selector/Indicator Panel lights will be off.

Allow the unit to cool. Reset the sterilizer by turning the

power switch (under the front right corner of the unit) to OFF.
Wait 30 seconds and turn the power switch back on. Drain
excess water from the sterilizer chamber. Then reprocess
your load normally.

45

Problem Solving Chart

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115

Fault Indication

Fault Cause

Solution

46

PROBLEM SOLVING CHART

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International

International

International

the

power supply

Power Supply

47

Maintenance Schedule Chart

Maintenance Required Person Responsible

Daily

Clean Door Gasket User

Clean Chamber* User

Weekly

Clean Chamber, Trays and Rack User

Monthly

Check Pressure Relief Valve Qualified Service Personnel

Clean Reservoir User

Yearly

Temperature Readout Verification Qualified Service Personnel

As Required

Install Paper Roll User

Changing Door Gasket Qualified Service Personnel

*When processing liquid loads

48

Warning

Refer servicing to qualified person­nel.

Maintenance

Daily Maintenance

Never use a wire brush, steel
wool, abrasive material, or chlo­ride-containing products to clean
door and chamber assembly.

"Caution: Hot Surface. Avoid
Contact." Ensure that the sterilizer
is cool before cleaning to avoid
burns.

Caution

Failure to keep the interior of the
stainless steel chamber free of
mineral deposits and debris can
cause premature failure of the
sterilizer.

Cleaning Door Gasket

The door gasket and the mating surface should be wiped
clean each day with a clean, damp cloth. Do not use abra­sive cleaners on the gasket or mating surface.

The gasket should be examined for cracks and dam­age that could result in a poor pressure seal. If replacement
is necessary, refer to Gasket Replacement under the When
Required heading of this Maintenance section.

Cleaning After Liquid Loads

Biological media tends to boil at a higher rate than other liq­uids during venting. This causes media to be spattered inside
the chamber. Therefore, the chamber must be cleaned daily
when you are sterilizing media. Clean as follows:

1. Allow unit to cool.

2. Wipe out chamber and door with a clean, damp
cloth.

Weekly Maintenance

(More often if necessary.)

Warning

To prevent collection of mineral
deposits and corrosion of chamber
components, use distilled or deion­ized water only as specified. Clean
chamber after each use if steriliz­ing saline solutions.

Cleaning Chamber, Trays and Rack

At least once a week, the trays and tray rack should be
removed from the sterilizer chamber. The trays, tray rack and
chamber should be thoroughly cleaned to remove any
deposits from the surfaces.
Clean the trays, rack and chamber (especially the bottom of
the chamber) with appropriate anti-biological cleaners. Wipe
all residue from the surfaces with a dampened, lint-free cloth.

49

MAINTENANCE

Warning

Pressurized steam will be dis­charged when the relief valve is
opened. To prevent burns, place a
steam barrier (such as a rolled
towel) around the opening in the
back of the unit. To prevent burns,
wear gloves or use an extension
device if it becomes necessary to
operate the pull ring.

Monthly Maintenance

Pressure Relief Valve Check

To ensure that the pressure relief valve is functioning proper­ly, you must have a qualified person check the valve each
month.

The pressure relief valve is located on the pressure
line in the back of the unit and is accessed through a round
access hole in the back panel. A suitable tool (screwdriver,
rod, etc.) will be needed to test the pressure valve.

1. Run a sterilize cycle at 135°C (275°F) without a
load in the chamber.

2. Allow the pressure in the chamber to reach 30 psi
(206 kPa).

3. Insert a suitable tool through the access hole and
push the lever on the pressure relief valve. Push
the valve lever away from the valve to open the
valve. Hold the valve open for 3 seconds. Steam
should discharge freely.

Note

In the event that you have lost the
supplied drain tubing, you can
drain the reservoir as follows:

1. Tilt the front of the sterilizer up
until you can access the small
panel on the bottom front of the
sterilizer, beneath the drain
assembly.

2. Remove the screws securing the
panel. Remove the panel.

3. Have a suitable container pre­pared for the water in the reser­voir. Disconnect the reservoir drain
tube from the quick disconnect fix­ture on the front of the sterilizer.
The reservoir will drain.

Note

Do not add more than 7 liters of
water to the reservoir after cleaning.

4. Release the valve lever. The steam discharge
should cease entirely.

5. After checking the valve, turn the sterilizer off by
pressing "Stop" to prevent overheating.

If the valve malfunctions, the valve must be replaced.

Cleaning Reservoir

1. The reservoir drain assembly is located on the
lower right front side of the sterilizer cabinet. Place
a suitable container below the drain assembly.
Connect the drain adapter and tube to the drain
assembly and drain the reservoir into the contain­er.

2. When the reservoir is empty, wipe out the inside of
the reservoir with a clean, lint-free cloth. Take care
not to push debris back into the water line.

3. Refill the reservoir with distilled or low quality
deionized water (minimum 0.5 megohms/cm, maxi­mum 1.5 megohms/cm) and replace the reservoir
cover.

50

Warning

BURN HAZARD: Do not empty the
collection bottle when the sterilizer is
in operation.

MAINTENANCE

Emptying Collection Bottle

1. Empty the collection bottle when the water in the
bottle reaches the FULL mark.

3. Slide the bottle away from the cooling tank to
remove.

4. Pour the contents down the drain.

Optional

Overflow

Drain

Waste Water

Cooling

Tank

Note

It is important to periodically check
the water level in the collection bot­tle. Failure to empty the bottle will
result in water overflowing onto sur­rounding surfaces.

Collection

Bottle

From

Sterilizer

51

MAINTENANCE

Warning

BURN HAZARD: Do not clean the
tank when the sterilizer is in opera­tion. Allow the non-recirculating cool­ing tank to cool to room temperature
before cleaning the tank.

Cleaning Non-Recirculating Water
Cooling Tank

The non-recirculating water cooling tank should be drained
and rinsed out every six months. Do not clean the tank when
the sterilizer is in operation.

Using the optional overflow tube (supplied), push the connec­tor fitting into the drain connection at the bottom of the tank to
empty it.

Remove the drain tube when the tank is empty, and rinse the
tank with a solution of household bleach (3/4 cup) and dis­tilled or deionized water (1 gal.). Drain solution and rinse
with distilled or deionized water before refilling.

Refill the tank with clean distilled or deionized water to put the
system back in service.

Overflow Drain

To Empty:

Push in overflow

tube until it “clicks.”

Optional
Overflow

Tube

Tank

Drain

52

To Remove

Overflow Tube:

Press tab to release.

MAINTENANCE

Changing Door Gasket

1. Disconnect the sterilizer from the power supply.
Ensure that the sterilizer is cool and depressur­ized.

2. Remove the old gasket by pulling it out of the
door.

3. Use a warm, soapy water combination to lubricate
the gasket for easier installation.

4. Working around the door from one point, insert the
outer edge of the gasket under the machined lip of
the gasket groove in the door.

5. Working around the door from one point, press the
inner edge of the gasket into the gasket groove,
ensuring that the gasket is fully seated in the
groove.

6. Reconnect the sterilizer to the power supply.

53

Figures

Power Supply Board
With Sheild Cover

On/Off Switch
(underneath)

R

eservoir Cover

Door Release

Door Handle

Membrane Panel

Main Control Board

Pump

Power Module

OTP PC Board

Solenoid PC
Board

Sterilizer Component Layout - Interior

54

FIGURES

T

rays

R

ack

D

oor Interlock

Reservoir Drain

Door Switch

Sterilizer Component Layout - Chamber and Door

55

FIGURES

Solid State 
R

elay

O

TP Mechanical Relay

Pressure Relief Valve

Calibration Port

T

emperature Sensor

Fan

Vent Solenoid

Insulation

Reservoir

Pressure Transducer

Insulation Support 
Bracket

Door Switch

Insulation Support
Bracket

Sterilizer Component Layout - Top View

56

Parts List

Warning

Replace fuses with same type and rating

120 V 220V~

Qty. Description Part No. Part No.

1 Printer Ribbon AYX21 AYX21
1 Printer Paper Tape Roll AY669X4 AY669X4
2 Solenoid Valve RY759X1A RY759X1A
1 Power Supply TNX116 TNX116

PC Board (Solenoid) PC1277X2 PC1277X2
Pressure Relief Valve 250052401 250052401
Tank, Lower Float SW759X1A SW759X1A
PC Board (Logic) PC1277X1 PC1277X1
ON/OFF Switch SWX141 SWX104
Terminal Strip TRX177 TRX177
Relay Contact RYX60 RYX60
Pump PUX16 PUX16
Door Gasket GS759X1A GS759X1A
Fan FA981X1A FA759X1A
Heater ELX9 ELX10
Gasket (Chamber) GS759X4 GS759X4
Relay, Solid State RYX34 RYX34
PC Board (OTP) PC1118X2 PC1118X2
Tray (Large) TY759X2A TY759X2A
Tray (Small) TY759X3A TY759X3A
Door Switch SW1118X1 SW1118X1
Membrane Panel SW759X3 SW759X3
Water Reservoir TY759X1 TY759X1
Safety Latch SF759X1A SF759X1A
Shaft Ass'y (Main Door Latch) SF759X2A SF759X2A

Pressure Pin (Door) SP759X1 SP759X1
2 Handle (Yoke Assembly) HNX18 HNX18
1 Drain Tube Assembly TU759X9A TU759X9A

Reservoir Cover DL759X2 DL759X2

Chamber Temp. Sensor RS1277X1 RS1277X1

Automatic OTP Sensor RS759X2A RS759X2A

Mechanical OTP Sensor FZ759X1 FZ759X1
1 Pressure Transducer TDX5 TDX5

Fuse for TBX116 AZ9027 AZ9027

57

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 Thermo
Scientific 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,
then contact our Customer Service Department at 563-556­2241 or 800-553-0039.

Prior to returning any materials, please contact our Customer
Service Department for a “Return Materials Authorization”
number (RMA). Material returned without an RMA number will
be refused.

58

Decontamination Statement

We cannot accept any product or component sent for repair or credit that is contaminated

with or has been exposed to potentially infectious agents or radioactive materials.

No product or component will be accepted without a "Return Materials Authorization"

(RMA) number.

59

One Year Limited Warranty

This Thermo Scientific product shall be free of defects in materials and workmanship for one (1) year from the first
to occur of (i) the date the product is sold by the manufacturer or (ii) the date the product is purchased by the origi­nal retail customer (the "Commencement Date"). Except as expressly stated above, WE MAKE NO OTHER WAR­RANTY, EXPRESSED OR IMPLIED, WITH RESPECT TO THE PRODUCTS AND EXPRESSLY DISCLAIM ANY
AND ALL WARRANTIES, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF DESIGN, MERCHANT ABILITY
AND FITNESS FOR A PARTICULAR PURPOSE.

An authorized representative of the manufacturer must perform all warranty inspections. In the event of a defect
covered by this warranty, the manufacturer shall, as its sole obligation and exclusive remedy, provide free replace­ment parts to remedy the defective product. In addition, for products sold by the manufacturer within the continen­tal United States or Canada, the manufacturer shall provide free labor to repair the products with the replacement
parts, but only for a period of ninety (90) days from the Commencement Date.

The warranty provided hereunder shall be null and void and without further force or effect if there is any (i) repair
made to the product by a party other than the manufacturer or its duly authorized service representative, (ii) misuse
(including use inconsistent with written operating instructions for the product), mishandling, contamination, over­heating, modification or alteration of the product by any customer or third party or (iii) use of replacement parts that
are obtained from a party who is not an authorized dealer of Thermo Scientific products.

Heating elements, because of their susceptibility to overheating and contamination, must be returned to the factory
and if, upon inspection, it is concluded that failure is due to factors other than excessive high temperature or conta­mination, the manufacturer will provide warranty replacement. As a condition to the return of any product, or any
constituent part thereof, to the factory, it shall be sent prepaid and a prior written authorization from the manufactur­er assigning a Return Materials Number (RMA) to the product or part shall be obtained.

IN NO EVENT SHALL THE MANUFACTURER BE LIABLE TO ANY PARTY FOR ANY DIRECT, INDIRECT, SPE­CIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY DAMAGES RESULTING FROM LOSS OF
USE OR PROFITS, ANTICIPATED OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THE SALE,
USE OR PERFORMANCE OF ANY PRODUCTS, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT
(INCLUDING NEGLIGENCE), ANY THEORY OF STRICT LIABILITY OR REGULATORY ACTION.

For the name of the authorized Thermo Scientific dealer nearest you or any additional information, contact us:

2555 Kerper Blvd., Dubuque, Iowa, 52001-9918

Phone: [phone] or 1-800-553-0039

Fax: [phone]

E-mail: [e-mail]

Web: www.thermo.com