Midmark M9, M9D, M11, M11D Operation Manual

M9 / M9D

Important

Information

Page 2

M11 / M11D

Self-Contained Steam Sterilizer

Installation

Page 4

Description

Page 7

Component

Overview

Page 8

Controls &

Indicators

Page 9

Operation

Page 11

Maintenance

Page 24

Calling For

Service

Page 33

Specifications

Page 33

Limited

Warranty

Page 43

Owner’s Product Identification

1

MA616300i

1

2

MODEL

NUMBER

SERIAL

NUMBER

SERIAL

NUMBER

(information that you will need to provide for servicing - key information is highlighted)

Model Number

Name of Owner / Facility / Department Date of Purchase

Name of Authorized Midmark Dealer Telephone # of Authorized Midmark Dealer

Address of Authorized Midmark Dealer

Serial Number

CONTENTS

IMPORTANT INFORMATION ........................................................................................................ 2

Intended Use of Product........................................................................................................ 2

Safety Instructions................................................................................................................. 2

Explanation of Safety Symbols and Notes ............................................................................ 2

Transportation and Storage Conditions................................................................................. 3

INSTALLATION.............................................................................................................................. 4

Location Requirements For Sterilizer .................................................................................... 4

Operating Environment Conditions ....................................................................................... 5

Re-Location Requirements For Sterilizer .............................................................................. 6

Electrical Requirements ........................................................................................................ 6

DESCRIPTION............................................................................................................................... 7

Safety Features ..................................................................................................................... 7

COMPONENTS OVERVIEW ......................................................................................................... 8

CONTROLS & INDICATORS ........................................................................................................ 9

OPERATION ................................................................................................................................ 11

Sterilizer Preparation Before Operation............................................................................... 11

Recommended Steam Sterilization Monitoring Program .................................................... 12

Cleaning Instruments .......................................................................................................... 13

Guidelines For Loading the M9 / M11 ................................................................................. 13

Operating the Sterilizer........................................................................................................15

Standard Cycle Parameters ................................................................................................ 16

Standard Cycle Operation................................................................................................... 17

Programming Mode............................................................................................................. 20

Unloading Hot Trays and Cassettes (Using Tray/Cassette Tool) ......................................... 22

List of Authorized Accessories ............................................................................................ 24

MAINTENANCE........................................................................................................................... 24

Tray Rack & Plate Removal / Installation............................................................................. 24

Daily .................................................................................................................................... 25

Weekly................................................................................................................................. 26

Monthly................................................................................................................................ 26

Non-Scheduled Maintenance.............................................................................................. 28

Extended Use Maintenance ................................................................................................ 29

Troubleshooting Guide ........................................................................................................ 29

Message Guide ...................................................................................................................31

CALLING FOR SERVICE ............................................................................................................ 33

SPECIFICATIONS ....................................................................................................................... 34

PRINTER INSTALLATION AND OPERATION ............................................................................ 36

Installing the Printer ............................................................................................................ 36

Operating the Printer...........................................................................................................37

Inserting the Paper Roll....................................................................................................... 38

About the Cartridge Ribbon................................................................................................. 39

Installing a New Cartridge Ribbon....................................................................................... 39

Removing the Paper Roll..................................................................................................... 40

Power Up Message ............................................................................................................. 40

Printer Tape Description...................................................................................................... 40

LIMITED WARRANTY ................................................................................................................. 43

Important

Information

IMPORTANT INFORMATION

Intended Use of Product

The M9/M11 Ultraclave or M9D/M11D Autoclave can be used in medical and
dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities
to sterilize heat and moisture stable reusable items (including dental handpiec­es) that are compatible with steam sterilization. Refer to Loading Trays

Standard Cycle Parameters

later in this manual for detailed information.

and

Safety Instructions

The primary concern of Midmark is that this equipment is operated and main­tained with the safety of the patient and staff in mind. To assure safer and more
reliable operation:

• Read and understand this manual before attempting to install or operate the
sterilizer.

• Assure that appropriate personnel are informed on the contents of this man­ual; this is the responsibility of the purchaser.

• Assure that this manual is located near the sterilizer, or if possible, perma­nently affixed to the sterilizer.

Explanation of Safety Symbols and Notes

DANGER

Indicates an imminently hazardous situation which will result in seri­ous or fatal injury if not avoided. this symbol is used only in the

most extreme conditions.

WARNING

Indicates a hazardous situation which could result in serious injury if
not avoided.

CAUTION

Indicates a potentially hazardous situation which could result in minor or
moderate injury if not avoided. It may also be used to alert against unsafe

practices.

EQUIPMENT ALERT

Indicates a potentially hazardous situation which could result in equip­ment damage if not avoided.

NOTE

Amplifies an operating procedure, practice, or condition.

2

Transportation and Storage Conditions

4

5

60°C
140°F

30°C
22°F

EQUIPMENT ALERT

The water must be drained from the unit’s reservoir before transporting or
storing at 32°F (0°C) or below.

• Storage Temperature Range: ..... -22°F to 140°F (-30°C to +60°C)

• Relative Humidity........................ 10% to 90% (non-condensing)

Consult operator’s manual for impor­tant information

Proper shipping orientation

Fragile.

Keep dry.

Maximum stacking height of

M11

palleted units

Maximum stacking height of

M9

palleted units

Minimum and maximum storage
temperature for the unit.

Important
Information

3

INSTALLATION

D

A B

MA594702i

C

E

F

1" (2.54 cm)

Minimum

E*

Location Requirements For Sterilizer

Installation

DANGER

Do not operate this sterilizer in areas where flammable anesthetics
are used or stored. An explosion could occur, causing fatal or seri-

ous injury.

Adherence to the following recommendations for location of the sterilizer will
contribute to optimum performance of the unit:

Support Surface (A)
the chamber will fill correctly. Improper water level in the chamber could cause
a sterilizer malfunction.

Support Surface Material (B)
stone, or other water resistant material.

4

- Sterilizer must be placed on a level surface to ensure that

- Place sterilizer on a Formica, stainless steel,

Support Surface Depth (C) - Support surface should be at least 21 in. (53.3 cm)
(M11) or 18 in. (45.7 cm)(M9) deep. Allow at least 2 in. (5.1 cm) clearance be-
hind the sterilizer for air circulation.

Distance To Side Wall (D)
be no less than 2 in. (5.1 cm) clearance between the side of the sterilizer and
the wall.

Distance Above Sterilizer (E)
or shelves, the underside of the cabinets or shelves should be at least 23 in.
(58.4 cm)(M11) or 22 in. (55.9 cm)(M9) above the support surface or *5” clear­ance above top of sterilizer to allow access to the printer for changing the printer
paper roll.

Overhang (F)
side of the overhang should project no further than 15 in. (38.1 cm)(M9) or 18 in.
(45.7 cm)(M11) over the rear of the sterilizer.

Location On Support Surface
less than 1" (2.54 cm) back, from the front of the support surface, but no more,
so water can be easily drained from the tube into a container (See sketch on
Location).

Neighboring Materials and Equipment
tinuous cycles, locate the sterilizer where steam will not damage materials or
equipment in the surrounding area.

- If the sterilizer is to be located beneath an overhang, the under-

- If sterilizer is located next to side walls, there should

- If sterilizer is to be located beneath wall cabinets

- The front of the sterilizer should be located no

- If the sterilizer will be operated in con-

Installation

Operating Environment Conditions

EQUIPMENT ALERT

The unit should be allowed to reach room temperature before operating.
Failure to do so could result in damage to the unit.

• Operating Environment

Temperature Range: ................. 68°F to 104°F (20°C to 40°C)

• Normal Operating Altitude: ......... Below 9842 ft. (3000 m) above sea level.

• Device approved for Indoor Use Only.

• Device to be operated in a relatively dust free environment. An excessive
relative humidity environment should be avoided. Less than 80% (non con­densing) is recommended. (Pollution Degree 2, in accordance to IEC664)

• Device should be connected to a power source with over-voltage limits less
than 1500 watts from mains to ground. (Installation Category II in accor­dance to IEC 664)

• The M9 and M11 will emit 5000 BTU/HR. during operation.

5

Re-Location Requirements For Sterilizer

1. Disconnect power cord from electrical outlet and allow sterilizer to cool.

2. Drain water from reservoir or do not tip sterilizer, allowing water to spill.

Installation

Electrical Requirements

DANGER

Do not use this sterilizer in an explosive or oxygen-enriched atmo­sphere, or where flammable anesthetics are stored. An explosion or

fire could occur, causing fatal or serious injury.

WARNING

Use 104 - 127 VAC, 50/60 HZ alternating current only for 115 VAC rat-

ed models and 207 - 253 VAC, 50/60 HZ alternating current only for
230 VAC rated models. Failure to do so could result in electrical shock to per­sonnel and will result in damage to sterilizer.

EQUIPMENT ALERT

Unit should be allowed to reach room temperature before operating. Fail-

ure to do so could result in damage.

NOTE

Grounding reliability can only be achieved if this unit is connected to a matching three­pronged, grounded, isolated, correctly polarized receptacle.

6

Electromagnetic Interference

This Midmark Sterilizer is designed and built to minimize electromagnetic inter­ference with other devices. However, if interference is noticed between another
device and this Sterilizer, remove interfering device from the room and / or plug
Sterilizer into an isolated circuit.

The three-pronged grounding plug on sterilizer power cord must be plugged into
a matching three-pronged, grounded, dedicated, correctly polarized receptacle.

ELECTRICAL RATINGS

M9 / M11
M9D / M11D

115 VAC Unit 115 VAC, 50/60 Hz, 12 amp

Dedicated Supply Circuit: 120 VAC, 50/60 Hz, 15 amp
Maximum Power Consumption: 1425 Watts

230 VAC Unit 230 VAC, 50/60 Hz, 6.5 amp

Dedicated Supply Circuit: 230 VAC, 50/60 Hz, 10 amp
Maximum Power Consumption: 1500 Watts

DESCRIPTION

Safety Features

The M9 / M11 UltraClave™ or M9D / M11D Autoclave sterilizers have the follow­ing Safety Features . . .

• dry cycle door stop prevents door from opening fully if there is a slight resid­ual pressure in chamber when door handle is operated.
Door stop also retains door in a partially open position during drying cycle.

• door latched switch prevents operation until door is completely closed and
latched. An audible “beep” sounds and message “
displayed if door is not fully latched.

• monitors chamber temperature during a cycle to prevent an overheat con-
dition. If chamber temperature exceeds its preset limit, power to the heaters
is cut off and the cycle is aborted.

• pressure relief valve opens to reduce chamber pressure should chamber
steam pressure exceed allowable limit. Released steam is directed out of
bottom of unit’s cabinet.

• fault detection circuit monitors all functions of sterilizer during a cycle. If a
fault occurs during a cycle, the sterilizer monitoring circuitry stops the cycle,
sounds an audible signal, and displays an appropriate error message.

DOOR OPEN, CLOSE DOOR” is

Description

• displays message “
power loss, by the operator, or by a unit malfunction.

ITEMS NOT STERILE” if a sterilization cycle is interrupted by

7

6

2

5

SA172901i

3

4

1

7

Original

Present

Components

Overview

COMPONENTS OVERVIEW

Illustration below shows location of sterilizer’s major components..

1. Reservoir Access Cover 5. Display

2. Printer (Optional) 6. Trays and Tray Rack

3. Door and Dam Gaskets 7. Pressure Relief Valve

4. Water Level Indicator /
Reservoir Drain Tube

8

DESCRIPTION OF COMPONENTS

CONTROLS & INDICATORS

MA594800i

15

12

16

1

4

6

7

8

9

10

11

5

2

3

13

14

The following illustrations show the location of sterilizer’s controls and indica­tors. The chart describes their function.

Controls &
Indicators

Ref. Control Function

1 Display indicates cycle selected, cycle temperature

2 UNWRAPPED but-

ton

and exposure time for the selected cycle.
During the cycle, display shows messages
describing status of cycle. When cycle time
enters sterilization mode, remaining cycle time
is displayed as well as temperature and pres­sure.
Display also shows error message if a malfunc­tion occurs. Refer to Message Guide for a
detailed explanation for a message.

a program cycle designed to process
unwrapped instruments which runs at 270°F

(132°C) for 3:00 minutes with a 30 minute
drying cycle.

9

Ref. Control Function

3 POUCHES button a program cycle designed to process instru-

ments in combination paper / plastic steriliza­tion pouches or wrapped instruments at 270°F

(132°C ) for 5 minutes with a 30 minute dry­ing cycle.

4 PACKS but-

ton

a program cycle designed to process packs of
instruments at 250°F (121°C) for 30 minutes
with a 30 minute drying cycle.

Controls &

Indicators

5 HANDPIECES but-

ton

6START button initiates selected program or, when SELECT

7STOP button terminates selected program or function.

81 or 2 buttons Programmable cycle buttons that allows an

NOTE

All material run in these cycles
must be validated for steriliza­tion by the user.

9P button Programming mode button that allows opera-

10

11

12 Door Handle for latching / opening door.

13 Water Level Indicator / Res-

14 Fill opening access for filling reservoir with distilled water.

15 Pressure Relief Valve Test

16 Printer (Optional) The printer (optional equipment) can be used

+ button

- button

ervoir Drain Tube

Lever

a program cycle for dental handpieces,which
runs at 270°F (132°C) for 6:00 minutes with a

30 minute drying cycle

CYCLE is displayed, pressing START will acti­vate heater for 10 minutes.

operator to create two different programmed
cycles for special applications. Sterilization
time and temperature, along with Drying time
and Venting procedure can be adjusted or
changed.

tor to change temperature, time, and/or venting
procedure(s).Used in conjunction with buttons
1 or 2. (Refer to Programming Mode).

Allows temperature or time to be increased or
changes Vent to Fast mode when in location 1
or 2 and the P (programming) mode is acti­vated.

Allows temperature or time to be decreased or
changes Vent to Slow mode when in location 1
or 2 and the P (programming) mode is acti­vated.

shows amount of water in reservoir.
Tube also used for drainage of reservoir into
suitable container.

allows operator to check pressure relief valve .

to provide a permanent record of time, temper­ature, and pressure during a cycle.

10

OPERATION

INITIALIZING

SYSTEM

TOTAL CYCLES XXXX

M9*, vX.XX

SELECT CYCLE

DANGER

Do not use this sterilizer in an explosive or oxygen-rich atmosphere,
or where flammable anesthetics are stored. An explosion or fire

could occur, causing fatal or serious injury.

WARNING

Do not run the Sterilizer without the Tray Plate in place.

If the sterilizer malfunctions, immediately unplug sterilizer, and
call for service; do not attempt to repair the sterilizer yourself. Doing so
could result in serious injury.

EQUIPMENT ALERT

For optimal sterilizer performance, allow the sterilizer to reach room tem-

perature before operating.

Also, Do not use toweling or packaging which may contain chlorine bleach
residue. Doing so could result in trays and/or chamber rusting or discoloring.
In extreme cases, the life of the chamber may be significantly shortened.

Sterilizer Preparation Before Operation

WARNING

Check the serial number label (1) on back panel of sterilizer to verify volt-

age rating for the unit. Failure to connect sterilizer to an appropriate pow-

er supply could result in damage to the unit, and electrical shock to personnel.

1. Plug in sterilizer power cord.
Follow instructions.
Display shows:

Operation

(*will display Model Number, M9, M9D, M11, or M11D)

11

EQUIPMENT

2

3

4

ALERT

Use only distilled
water. Chlorine found in nor­mal tap water has a severe
corrosive effect on the stain­less steel chamber. Failure
to use distilled or demineral­ized water may cause seri­ous deterioration and
premature failure of the
stainless steel chamber
which could result in serious
injury.

2. Open door and pour distilled
water into fill opening (2) until the water level found in the Water Level Indica­tor Tube (3) is at the top of the fill level label (4).

Recommended Steam Sterilization Monitoring Pro-

Operation

gram

Physical monitors (temperature and pressure measuring devices) can help

detect sterilizer malfunctions. The sterilizer control system aborts the cycle and
displays a message if physical conditions go outside established limits.
The Printer Accessory should be used to create a record of each load’s actual
cycle time, temperature, and pressure.

Process monitors (biological and chemical indicators) indicate if conditions in
the sterilizing chamber were adequate to achieve sterilization. Process monitors
cannot
If a process monitor indicates a sterilization failure, items in that load are consid­ered non-sterile. Improper packaging, improper loading, and sterilizer malfunc­tion can cause sterilization failures.
Determine the cause for all sterilization failures and take steps to remedy the
cause before processing additional items in sterilizer. Follow the process moni­tor manufacturer’s instructions for proper selection, storage, use, and interpreta­tion for their devices.

Follow appropriate agency (state dental or medical board) sterilization monitor­ing guidelines for your office. Information can also be obtained from CDC,
AAMI, OSAP, and ADA on monitoring programs and other sterilization issues.

establish that a processed item is actually sterile.

12

NOTE

Use only FDA cleared chemical & biological indicators designed for steam sterilization
that are compatible with the particular sterilization cycle temperature and exposure
time being monitored. Use sterility monitors with each sterilization load. If a sterilizing
cycle is terminated prematurely, reprocess instruments to ensure sterility of the load.

DANGER

Clean and dry instruments before putting them into sterilizer.

Incomplete and improper cleaning of instruments will impede steril­ization and could result in non-sterile instruments which could lead to personal
or fatal injury.

Cleaning Instruments

Follow item manufacturer’s and OSHA recommendations for handling and
cleaning items.

• As soon as possible after use, remove all material or residue accumulated
during use.

• Rinse items thoroughly to complete removal of material and residue.

• Dry items completely.

Guidelines For Loading the M9 / M9D or M11 / M11D

• Refer to manufacturers’ recommendations for loading their items.

• Refer to cassette manufacturers’ recommendations for using their cassettes.

• Pouch or wrap items to preserve sterility after processing. Use only sterilizer
pouches and wraps that have been cleared by the FDA and labeled for use
with the steam sterilization cycles being used. Do not wrap items too tightly.

Sterilization will be compromised if an item is excessively wrapped.

WARNING

Do not overload the chamber. Adequate space is required around

items in trays for steam circulation and drying. Failure to allow ade­quate space will compromise sterilization and drying. Do not run the Sterilizer
without the Tray Rack in place.

EQUIPMENT ALERT

Trays must be used at all times when operating this sterilizer, seri-

ous equipment damage could result.

Operation

13

• Place all containers so that the
opening allows steam to enter,
and air and condensate to
drain from the container.

• Sterilize jointed items in an
open position.

• Use only M9/M9D or M11/M11D trays in their appropriate sterilizer. Using
other trays could restrict air and steam flow to items.

• Place unwrapped items on a towel or absorbent paper.

• Pouches may overlap, but handpieces and instruments must be single
height loaded (not piled or stacked), to permit proper steam flow and pene­tration to the items.

• Refer to below chart for maximum M9/M9D sterilization loads. If a load sur­passes these limits, we recommend dividing the load and running multiple
cycles. Listed below are the maximum recommended loads for each

and total

loads:

tray

Maximum Capacities

Operation

Load Type

Solid Items 42 instruments - 1089

Handpieces 9 in rack or 9 in rack or 9 handpieces in rack

(†)

Packs

M9/M9D Large /

Deep Tray

grams (2.4 lbs.) or

1082 cu. cm up to 2.5
cm thick (66 cu. in. up
to 1 in. thick)

M9/M9D Small

Tray

28 instruments - 726
grams (1.6 lbs.) or

787 cu. cm up to 2.5
cm thick (48 cu. in. up
to 1 in. thick)

M9/M9D Sterilizer

Tota l

140 instruments - 3629
grams (8.0 lbs) or

and 75 instruments or

3736 cu.cm up to 2.5
cm thick (228 cu. in. up
to 1 in. thick)

† Packs to have a minimum of 1/4 in. (6.4 mm) space between each other and

away from all sterilizer surfaces.

Refer to below chart for maximum M11/M11D sterilization loads. If a load sur­passes these limits, we recommend dividing the load and running multiple cy­cles. Listed below are the maximum recommended loads for each

tray and total

loads:

Maximum Capacities

Load Type

M11/M11D

Large / Deep

Tray

M11/M11D
Small Tray

M11/M11D

Sterilizer Total

Solid Items 45 instruments - 1225

Handpieces 9 in rack or 9 in rack or 9 handpieces in rack

14

grams (2.7 lbs.) or

30 instruments - 816
grams (1.8 lbs.) or

150 instruments - 4082
grams (9.0 lbs) or

and 75 instruments or

Maximum Capacities

Load Type

Packs (†)

M11/M11D

Large / Deep

Tray

4425 cu. cm up to 5.0
cm thick (270 cu. in.
up to 2 in. thick)

M11/M11D
Small Tray

3195 cu. cm up to 5.0
cm thick (195 cu. in.
up to 2 in. thick)

M11/M11D

Sterilizer Total

15240 cu. cm up to 5.0
cm thick (930 cu. in. up
to 2 in. thick)

† Packs to have a minimum of 1/4 in. (6.4 mm) space between each other and

away from all sterilizer surfaces.

Operating the Sterilizer

WARNING

Do not use this sterilizer for sterilizing volatile substances or for any
purpose other than its intended design. Burns and toxic or explo-

sive conditions could result.

Do not
open with extreme force. If door handle does not move freely, allow unit to cool
and depressurize for 40 minutes before opening door. Failure to adhere could
result in serious personal injury.

force door handle at any time. Chamber pressure may cause door to

CAUTION

Programmable cycles 1 & 2 are provided for those applications requiring

sterilization parameters different than the preset cycles. All material pro­cessed in these cycles must be validated by the user
cessed load.

Operation

to ensure sterility of the pro-

15

Standard Cycle Parameters

The following table lists the standard cycle parameters for the various cycles.

Standard Cycle Parameters

Operation

PROGRAM TEMP / PRESSURE/

TIME (minimums)

270°F (132°C) /

27.1 psi (186 kPa)
Sterilize for 3
minutes
30 minute Dry*

270°F (132°C) /

27.1 psi (186 kPa)
Sterilize for 5
minutes
30 minute Dry*

250°F (121°C) /
15 psi (104 kPa)
Sterilize for 30
minutes
30 minute Dry*

ITEMS TO BE STERILIZED

(Always consult the item manufacturer’s recommen­dations for sterilization.)

• Instruments loose on a tray.

• Open glass or metal canisters.

• Tubing not used in surgical procedures.

• Loose items manufacturers recommend
for exposure at 270°F (132°C).

The sterility of unwrapped items is compromised
on exposure to a non-sterile environment.

• Pouched or loosely wrapped instruments. • Mul­tiple layers of instruments separated by
fabric.

• Wrapped trays of loose instruments.

• Tubing not used in surgical procedures.

• Wrapped items manufacturers recom­ mend for exposure at 270°F (132°C).

• Textiles and surgical packs wrapped for
sterilization.

• Items, except liquids, manufacturers
recommend for exposure at 250°F (121°C)
for 30 minutes.

16

270°F (132°C) /

27.1 psi (186 kPa)
Sterilize for 6
minutes

• Dental handpieces

NOTE
Verify acceptability of sterilization parameters with
handpiece manufacturer.

30 minute Dry*

Programmable
User Defined

230°F (110°C) to
275°F (135°C)
6 PSI (41 kPa) to
31 PSI (214 kPa)
3 min. to 90 min.

• Items appropriate for user’s defined parameters.
CAUTION

All material run in these cycles must
be validated by the user.

These programmable functions allow

you to set different time and temperature pa­rameters. It is important to properly coordi­nate sterization temperature with cycle time.
Permitted temperature range for proper steril­ization is 250°- 275°F (121°- 135°C). Tem­peratures below 250°F (121°C) should only
be used for disinfection.
Items with long small diameter tubular canals
(complex lumens), e.g. dental handpieces,
scopes, etc. should not be processed for less
than 6 minutes at 270°F (132°C).

*Dry time can be changed from 0 to 60 minutes. Refer to Standard Cycle Operation.

Standard Cycle Operation

SELECT CYCLE

UNWRAPPED

270°F, 3 MINUTES

FAST VENT

30 MINUTE DRY

Refer to following steps for a detailed description of operating procedures:

1. Display shows:

2. Close and latch door; sterilizer will not

operate unless door is closed and

latched properly.

EQUIPMENT ALERT

Using an incorrect sterilization program could result in non-sterile goods
and may damage instruments. Consult instrument manufacturer for spe-

cific sterilization instructions.

NOTE

Pressing the START button when SELECT CYCLE is displayed, at beginning or end of
a cycle, activates the heater for 10 minutes
ADDITIONAL HEAT. This allows the Operator to preheat the chamber before starting
an operation or to add additional time to the Dry mode at the end of an operation.
Pressing STOP will end the ADDITIONAL HEAT time.

3. Select either Unwrapped, Pouches, Packs, or Handpieces sterilization
cycle in accordance with the Standard Cycle Parameters table.

• Press UNWRAPPED. Display shows the program’s parameters:

. The display flashes

Operation

and then

NOTE

On units using the metric display,°F will display as°C and PSI will display as KPA.

Pressing enables operator to change DRY time from 0 to 60 minutes in 1 minute

increments on a pre-programmed cycle.

Pressing decreases time. Pressing increases time.

17

WARNING

FILLING

CHAMBER

CHAMBER

IS FULL

HEATING - UNWRAPPED

XXX°F XX.X PSI

STERILIZING

MM:SS XXX°F XX.X PSI

READY TO VENT

XXX°F XX.X PSI

FAST V EN T

XXX°F XX.X PSI

STOP button may be pressed at any time to stop or interrupt a cycle.
Goods must not
Sterilizer will return to SELECT CYCLE mode.

Press START.

be considered sterile if this occurs before Dry Cycle.

Operation

Sterilizer sounds a “beep

• Filling Chamber

:

” for two seconds to indicate cycle has started.

Display shows:

Chamber automatically begins to fill to the correct level with water.

When chamber is full

• Heat Up

portion of the cycle begins.

, display shows

Display shows:

(can also be in metric values depending on set-up).

Display changes as temperature and pressure in chamber changes.

• Sterilizing

portion of cycle begins when correct temperature and pres-

sure is reached.

Display shows:

Time remaining in cycle is counted down while current temperature and
pressure in chamber is continuously updated.

• Ready to Vent
ization Cycle.

Display shows:

• Vent opens

Display shows:

The display changes as temperature and pressure in chamber changes.
Vent valve opens, venting steam and water from chamber back into reser­voir.

Failure to do so could result in severe burns from steam being released.

18

is displayed when there is 10 seconds remaining in Steril-

when time runs out in Sterilizing mode.

CAUTION

Keep clear when M9/M11 door is ready to open. Do not attempt to
open M9D/M11D door until steam dissipates.

• Automatic Door Open (Pertains only to M9/M11 UltraClave™)

DOOR TO OPEN

XXX°F XX.X PSI

OPEN DOOR TO DRY
STOP TO ABORT

DRYING

MM:SS

DRY CYCLE

COMPLETE

SELECT CYCLE

• Door To Open

Display shows:

An Audible signal is emitted to indicate to Operator door is about to open.
When pressure in chamber reaches zero, door actuates to partially open
(Drying mode) position.

Manual Door Open

• Open Door

Display shows (top display line flashes):

An Audible signal is emitted when pressure inside chambers reaches zero
to indicate to Operator to open door. The door should be opened to the
first stop (drying mode) position.
The audible signal will continue to repeat every minute until either the
door is opened to the DRY (partially opened) position, or by pressing the

STOP button, aborting the DRY cycle.

• Drying

(Pertains only to M9D/M11D AutoClave)

Display shows:

Time of Dry Cycle is counted down.

NOTE

If desired, Drying Cycle can be aborted by pressing STOP button.

• Dry Cycle Complete

when Drying time reaches 0:00.

Display shows:

An audible signal is emitted for 10 seconds, the display shows:

CAUTION

The processed load and inner surfaces will be hot. Avoid contact
with hot surfaces. Failure to do so could result in serious burns

4. Remove processed load from chamber (See Unloading Hot Trays and Cas­settes later in this manual).

5. The sterilizer may now be reloaded for another cycle.

Operation

19

Programming Mode

SELECT CYCLE

PROGRAM 1

XXX°F, XX MINUTES

FAST VENT

XXX MINUTE DRY

STERILIZATION TEMP:

XXX.X°F

<+> OR <-> TO ADJUST

<P> FOR NEXT

<STOP> TO CANCEL

<P> FOR NEXT

<STOP> TO CANCEL

STERILIZATION TIME

XX MINUTES

<+> OR <-> TO ADJUST

The following steps are for programming buttons 1 and/or 2 for applications that
are not covered by standard cycle programs:

Displays: Press

Displays: then Press

Displays: then then

Operation

Press raises temperature 1°. Press lowers temperature 1°.

Sterilization temperature can be adjusted from a minimum of 230°F (110°C)

maximum of 275°F (135°C).

Permitted temperature range for proper sterilization

is 250°- 275°F (121°- 135°C).

CAUTION

Temperatures set below 250° F (121°C) should not be used for steril­ization, unless otherwise required by the device manufacturer. Tem-

peratures below 250° (121°C) are provided for disinfection only.

NOTE

If the STOP button is pressed anytime during the Programming Mode the settings en­tered will be aborted and revert back to the original settings before programming be­gan.

then displays: Press

Displays: then

to a

Press raises time 1 minute. Press lowers time 1 minute.

Sterilization time can be adjusted from a minimum of 3 minutes

90 minutes. It is important to properly coordinate the cycle time with the steriliza­tion temperature.

20

to a maximum of

then displays: Press

<P> FOR NEXT

<STOP> TO CANCEL

VENT TYPE:

FAST

<+> OR <-> TO ADJUST

<P> FOR NEXT

<STOP> TO CANCEL

DRY TIME

XX MINUTES

<+> OR <-> TO ADJUST

<P> FOR NEXT

<STOP> TO CANCEL

PROGRAM 1

XXX°F, XX MINUTES

FAST VENT

XX MINUTE DRY

SELECT CYCLE

Displays: then

Press changes VENT to FAST

When in FAST
When in SLOW

vent, valve fully opens and vents chamber.

vent, valve opens periodically for a fraction of a second once

. Press changes VENT to SLOW.

per minute to slowly vent chamber.

then displays: Press

Displays: then

Press raises time by 1 minute. Press lowers time by 1 minute.

Dry time can be adjusted from zero

to a maximum of 60 minutes, in 1 minute

increments.

then displays: Press

The display shows the new programmed conditions.

Displays: then

Operation

NOTE

The programmed settings entered are retained under Program 1 button. Even if power
is interupted or the unit unplugged the settings will be retained.

Load articles to be sterilized into chamber.

CAUTION

All materials run in these cycles must be validated by the user.

Failure to do so could result in incomplete sterilization.

Press START button to begin sterilization cycle for Program 1.

NOTE

After any cycle has been selected but not started, depressing the STOP button

or allowing 5 minutes or more time to pass, the display will go back to

.

21

Unloading Hot Trays and Cassettes (Using Tray/Cas-

MA598400i

1

2

3

2

sette Tool)

CAUTION

Only use the 9A307001 Tray / Cassette tool with Midmark manufactured

trays. Use care when removing or transporting trays, or cassettes as they
may be hot. Hold the tray level and slightly elevated to prevent it from shifting and be­coming dislodged. Failure to comply may result in personal injury due to burns.

Tray Removal

Operation

Insert tray (smaller) plate (1) into end of tool (2)

Hook the top tab of the tool (2) to top center of tray lip.

Rotate tool (2) downward until bottom forks are completely beneath tray (3).

Check to ensure tray (3) is being held securely and then remove tray from
chamber.

22

Cassette Removal

3

MA578701i

1

2

2

NOTE

Cassette tool can handle cassettes up to 1 1/’2" (3.8 cm) thick

Insert cassette plate (A) (larger plate) into end of the tool.

CAUTION

When removing the cassette, hold the cassette tool so the end of the cas­sette is slightly elevated and use care to prevent it from sliding off the cas­sette tool.

Hook top, saw-toothed tab of tool to the top center of the cassette (3) while ro­tating tool downward until bottom plate is completely beneath the cassette.

Check to ensure the cassette is being held securely and then remove the cas­sette from the chamber.

Operation

23

List of Authorized Accessories

PERFORM WEEKLY

MAINTENANCE

PERFORM MONTHLY

MAINTENANCE

MA601500i

B

A

Listed below are the accessories which are authorized for use with these
sterilizers. Unless noted, accessory can be used on the M9 and M11.

Operation

Accessory Name

• Speedclean, 1 (16 oz. [.47 liter] ) bottle 002-0396-00

• Speedclean, 1 case (12-16 oz. [.47 liter] bottles) 002-0396-01

• Printer Refill Kit 002-0371-00

• Rack / Cassette (Horizontal) 9A215001 (M11/M11D Only)

• Rack / Cassette (Vertical) 9A215002 (M11/M11D Only)

• Tray / Deep (2 1/2" [6.4 cm ]) 9A224001 (M9/M9D Only)

• Tray / Deep (2 1/2" [6.4 cm ]) 9A225001 (M11/M11D Only)

• Rack / Pouch 9A226001

• Printer 9A259001

• Cassette Tray (Large) 9A306001 (M11/M11D Only)

• Tray / Cassette Tool 9A307001

• External Condensing Tank 9A260001

Order Number

MAINTENANCE

User is responsible to establish a periodic maintenance procedure to assure
correct operation of equipment and reliable sterilization of loads.
Contact your local Midmark distributor or service representative to develop a
program for planned maintenance.

NOTE

After the Sterilizer is plugged into a power source at 7, 14, and 21 days a message

Maintenance

will be displayed informing the Operator that maintenance is due.

At the 28th day a message will be displayed . Refer to the appro-
priate maintenance instructions in this manual.
If power is interrupted the timer will reset initiating a new cycle of messages.

Tray Rack & Plate

WARNING

Make sure that unit is cool before attempting to remove or

install tray rack and plate. Use care to prevent injury when handling

metal tray rack. Do not run Sterilizer without Tray Rack in place.

1. Removal

• After removing trays, pry upward (A) on
end of tray plate with a screwdriver while
pulling tray rack and plate assembly out (B)
of chamber.

24

2. Installation

MA601600i

B

A

EQUIPMENT
ALERT

Install tray rack and plate assembly
so that angled end of plate is toward back
chamber. Do not
lever sensor.

allow plate to contact water

• Place back edge of tray in chamber.
Pressing downward (A) on top of tray
rack, slowly insert assembly into
chamber (B).

Daily

EQUIPMENT ALERT

If the sterilizer is used frequently to process dental handpieces that have
been lubricated or dipped in dental milks, drain the water from the reservoir

daily. Refill the reservoir with distilled water.

1. Clean External Surfaces .

of

CAUTION

Make sure that unit is cool when cleaning door gasket and any mat­ing surfaces to prevent being burned.

2. According to your facility’s procedure

• Use only quaternary disinfectants to disinfect unit . Staining, pitting, dis­coloration, or softening could occur if phenolic, iodophor, or glutaralde­hyde-based disinfectant is used on plastic surfaces of the unit. Also, use
of alcohol or aerosol spray cleaner / disinfectant containing substantial
amounts of alcohol in the formula can damage the faceplate.

• Wring excess solution from cloth.

• Using soft cloth, wipe all external surfaces.

• Do not rinse or dry external surfaces. Allow germicidal solution to air dry.

3. Clean Sterilizer Door Gasket

• Clean door gasket sealing lip and mating surface with a damp cloth.

• Examine gasket for possible damage.

:

Maintenance

25

Weekly

MA8195i

E

EQUIPMENT ALERT

Do not use abrasive or bleaching agents in chamber (i.e. steel wool,
scouring powder, bleach, etc.) or wire brush.

Possible damage to metal surfaces of chamber and other components could result.

1. Clean Chamber and Trays

• Drain water from the reservoir using drain tube located on front of unit.

• Wash inside of chamber and trays with mild soap or Speed-Clean and
distilled water.

• Refill reservoir with distilled water.

Monthly

NOTE

Do not process instruments while cleaning sterilizer.

1. Clean Chamber and Plumbing

(a) With a cooled chamber, drain reservoir and fill with clean, distilled water.

Add one ounce of Speed Clean Sterilizer Cleaner (E) directly to the bot­tom of chamber.

Maintenance

(b) Run one

(c) Press STOP

(d) Drain reservoir and refill with clean, distilled water.

(e) Rinse by running one

(f) After cycle has completed:

Drain and refill reservoir with clean
distilled water, then allow sterilizer
to cool.

(g) Remove trays and tray rack and

wipe off with a damp cloth.

(h) Remove and clean filters (A) (Refer

to Non-Scheduled Maintenance in
this booklet)

(i) Wipe out the inside of chamber

using care not to damage the heat­ing element (B), steam temperature probe (C), or level sensor probe (D).

POUCHES cycle.

button when Drying portion of cycle begins.

UNWRAPPED cycle.

(j) Re-install filters (A) and tray rack.

26

Perform Pressure Relief Valve Check

HEATING - UNWRAPPED

XXX°F 20.0 PSI

NOTE

Pressure Relief Valve must be checked each month to assure it functions properly.

(a) Press UNWRAPPED

(b) Press START

CAUTION

During the pressure relief valve check, steam will be vented from un­der the sterilizer. To keep from being burned, place a steam barrier

(a rolled up towel) around the bottom of the sterilizer.

(c) Wait until pressure in chamber reaches 20 PSI (138 kPa).

Display:

Pull upward on the pressure relief
lever (A) for approximately 3 sec­onds. Steam should discharge
freely from beneath rear of unit.

NOTE

If pressure relief valve does not close com­pletely when lever is released, pull upward
on lever again and release it quickly so
valve snaps back into position. Do this until
valve seats properly.

(a) Release lever (B). Valve should

close, stopping release of steam.

(b) Press STOP button to abort the cycle, preventing unit from over-

heating.

(c) If excessive force is required to open pressure relief valve or pressure

relief valve will not reseat properly, the pressure relief valve must be
replaced (See Calling For Service later in this manual).

Maintenance

27

Non-Scheduled Maintenance

MA601400i

1

CAUTION

Always unplug unit power cord from outlet and allow unit to cool be­fore performing maintenance. Failure to comply may result in injury.

1. Cleaning Fill / Vent and Air
Filter Screens
The filter screens (1) are
intended to prevent debris
from causing valve failures.
The screens should be
cleaned if fill or vent times
become too long or items
will not dry.

(a) Unplug the power cord

from outlet receptacle.
Open door and remove
trays.

Maintenance

(b) To access Fill / Vent fil-

ter screen,remove tray
rack.
Air filter screen is
located in back of chamber.

(c) Grasp filters (1) and gently pull upward while twisting slightly

(a pair of pliers may be used if filter is stuck).
Clean filters with mild soap and distilled water. A small stiff bristled
brush or ultrasonic cleaner may be helpful. Rinse filters with distilled
water.

EQUIPMENT ALERT

Do not operate sterilizer without filters in place.

(d) Re-install filters (1) by inserting into the hole, and pressing downward

while twisting slightly.

(e) Install tray rack.

(f) Plug unit power cord into outlet receptacle.

28

Extended Use Maintenance

The M9/M9D and M11/M11D are designed and tested to provide exceptional
reliability throughout their service life. However, like all electro-mechanical
devices they are subject to wear and degradation with use.

To ensure the integrity, performance, and safety of all major components it
is the responsibility of the user to have the sterilizer performance / operation
verified by a Midmark Authorized Service Provider at least every 10 years or
10,000 cycles, whichever comes first. After 10 years or 10,000 cycles of use, an
annual inspection by a Midmark Authorized Service Provider is recommended.

Troubleshooting Guide

Use the following table to assist in correcting minor problems with the sterilizer.

TroubleShooting Guide

Problem Possible Cause Solution

Sterilizer does not
operate (no display)

Steam is escaping
from pressure relief
valve

Sterilization failure
evidence from
process monitor
(chemical indicator,
biological indicator,
etc.)

Sterilizer power cord came
loose from supply outlet or
back of sterilizer.

No power at Sterilizer
supply outlet

Fuse open on main P.C.
Board.

pressure relief valve not
properly seated.

sterilization conditions
were not present at
location of the indicator.

Assure Sterilizer power cord is
plugged into outlet and
sterilizer.

Check circuit breaker for supply
outlet. If problem recurs, unplug
unit power cord and contact an
authorized service technician
(see Calling For Service).

Unplug unit power cord and
contact an authorized service
technician (see Calling For
Service).

reseat pressure relief valve (see
Perform Pressure Relief Valve
Check under Monthly
maintenance).

reload sterilizer in accordance
with Guidelines For Loading the
M9/M9D or M11/M11D.
If problem recurs, unplug unit
power cord and contact an
authorized service technician
(see Calling For Service).

Maintenance

indicator is out-of-date, is
inappropriate for
sterilization cycle, or has
otherwise malfunctioned.

use an indicator, appropriate for
the load and cycle selected, that
has been stored properly.
Contact the indicator
manufacturer for additional
information on proper selection,
use, storage, and potential
misapplication or malfunction.

29

TroubleShooting Guide - Continued

Problem Possible Cause Solution

Door gasket leaks door gasket is damaged or

dirty.

Items are not dry at
end of drying portion
of cycle.

Printer not printing Printer cable is not

sterilizer is improperly
loaded.

filter screen(s) clogged.
(Check Fill / Vent and Air
Valve filter screens)

connected properly.

Software malfunction. Unplug sterilizer power cord,

Printer is out of paper. Insert a new paper roll (see

clean or replace door gasket
(see Clean Door Gasket under
Weekly maintenance).

reload sterilizer in accordance
with Guidelines For Loading the
M9/M9D or M11/M11D. If
problem recurs, unplug unit
power cord and contact an
authorized service technician
(see Calling For Service)

clean or replace filter screen(s)
(see Non-Scheduled
Maintenance).

Ensure that printer cable is
connected to printer and PC
board properly.

wait 15 seconds, and then plug
sterilizer power cord back in.

Inserting the Paper Roll under
Printer Installation and
Operation).

Maintenance

Cartridge Ribbon is dried
out or needs to be
replaced.

Hold the switch in the ON /
FEED position for three
seconds. If this doesn’t correct
the problem, replace the
cartridge ribbon (see Installing a
New Cartridge Ribbon under
Printer Installation and
Operation in this manual).

30

Message Guide

CAUTION

The Message Guide list some of the messages that may occur during op-

eration, along with possible causes and solutions.
If an error occurs more than once, do not continue to use sterilizer.
Note the message or error code, unplug unit and call an authorized service represen­tative (see “Calling For Service”).
Also, if an error message contains the phrase “Items Not Sterile”, the items in steriliz­er shall not be considered sterile; they must be run through a successful sterilization
cycle.

Message Guide

Message Possible Cause Solution

Informational Messages

INITIALIZING SYSTEM

TOTAL CYCLES XXXX

M9*, vX.XX.

(*will display Model Number,

M9, M9D, M11, or MllD).

PERFORM WEEKLY

MAINTENANCE

PERFORM MONTHLY

MAINTENANCE

Unit power cord was
just plugged in ­standard informational
message.

Unit power cord was
just plugged in ­standard informational
message.

This message is
displayed every 7, 14,
and 21 days after the
unit is plugged into a
power source to prompt
the operator to perform
weekly maintenance
described in this
manual.

This message is
displayed every 28 days
to prompt operator to
perform monthly
maintenance described
in this manual.

Error Messages

normal operation will occur after
a 4 second pause.

normal operation will occur after
this message.

Perform weekly maintenance.
The message will automatically
clear after the next cycle is
completed.

Maintenance

Perform monthly maintenance.
The message will automatically
clear after the next cycle is
completed.

C010: POWER UP MODE

SYSTEM PWR LOSS

ITEMS NOT STERILE

PUSH STOP TO RESTART

Unit had loss of power
during cycle.

Press STOP button to restart.

31

Message Guide - Continued

Message Possible Cause Solution

C060: POWER UP MODE

SYSTEM HARDWARE

C102: FILL MODE

STOP PRESSED

C103 through C105

HEATUP, STERILIZE, OR

VENT MODE

STOP PRESSED

C106: DOOR MODE

STOP PRESSED

C232: FILL MODE

WATER LOW

Power was interupted
briefly or an internal
glitch.

STOP button was
pressed during cycle.

STOP button was
pressed during cycle.

STOP button was
pressed during cycle.

Water level in reservoir
is too low.

Fill / Vent filter (in
bottom of chamber)
clogged.

Unplug unit power cord for 1
minute and then plug back in.

If problem persists, contact an
authorized service
representative (see Calling For
Service later in this manual).

Press STOP button to restart.

Wait briefly (up to one minute)
while chamber pressure /
temperature dissipates.

Press STOP button to return to

Select Cycle mode where a new
cycle may be initiated.

Press STOP button to restart.

Refill water reservoir with distilled
or demineralized water. Wait
briefly (up to one minute).

Press STOP button to return to

Select Cycle mode where a new
cycle may be initiated

Clean Fill / Vent filter (Refer to

Non-Scheduled Maintenance).

Maintenance

C326: DOOR MODE

DOOR CLOSED

C382 FILL

DOOR OPEN

C383 HEATUP MODE

DOOR OPEN

C384 STERILIZE MODE

DOOR OPEN

Door latch is still
making contact after
door motor operated.

Sterilizer detects that
door switch contacts
opened.

Sterilizer detects that

door switch contacts

opened.

Sterilizer detects that

door switch contacts

opened.

Open Door

Close the sterilizer door.

(Cycle will continue where left
off.)

Wait briefly (1 minute) while
chamber pressure / temperature
dissipates.

Press STOP button to return to
Select Cycle mode.
Initiate a new cycle.

Unplug unit power cord for 1
minute and then plug back in.

If problem persists, contact an
authorized service
representative (see Calling For
Service later in this manual).

32

Message Guide - Continued

Message Possible Cause Solution

C533 through C633
STEAM TEMP LOW

or

STEAM TEMP HARDWARE

or

PRESSURE LOW

C642 through C647

PRESSURE HIGH

C660 through C677

PRESSURE HARDWARE

or

PRESSURE OVERLIM

C980 through C987

HI-LIMIT OPEN

Sterilizer detects that

temperature and / or

pressure is outside the

limits for normal

operation.

Pressure inside

chamber is outside the

limits for normal

operation.

Pressure inside

chamber is outside the

limits for normal

operation.

High Limit switch has

opened for at least 1/4

second during specific

operational mode.

Unplug unit power cord for 1
minute and then plug back in.

If problem persists, contact an
authorized service
representative (see Calling For
Service later in this manual).

Wait briefly (up to one minute)
while chamber pressure /
temperature dissipates.

Press STOP button to return to
Select Cycle mode.
Initiate a new cycle.

Unplug unit power cord for 1
minute and then plug back in.

If problem persists, contact an
authorized service
representative (see Calling For
Service later in this manual).

Unplug unit power cord for 30
minutes ,to allow unit to cool,
and then plug back in.

If problem persists, contact an
authorized service
representative (see Calling For
Service later in this manual).

CALLING FOR SERVICE

NOTE

Please mark down any displayed Code(s) and be sure to relay this information to the
Service Technician.

Contact your Midmark Authorized Dealer, or log onto www.midmark.com

Model and serial number information will be required

vice. To contact Midmark directly:

1-800-Midmark (1-800-643-6275) or 937-526-3662
8:00 a.m. until 5:00 p.m. Monday through Friday

(Eastern Standard Time in the U.S.)
[excluding standard U.S. holidays].

when calling for ser-

Maintenance

Calling For
Service

33

SPECIFICATIONS

UL61010A-1

LABORATORY

EQUIPMENT

59FM

M9/M9D Sterilizer

Physical Dimensions:

Overall Length w/Plug .....................20.38 in. (51.8 cm)

Overall Width ...................................15.3 in. (38.9 cm)

Overall Height w/Printer ..................15.8 in. (40.1 cm)

Counter Area ...................................15.3 in. x 18 in. (38.9 cm x 45.7 cm)

Chamber 9.0 in. diam. x 15.0 in. deep

(22.9 cm x 38.0 cm)

Standard Trays ..................... Large: 7 5/16 in. x 12 in. x 7/8 in.

(18.6 cm x 30.5 cm x 2.2 cm)

Small: 5 5/8 in. x 12 in. x 7/8 in.

(14.3 cm x 30.5 cm x 2.2 cm)

Weight:

Empty Reservoir..............................73 lbs (33.1 Kgs)

With Shipping Carton ......................81 lbs (36.7 Kgs)

Water Reservoir Capacity .............1.1 Gallons (4.1 liters) to Full Mark

usable volume is 0.5 gallons (1.9 liters)

Electrical Requirements:
NOTE: A separate (dedicated) circuit is required for this sterilizer. Sterilizer

should not be connected into an electrical circuit with other appliances or equip­ment unless circuit is rated for the additional load.

115 VAC, 50/60 Hz Model ...............15 AMP Circuit, Single Phase (1425 Watts)

230 VAC, 50/60 Hz Model ...............10 AMP Circuit, Single Phase (1500 Watts)

Fuse Ratings

115 VAC Unit

F1 ................................. 0.25 Amp, 250 V, Slo-blo, 1/4" x 1 1/4"

F2.................................. 15 Amp, 250 V, Fast Acting, 1/4" x 1 1/4"

230 VAC Unit

F1.................................. 0.125 Amp, 250 V, Slo-blo, 5 x 20 mm

F2.................................. 8 Amp, 250 V, Fast Acting, 5 x 20 mm

Chamber Pressure at

Specifications

270°F (132°C) ................................. 27.1 psi. (186.2 kPa)

Safety Valve Setting ......................40 psi. (275.8 kPa)

Certifications .................................ASME Boiler & Pressure Vessel Code,

34

Section VIII, Division1.
Canadian Registration Number Available

M11/M11D Sterilizer

UL61010A-1

LABORATORY

EQUIPMENT

59FM

Physical Dimensions:

Overall Length w/Plug ..................... 23.8 in. (60.5 cm)

Overall Width................................... 17.8 in. (45.2 cm)

Overall Height w/Printer .................. 17.8 in. (45.2 cm)

Counter Area................................... 17.8 in. x 21 in. (45.2 cm x 53.3 cm)

Chamber ......................................... 11.0 in. diam. x 18 in. deep

(28 cm diam. x 46 cm deep)

Standard Trays ..................... Large: 9 in. x 15 in. x 1 1/8 in.

(22.9 cm x 38 cm x 2.9 cm)

Small: 6 5/8 in. x 15 in. x 1 1/8 in.

(14.3 cm x 38 cm x 2.9 cm)

Weight:

Empty Reservoir.............................. 99.0 lbs (44.9 Kgs)

With Shipping Carton ...................... 131.0 lbs (59.4 Kgs)

Water Reservoir Capacity............. Approximately 1.4 Gallons (5.3 liters) to

Full Mark
usable volume is 1.0 gallons (3.8 liters)

Electrical Requirements:
NOTE: A separate (dedicated) circuit is required for this sterilizer. The sterilizer

should not be connected into an electrical circuit with other appliances or equip­ment unless the circuit is rated for the additional load.

115 VAC, 50/60 Hz Model ............... 15 AMP Circuit, Single Phase (1425 Watts)

230 VAC, 50/60 Hz Model ............... 10 AMP Circuit, Single Phase (1500 Watts)

Fuse Ratings

115 VAC Unit

F1 ................................. 0.25 Amp, 250 V, Slo-blo, 1/4" x 1 1/4"

F2 ................................. 15 Amp, 250 V, Fast Acting, 1/4" x 1 1/4"

230 VAC Unit

F1 ................................. 0.125 Amp, 250 V, Slo-blo, 5 x 20 mm

F2.................................. 8 Amp, 250 V, Fast Acting, 5 x 20 mm

Chamber Pressure at

270°F (132°C) ................................. 27.1 psi. (186.2 kPa)

Safety Valve Setting ...................... 40 psi. (275.8 kPa)

Certifications ................................. ASME Boiler & Pressure Vessel Code,

Section VIII, Division 1.
Canadian Registration Number Available

35

MA595000i

EJECT

4

B

3

A

1

2

7

6

5

Figure 1

PRINTER INSTALLATION AND OPERATION

The printer is an optional add-on that some units may have. The printer may al­so be purchased as an accessory at a later date and installed.

Installing the Printer

WARNING

Disconnect all

electrical power
to the unit before removing
any of the unit’s covers/
shrouds or making any re­pairs to prevent possibility
of electrical shock. Failure
to comply with these in­structions could result in
serious personal injury.

1. Unplug sterilizer power cord
from electrical outlet.

2. Using a flat bladed screw­driver, carefully pry existing
printer cover plate (1, Fig. 1)
from top cover (2) and dis­card (cover plate is held in

place with double sided
tape).

36

3. If not already assembled,
attach printer assembly (3)
to printer housing (4) by
inserting two locking tabs
(A) into locking slots (B). Set
printer assembly aside.

4. Remove two screws (5) and
one screw (6) securing right hand side panel (7).

5. Pull outward and down on top edge of right hand side panel (7) and remove
right hand side panel from sterilizer.

6. Route loose end of

R

1

3

A

MA595100i

4

2

Figure 2

3

4

5

B

A

1

2

Figure 3

PCB printer harness
(1, Figure 2) through
slot (A) in printer cav­ity (4) of top cover.

7. Plug PCB printer har­ness (1) into printer
terminal (2) of PC
Board.

8. Position printer
assembly (3) in
printer cavity (4).

9. Insert two tabs (A,
Figure 3) of right
hand side panel (1)
into slots (B) in
base (2).

10. Raise top edge of
right hand side panel (1) into
position under top cover (3)
and secure using two
screws (4) and one screw (5).
Make sure back lip of right
hand side panel is on outside
of back panel; not on inside.

11. Plug sterilizer power cord into

12. Insert a paper roll if necessary

electrical outlet.

(see Inserting Paper Roll later
in this manual).

Operating the Printer

When the sterilizer is plugged in,
the printer is automatically pow­ered up and initialized; no user in­tervention / setup is required.

37

Inserting the Paper Roll

1

MA465001i

A

6

D

C

7

2

5

3

4

B

Figure 4

1. Remove the
printer assem­bly (1,Fig. 4)
from the printer
cavity (A) and
turn it onto its
back.

2. Remove paper
spindle (2) from
used paper roll
and insert it in
new paper
roll (3).

3. Unroll 2 to 3
in.(5 to 7.5 cm)
of paper (3).

4. Cut a straight
edge on the
paper (3) if it is
torn or jagged;
this will facili­tate the entry of paper into the printer.

38

5. Slide the paper (3) into the slot (B) on the back of the printer; it will slide in 1/
4 in. (6.4 mm) before it stops.

NOTE

If paper (3) does not feed out of top of printer by itself, remove printer assembly (6)
from printer housing (7) by pulling two locking tabs (C) from locking slots (D). Feed pa­per through paper slot in printer housing (7) by hand and then re-attach printer assem­bly (6) to printer housing (7) by inserting two locking tabs (C) into locking slots (D).

6. While holding the paper (3) in place, press the PAPER FEED button (5) and
hold. The printer will activate and a rubber roller will pull the paper into the
printer compartment. Continue to hold the PAPER FEED button down until
the paper emerges from the top of the printer mechanism. Then, when 1 in.
(2.5 cm) of paper has emerged from the top of the printer, release the
PAPER FEED button.

7. Pull the paper (3) through the printer until 2 to 3 in. (5 to 7.5 cm) of paper is
exposed.

8. Install the paper roll (3) by inserting the ends of the paper spindle (2) in slots
of spindle holders (4).

9. Turn the paper roll so as to take up the slack in the paper feeding to the

EJECT

C

1

4

A

B

2

D

3

Figure 5

printer. Make sure the roll of paper turns freely. If it does not turn freely, the
paper will jam and possibly damage the printer mechanism.

10. Install the printer assembly (1) back into the printer cavity (A).

About the Cartridge Ribbon

The printer takes a cartridge ribbon. If the printed material is difficult to read
and you suspect a dried out ribbon is the cause of the problem, advance to a
properly inked portion of the ribbon by pressing the PAPER FEED button for
three seconds. When printing becomes faint or difficult to see and pressing the
PAPER FEED button for three seconds does not correct the problem, you
should replace the cartridge (see Installing a New Cartridge Ribbon later in this
manual).

Installing a New Cartridge Ribbon

1. Unplug the sterilizer power
cord from electrical outlet.

2. Remove the printer assembly
(1,Figure 5) from the printer
cavity (A).

3. Separate the printer (2) from
the cover (3) by slightly bend­ing the housing (B) to release
the locking tabs (C)

4. Push down on side of printer
cartridge (4) marked EJECT
and remove the old ribbon car­tridge.

5. When installing the new car­tridge be sure the ribbon is
inserted in front of the paper
and flat against the paper
Press the ribbon cartridge (4)
downward until it snaps into
place.

6. Turn the knob (D) on the rib­bon cartridge clockwise until
ribbon is tight.

.

7. Re-attach cover (3) to printer
(2) by inserting locking tabs (C) into slots of housing (B).

8. Place printer assembly (1) in cavity (A).

9. Plug sterilizer power cord into electrical outlet.

39

Removing the Paper Roll

EQUIPMENT ALERT

Be sure to pull the paper out of the top of the printer. Pulling the paper
out of the back of the printer will damage the printer mechanism.

Before removing the paper roll, advance the paper about 1 in. (2.5 cm) by press­ing down and holding the PAPER FEED button. Lift the paper roll away from the
printer housing, and with a scissors, cut the paper roll feeding to the printer. Try
to make the cut as straight as possible to facilitate the next reloading of the pa­per. Now, pull the remaining paper through the printer mechanism.

Power Up Message

When the printer successfully initializes after the sterilizer is powered up, it
prints the word READY to assure the operator that its built in microprocessor is working prop­erly and the sterilization cycles will be recorded by the printer.

Printer Tape Description

The printer will print the following information for each program cycle:
Cycle Number
Identification: a line is printed so the sterilizer I.D. can be recorded
on the printer tape.
Operator: a line is printed so the operator’s signature can be recorded
on the printer tape.
Date: lines are printed for the month, day, year, hour, and minute so the
date and time can be recorded by the operator on the printer tape.
“BEGIN selected
by the operator.
Summary of selected cycle set points.

CYCLE”: to indicate the beginning of the cycle selected

Once the cycle starts, the printer will print the words “FILLING CHAMBER”
to show that the sterilizer chamber is filling with water.

Once the sterilizer begins the Heating Phase of the sterilization cycle the word
“HEATING” is printed and the printer will print the chamber temperature,
pressure, and elapsed time in 30 sec. increments until the Heating
Phase is completed.

When the sterilizer enters the Sterilization Phase the word “STERILIZING” is
printed and the printer will print the chamber temperature, pressure, and
elapsed time in 30 sec. increments until the Sterilization Phase is completed.

When the sterilizer has completed the Sterilization Phase of the program cycle,
the printer will print the words “VENTING CHAMBER” to show that the steam
pressure is being exhausted from the chamber.

40

When the sterilizer enters the Drying Phase the word “DRYING” is printed and
the printer will print the elapsed time in 5 minute increments starting with 0:00
and the words “Drying Start”. The printer continues to print the elapsed time in
5 minute increments until the Drying Phase is completed. The final record for
the Drying Phase will include the words “Drying Complete”. In the event the
Drying time is programmed to a time that isn’t divisible by 5 the final printed
record for the Drying Phase will reflect the actual programmed drying time in 1
minute increments, e.g. a programmed Dry time of 12 minutes will have 5, 10,
and 12 minutes printed on the printer tape.

When the sterilizer has completed the Drying Phase of the sterilization cycle the
printer will print a summary of the sterilization cycle with the duration of each
phase of the cycle and the Total Cycle Time. Following the summary the printer
will print “CYCLE COMPLETE”.

NOTE

In the event the Drying Phase is aborted by the operator before it is complete the words
“Drying Complete” and “CYCLE COMPLETE” will not be printed.

41

The figure below shows an example of a typical printout of a program cycle:

Line provided for
sterilizer identification.

Space provided for
recording date & time.

Sterilization temperature
& time, and Dry time
set points.

During Heat-Up Phase,
the printer records chamber
temperature & pressure in
30 sec. increments.

During Sterilization Phase
the printer records chamber
temperature & pressure in
30 sec. increments.

Midmark M9 - v1.0.3
Total Cycles: 10

- - - - - - - - - - - - - - - - - - ­ Sterilizer ID

- - - - - - - - - - - - - - - - - - ­ Operator

- - / - - / - - - - - - : - ­ mm / dd / yyyy hh : mm

BEGIN UNWRAPPED CYCLE
Temp: 270 Degrees F
Time: 3 Minutes
Dry: 30 Minutes

FILLING CHAMBER

HEATING
mm:ss Degrees PSI
0:00 233.8 F 0.0
0:30 231.3 F 1.9
8:00 265.7 F 25.0
8:30 271.3 F 28.8

STERILIZING
mm:ss Degrees PSI

0.00 271.8 F 28.9
0:30 272.4 F 29.5
2:30 272.7 F 29.3
3:00 272.6 F 29.3

Total # of cycles
run on unit.

Line provided for
Operator Signature.

Selected Cycle

Indicates Chamber
filling phase initiated.

Indicates venting
phase initiated.

These lines will show the
total Dry time completed.

42

Min 271.8 F 28.7
Max 273.2 F 29.9

VENTING CHAMBER

DRYING
mm:ss
0:00 Drying Start
5:00
25:00
30:00 Drying Complete

FILLING: 3:22
HEATING: 8:54
STERILIZING: 3:00
VENTING: 2:16
DRYING: 30:00
TOTAL CYCLE: 00:47:32

CYCLE COMPLETE

Summary of
Sterilization phase.

During Drying phase
the printer records
drying time in 5
minute increments.

Cycle
Summary

These lines don’t print
if Dry Cycle is aborted
before it completes.

LIMITED WARRANTY

SCOPE OF WARRANTY

Midmark Corporation (“Midmark”) warrants to the original purchaser its new Alter­nate Care products and components (except for components not warranted under
“Exclusions”) manufactured by Midmark to be free from defects in material and
workmanship under normal use and service. Midmark’s obligation under this war­ranty is limited to the repair or replacement, at Midmark’s option, of the parts or the
products the defects of which are reported to Midmark within the applicable warranty
period and which, upon examination by Midmark, prove to be defective.

APPLICABLE WARRANTY PERIOD

The applicable warranty period, measured from the date of delivery to the original
user, shall be one (1) year for all warranted products and components.

EXCLUSIONS

This warranty does not cover and Midmark shall not be liable for the following: (1)
repairs and replacements because of misuse, abuse, negligence, alteration, acci­dent, freight damage, or tampering; (2) products which are not installed, used, and
properly cleaned as required in the Midmark “Installation” and or “Installation / Oper­ation Manual for this applicable product. (3) products considered to be of a consum­able nature; (4) accessories or parts not manufactured by Midmark; (5) charges by
anyone for adjustments, repairs, replacement parts, installation, or other work per­formed upon or in connection with such products which is not expressly authorized
in writing in advance by Midmark.

EXCLUSIVE REMEDY

Midmark’s only obligation under this warranty is the repair or replacement of defec­tive parts. Midmark shall not be liable for any direct, special, indirect, incidental,
exemplary, or consequential damages or delay, including, but not limited to, dam­ages for loss of profits or loss of use.

NO AUTHORIZATION

No person or firm is authorized to create for Midmark any other obligation or liability
in connection with the products.

THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED. MIDMARK MAKES NO
IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. THIS
WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE
PART S.

SF-1487 REV. A1

Limited
Warranty

43

Notes:

44

Midmark Corporation

To reorder informational materials for this unit, use the following part numbers:
User Training CD: Go to Midmark.com Paper I/O Manual: 003-1249-00

60 Vista Drive
P.O. Box 286
Versailles, Ohio 45380-0286
937-526-3662
Fax [phone]
midmark.com

003-1249-00 Rev. Z (11/22/2011)