Midmark M9-042, M9D-042, M9-041, M9-040, M11-042 User Manual
...
M9 / M9D / M11
Self -Contained Steam Sterilizer
English
Español
Français
For Models:
M9 (-040 / -041 / -042)
M9D (-042)
M11 (-040 / -041 / -042)
User Guide
TP202 20-42-FO-00014 Rev A1 C2169
TP202 20-42-FO-00014 Rev A1 C2169 TP202 20-42-FO-00014 Rev A1 C2169
Style U
003-2915-99 Rev AA8 (12/30/19)
Product Information
Attention Canadian Users - Action Required!
Thank you for purchasing an M9/M11 Steam Sterilizer.
To comply with changes in Canadian regulatory requirements you must now provide documentation, a
Manufacturer’s Data Report (MDR), to your appropriate provincial regulatory agency when purchasing and
using a steam sterilizer.
To obtain the MDR from Midmark, record the sterilizer Serial Number and the ASME National Board Number
of your sterilizer. See the illustration below for the location of these numbers. Then, contact Midmark
customer service at 1.800.MIDMARK and provide the recorded numbers.
Midmark will then complete the MDR and send it to you. Once you have the MDR, you must submit it to the
appropriate provincial regulatory agency.
We apologize for any inconvenience and appreciate your assistance in helping maintain compliance
to Canadian regulations for sterilizers. If you have any questions or concerns, please contact 1.800.
MIDMARK.
Serial Number
003-2915-99
ASME National Board
Number Location
English - 2
Product Serial
Number Location
© Midmark Corporation 2018
Table of Contents
Important Information
Safety Instructions ...........................................4
Intended Use....................................................4
Sterilization Technology ...................................4
Electromagnetic Interference ...........................4
Safety Symbols ................................................4
Shipping Symbols ............................................5
Transportation / Storage Conditions ................5
Accessories, Tools and Service Parts. .............5
Included with Sterilizer .....................................6
Component Location ........................................7
Controls and Indicators ....................................8
Sterilization Monitoring Guidelines.................10
Installation
Operating Environment .................................. 11
Location Requirements .................................. 11
Electrical Requirements .................................12
Connecting the Power Cord ...........................13
User Settings .................................................14
Operation
Before Operating the Sterilizer.......................15
Filling the Reservoir .......................................15
Qualication Testing .......................................16
Guidelines for Loading ...................................16
Standard Cycle Parameters ...........................24
Cycle Operation .............................................25
Post-Sterilization Processing .........................28
Programmable Cycle Buttons ........................29
Thermal Printer (Optional)
Operating the Printer......................................38
Printer Tape Description ................................38
Example of Typical Printout
of a Program Cycle ........................................39
Paper Roll Removal / Installation ...................40
Tray and Cassette Tool (optional)
Using the Optional Tray / Cassette Tool.........41
Troubleshooting
Troubleshooting Chart ....................................42
Informational Messages .................................43
Accessing the last 5 Error Codes ..................43
Error Messages..............................................43
Calling for Service ..........................................45
Specications / Compliance
Specications Chart:
M9 / M9D .................................................46
M11 .........................................................47
Water Purity Specications ............................48
Warranty Information
Scope of Warranty .........................................49
Maintenance
Maintenance Messages .................................31
Daily Maintenance .........................................32
Weekly Maintenance ......................................33
Monthly Maintenance .....................................35
Extended Use Maintenance ...........................37
003-2915-99
English - 3
© Midmark Corporation 2018
Important Information
Safety Instructions
The primary concern of Midmark is that this equipment is operated and maintained with the safety of the
patient and sta in mind. To assure safe and reliable operation:
• Read and understand this manual before attempting to install or operate the sterilizer.
• Assure that the 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 axed
to the sterilizer.
Intended Use
The Midmark and Ritter M9, M9D and M11 Steam Sterilizers can be used in medical and dental oces,
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 Guidelines
for loading and Standard Cycle Parameters in this manual for detailed information.
Sterilization Technology
The Midmark M9 / M9D and M11 utilize a dynamic air removal system called Steam Flush Pressure Pulse to
remove air from the chamber.
Electromagnetic Interference
This sterilizer is designed and built to minimize electromagnetic interference with other devices. However, if
interference is noticed between another device and this product:
• Remove interfering device from room
• Plug sterilizer into isolated circuit
• Increase separation between sterilizer and interfering device
• Contact Midmark if interference persists
Safety Symbols
WARNING
Indicates a potentially hazardous situation which could result in serious injury.
Caution
Indicates a potentially hazardous situation which may result in minor or moderate injury.
It may also be used to alert against unsafe practices
Equipment Alert
Indicates a potentially hazardous situation which could result in equipment damage.
003-2915-99
English - 4
© Midmark Corporation 2018
Shipping Symbols
Caution Shipping Damage
Keep dry
Proper shipping orientation
Max. stacking height
Fragile
(Refer to “n” number on package)
Transportation / Storage Conditions
Equipment Alert
Water must be drained from the unit’s reservoir before transporting / storing below +32°F (0°C).
Ambient Temperature Range: -22°F to 140°F (-30°C to +60°C)
Relative Humidity: 10% to 90% (non-condensing)
Atmospheric Pressure: 7.2 psia to 15.4 psia (49.6 kPa to 106.4 kPa)
Accessories, Tools and Service Parts
Unless noted, items can be used on the M9 / M9D and M11.
Accessories Order Number
Speed-Clean, 1 (16oz. [.47 liter]) bottle 002-0396-00
Speed-Clean, 1 case (12 - 16oz. [.47 liter]) bottles 002-0396-05
Thermal Printer 9A599001
Cassette Rack (Horizontal) 9A215001 (M11 only)
Cassette Rack (Vertical) 9A215002 (M11 only)
Printer Thermal Paper Roll (Rell) 060-0016-00
Printer Stick-able Thermal Paper (Rell) 060-0016-01
Door and Dam Gasket Kit (M11 only) 002-0504-00
Door and Dam Gasket Kit (M9 / M9D only) 002-0361-01
Pouch Rack Kit (M11 only) 002-2108-00
Pouch Rack Kit (M9 / M9D only) 002-2108-01
Tray/Cassette Tool 9A307001
VistaCool ™ direct-to-drain thermal reduction system 9A586002 (Dual)
003-2915-99
Common Service Parts / Tools Order Number
English - 5
© Midmark Corporation 2018
Included with Sterilizer
Speed-Clean
Power Cord
Speed-Clean SDS SheetCare / Operation Card
2 Small Trays
Pouch Rack
(M11 Rack Shown)
003-2915-99
English - 6
2 Large Trays
© Midmark Corporation 2018
Component Location
Display / Touch Pad
Pressure Relief
Valve Test Lever
Fill Opening
Door Gasket
Dam Gasket
Thermal Printer
(optional)
Tray Rack
Tray(s)
Water Level Indicator /
Reservoir Drain Tube
Tray Plate
003-2915-99
English - 7
© Midmark Corporation 2018
Controls and Indicators
The sterilizer controls and indicators are shown in the illustrations on this, and the following page.
The accompanying tables describe the function of each control / indicator.
Control Function
Display See illustration Indicates cycle selected, cycle temperature and exposure time
for the selected cycle. During the cycle, display shows messages
describing status of cycle. When cycle 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 the Troubleshooting section of this manual for a
detailed explanation of Informational / Error Messages.
Unwrapped button
A program cycle designed to process unwrapped instruments at:
270°F (132°C) for 3:00 minutes / 30 minute drying cycle.
Pouches button
Packs button
Handpieces
button
Start button
Stop button
1 or 2 buttons
NOTE: All material
run in these cycles
must be validated
for sterilization by
the user.
003-2915-99
A program cycle designed to process instruments in combination
paper / plastic sterilization pouches or wrapped instruments
at: 270°F (132°C) for 4 minutes / 30 minute drying cycle.
A Program cycle designed to process packs of instruments or
textiles at: 250°F (121°C) for 30 minutes / 30 minute drying
cycle.
A program cycle for dental handpieces which runs at:
270°F (132°C) for 4 minutes / 30 minute drying cycle.
Initiates selected program or, when SELECT CYCLE is displayed,
pressing Start will activate heater for 10 minutes.
Terminates selected program or function.
Programmable cycle buttons that allow an operator to create two
dierent programmed cycles for special applications. Sterilization
time and temperature, along with drying time and venting procedure can be adjusted or changed.
Caution
These cycles are not FDA cleared and validation of sterility
of items processed using them is the responsibility of the
user.
English - 8
© Midmark Corporation 2018
Controls and Indicators - continued...
Pressure Relief
Thermal Printer
Fill Opening
Water Level Indicator and
Reservoir Drain Tube
(optional)
Door Handle
Control Function
P button Programming mode button that allows operator to
change temperature, time, dry time and/or venting
procedure. Used in conjunction with buttons 1 or 2.
(Refer to Programming Mode).
+ (plus) button
- (minus) button
Door Handle refer to illustration For latching / opening door.
Water Level Indicator /
Reservoir Drain Tube refer to illustration
Fill Opening refer to illustration Access for lling reservoir with water.
Pressure Relief Valve Test Lever refer to illustration Allows operator to check pressure relief valve.
Thermal Printer (Optional) refer to illustration The printer (optional equipment) can be used to
Allows temperature, time, vent mode or dry time to
be increased or changed when in location 1 or 2
and the P (programming) mode is activated.
Allows temperature, time, vent mode or dry time to
be decreased or changed 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.
provide a permanent record of time, temperature,
and pressure during a cycle.
Valve Test Lever
003-2915-99
English - 9
© Midmark Corporation 2018
Sterilization Monitoring Guidelines
Note
This information below is provided for reference only. Contact appropriate state/local agencies for
specific sterilization guidelines for your office. Additional information on infection control is available
from the Centers for Disease Control and Prevention (CDC), Organization for Safety and Asepsis
Procedures (OSAP) ), Association for the Advancement of Medical Instrumentation (AAMI), and
Association for Professionals in Infection Control and Epidemiology (APIC).
Physical Monitors
Temperature and pressure measuring devices can help detect sterilizer malfunctions. The sterilizer’s control
system aborts the cycle and displays a message if physical conditions go outside established limits. The
optional thermal printer can be used to create a record of each load’s actual cycle time, temperature, and
pressure.
Note
Use only FDA cleared chemical and 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. Follow manufacturer’s instructions for proper
disposal of used indicators.
Chemical Indicators
Chemical indicators are designed to verify that conditions in the sterilizer chamber were adequate to achieve
sterilization. They do not validate that a processed item is sterile. If a chemical indicator shows a failure,
items in that load are considered non-sterile. Potential causes for sterilization failure include: improper
cleaning, packing, loading, or a sterilizer malfunction. Determine the cause of any sterilization failure, and
remedy the situation before running the next cycle. Only FDA cleared chemical indicators labeled for use
with the steam sterilization cycle parameters. e.g. temperature and exposure time, of the M9 / M9D / M11
Sterilizers should be used for monitoring the cycles. Follow the chemical indicator’s instructions for proper
storage, use, interpretation, and disposal.
Biological Indicators
Biological indicators are microbiological devices designed to accompany items being sterilized to monitor
adequacy of the sterilization process. If a biological indicator shows a failure, items in that load are
considered non-sterile. Potential causes for sterilization failure include: improper cleaning, packing, loading,
or a sterilizer malfunction. Determine the cause of any sterilization failure, and remedy the situation before
running the next cycle. Only FDA cleared biological indicators labeled for use with the steam sterilization
cycle parameters. e.g. temperature and exposure time, of the M9 / M9D / M11 Sterilizers should be used for
monitoring the cycles. Follow the biological indicators instructions for proper storage, use, interpretation, and
disposal.
003-2915-99
English - 10
© Midmark Corporation 2018
Installation
Operating Environment
Ambient Temperature Range: 68°F to 104°F (+20°C to +40°C)
Relative Humidity: < 80% (non-condensing)
(Pollution Degree 2, in accordance to IEC664)
Normal Operating Altitude: < 9842 ft. (3000 m) above sea level
Device approved for INDOOR USE ONLY.
Device to be operated in a relatively dust-free environment.
(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 IEC664)
The M9 / M9D and M11 will emit 5000 BTU / HR during operation.
Location Requirements
Allow Clearance
on Both Sides
003-2915-99
Clearance
5"
(13 cm)
2"
(5 cm)
Support Surface
English - 11
1"
(3 cm)
Requirements
5"
(13 cm)
Overhang/Shelf
M9/M9D
15"
(38 cm)
M11
18"
(46 cm)
M9/M9D
M11
21"
(53 cm)
© Midmark Corporation 2018
2"
(5 cm)
18"
(46 cm)
M11
23" (58 cm)
M9/M9D
22" (56)
Location Requirements - continued...
Support Surface
• Material should be water-resistant material. (Ex. laminate, stainless steel, stone, etc.)
• Surface must be level to ensure chamber lls with correct water level.
Improper water level in the chamber could cause a sterilizer malfunction.
• Surface should meet minimum dimensions listed below:
Dimensions
Depth (front to back) M11 - 21” (53 cm) M9 / M9D - 18” (46 cm)
Clearance Requirements
To ensure proper air circulation, and to allow access to the reservoir ll port and drain coupling,
adhere to the minimum clearance requirements listed below. If the sterilizer will be operated
in continuous cycles, locate sterilizer where steam will not damage materials or equipment in
the surrounding area.
Back of Unit - Back Wall ................................. 2” (5 cm)
Front Support Surface - Front Sterilizer ........ 1” (3 cm)
Sides of Unit - Side Wall ................................ 2” (5 cm)
Distance above Unit for Printer Access .......... 5” (13 cm)
Maximum Upper Cabinet Shelf Overhang ..... M11 - 18” (46 cm) M9 / M9D - 15” (38 cm)
Under Cabinet or Shelf................................... M11 - 23” (58 cm) M9 / M9D - 22” (56 cm)
Relocation Requirements for Sterilizer
Disconnect power cord from electrical outlet and allow sterilizer to cool.
Drain water from reservoir or do not tip sterilizer, allowing water to spill.
Electrical Requirements
WARNING
For 115 VAC models: Use 104 - 127 VAC, 50/60 Hz alternating current only.
For 230 VAC models: Use 207 - 253 VAC, 50/60 Hz alternating current only.
Failure to do so may result in electric shock to personnel and / or damage to sterilizer.
Note
For safety, the unit must be connected to a properly polarized and grounded receptacle. Always use a
power cord with grounding connections that match the receptacles in your location.
115 VAC Unit: 115 VAC, 50/60 Hz, 12 amp
Dedicated Supply Circuit*: 120 VAC, 50/60 Hz, 15 amp
Max. Power Consumption: 1425 Watts
230 VAC Unit: 230 VAC, 50/60 Hz, 6.4 amp
Dedicated Supply Circuit*: 230 VAC, 50/60 Hz, 10 amp
Max. Power Consumption: 1500 Watts
* Power source must have over-voltage limits less than 1500 watts from mains to ground.
(Installation Category II in accordance to IEC664)
003-2915-99
English - 12
© Midmark Corporation 2018
Connecting the Power Cord
WARNING
Equipment is not suitable for use in the presence of a flammable anesthetic mixture
with oxygen, air, or nitrous oxide.
Clarification: Equipment is suitable for use in the presence of oxygen, air, or nitrous oxide.
WARNING
Check the serial number label on back panel of sterilizer to verify voltage rating for
the unit. Failure to connect sterilizer to an appropriate power supply could result in
damage to the unit, and electrical shock to personnel.
Equipment Alert
For optimal performance, allow sterilizer to reach room temperature before operating.
To connect the power cord...
A) Plug power cord into receptacle on back of sterilizer.
B) Plug power cord into a properly polarized and grounded receptacle rated for a
minimum of 15 amps. A dedicated circuit only used for the sterilizer is recommended.
C) M9 / M9D and M11 are not equipped with an on/off switch, the display operates off
very low power. (example: microwave oven display)
Note: When power is connected, the messages shown below will appear on the display.
Display:
Voltage Rating
*
*
* These screens will display the total number of cycles run on the unit, the model number
(M9 / M9D or M11), the software version number, serial number date, and time.
003-2915-99
English - 13
© Midmark Corporation 2018
User Settings
User setting mode will enable the user to set the desired unit of measure and adjust the time
clock. To enter the user settings mode, unplug and replug the power cord while pressing and
holding the button until the User Settings screen below appears.
Action Description Display
Press Press start to initialize the User Settings
menus.
Adjust Units of
Measure
Press
Adjust Time Clock The “+“ and “-” buttons will adjust the
Press To store setting and bring up the next
NOTE: User Settings for Date and Clock must be updated manually for day light savings.
003-2915-99
The “+” and “-” buttons alternate the
setting between English or Metric
When the desired Units of Measure
appear on the display...
To store the desired Units of Measure
This brings up the Time Clock programing
display
values of the following settings
- Year / Month / Day / Hour / AM or PM /
Minute.
When the desired values appear on the
display...
setting in the list. Repeat as necessary
for all settings. When all settings are
completed pressing the “P” will initiate
normal power up.
English - 14
© Midmark Corporation 2018
Operation
Before 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 explosive conditions could result.
Do not force door handle at any time. Chamber pressure may cause door to 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.
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.
Caution
Programmable cycles 1 and 2 are provided for those applications requiring sterilization
parameters different than the preset cycles. These cycles are not FDA cleared for medical
use. All material processed in these cycles must be validated by the user to ensure sterility of the
processed load.
For optimal performance, allow the sterilizer to reach room temperature before operating.
Equipment Alert
Filling the Reservoir
To fill reservoir...
A) Open door to unit.
B) Pour distilled water into fill opening until
water level reaches the top of the fill level
label on the water level indicator tube.
Equipment Alert
Use distilled water or water that meets the
referenced water purity specifications.
Failure to comply may result in sterilizer
malfunction and/or premature failure due
to excessive corrosion.
003-2915-99
English - 15
© Midmark Corporation 2018
Qualication Testing
Your sterilizer should be tested after sterilizer installation, malfunctions, relocation, major repairs, and
after sterilization process failure. Qualication testing should be performed prior to placing the sterilizer in
service. If multiple cycle types are used, e.g. “Pouches” and “Packs” each cycle type should be qualied.
Qualication testing should include at least one Biological Indicator (BI) (sometimes referred to as Spore
Tests) and one Chemical Indicator (CI). The test pack should be placed on the bottom tray near the chamber
door and performed with items routinely processed and considered to be the most dicult to sterilize.
Additional items should be placed in the chamber along with the Biological Indicator and Chemical Indicator
so that chamber is fully loaded (don’t exceed the maximum capacities listed in the tables under “Guidelines
for Loading” in this manual). Three consecutive test runs, for each cycle type tested, with negative results
from the BIs, and the appropriate readings from all physical monitors and chemical indicators demonstrating
complete sterilization, provide verication that the sterilizer has been properly installed (or reinstalled after
relocation) or repaired to the manufacturer’s specications and that it will function eectively in the facility in
which it is installed. All items processed during qualication testing should be quarantined until the results of
the biological testing for all three test runs are available.
Guidelines for Loading
All items must be processed in accordance with Centers for Disease Control and Prevention (CDC),
“Guidelines for Infection Control in Dental Healthcare Settings” – 2003, MMWR; 52 (no.RR-17), and
“Guidelines for Disinfection and Sterilization in Healthcare Facilities” – 2008, which states:
“Items to be sterilized should be arranged to permit free circulation of the sterilizing agent (e.g.,
steam, chemical vapor, or dry heat); manufacturer’s instructions for loading the sterilizer should
be followed.”
Equipment Alert
Loads must be placed on trays at all times – unless the optional cassette racks are
used – otherwise, serious instrument or equipment damage may occur.
Types of Items that can be processed in the M9 / M9D and M11
Before placing any instrument in the M9 / M9D or M11, check with the instrument manufacturer to be sure
the
materials are compatible with steam sterilization, and to verify the acceptability of sterilization parameters.
The M9 / M9D and M11 are designed to sterilize the following:
• Metal instruments
• Rubber / plastic devices (ex. suction cannulas, impression trays, etc.)
• Wrapping / bundling materials (ex. CSR wrap, instrument pouches, etc.)
• Cassettes (which t in the sterilizer trays or the cassette rack accessories)
• High / low speed handpieces
• Surgical instruments (ex. opthalmologic instruments)
003-2915-99
English - 16
© Midmark Corporation 2018
Types of Items that can be processed in the M9 / M9D and M11 - Continued...
Equipment Alert
Do not sterilize items composed of any of the following materials in the M9 / M9D or M11.
• Corrosion sensitive metal (ex. carbon steel, iron, etc.)
• Fragile items susceptible to breaking under pressure / high temperature
• Biomedical waste
• Plastics that may break down or produce residue when exposed to steam / high
temperatures.
Examples
Polyethylene, Styrene, Cellulosics, ABS, PVC, Acrylic (Plexiglass™), PPO (Noryl™),
Latex, and Neoprene
Preparing Items for Sterilization
WARNING
Clean and dry instruments thoroughly before placing them into tray. Improper cleaning may
result in non-sterile instruments or damage to the unit. Follow instrument manufacturer’s
guidelines and CDC recommendations for handling and cleaning instruments prior to sterilization.
Instruments must be thoroughly cleaned to remove all residual matter, such as debris, disinfectant
residuals, blood, organic tissue, etc. General cleaning guidelines are listed below but the device
manufacturer’s instructions for proper cleaning and preparation of the device for sterilization should always
be followed:
• Clean instruments immediately after use to avoid drying of residual matter.
• The use of automated cleaning equipment (e.g. ultrasonic cleaner or washer-disinfector) is
recommended over manual cleaning for clinician safety and cleaning eectiveness.
• After cleaning, thoroughly rinse instruments with tap water to remove any loosened debris or
residual cleaning uid. The purity of tap water varies signicantly thus, it’s recommended the nal
rinse be done with water of adequate quality to avoid instrument staining. After rinsing
instruments should be inspected for damage, debris, detergent residue and then dried before
packaging.
• If the instrument manufacturer’s instructions require lubrication of the instruments after cleaning,
wipe o excess lubricant before packing for sterilization or loading into the sterilizer.
Immediate Use Sterilization
The M9 / M9D and M11 are capable of Immediate Use sterilization - sterilizing unwrapped instruments for
immediate use. Place a surgical cotton towel, paper tray liner or CSR wrap folded to t on the tray bottom
before putting unwrapped items in the tray. Arrange unwrapped items on the towel so they do not touch one
another (See Photo 1).
003-2915-99
English - 17
© Midmark Corporation 2018
Immediate Use Sterilization - Continued...
Photo 1
Please consider the following when choosing whether or not to sterilize your instruments unwrapped:
• The sterility of unwrapped instruments is compromised upon exposure to a non-sterile
environment. Follow CDC guidelines for using unwrapped, sterilized instruments.
• Due to the sensitive nature of some types of surgery (including, but not limited to
ophthalmological), instruments used in such procedures must be wrapped or pouched in order
to reduce their exposure to sterilization process residues. The water reservoir should also be
drained and relled with fresh distilled water on a daily basis when processing instruments for
these procedures on a routine basis
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. Items and packaging should be completely dry when removed from
the sterilizer to minimize the potential for recontamination.
General Guidelines
• Use only M9 / M9D and M11 trays in their appropriate sterilizer. Using other trays could restrict air
/steam ow to items resulting in inadequate sterilization and drying.
• All items must t within the tray and not extend over the lip of the sterilizer tray. Instruments
must not scrape the chamber walls when sliding the tray into the chamber.
• Jointed items must be sterilized in an open position so all surfaces are exposed to the steam
(See Photo 2).
003-2915-99
English - 18
© Midmark Corporation 2018
General Guidelines - Continued...
Photo 2
• Handpieces and instruments must be arranged in a single layer on the trays (not piled or
stacked), to permit proper steam ow and drying.
• Glassware or utensils capable of holding water, e.g. bottles, basins, beakers, etc., should be
positioned on the tray with the open side down so any water condensate drains from the
container (See Photo 3). When sterilizing glassware check with the manufacturer to make sure
it is compatible with steam sterilization.
Photo 3
• Rinse tubing with distilled water or water that meets the referenced water purity specications
and do not dry prior to sterilizing. Arrange tubing on the tray so there are no sharp bends and
the tubing ends are open and unobstructed (See Photo 4).
Photo 4
003-2915-99
English - 19
© Midmark Corporation 2018
General Guidelines - Continued...
• Follow the device manufacturer’s instructions for disassembly of multi-part instruments prior to
packaging / sterilization to assure all parts are adequately exposed to the steam.
• If items are being sterilized and stored for later use they must be packaged, e.g. pouched,
wrapped, etc., and completely dry when removed from the sterilizer chamber to avoid potential
recontamination.
• Variations in load conguration, size, wrapping materials, and the environment may require the
operator to increase the default drying time to assure all packaging and instruments are
completely dry. See “Cycle Operation” section of this manual for instructions on adjusting drying
time.
• When sterilizing a load that contains one or more handpieces, utilize the hand piece cycle, not
Pouches or Unwrapped Cycle.
Pouching and Wrapping Items
The M9 / M9D and M11 are capable of sterilizing pouched or wrapped items to preserve sterility
after processing.
• When pouching or wrapping items, use only sterilization pouches and wraps that have been
cleared by the FDA and labeled for use with the steam sterilization cycle being used. Follow the
manufacturer’s instructions for use.
• Instruments made from dierent materials (stainless steel, carbon steel, plastic, etc.) should not
be mixed in the same pouch or wrapped pack to avoid potential instrument damage.
• Pouches, wraps and the included instruments should not touch the chamber wall to allow proper
steam circulation and avoid potential instrument damage.
• For proper steam circulation and drying the preferred orientation of pouches is resting on their
edge, best accomplished using the Midmark Pouch Rack supplied with the M9 / M9D / M11
sterilizer. If additional pouch racks are needed order kit P.N. 002-2108-00 (M11- 6 slot) or
002-2108-01 (M9 / M9D - 5 slot). If more than two (2) pouch racks are used in a single load
additional dry time may be required.
M11 Pouch Rack
002-2108-00
• The use of the Pouch Rack requires the removal of some of the sterilizer trays. When using the
Pouch Rack load a single pouch per rack slot. When using paper / plastic sterilization pouches
the pouches should be oriented in the rack so the plastic side of one pouch faces the paper side
of the adjacent pouch.
• Pouches loaded directly in the trays will dry best if loaded with plastic side up.
• Do not layer pouches in the trays. Pouches should be loosely packed with handpieces and
instruments single height loaded (not piled or stacked), to permit proper steam ow and
penetration to the items (See Photo 2).
003-2915-99
English - 20
M9 / M9D Pouch Rack
002-2108-01
© Midmark Corporation 2018
Pouching and Wrapping Items - Continued...
• If pouches or wrapped packs are labeled using a marking pen the ink should be nontoxic. On
paper-plastic pouches only mark on the plastic side of the pouch. On wrapped packs mark the
labeling information on the indicator tape or apply a separate label.
Shown below are some recommended pouch load congurations for the M9 / M9D (Photo 5 and 6)
and M11 (Photo 7 and 8):
M9 / M9D Pouches with Pouch Rack
Photo 5
M11 Pouches with Pouch Rack
Photo 7
M9 / M9D Pouches Mixed
Photo 6
M11 Pouches Mixed
Photo 8
• When using cassettes in the M9 / M9D / M11, follow the cassette manufacturer’s instructions for
use.
• Do not wrap items too tightly. Sterilization can be compromised if an item is excessively
wrapped and the wrap is more likely to tear if wrapped too tightly.
• Cassettes can be loaded on the trays but they must t within the boundaries of the tray and they
should not touch each other, the tray above, or the chamber wall to allow proper steam
circulation. The total instrument load, including the cassettes, should not exceed the limits listed
in maximum capacities tables.
• When using the optional Horizontal and Vertical cassette racks (9A215001 and 9A215002) in
the M11 the maximum load including the cassettes can be increased to 12 lbs. (5.44 kg).
Additional dry time may be required.
003-2915-99
English - 21
© Midmark Corporation 2018
Pouching and Wrapping Items - Continued...
Shown below are some recommended cassette load congurations for the M9 / M9D (Photos 9 and10) and
M11 (Photos 11, 12, 13, and 14):
M9 / M9D Large Cassette
Photo 9
M11 Mixed Load with Cassette and Pouches
Photo 11
M9 / M9D Mixed Load with Small Cassette and Pouches
Photo 10
M11 with Vertical Cassette Rack
Photo 12
003-2915-99
M11 with Horizontal Cassette Rack
Photo 13
English - 22
M11 with Horizontal Cassette Rack and Top Tray
Photo 14
© Midmark Corporation 2018
Textile Loads
• Clean textiles recommended for steam sterilization can be processed in the Packs cycle. Verify the
acceptability of the Packs cycle sterilization parameters with the textile manufacturer to assure the
textiles are compatible.
• All textile packs must not exceed the thickness limits specied in the maximum capacity tables below
and must t within the boundaries of the sterilizer trays.
• If multiple packs are placed on a single tray maintain a minimum of 1/4” (6.4 mm) between packs for
proper steam circulation and drying. (Photo 15)
Equipment Alert
Do not use towels or packaging containing chlorine bleach
residue. Failure to comply may cause rusting or discoloration
of the chamber / trays, and significantly shorten the life of the
sterilizer.
Textile load
Photo 15
Load Size
Successful sterilization is dependent on correct loading of the sterilizer. Do not overload the sterilizer
chamber! Adequate space must be maintained around all items placed in the chamber to assure proper
steam circulation and adequate drying. The charts below are provided as a reference regarding the
maximum loads that can be processed in the sterilizers but maintaining proper spacing between all items
processed to assure good steam circulation and drying should be the guiding factor in determining the
maximum load that can be processed.
M9 / M9D Maximum Capacities **
Load Type Large Tray Small Tray Total
Solid Instruments 2.4 lbs. (1089 grams) or 1.6 lbs. (726 grams) or 8.0 lbs. (3629 grams) or
Handpieces 2 handpieces with other
Packs* 90 in
instruments
2.4 lbs. (1089 grams) or
3
≤ 1.25 in. thick
(1475 cm3 ≤ 3.2 cm thick)
2 handpieces with other
instruments
1.6 lbs. (726 grams) or
55 in3 ≤ .75 in. thick
(901 cm3 ≤ 1.9 cm thick)
8 handpieces with other
instruments
8.0 lbs. (3629 grams) or
3
290 in
(4752 cm3)
M11 Maximum Capacities **
Load Type Large Tray Small Tray Total
Solid Instruments 2.7 lbs., (1225 grams) or 1.8 lbs., (816 grams) or 9.0 lbs., (4082 grams) or
Handpieces 2 handpieces with other
Packs* 145 in
* Allow a minimum of 1/4” (6.4 mm) space between each pack, and from the chamber wall.
** The default dry time may need increased due to variations in load conguration, wrapping materials, and the environment to
completely dry the chamber contents at these capacities.
003-2915-99
instruments
2.7 lbs. (1225 grams) or
3
≤ 1.5 in. thick
(2376 cm3 ≤ 3.8 cm thick)
English - 23
2 handpieces with other
instruments
1.8 lbs. (816 grams) or
108 in3 ≤ 1.5 in. thick
(1770 cm3 ≤ 3.8 cm thick)
8 handpieces with other
instruments
9.0 lbs. (4082 grams) or
3
505 in
(8275 cm3)
© Midmark Corporation 2018
Standard Cycle Parameters
Cycle Parameters
Drying
(Ref.)
1
Time
30 min. • Instruments loose on a tray.
30 min. • Pouched or loosely wrapped instruments.
30 min. • Textiles and surgical packs wrapped for
30 min. • Dental handpieces (wrapped or unwrapped).
Cycle Type
Temp.
Time Press.
(Min.)
270°F
(132°C)
Unwrapped
Pouches
Packs
Handpieces
1. The pressure shown in this table is for reference only. It’s the ideal pressure of saturated steam
at the sterilization temperature. The pressure shown on the sterilizer display may be higher.
2. Dry time can be changed from 0 to 60 minutes. Refer to Cycle Operation.
270°F
(132°C)
250°F
(121°C)
270°F
(132°C)
3 min. 27.1 psi
(186 kPa)
4 min. 27.1 psi
(186 kPa)
30 min. 15 psi
(104 kPa)
4 min. 27.1 psi
(186 kPa)
(Always consult the item manufacturer’s
2
• Open glass or metal canisters.
• Tubing not used in surgical procedures.
(Max. length - 40” and Min. inside diameter - .187”)
• Loose items manufacturers recommend for
exposure at 270°F (132°C) for 3 minutes.
Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
• Multiple layers of instruments separated by
fabric.
• Wrapped trays of loose instruments.
• Wrapped cassettes.
• Wrapped items manufactures recommend for
exposure at 270°F (132°C) for 4 minutes.
sterilization.
• Items, except liquids, manufacturers
recommend for exposure at 250°F (121°C) for
30 minutes.
Note: Verify acceptability of sterilization
parameters with handpiece manufacturer.
Items to be Sterilized
recommendations for sterilization.)
003-2915-99
English - 24
© Midmark Corporation 2018
Cycle Operation
Refer to the following steps for a detailed description of cycle operation:
Equipment Alert
The sterilizer will not operate unless the door is closed and latched properly.
Step 1: Close and latch the door.
A) Lift the door handle, then push the door closed.
B) While pushing in on the door, slide the door handle down to engage the latch.
Cycle Buttons
(Programmable)
Cycle Buttons
(Pre-set)
Note
Pressing the Start button when ‘SELECT CYCLE’ is
displayed, at beginning or end of a cycle, activates
the heater for 10 minutes. The display flashes
‘ADDITIONAL HEAT’. This allows the operator to
preheat the chamber before starting a cycle or to
add additional time to the Dry mode at the end of a
cycle. Pressing the Stop button will end the
‘ADDITIONAL HEAT’ time.
Equipment Alert
Using an incorrect sterilization program could result in non-sterile goods and may
damage instruments. Consult instrument manufacturer for specific sterilization instructions.
Step 2: Select the desired cycle.
A) Press the appropriate cycle button on the display panel.
(Refer to “Cycle Parameters” chart for time / temperature specifications).
003-2915-99
English - 25
© Midmark Corporation 2018
Cycle Operation - continued...
After the cycle button is pressed, the parameters for that cycle will appear on the display.
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-set cycle.
Pressing decreases time. Pressing increases time.
If the new Drying Time is desired on a regular basis pressing “P” after adjusting the dry time will
store the new time as the default dry time for the selected cycle.
003-2915-99
WARNING
STOP button may be pressed at any time to stop or interrupt
a cycle. Goods must not be considered sterile if this occurs
before the Dry Cycle. Sterilizer will return to SELECT CYCLE mode.
Step 3: Press ‘Start’ button to initiate cycle.
You will hear a “beep” for two seconds, indicating the cycle has started.
English - 26
© Midmark Corporation 2018
Start
Stop
Cycle Operation - continued...
After the ‘Start’ button is pressed, the stage / status of the current cycle will appear on the display.
The chart below illustrates the display messages that will appear during each stage of the cycle.
Stage of Cycle Description Display
Filling Chamber begins lling with water.
When water reaches the proper level...
Heating Display changes as temperature and
pressure in chamber changes.
(Metric units may be displayed if desired).
Sterilizing Sterilizing begins when correct
temperature / pressure is reached.
Time remaining in cycle counts down
while current temperature / pressure in
chamber is continuously updated.
Ready to Vent ‘READY TO VENT’ is displayed when
10 seconds remain in sterilization cycle.
Fast Vent When time runs out in sterilizing mode,
Door To Open
(automatic)
Pertains only to
M9/M11 Steam Sterilizers
003-2915-99
the vent valve opens. Steam / water are
released back into the reservoir.
The display changes as temperature and
pressure in chamber changes.
Caution
Keep clear when M9 / M11 door is ready to open!
Failure to do so could result in severe burns from steam being released.
An audible signal is emitted to indicate
that the door is about to open.
When pressure in chamber reaches zero,
the door actuates to partially open (drying
mode) position.
This chart continues on the following page...
English - 27
© Midmark Corporation 2018
Cycle Operation - continued...
Stage of Cycle Description Display
Manual Door Open
Pertains only to
M9D Steam Sterilizer
Drying Time of Dry Cycle is counted down. If
Cycle Complete An audible signal is emitted for 10
An Audible signal is emitted when
pressure inside chambers reaches zero
to indicate Operator to open door. The
door should be opened to the rst 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.
Caution
The processed loads may still be wet if the Dry Cycle is aborted
prior to completion. Always allow processed loads to dry in the
sterilizer before they are handled to avoid re-contamination.
desired, the Dry Cycle can be aborted by
pressing the STOP button.
When Drying time reaches 0:00...
seconds.
Caution
• The processed load and inner surfaces will be hot. Avoid contact with hot surfaces. Failure
to do so could result in serious burns.
• Do not apply downward pressure to the open sterilizer door while unloading the chamber.
Doing so could cause the sterilizer to tip resulting in serious burns or injury from the trays or
instruments sliding out of the chamber.
Step 4: Remove processed load from the chamber.
A) Refer to “Using the Optional Tray/Cassette Tool” later in this manual.
B) Sterilizer is now ready for another cycle.
Post-Sterilization Processing
After sterilization is complete, all items must be handled in accordance with accepted and documented
standards, such as the Centers for Disease Control and Prevention (CDC) documents, “Guidelines for
Infection Control in Dental Healthcare Settings” - 2003, MMWR; 52 (no. RR-17), and “Guidelines for
Disinfection and Sterilization in Healthcare Facilities” - 2008, as well as any local requirements that may
apply.
Qualied personnel responsible for infection control should prepare a protocol for handling sterilized items.
This protocol should be followed by all personnel responsible for handling sterilized items.
003-2915-99
English - 28
© Midmark Corporation 2018
Programmable Cycle Buttons
Cycle buttons can be used for custom applications that are not covered by standard cycle
programs. These cycles have not been FDA cleared for medical use. The programmable cycles allow the
user to adjust cycle parameters in order to sterilize items that cannot be sterilized in any of the standard
pre-programmed cycles. Once a custom program has been stored, it can be used just by pushing the
or button. Use the instructions in the chart below to set time / temperature parameters for these
buttons. (If you wish to change the settings, these buttons may be reprogrammed at any time).
Note:
The programmable cycles can
be programmed for the monthly
cleaning cycles with no dry time
to expedite monthly maintenance.
NOTE:
Pressing the STOP button during this procedure will abort the changes, and revert to the original settings.
Action Description Display
Press desired
button
This selects the button that will be
programmed.
Press This brings up the sterilization
Adjust Sterilization
Temperature
003-2915-99
temperature programing display.
Caution
Sterilization temperature can be adjusted from a minimum of 250°F (121°C) to
a maximum of 275°F (135°C). At high altitudes sterilization temperatures above
270° F (132° C) may cause the pressure relief valve to leak.
The “+” and “-” buttons adjust the
temperature by 1°increments.
When the desired temperature appears
on the display...
This continues on the following page...
English - 29
© Midmark Corporation 2018
Programmable Cycle Buttons - continued...
NOTE:
Pressing the STOP button during this procedure will abort the changes, and revert to the original settings.
Action Description Display
Press To store the temperature. This brings up
the sterilization time programing display
showing the current value.
Caution
Sterilization time can be adjusted from a minimum of 3 minutes to a maximum
of 45 minutes. Because it is important to properly coordinate the cycle time with
the sterilization temperature the minimum selectable time will be determined by
the temperature setting.
Adjust Sterilization
Time
Press To store the sterilization time. This brings
The “+” and “-” buttons adjust the
time by 1 minute increments.
When the desired time appears on the
display...
up the vent speed programing display and
the current value.
Adjust Vent Speed In FAST vent, the valve fully opens and
vents the chamber.
In SLOW vent, the valve opens for a
fraction of a second (once per minute)
to slowly vent the chamber.
Pressing “+” sets it to: FAST
Pressing “-” sets it to: SLOW
When the desired setting appears on the
display...
Press To store the setting and bring up the dry
time programing display and the current
value.
This chart continues on the following page...
003-2915-99
English - 30
© Midmark Corporation 2018
Loading...