Go To Table Of Contents Installation & Operation Manual Important Information Page 2 Installation Page 4 Description M11 UltraClave™ Steam Sterilizer Page 6 AV SE No AI RV Lo LA IC n BL E P ger E A in FO RT P R S N rod TH O uc IS LO tion PR N : O GE D R U C T! Components Overview Page 8 Controls & Indicators Page 9 Operation Page 11 R RO ER R OR DO AJA Y DB AN /ST ON W R LO TE WA OP ST TE LE MP CO T AR ST G YIN DR ING S CK ILIZ ER PA ST S UID LIQ G LIN FIL ON S DS) HE UC PO :
Go To Table Of Contents Owner’s Product Identification (information that you will need to provide for servicing - key information is highlighted) Date of Purchase Serial Number Name of Owner / Facility / Department Model Number Name of Authorized Dealer Telephone # of Authorized Dealer Address of Authorized Dealer MODEL AND SERIAL NUMBER LOCATION MODEL NUMBER SERIAL NUMBER MA439101
CONTENTS IMPORTANT INFORMATION ........................................................................................................ 2 Scope and Purpose of This Manual ...................................................................................... 2 Intended Use of Product........................................................................................................ 2 Safety Instructions.......................................................................................................
Return To Table Of Contents Important Information IMPORTANT INFORMATION Scope and Purpose of This Manual This manual provides complete instructions for the installation, operation, and normal care of the M11 UltraClave™ Steam Sterilizer. It is intended that this manual be used by all personnel operating the sterilizer or performing operator level maintenance. No repair information is included in this manual as no repairs are authorized at the operator level.
Return To Table Of Contents Explanation of Safety Symbols and Notes DANGER Important Information Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. The DANGER symbol is limited to the most extreme situations. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
Return To Table Of Contents INSTALLATION 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 personal injury. Adherence to the following recommendations for location of the sterilizer will contribute to optimum performance of the unit: F E B D C A MA439500 Support Surface (A) - Sterilizer must be placed on a level surface to ensure that the chamber will fill correctly.
Return To Table Of Contents Support Surface Depth (C) - Support surface should be approximately 533 mm (21 in) deep. Allow at least 51 mm (2 in) clearance behind the sterilizer for air circulation. Distance To Side Wall (D) - If the sterilizer is located next to side walls, there should be no less than 51 mm (2 in) clearance between the side of the sterilizer and the wall.
Return To Table Of Contents Electrical Requirements WARNING Installation Use 220 - 240 VAC, 50/60 HZ alternating current only for 230 VAC models and 90 - 110 VAC, 50/60 HZ alternating current only for 100 VAC models. Failure to do so could result in electrical shock to personnel and will result in damage to sterilizer. Description Do not use this sterilizer in an explosive or oxygen-enriched atmosphere. Failure to do so could result in serious personal injury or death.
Return To Table Of Contents program cycle is complete by sounding five audible “beeps”. The sterilizer may be switched to standby at this time or restarted if additional sterilization programs are desired. Mechanical Features The M11UltraClave™ sterilizers . . . • have a tray rack which can hold two small and two large trays. The tray rack can be removed for periodic cleaning of the chamber, tray plate, tray rack, and filter.
Return To Table Of Contents COMPONENTS OVERVIEW The illustration below shows the location of the sterilizer’s major components and the chart below provides their descriptive name. 1 8 3 6 2 Components Overview 5 4 7 MA439900 DESCRIPTION OF COMPONENTS 8 1. Access Cover 5. Door and Dam Gaskets 2. Reservoir Lid 6. Display / Control Pad 3. Printer (Optional) 7. Wire Tray Rack and Tray Plate 4. Level Indicator / Reservoir Drain Tube 8.
Return To Table Of Contents CONTROLS & INDICATORS The following illustrations show the location of the sterilizer’s controls and indicators and the chart on the following pages describes their function.
Return To Table Of Contents Controls & Indicators Ref. Control Function 1 Temperature / Time display alternately indicates cycle temperature and exposure time when a cycle is selected. During a cycle, the cycle time remaining is displayed. 2 Pressure display indicates current chamber pressure during a cycle. 3 FILLING indicator illuminates when the chamber is being filled with water at the beginning of a cycle.
Return To Table Of Contents Ref. Control Function 14 START button when pressed, initiates the program cycle that has been selected. 15 STOP button when pressed, terminates the program cycle currently in progress. 16 ON / STANDBY button when pressed, turns the sterilizer ON or into STANDBY mode. If the ON / STANDBY button is pressed during a cycle, the program cycle is aborted. In Standby mode, all program buttons and indicator lights are locked out to prevent accidental program initiation.
Return To Table Of Contents Recommended Steam Sterilization Monitoring Program Physical monitors (temperature and pressure measuring devices) can be used to help detect failures in sterilizer function. The sterilizer notifies the user if sterilization conditions fall outside of established limits. It is recommended that the Printer Accessory be used to create a record of each load’s actual cycle time, temperature, and pressure.
Return To Table Of Contents 2. Open the door and pour distilled or demineralized water into the fill opening (2) until the water level found in the Level Indicator Tube (3) is at the top of the red / green fill level label (4). 3. If the unit has a printer (optional equipment), turn the printer to ON. Cleaning Instruments 1 3 2 DANGER Clean and dry instruments before putting them into the sterilizer.
Return To Table Of Contents Guidelines For Loading Trays Sterilizer loading is critical to effective sterilization. Protective coverings designed to be used in steam sterilization processes should be used to help ensure that items retain sterility until used. A proper load for a sterilizer is determined by the number of items to be sterilized, their characteristics, and how they are prepared and positioned within the sterilizer.
Return To Table Of Contents Loads Including Dental Handpieces and/or Instruments NOTE Dental handpieces should only be sterilized when placed in a pouch and in the POUCHES cycle. Only one handpiece should be placed in each pouch. The maximum M11 load shall be nine handpieces (in the pouch rack) and 75 instruments. Other combinations of fewer handpieces and items can be processed in a single load if that allows for efficient sterilization.
Return To Table Of Contents Operation WARNING Do not use this sterilizer in an explosive or oxygen-rich atmosphere, or where flammable anesthetics are stored. To do so could result in an explosion or fire. 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. Clean and dry instruments before putting them into the sterilizer.
Return To Table Of Contents hide 5 3 6 8 9 TEMP (°F) \ TIME (MIN : SECONDS) PRESSURE (PSI) FILLING STERILIZING DRYING COMPLETE WATER LOW DOOR AJAR ERROR UNWRAPPED POUCHES LIQUIDS PACKS START STOP ON/STANDBY 7 2 1 4 MA439200 1. Press the ON / STANDBY button (1). • The Selector / Indicator panel turns on (displays will illuminate). • The Program Indicator lamps (2) flash until a sterilization program is selected.
Return To Table Of Contents • The sterilizer automatically begins processing its sterilization load. • The FILLING lamp (5) illuminates and the chamber automatically fills to the correct level. • The STERILIZING lamp (6) illuminates, indicating that the sterilizer is in the heating and sterilization phase of the selected cycle. • When the correct temperature (3) and pressure (7) are reached, the sterilizer begins its time countdown.
Return To Table Of Contents Standard Cycle Parameters The following table lists the standard cycle parameters for the four different types of sterilizer loads (follow state and federal guidelines regarding sterilization of single use devices and instruments). Standard Cycle Parameters CYCLE TEMP / PRESSURE/TIME (minimums) ITEMS TO BE STERILIZED Unwrapped 132°C (270°F) / 186 kPa (27 psi) for 3 minutes Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures.
Return To Table Of Contents • • • • M11 Sterilizer Deep Tray Sterilizer Pouch Rack M11 Horizontal Cassette Rack M11 Vertical Cassette Rack 9A225001 9A226001 9A215001 9A215002 OPERATOR MAINTENANCE It is the responsibility of the user to establish a periodic maintenance procedure to assure correct operation of the equipment and reliable sterilization of the loads. Contact your local distributor or representative to develop a program for planned maintenance. Daily 1.
Return To Table Of Contents (a) Drain reservoir and fill with clean, distilled water then add one ounce of Speed Clean Sterilizer Cleaner to a cool chamber. (b) Run one 30 minute cycle (PACKS) at 121°C (250°F). Instruments must not be sterilized while cleaning the sterilizer. (c) Drain reservoir fill with clean distilled or demineralized water and run one 3 minute cycle (UNWRAPPED) at 132°C (270°F). (d) Drain reservoir and allow sterilizer to cool to room temperature.
Return To Table Of Contents (a) Remove the top inspection cover (1). (b) Select the UNWRAPPED cycle and START the cycle. 1 A WARNING The pressure relief valve will be hot. Do not use bare hands to pull wire ring; use a screwdriver or rod. Failure to do so will result in burns to hands. Also, steam will be vented from under the rear of the sterilizer. To keep from being burned, place a steam barrier (a rolled up towel around the bottom of the sterilizer.
Return To Table Of Contents 3. Cleaning Chamber Filter: (a) Before performing this procedure, make sure that the sterilizer has cooled to room temperature. (b) Open the sterilizer door and remove all trays, tray rack, and tray plate from the chamber. Locate the chamber filter (1) on the bottom of the chamber. 1 NOTE If the filter cannot be cleaned effectively, the filter must be replaced.
Return To Table Of Contents (a) Open sterilizer door. Then, remove dam gasket (1) and door gasket (2) from door (3). A 3 (b) Clean the gaskets (1 and 2) with a mild detergent and inspect the gaskets for cracks, cuts, shrinkage, or swelling. Replace gaskets if necessary. 1 (c) Clean the gasket housing channel (A) with a solution of mild soap and distilled or demineralized water. A small brush (not wire brush) may be used to aid the cleaning.
Return To Table Of Contents Troubleshooting Guide - (Continued) Problem Sterilization failure evidence from process monitor (chemical indicator, biological indicator, etc.) Door gasket leaks. Packs not dry Possible Cause Solution sterilization conditions were not present at the location of the indicator. reload the sterilizer in accordance with Guidelines for Loading Trays.
Return To Table Of Contents Troubleshooting Guide - (Continued) Problem Possible Cause Solution sterilizer is not level level the sterilizer. input voltage is too low. have a qualified electrician connect sterilizer to a separate (dedicated) circuit with proper voltage level. Error Code Guide Use the following table to determine the meaning of an error code and assist in correcting minor problems with the sterilizer.
Return To Table Of Contents Error Code Guide - (Continued) Problem Possible Cause Solution sterilizer overloaded with gauze or linen packs. reload the sterilizer in accordance with Guidelines for Loading Trays. If the problem recurs, take the unit out of service and contact an authorized service representative (see Calling For Service later in this manual). Unit is out of calibration or bellows is not functioning properly. allow sterilizer to cool completely. Restart sterilizer.
Return To Table Of Contents Error Code Guide - (Continued) Problem Operator Maintenance Calling For Service Possible Cause Solution door switch out of adjustment or is malfunctioning. contact an authorized service representative (see Calling For Service later in this manual). DO NOT OPERATE STERILIZER AGAIN UNTIL SERVICED. Error Code 9 (door malfunction) door did not pop open at end of cycle. Unit may be out of calibration. Rerun cycle to ensure dryness of load.
Return To Table Of Contents SPECIFICATIONS Physical Dimensions: Overall Length ................................. 559 mm (22 in) Overall Width................................... 457 mm (18 in) Overall Height.................................. 445 mm (17.5 in) Counter Area................................... 457 mm x 406 mm (18 x 16 in) Chamber ......................................... 279 mm Diameter x 457 mm depth (11 in Diameter x 18 in depth) Large Trays (2) ................................
Return To Table Of Contents 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.
Return To Table Of Contents 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 the possibility of electrical shock. Failure to comply with these instructions could result in serious personal injury or death. 1. Unplug the power cord from wall outlet. 2. Remove top inspection cover (1) from top cover (2). 1 3 5 4 2 6 2 MA438400 3.
Return To Table Of Contents 6. Plug PCB printer harness (1) into PC board (2). 2 3 5 4 1 D EE /F F OF ON 7. Route PCB printer harness (1) through harness clip (3) to prevent harness from contacting hot pressure relief valve. 8. Place the printer (4) on the top cover in the recessed area. 9. Connect PCB printer harness (1) into printer harness (5).
Return To Table Of Contents 10. Insert two tabs (A) of right hand side panel (1) into two slots (B) of base (2). 3 4 1 B C 5 2 6 A 4 MA438600 11. Raise top edge of right hand side panel (1) into position under top cover (4) and secure using two screws (3). 12. Install top inspection cover (5) on top cover (4), making sure PCB printer harness (6) is routed into harness cutout (C) of top inspection cover. 13. Plug power cord into wall outlet.
Return To Table Of Contents Operating the Printer The paper feed switch on the printer is a rocker type switch. Push the left side (A) of the rocker switch to toggle the printer ON and OFF. Push the right side (B) of the rocker switch to ON / FEED position to advance the paper. D EE F ON /F OF B A When the printer is first turned on, it prints the word READY to assure the operator that its built in microprocessor is working properly.
Return To Table Of Contents 6. While holding the paper (1) in place, press the right side (B) of the switch to the ON / FEED position and hold. The printer will activate and a rubber roller will put the paper into the printer compartment. Continue to hold the switch down until the paper emerges from the top of the printer mechanism. Then, when 2.5 cm (1 in.) of paper has emerged from the top of the printer, release the switch. 7. Pull the paper (1) through the printer until 5 to 7.5 cm (2 to 3 in.
Return To Table Of Contents Installing a New Cartridge Ribbon 1. Press the left side (A) of the rocker switch to toggle the printer OFF (the lamp will turn off). 1 2. Four small grooves (1) are embossed on the left and right side of the printer cover. With the index finger of each hand, press down gently on these grooves. ED D FE F/E O/N FON FFF OO 3. When the printer cover (1) is tilted up to a near-vertical position, you may lift it completely off.
Return To Table Of Contents Removing the Paper Roll EQUIPMENT ALERT Be sure to pull the paper out of the top of the printer (paper cutter side). Pulling the paper out of the back of the printer will damage the printer mechanism. Before removing the paper roll, advance the paper about 2.5 cm (1 in.) beyond the paper cutter by pressing down and holding the switch to the ON / FEED position. Lift the paper roll away from the printer housing, and with a scissors, cut the paper roll feeding to the printer.
Return To Table Of Contents The figure below shows an example of a typical printout of a program cycle: Typical Printout of a Program Cycle READY BEGIN SET TEMP: SET TIME: RUN # 270F 015 001 TEMPERATURE TIME CYCLE NUMBER MIN 000 002 004 006 008 010 012 HEAT UP PHASE DATE HEAT UP DEG 066 066 074 164 219 234 261 PSI 00.0 00.0 00.0 00.0 04.1 09.4 22.6 STERILIZE DEG 272 272 273 274 273 273 273 272 272 272 272 272 273 273 274 273 PSI 30.2 30.7 31.3 31.0 30.7 30.4 30.1 30.0 30.1 30.4 30.4 30.7 31.0 30.
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Return To Table Of Contents NOTES: 40
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Return To Table Of Contents Midmark Corporation 60 Vista Drive P.O. Box 286 Versailles, Ohio 45380-0286 937-526-3662 Fax 937-526-5542 midmark.com 003-1030-00 Rev.
