M9 / M9D / M11 Self -Contained Steam Sterilizer For Models: M9 (-020 /-021 -022) M9D (-022) M11 (-020 / -021 / -022) Installation Operation Guide TP202 Rev. A 003-2707-00 Rev.
Product Information Dealer : Date of Purchase: Model / Serial Number: Authorized Service Company: MA616300i Model / Serial Number Label Serial Number TP202 Rev.
Table of Contents Important Information Printer (optional) Safety Instructions............................................4 Intended Use....................................................4 Electromagnetic Interference............................4 Safety Symbols.................................................4 Shipping Symbols.............................................5 Transportation / Storage Conditions.................5 Authorized Accessories....................................
Important Information 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 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).
Shipping Symbols Consult user guide Keep dry Proper shipping orientation Max. stacking height (Refer to “n” number on package) 140 F Fragile 60 C Min. / Max. storage temperature -22 F -30 C Transportation / Storage Conditions Equipment Alert Water must be drained from the unit’s reservoir before transporting / storing below +32° (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.
Included with Sterilizer Speedclean Care / Operation Card Speedclean MSDS Sheet 2 Large Trays 2 Small Trays Power Cord TP202 Rev.
Component Location Pressure Relief Valve Test Lever Display / Touch Pad Printer (optional) Fill Opening Door Gasket Tray Rack Tray(s) Dam Gasket Water Level Indicator / Reservoir Drain Tube Tray Plate SA1775i TP202 Rev.
Controls & 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 Display Function 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.
Controls & Indicators - continued Printer (optional) Fill Opening Pressure Relief Valve Test Lever Water Level Indicator & Reservoir Drain Tube 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).
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).
Installation Operating Environment Equipment Alert Allow unit to reach room temperature before operating. Failure to do so may result in damage to sterilizer. 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.
Installation Location Requirements continued... Support Surface • Material should be water-resistant material. (Ex. laminate, stainless steel, stone, etc.) • Surface must be level to ensure chamber fills with correct water level. Improper water level in the chamber could cause a sterilizer malfunction.
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.
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 until to cool and depressurize for 40 minutes before opening door. Failure to adhere could result in serious personal injury.
Qualification Testing After sterilizer installation, relocation, major repairs, and sterilization process failures qualification testing using BI challenge test packs or trays 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 qualified. The BI challenge test pack or tray should contain items routinely processed and considered to be the most difficult to sterilize along with at least one BI and one CI.
Guidelines for Loading - continued General Guidelines Caution 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. • Place all containers so that the opening allows steam to enter, and air / condensate to drain from the container.
Guidelines for Loading - continued Packing the Trays Equipment Alert sterilizer. 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 Trays must be used at all times when operating this sterilizer - unless the optional cassette rack kit is used - otherwise, serious equipment damage could result.
Guidelines for Loading - continued Load Size Refer to the charts below for maximum 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: 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.
Cycle Parameters Program Temp / Pressure / Time (minimums) Items to be Sterilized (Always consult the item manufacturer’s recommendations for sterilization.) 270°F (132°C) 27.1 psi (186 kPa) Sterilize: 3 min. Dry: 30 min.* • 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). Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
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 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. MA596700i Start Stop MA596700i WARNING STOP button may be pressed at any time to stop or interrupt a cycle.
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. MA596700i Stage of Cycle Filling Description Display Chamber begins filling 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).
Cycle Operation - continued Stage of Cycle Description Manual Door Open An Audible signal is emitted when pressure inside chambers reaches zero to indicate 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.
Unloading Hot Trays / Cassettes (Using the Optional Tray / Cassette Tool) Caution Only use the 9A307001 Tray / Cassette tool with Midmark manufactured trays. Trays / cassettes may be HOT - use care when removing or transporting. 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. Step 1: Assemble the tray / cassette tool. A) Slide the proper plate* into the handle as shown.
Unloading Hot Trays / Cassettes - continued (Using the Optional Tray / Cassette Tool) To remove M9 / M11 trays... A) Hook the top, saw-toothed tab of tool to top center tray lip. B) Rotate tool downward until the tool plate is completely under tray. C) Check to ensure tray is being held securely and then remove tray from chamber. 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 casette tool.
Programmable Cycle Buttons Cycle buttons can be used for custom applications that are not covered by standard cycle programs. 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).
Programmable Cycle Buttons - continued NOTE: Pressing the STOP button during this procedure will abort the changes, and revert to the original settings. Action Press Description Display 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 90 minutes. It is important to properly coordinate the cycle time with the sterilization temperature.
Programmable Cycle Buttons - continued NOTE: Pressing the STOP button during this procedure will abort the changes, and revert to the original settings. Action Adjust Dry Time Description Display Dry time can be adjusted from 0 to 60 minutes. The “+” and “-” buttons adjust the time by 1 minute increments. When the desired time appears on the display... Press To store the setting and complete the programming process. The display will show the new cycle parameters.
Daily Maintenance 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. • Clean External Surfaces A) B) C) D) Wash the exterior of the sterilizer each day according to your facility’s procedure for clinical contact surfaces, noting the following: (Use only quaternary disinfectants to disinfect unit.
Weekly Maintenance Equipment Alert Failure to change water may result in sterilizer malfunction. Do not use bleaching agents or any abrasive materials / substances in chamber (i.e. bleach, steel wool, wire brush, scouring powder, etc.). Failure to comply may result in damage to the chamber and/or other components. Note Every seven days, the autoclave will automatically display the PERFORM WEEKLY MAINTENANCE message. If power is disconnected, the cycle of weekly messages will be reset.
Weekly Maintenance - continued WARNING Allow unit to cool before removing or installing tray rack and plate. Handle metal tray rack carefully to avoid injury. Do not run sterilizer without tray plate in place. To remove tray rack / plate... A) Remove trays. B) Using a screwdriver, pry plate up while pulling tray rack / plate out of chamber. Tray Rack Tray Plate (Angled end must face back of chamber) Equipment Alert Install tray rack / plate with angled end of plate toward the back of the chamber.
Monthly Maintenance warning Do not process instruments while flushing system. Note Every 28 days, the sterilizer will automatically display the PERFORM MONTHLY MAINTENANCE message. This is a more thorough cleaning of the unit and involves multiple steps. If power is disconnected, the cycle of monthly messages will be reset. • Clean Chamber / Plumbing A) B) With a cooled chamber, drain the sterilizer’s reservoir and refill with clean, distilled water.
Monthly Maintenance - continued J) Grasp filter and gently pull away from chamber wall while twisting slightly. (If necessary, pliers may be used to remove filters) K) Clean filters with SpeedClean and distilled water. A small stiff bristled brush or ultrasonic cleaner may be helpful. Rinse filters with distilled water. (Note: Replace filter(s) if debris cannot be remvoved by cleaning). Equipment Alert Use care when wiping the inside of the chamber.
Monthly Maintenance - continued • Check Pressure Relief Valve (must be checked each month to assure it functions properly) A) Press Unwrapped button B) Press Start button 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).
Printer (Optional) Operating the Printer When the sterilizer is plugged in, the printer is automatically powered up and initialized. No user intervention or setup is required. 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.
Example of Typical Printout of a Program Cycle Total # of cycles run on unit Midmark M9 - v1.0.
Cartridge Ribbon Replacement Note 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. If this procedure does not correct the problem, replace the cartridge ribbon. To replace the cartridge ribbon... A) B) C) D) Remove printer assembly from top cover. Remove the printer cover. (Bend the housing out slightly to release tabs).
Paper Roll Installation Equipment Alert Using paper rolls larger than 1.97” (50 mm) in diameter, may cause the paper feed mechanism to slip and / or damage the printer. To install the paper roll... A) B) C) D) E) F) Turn printer onto its back. Insert spindle into new paper roll. Unroll 2” to 3” (5 to 7.5 cm) of paper. If necessary, cut a straight edge on the paper to feed into the printer slot. Feed approx. 1/4” (6.4 mm) of paper into the printer slot.
External Condensing Tank (Optional) Using the External Condensing Tank Equipment Alert Do not operate the sterilizer with the external condensing tank completely empty. The water level must remain between the Min. / Max. lines shown on the tank label. Failure to comply may result in damage to the tank. During the Vent mode, steam / heated water will be released into the external condensing tank. When the water level in the tank reaches the Max. line on the tank label, it must be emptied.
Troubleshooting Troubleshooting Chart Use the following chart to assist in correcting minor problems with the sterilizer. Problem Sterilizer does not operate (no display). Possible Cause Solution Sterilizer power cord came loose from supply outlet or back of sterilizer. Assure Sterilizer power cord is plugged into outlet and sterilizer. No power at Sterilizer supply outlet. Check circuit breaker for supply outlet. If problem recurs, unplug unit power cord and contact an authorized service technician.
Informational Messages The chart below lists the informational messages that may appear during operation. Message Possible Cause Solution INTIALIZING SYSTEM Unit power cord was just plugged in - standard informational message. Normal operation will occur after a 4 second pause. TOTAL CYCLES XXX M9*, VX.X.X (*will display model number, M9, M11) Unit power cord was just plugged in - standard informational message. Normal operation will occur after this message.
Error Messages - continued Message CO60: POWER UP MODE SYSTEM HARDWARE Possible Cause Solution Power was interrupted briefly or an internal glitch. Unplug unit power cord for 1 minute and then plug back in. If problem persists, contact an authorized service representative (see “Calling For Service”). C102: FILL MODE STOP PRESSED STOP button was pressed during cycle. Press STOP button to restart. C103: THROUGH C105 HEATUP, STERILIZE OR VENT MODE STOP PRESSED STOP button was pressed during cycle.
Error Messages - continued Message Possible Cause Solution C642 THROUGH C647 PRESSURE HIGH Chamber pressure is outside the limits for normal operation. Wait briefly (up to one minute) while chamber pressure / temperature dissipates. Press STOP button to return to select cycle mode. Initiate a new cycle. C660 THROUGH C677 PRESSURE HARDWARE or PRESSURE OVERLIMIT Chamber pressure is outside the limits for normal operation. Unplug unit power cord for 1 minute and then plug back in .
Specifications Specifications Chart: M9 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 in. dia. x 15 deep (22.9 cm x 38 cm) Standard Tray, Large 7 5/16 in. x 12 in. x 7/8 in. (18.6 cm x 30.5 cm x 2.2 cm) Standard Tray, Small 5 5/8 in. x 12 in. x 7/8 in. (14.3 cm x 30.5 cm x 2.2 cm) Weights: Weight with Empty Reservoir 73 lbs. (33.
Specifications Chart: M11 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. x 21 in. (45.2 cm x 53.3 cm) Chamber 11 in. dia. x 18 in. deep (28 cm x 46 cm) Standard Tray, Large 9 in. x 15 in. x 1 1/8 in. (22.9 cm x 38 cm x 2.9 cm) Standard Tray, Small 6 5/8 in. x 15 in. x 1 1/8 in. (16.8 cm x 38 cm x 2.9 cm) Weights Weight with Empty Reservoir 99 lbs. (44.
Warranty Information 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.
Notes: TP202 Rev.
Midmark Corporation 60 Vista Drive Versailles, OH 45380 USA 1-800-643-6275 1-937-526-3662 www.midmark.com TP202 Rev.
