M9 / M9D M11 / M11D Self-Contained Steam Sterilizer Important Information Page 2 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 (information that you will need to provide for servicing - key information is highlighted) Model Number Serial Number Name of Owner / Facility / Department Date of Purchase Name of Authorized Midmark Dealer Telephone # of Authorized Midmark Dealer Address of Authorized Midmark Dealer MODEL 1 NUMBER 2 SERIAL NUMBER SERIAL NUMBER 1 MA616300i
CONTENTS IMPORTANT INFORMATION ........................................................................................................ 2 Intended Use of Product........................................................................................................ 2 Safety Instructions................................................................................................................. 2 Explanation of Safety Symbols and Notes .....................................................................
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 and Standard Cycle Parameters later in this manual for detailed information.
Transportation and Storage Conditions EQUIPMENT ALERT Important Information 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 ........................
INSTALLATION Location Requirements For Sterilizer DANGER Installation Do not operate this sterilizer in areas where flammable anesthetics are used or stored. An explosion could occur, causing fatal or serious injury. Adherence to the following recommendations for location of the sterilizer will contribute to optimum performance of the unit: F E* E D 1" (2.
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 behind the sterilizer for air circulation. Distance To Side Wall (D) - If sterilizer is located next to side walls, there should be no less than 2 in. (5.1 cm) clearance between the side of the sterilizer and the wall.
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.
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.
COMPONENTS OVERVIEW Illustration below shows location of sterilizer’s major components.. 2 7 Present Original 5 1 Components Overview 3 4 6 SA172901i DESCRIPTION OF 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.
CONTROLS & INDICATORS The following illustrations show the location of sterilizer’s controls and indicators. The chart describes their function. 9 10 11 6 3 2 8 1 4 5 7 15 12 14 16 Controls & Indicators 13 MA594800i Ref. Control Function 1 Display indicates cycle selected, cycle temperature and exposure time for the selected cycle. During the cycle, display shows messages describing status of cycle.
Ref. Controls & Indicators Control 3 POUCHES button a program cycle designed to process instruments 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 button a program cycle designed to process packs of instruments at 250°F (121°C) for 30 minutes with a 30 minute drying cycle.
OPERATION 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.
3 2 EQUIPMENT 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. 4 2. Open door and pour distilled SA110000i 1 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).
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.
• 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.
Maximum Capacities Load Type Packs (†) † M11/M11D Large / Deep Tray M11/M11D Small Tray M11/M11D Sterilizer Total 4425 cu. cm up to 5.0 cm thick (270 cu. in. up to 2 in. thick) 3195 cu. cm up to 5.0 cm thick (195 cu. in. up to 2 in. thick) 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.
Standard Cycle Parameters The following table lists the standard cycle parameters for the various cycles. Standard Cycle Parameters PROGRAM Operation TEMP / PRESSURE/ TIME (minimums) 270°F (132°C) / 27.1 psi (186 kPa) Sterilize for 3 minutes 30 minute Dry* • 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).
Standard Cycle Operation MA596700i Refer to following steps for a detailed description of operating procedures: 1. Display shows: SELECT CYCLE 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 specific sterilization instructions.
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 Dry Cycle. Sterilizer will return to SELECT CYCLE mode. Press START. Sterilizer sounds a “beep” for two seconds to indicate cycle has started. • Filling Chamber: FILLING CHAMBER Display shows: Chamber automatically begins to fill to the correct level with water. When chamber is full, display shows CHAMBER IS FULL • Heat Up portion of the cycle begins.
• Automatic Door Open (Pertains only to M9/M11 UltraClave™) • Door To Open Display shows: DOOR TO OPEN XXX°F XX.X PSI 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.
Programming Mode MA596700i The following steps are for programming buttons 1 and/or 2 for applications that are not covered by standard cycle programs: Displays: Displays: PROGRAM 1 XXX°F, XX MINUTES Displays: STERILIZATION TEMP: XXX.X°F Press Operation SELECT CYCLE Press FAST VENT XXX MINUTE DRY then then <+> OR <-> TO ADJUST raises temperature 1°. Press Press then
FOR NEXT TO CANCEL lowers temperature 1°.
then displays: VENT TYPE: FAST Displays: Press
FOR NEXT TO CANCEL then Press <+> OR <-> TO ADJUST changes VENT to FAST. Press changes VENT to SLOW. When in FAST vent, valve fully opens and vents chamber. When in SLOW vent, valve opens periodically for a fraction of a second once per minute to slowly vent chamber. FOR NEXT TO CANCEL then displays: DRY TIME XX MINUTES Displays: Press then Press <+> OR <-> TO ADJUST raises time by 1 minute. Press lowers time by 1 minute.
Unloading Hot Trays and Cassettes (Using Tray/Cassette 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.
Cassette Removal 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. 2 3 2 1 Operation MA578701i 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.
List of Authorized Accessories Listed below are the accessories which are authorized for use with these sterilizers. Unless noted, accessory can be used on the M9 and M11. Accessory Name • • • • • • • • • • • • Order Number Speedclean, 1 (16 oz. [.47 liter] ) bottle Speedclean, 1 case (12-16 oz. [.47 liter] bottles) Printer Refill Kit Rack / Cassette (Horizontal) Rack / Cassette (Vertical) Tray / Deep (2 1/2" [6.4 cm ]) Tray / Deep (2 1/2" [6.
2. Installation EQUIPMENT ALERT A Install tray rack and plate assembly so that angled end of plate is toward back of chamber. Do not allow plate to contact water lever sensor. • Place back edge of tray in chamber. Pressing downward (A) on top of tray rack, slowly insert assembly into chamber (B). B MA601600i 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.
Weekly 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.
Perform Pressure Relief Valve Check 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: HEATING - UNWRAPPED XXX°F 20.
Non-Scheduled Maintenance 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. 1 (a) Unplug the power cord from outlet receptacle. Open door and remove trays.
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.
TroubleShooting Guide - Continued Problem 30 Solution Door gasket leaks door gasket is damaged or dirty. clean or replace door gasket (see Clean Door Gasket under Weekly maintenance). Items are not dry at end of drying portion of cycle. sterilizer is improperly loaded. 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) filter screen(s) clogged.
Message Guide CAUTION The Message Guide list some of the messages that may occur during operation, 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 - Continued Message 32 Solution C060: POWER UP MODE SYSTEM HARDWARE Power was interupted 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 later in this manual). C102: FILL MODE STOP PRESSED STOP button was pressed during cycle. Press STOP button to restart.
Message Guide - Continued Message Possible Cause Solution C533 through C633 STEAM TEMP LOW or STEAM TEMP HARDWARE or PRESSURE LOW Sterilizer detects that temperature and / or pressure is outside the limits for normal operation. 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). C642 through C647 PRESSURE HIGH Pressure inside chamber is outside the limits for normal operation.
SPECIFICATIONS 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.
M11/M11D Sterilizer 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.
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 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).
6. Route loose end of PCB printer harness (1, Figure 2) through slot (A) in printer cavity (4) of top cover. Figure 2 7. Plug PCB printer harness (1) into printer terminal (2) of PC Board. 3 4 A R 2 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).
Inserting the Paper Roll 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). Figure 4 7 B C D 4 6 5 3 1 2 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. MA465001i A 5.
9. Turn the paper roll so as to take up the slack in the paper feeding to the 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.
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.
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”.
The figure below shows an example of a typical printout of a program cycle: Midmark M9 - v1.0.3 Total Cycles: 10 ------------------Sterilizer ID Line provided for sterilizer identification. Total # of cycles run on unit. Line provided for Operator Signature. ------------------Operator Space provided for recording date & time. Sterilization temperature & time, and Dry time set points.
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.
Notes: 44
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 Midmark Corporation 60 Vista Drive P.O. Box 286 Versailles, Ohio 45380-0286 937-526-3662 Fax 937-526-5542 midmark.com 003-1249-00 Rev.
